what statement about risks in social and behavioral sciences research is most accurate:

what statement about risks in social and behavioral sciences research is most accurate:


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Asked by 10 months ago
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Three principles of Belmont ReportRespect for Persons Beneficence Justice
The Belmont Report Principle of BeneficenceMAXIMIZATION of benefits and MINIMIZATION of risks
T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interestTRUE
The Belmont Report Respect for PersonRequires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent)
The Belmont Report defines and delineates..."Practice" and "Research"
The Belmont Report The Principle of JusticeResearch benefit and burden distribution and that selection of subjects is fair.
T/F The Belmont report describes the necessity to effectively manage conflicts of interestFALSE
Students in Research The history of ethical regulations in human subjects research began with theNuremberg Code
Nuremberg CodeHuman subjects research guidelines and regulations
Year of the Nuremberg Code1949
Additional resources regarding IRB approval processFaculty advisor/Research Mentor IRB office Human subjects research websites
What element must be included in an informed consent?All foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB?If the study qualifies for EXEMPTION
Another name for the "Exempt" statusthe Common Rule stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects?Avoid using their own students in their research
Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information.Exempt Review category 2
Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects.Full Board Review
Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimalExpedited review
Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a businessNot Human Subjects
Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components)"1.data through intervention or interaction with the individual 2. identifiable private information"
Name the 3 responsibilities the IRB is charged with1. Protecting the rights and welfare of human subjects 2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed 3. Reviewing subject recruitment materials and strategies
T/F IRB's investigate scientific misconductFalse
T/F IRB's do not review manuscripts prior to submission for publicationTrue
DHHS FDADepts. IRB's review for current policies -Department of Health and Human Services -Food and Drug Administration
Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately the Belmont Report and Federal regulations for human subject protectionThe Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle?The principle of beneficence: Potential benefits justify the risks of harm
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:Respect for persons Belmont Report
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:Justice
How is the principle of beneficence applied to a study involving human subjects?Ensuring that risks are reasonable in relationship to anticipated benefits.
Human subject study or not? Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggressionYes
Human subject study or not? The study of a list with deceased passengersNo:Human subject is a living individual
Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases?No: 'what' question rather than 'who' question
Human subject study or not? Conducting linguistic analysis of comments posted on a public blogNot: involves neither interaction with individuals nor collecting private identified info
Human subject study or not? A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledgeYes: humans
Human subject study? A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviorsYes: Interacting w/ living individuals.
Human subject study or not? Questioning a superintendent of schools to acquire data about the ethnic composition of a schoolNo: it is an "about what" question rather than "about whom" question
Human subject study or not? Study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over 3-month periodYes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation
Human subject study or not? Info collected by play ground designerNo: does not involve info about human subjects even though there is interactions between designer and school staff.
Human subject study or not? An analysis of aggregate dataNo: doesn't involve interactions w/ living individuals nor collection of private identifiable data
Human subject study or not? An economic feasibility studyNo: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer "about what" ? rather than "about whom" ?
According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or:identifiable PRIVATE information (Public info does not meet criteria)
Subpart of DHHS regulations provides additional protections for which vulnerable populations?1. Pregnant women 2. Fetuses 3. Neonates 4. Prisoners
Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations?1. elderly 2. students 3. for persons whose decision-making capabilities are impaired
The expedited review process may be used when the study procedures pose:No more than minimal risk and the research activities fall within regulatory categories identified as eligible
The expedited review process may NOT be used when the study procedures pose:-more than minimal risk, even if the subjects are adults, -the sponsor is in a hurry -the study replicates previously approved research
Continuing review of an approved and ongoing protocol...?Must occur within 12 months of the approval date (even if no additional risks have been identified)
Continuing review process must include:-unanticipated problems -number of subjects accrued -recent relevant literature -copy of current consent form
T/F Officials of the institution may overrule an IRB approvalTrue, however no one may overrule if an IRB disapproved a protocol
An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate meausre will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:Experience emotional or psychological distress
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful?Obtain a waiver of documentation of informed consent
The primary purpose of a Certificate of Confidentiality is to:Protect identifiable research info from compelled disclosure
Certificates of Confidentiality protect sensitive info provided by research subjects from:civil, criminal, or administrative subpoena
T/F Risk should be evaluated solely by the magnitude or severity of expected harm, not probabilityFalse: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered.
Risks are specific to:Time, situation, and culture
A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will:Not affect future care
T/F The fact that a therapist has access to her clients' records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assentFalse: S/he needs both parental permission & child assent
T/F School authority's permission to conduct research replaces the need for permission and assentFalse
T/F Children's right to choose cannot be overridden in the pursuit of an indeterminate community interestTrue, it cannot be overridden
Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the studyinforming participants they were assigned to a study based on undesirable or unflattering physical characteristics for example, or anything that may be judged negative or distressing would be considered appropriate criterion
A waiver of the requirement for documentation of informed consent may be granted when:The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality
As part of the consent process, the federal regulations require researchers to:Provide potential subjects with information at the appropriate reading comprehension level.
Data are made anonymous byDestroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which confidentiality procedure would protect against compelled disclosure of individually identifiable information?Securing a Certificate of Confidentiality.
When a focus group deals with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct?The researcher cannot control what participants repeat about others outside the group.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?There was neither a violation of privacy nor a breach of confidentiality
Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:Confidentiality of the prisoners' health status is maintained
Which of the following statements about prison research is true?Researchers may study the effects of privilege upgrades awarded by the prison.
An investigator is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:Not an excessive incentive.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:Not approve this project because the prisoners are merely a population of convenience for the student.
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in researchFederal regulations do not require the documentation of minors' assent.
According to Subpart D, research with children may be eligible for exemption when:The research involves the use of educational tests
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?The research must pose no more than minimal risk.
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
Parental notification, in lieu of active parental permission, is allowed when:An IRB has approved a waiver of the requirement for parental permission.
According to Subpart D, which of the following research activities with children would qualify for an exemption?Research about educational testing
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:Provide parents certain rights over their children's educational records.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?The Family Educational Rights and Privacy Act.
Which of the following is the LEAST important activity when protecting human subjects in international research?Assessing transportation conditions
The age of majority in international research is determined by theLaws, customs, and norms in the area in which the research will be conducted.
Which of the following activities constitutes engagement in research?Obtaining informed consent and conducting research interviews.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?Designing the survey so that subjects are not forced to answer one question before going to the next.
To minimize potential risks of harm, a researcher conducting an on-line survey can:Design the survey so that no direct or indirect identifiers are collected.
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
A HIPAA authorization has which of the following characteristics:Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...must be more detailed for disclosures that involve fewer than 50 subject records
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
Recruiting into research ...can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.
HIPAA's protections for health information used for research purposes...supplement those of the Common Rule and FDA.
HIPAAHealth Insurance Portability and Accountability Act of 1996
HIPAA privacy protections supplement those ofother federal regulations (viz., the Common Rule and FDA), state law, and certification/accreditation requirements.
HIPAA protectsprotects identifiable health information (PHI) originating or held in covered entities. De-identified data is not protected, and not all identifiable health information is considered PHI either
Under HIPAA, research activity using PHI generally requiresauthorization. However, there are several alternatives that allow bypassing the authorization requirement.
Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must beunderstood by researchers when HIPAA applies
If you're unsure about the particulars at your organization or have questions,consult with your organization's IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization's Security Official.
specified identifiers1.Names 2.All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: a.The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and bThe initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. 3.All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; 4.Telephone numbers; 5.Fax numbers; 6.Electronic mail addresses; 7.Social security numbers; 8.Medical record numbers; 9.Health plan beneficiary numbers; 10.Account numbers; 11.Certificate/license numbers; 12.Vehicle identifiers and serial numbers, including license plate numbers; 13.Device identifiers and serial numbers; 14.Web Universal Resource Locators (URLs); 15.Internet Protocol (IP) address numbers; 16.Biometric identifiers, including finger and voice prints; 17.Full face photographic images and any comparable images; and 18.Any other unique identifying number, characteristic, or code.
Vulnerable persons arethose who are less able to protect themselves than other persons in a given situation.
The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations,Pregnant Women, Human Fetuses and Neonates (Subpart B), Prisoners (Subpart C) and Children (Subpart D).
T/F Workers are considered vulnerable populationsFalse
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:pressure from their co-workers, unions and employers. Pressure can be applied to workers in subtle ways such as an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs, etc.
T/F When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.True
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:Conflict of interest
Significant financial interest can be defined as:- Equity/stock interests (regardless of value) in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000.
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) isGreater than $5,000 of ownership in any single public entity/public company.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:Any equity interest in a publicly held company that exceeds $50,000
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:Designated institutional officials
What constitutes "research" according to HIPAA?HIPAA defines research as any "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge
Who enforces HIPAA's protections?IRB Privacy Board Privacy Officer
Waivers and alterations of authorization requirementUse or disclosure of the PHI involves no more than minimal risk to the privacy of the research subjects, based on the following elements: oAn adequate plan to protect any data identifiers from improper use and disclosure. oAn adequate plan to destroy data identifiers at the earliest opportunity consistent with conduct of the research (unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law). oAdequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by HIPAA. oThe research could not practicably be conducted without the PHI. oThe research could not practicably be conducted without the waiver.
Activities preparatory to research, decedents' information exceptionsWhere the PHI will be used solely for reviews preparatory to research (e.g., for protocol development) and will not leave the covered entity. Where the PHI refers solely to deceased persons (the covered entity may ask for documentation of death of all data subjects
T/F A researcher may use fully "de-identified" health data without any authorization from data subjectsTrue
Grandfatherd researchif all informed consents and other legal permissions required at the time were in place before HIPAA took effect (April 2003 in most cases), and have not changed since, no new HIPAA authorization is required.
minimum necessary standardthe uses/disclosures must be no more than the minimum required for the described research purpose
accounting of disclosuresA list of all protocols for which their PHI may have been disclosed, along with the timeframe for those disclosures. The purpose of those protocols, and the types of PHI sought. The researcher's name and contact information for each study
Characteristics of authorizationsIn "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision. Executed in writing, and signed by the research subject (or an authorized personal representative).
T/F revocations for HIPAA authorizations for research can be revoked at any timeTrue Provided that the revocation is in writing
T/F It is permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriateTrue
Retrospective" researchuse or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board
An increase in cost is an acceptable reason for excluding women, minorities, and their subpopulations in clinical researchFalse
The Code of Federal Regulations (45 CFR 46.111), the U.S. Food and Drug Administration (FDA) and the National Institutes for Health (NIH) address the inclusion of women and minorities in research.True
A minority group is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.True
All research is expected to include both sexes and members of every racial/ethnic group and subpopulations as participants.False
Which of the following are the three principles discussed in the Belmont Report?Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?at the study has a maximization of benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT:The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.
The history of ethical regulations in human subjects research began with theNuremberg Code
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? (There may be more than one correct answer. Please be sure to select all correct answers.)- Faculty Advisor/Research Mentor - IRB Office
Which of the following elements must be included in an informed consent?All foreseeable risks and discomforts.
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?Exempt
How can faculty researchers avoid coercion of student subjects?Avoid using their own students in their research
A student is conducting a research project that involves using a survey. The survey asks participants about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?Exempt Review
A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?Full Board Review
A master's degree candidate needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stock and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?Not Human Subjects
Which of the following studies need IRB approval?Studies collecting data about living individuals.
What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.)- Protecting the rights and welfare of human subjects. - Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. - Reviewing subject recruitment materials and strategies.
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?The IRB will not review this study because it is not research as defined by the federal regulations.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:Identifiable private information.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
A medical record is an example of:Private information.
Continuing review of an approved and ongoing protocolMust occur within 12 months of the approval date.
According to federal regulations, the expedited review process may be used when the study procedures pose:No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?Prisoners
According to the federal regulations, research is eligible for exemption, ifThe research falls into one of six categories of research activity described in the regulations.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?Officials of the institution may overrule an IRB approval.
The primary purpose of a Certificate of Confidentiality is to:Protect identifiable research information from compelled disclosure.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:Obtain a waiver of documentation of informed consent.
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:Experience emotional or psychological distress.
What statement about risks in social and behavioral sciences research is most accurate:Risks are specific to time, situation, and culture.
Identify the example of when situation and time is key to assessing risk of harm in a research study:Asking women if they have had an abortion
Risk of harm in social and behavioral sciences generally fall in three categories, which are:Invasion of privacy, breach of confidentiality, and study procedures
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
Three principles of Belmont ReportRespect for Persons Beneficence Justice
The Belmont Report Principle of BeneficenceMAXIMIZATION of benefits and MINIMIZATION of risks
T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interestTRUE
The Belmont Report Respect for PersonRequires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent)
The Belmont Report defines and delineates..."Practice" and "Research"
The Belmont Report The Principle of JusticeResearch benefit and burden distribution and that selection of subjects is fair.
T/F The Belmont report describes the necessity to effectively manage conflicts of interestFALSE
Students in Research The history of ethical regulations in human subjects research began with theNuremberg Code
Nuremberg CodeHuman subjects research guidelines and regulations
Year of the Nuremberg Code1949
Additional resources regarding IRB approval processFaculty advisor/Research Mentor IRB office Human subjects research websites
What element must be included in an informed consent?All foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB?If the study qualifies for EXEMPTION
Another name for the "Exempt" statusthe Common Rule stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects?Avoid using their own students in their research
Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information.Exempt Review category 2
Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects.Full Board Review
Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimalExpedited review
Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a businessNot Human Subjects
Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components)"1.data through intervention or interaction with the individual 2. identifiable private information"
Name the 3 responsibilities the IRB is charged with1. Protecting the rights and welfare of human subjects 2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed 3. Reviewing subject recruitment materials and strategies
T/F IRB's investigate scientific misconductFalse
T/F IRB's do not review manuscripts prior to submission for publicationTrue
DHHS FDADepts. IRB's review for current policies -Department of Health and Human Services -Food and Drug Administration
Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately the Belmont Report and Federal regulations for human subject protectionThe Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle?The principle of beneficence: Potential benefits justify the risks of harm
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:Respect for persons Belmont Report
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:Justice
How is the principle of beneficence applied to a study involving human subjects?Ensuring that risks are reasonable in relationship to anticipated benefits.
Human subject study or not? Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggressionYes
Human subject study or not? The study of a list with deceased passengersNo:Human subject is a living individual
Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases?No: 'what' question rather than 'who' question
Human subject study or not? Conducting linguistic analysis of comments posted on a public blogNot: involves neither interaction with individuals nor collecting private identified info
Human subject study or not? A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledgeYes: humans
Human subject study? A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviorsYes: Interacting w/ living individuals.
Human subject study or not? Questioning a superintendent of schools to acquire data about the ethnic composition of a schoolNo: it is an "about what" question rather than "about whom" question
Human subject study or not? Study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over 3-month periodYes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation
Human subject study or not? Info collected by play ground designerNo: does not involve info about human subjects even though there is interactions between designer and school staff.
Human subject study or not? An analysis of aggregate dataNo: doesn't involve interactions w/ living individuals nor collection of private identifiable data
Human subject study or not? An economic feasibility studyNo: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer "about what" ? rather than "about whom" ?
According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or:identifiable PRIVATE information (Public info does not meet criteria)
Subpart of DHHS regulations provides additional protections for which vulnerable populations?1. Pregnant women 2. Fetuses 3. Neonates 4. Prisoners
Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations?1. elderly 2. students 3. for persons whose decision-making capabilities are impaired
The expedited review process may be used when the study procedures pose:No more than minimal risk and the research activities fall within regulatory categories identified as eligible
The expedited review process may NOT be used when the study procedures pose:-more than minimal risk, even if the subjects are adults, -the sponsor is in a hurry -the study replicates previously approved research
Continuing review of an approved and ongoing protocol...?Must occur within 12 months of the approval date (even if no additional risks have been identified)
Continuing review process must include:-unanticipated problems -number of subjects accrued -recent relevant literature -copy of current consent form
T/F Officials of the institution may overrule an IRB approvalTrue, however no one may overrule if an IRB disapproved a protocol
An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate meausre will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:Experience emotional or psychological distress
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful?Obtain a waiver of documentation of informed consent
The primary purpose of a Certificate of Confidentiality is to:Protect identifiable research info from compelled disclosure
Certificates of Confidentiality protect sensitive info provided by research subjects from:civil, criminal, or administrative subpoena
T/F Risk should be evaluated solely by the magnitude or severity of expected harm, not probabilityFalse: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered.
Risks are specific to:Time, situation, and culture
A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will:Not affect future care
T/F The fact that a therapist has access to her clients' records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assentFalse: S/he needs both parental permission & child assent
T/F School authority's permission to conduct research replaces the need for permission and assentFalse
T/F Children's right to choose cannot be overridden in the pursuit of an indeterminate community interestTrue, it cannot be overridden
Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the studyinforming participants they were assigned to a study based on undesirable or unflattering physical characteristics for example, or anything that may be judged negative or distressing would be considered appropriate criterion
A waiver of the requirement for documentation of informed consent may be granted when:The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality
As part of the consent process, the federal regulations require researchers to:Provide potential subjects with information at the appropriate reading comprehension level.
Data are made anonymous byDestroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which confidentiality procedure would protect against compelled disclosure of individually identifiable information?Securing a Certificate of Confidentiality.
When a focus group deals with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct?The researcher cannot control what participants repeat about others outside the group.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?There was neither a violation of privacy nor a breach of confidentiality
Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:Confidentiality of the prisoners' health status is maintained
Which of the following statements about prison research is true?Researchers may study the effects of privilege upgrades awarded by the prison.
An investigator is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:Not an excessive incentive.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:Not approve this project because the prisoners are merely a population of convenience for the student.
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in researchFederal regulations do not require the documentation of minors' assent.
According to Subpart D, research with children may be eligible for exemption when:The research involves the use of educational tests
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?The research must pose no more than minimal risk.
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
Parental notification, in lieu of active parental permission, is allowed when:An IRB has approved a waiver of the requirement for parental permission.
According to Subpart D, which of the following research activities with children would qualify for an exemption?Research about educational testing
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:Provide parents certain rights over their children's educational records.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?The Family Educational Rights and Privacy Act.
Which of the following is the LEAST important activity when protecting human subjects in international research?Assessing transportation conditions
The age of majority in international research is determined by theLaws, customs, and norms in the area in which the research will be conducted.
Which of the following activities constitutes engagement in research?Obtaining informed consent and conducting research interviews.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?Designing the survey so that subjects are not forced to answer one question before going to the next.
To minimize potential risks of harm, a researcher conducting an on-line survey can:Design the survey so that no direct or indirect identifiers are collected.
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
A HIPAA authorization has which of the following characteristics:Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...must be more detailed for disclosures that involve fewer than 50 subject records
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
Recruiting into research ...can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.
HIPAA's protections for health information used for research purposes...supplement those of the Common Rule and FDA.
HIPAAHealth Insurance Portability and Accountability Act of 1996
HIPAA privacy protections supplement those ofother federal regulations (viz., the Common Rule and FDA), state law, and certification/accreditation requirements.
HIPAA protectsprotects identifiable health information (PHI) originating or held in covered entities. De-identified data is not protected, and not all identifiable health information is considered PHI either
Under HIPAA, research activity using PHI generally requiresauthorization. However, there are several alternatives that allow bypassing the authorization requirement.
Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must beunderstood by researchers when HIPAA applies
If you're unsure about the particulars at your organization or have questions,consult with your organization's IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization's Security Official.
specified identifiers1.Names 2.All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: a.The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and bThe initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. 3.All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; 4.Telephone numbers; 5.Fax numbers; 6.Electronic mail addresses; 7.Social security numbers; 8.Medical record numbers; 9.Health plan beneficiary numbers; 10.Account numbers; 11.Certificate/license numbers; 12.Vehicle identifiers and serial numbers, including license plate numbers; 13.Device identifiers and serial numbers; 14.Web Universal Resource Locators (URLs); 15.Internet Protocol (IP) address numbers; 16.Biometric identifiers, including finger and voice prints; 17.Full face photographic images and any comparable images; and 18.Any other unique identifying number, characteristic, or code.
Vulnerable persons arethose who are less able to protect themselves than other persons in a given situation.
The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations,Pregnant Women, Human Fetuses and Neonates (Subpart B), Prisoners (Subpart C) and Children (Subpart D).
T/F Workers are considered vulnerable populationsFalse
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:pressure from their co-workers, unions and employers. Pressure can be applied to workers in subtle ways such as an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs, etc.
T/F When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.True
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:Conflict of interest
Significant financial interest can be defined as:- Equity/stock interests (regardless of value) in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000.
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) isGreater than $5,000 of ownership in any single public entity/public company.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:Any equity interest in a publicly held company that exceeds $50,000
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:Designated institutional officials
What constitutes "research" according to HIPAA?HIPAA defines research as any "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge
Who enforces HIPAA's protections?IRB Privacy Board Privacy Officer
Waivers and alterations of authorization requirementUse or disclosure of the PHI involves no more than minimal risk to the privacy of the research subjects, based on the following elements: oAn adequate plan to protect any data identifiers from improper use and disclosure. oAn adequate plan to destroy data identifiers at the earliest opportunity consistent with conduct of the research (unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law). oAdequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by HIPAA. oThe research could not practicably be conducted without the PHI. oThe research could not practicably be conducted without the waiver.
Activities preparatory to research, decedents' information exceptionsWhere the PHI will be used solely for reviews preparatory to research (e.g., for protocol development) and will not leave the covered entity. Where the PHI refers solely to deceased persons (the covered entity may ask for documentation of death of all data subjects
T/F A researcher may use fully "de-identified" health data without any authorization from data subjectsTrue
Grandfatherd researchif all informed consents and other legal permissions required at the time were in place before HIPAA took effect (April 2003 in most cases), and have not changed since, no new HIPAA authorization is required.
minimum necessary standardthe uses/disclosures must be no more than the minimum required for the described research purpose
accounting of disclosuresA list of all protocols for which their PHI may have been disclosed, along with the timeframe for those disclosures. The purpose of those protocols, and the types of PHI sought. The researcher's name and contact information for each study
Characteristics of authorizationsIn "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision. Executed in writing, and signed by the research subject (or an authorized personal representative).
T/F revocations for HIPAA authorizations for research can be revoked at any timeTrue Provided that the revocation is in writing
T/F It is permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriateTrue
Retrospective" researchuse or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board
Data are made anonymous by -Destroying all identifiers connected to the data. -Requiring all members of the research team to sign confidentiality agreements. -Keeping the key linking names to responses in a secure location. -Reporting data in aggregate form in publications resulting from the research.Destroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? -Using data encryption for stored files. -Securing a Certificate of Confidentiality. -Waiving documentation of consent. -Using pseudonyms in research reports.Securing a Certificate of Confidentiality
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? -If group members know each other confidentiality is not an issue. -Using pseudonyms in reports removes the concern about any confidences shared in the group. -The researcher cannot control what participants repeat about others outside the group. -If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.The researcher cannot control what participants repeat about others outside the group
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? -There was neither a violation of privacy nor a breach of confidentiality -The subjects' privacy has been violated. -Confidentiality of the data has been breached -There was both a violation of privacy and a breach of confidentiality.There was neither a violation of privacy nor a breach of confidentiality
Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? -A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study. -A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. -A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. -In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
An investigator is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are: -Educational. -Not an excessive incentive. -Of high quality. -Age appropriate.Not an excessive incentive.
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that: The survey instrument is standardized. Confidentiality of the prisoners' health status is maintained. All prisoners receive HIV testing. A medical doctor serves as co-investigator.Confidentiality of the prisoners' health status is maintained.
Which of the following statements about prison research is true? Participation in research can be considered during parole hearings. Researchers may study the effects of privilege upgrades awarded by the prison. It is permissible for risks to be higher than those that would be accepted by non-prisoners. The regulations prohibit compensating prisoners.Researchers may study the effects of privilege upgrades awarded by the prison.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should: Approve this project but submit it for federal review. Approve this project since the risk appears to be no more than minimal. Not approve this project because the prisoners are merely a population of convenience for the student. Approve this project since the superintendent is the ultimate authority on what happens in his facility.Not approve this project because the prisoners are merely a population of convenience for the student
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Parents must approve written documentation. To protect minors documentation is always required. Documentation is required unless waived by an IRB. Federal regulations do not require the documentation of minors' assent.Federal regulations do not require the documentation of minors' assent.
According to Subpart D, research with children may be eligible for exemption when: The research involves the use of educational tests The children will be interviewed by the researcher. The research with children will involve participant observation with researcher interaction. The children will be asked to complete a surveyThe research involves the use of educational tests
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? Parents must be notified that the study is taking place. The students must be offered an optional classroom activity. An independent consultant must approve the waiver. The research must pose no more than minimal risk.The research must pose no more than minimal risk.
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors. Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review. The new research would need full review by a convened IRB because children are a protected population.Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
Parental notification, in lieu of active parental permission, is allowed when: The researcher anticipates a low response rate. An IRB has approved a waiver of the requirement for parental permission. The researcher has conducted a similar study at another institution. The superintendent of schools and the principals have approved the study.An IRB has approved a waiver of the requirement for parental permission
According to Subpart D, which of the following research activities with children would qualify for an exemption? Survey procedures Observation of public behavior when the researcher participates in the activities being observed. Interviews Research about educational testingResearch about educational testing
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: Ensure that surveys do not ask school children to provide sensitive information about their parents. Provide parents certain rights over their children's educational records. Give school principals the right to discuss students' behavioral problems with their parents. Allow school counselors to access students' grades.Provide parents certain rights over their children's educational records.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? The No Child Left Behind Act. Subpart D of 45 CFR 46. The Protection of Pupil Rights Amendment. The Family Educational Rights and Privacy Act.The Family Educational Rights and Privacy Act
Which of the following is the LEAST important activity when protecting human subjects in international research? Determining if the research might present unique risks to subjects given local socio-economic conditions. Considering local customs, norms, and laws. Assessing transportation conditions Consulting with members of the community from which subjects will be recruited.Assessing transportation conditions
The age of majority in international research is determined by the Legal drinking age where the research will take place. Laws in the state where the researchers' institution resides. Laws, customs, and norms in the area in which the research will be conducted. The research sponsor.Laws, customs, and norms in the area in which the research will be conducted.
Which of the following activities constitutes engagement in research? Providing potential subjects with written information about a study. Obtaining informed consent and conducting research interviews. Informing prospective subjects about the availability of research. Obtaining subjects' permission for researchers to contact them.Obtaining informed consent and conducting research interviews.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is: People assume pseudonymous on-line identities, such as an avatar in an MMORPG. Online studies do not require the documentation of informed consent. Recruiting, consenting and debriefing subjects takes place on-line, and may require little to no interaction with the subjects. Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings. A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her. A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? Designing the survey so that subjects are not forced to answer one question before going to the next. Giving examples in the consent process of the kinds of questions that will be asked. Including the institution's privacy policy on the survey site. Providing a thorough debriefing at the end of the study.Designing the survey so that subjects are not forced to answer one question before going to the next
To minimize potential risks of harm, a researcher conducting an on-line survey can: Specify that all respondents must be legal adults. Suggest that subjects print a copy of the informed consent form for their records. Comply with the survey software's Terms of Service agreement. Design the survey so that no direct or indirect identifiers are collected.Design the survey so that no direct or indirect identifiers are collected.
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects? Downloading a publically available dataset that includes high school students' academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states. Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual's social network. Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group. Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted.Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: Use of decedents' information, with certain representations by the researcher. Data that does not cross state lines when disclosed by the covered entity. Activities preparatory to research, with certain representations by the researcher. Limited data set with an approved data use agreement.Data that does not cross state lines when disclosed by the covered entity.
Under HIPAA, a "disclosure accounting" is required: for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets. for all research where the data crosses state lines, otherwise state law applies. for all human subjects research that uses PHI. solely at the principle investigator's discretion.for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
HIPAA protects a category of information known as protected health information (PHI). PHI includes: identifiable health information that is created or held by covered entities, provided the data subject is a US citizen. identifiable health information that is created or held by covered entities. any identifiable health information. Identifiable health information that is created or held by covered entities that operate across state lines.identifiable health information that is created or held by covered entities.
When required, the information provided to the data subject in a HIPAA disclosure accounting ... must be more detailed for disclosures that involve fewer than 50 subject records. is always the same, regardless of the number of records involved. is limited to the information elements the data subject specifically requests. is at the discretion of the organization, given its accounting policies.must be more detailed for disclosures that involve fewer than 50 subject records.
HIPAA includes in its definition of "research," activities related to ... anything a researcher does in a federally-supported laboratory. development of generalizable knowledge. quality assessment and improvement. population health.development of generalizable knowledge.
Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, except: Pregnant Women Prisoners Children WorkersWorkers
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. The research study's finding could affect an employee's pay, benefits or promotion potential. The employer may encourage or deny participation of workers. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. All of the aboveAll of the above
Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define: Who will have access to the data. If personal identifiers will be retained and used in the data analysis. How the data will be collected and secured. If the study results, if any, will be included in the employee's personnel records. All of the aboveAll of the above
When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject. True FalseTrue
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold: Any equity interest in a publicly held company that exceeds $5,000 Any equity interest in a publicly held company that exceeds $30,000 Any equity interest in a publicly held company that exceeds $50,000 Any equity interest in a publicly held company that exceeds $15,000Any equity interest in a publicly held company that exceeds $50,000
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of: Conflict of Interest Fraud Research Misconduct MalfeasanceConflict of Interest
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is: Greater than $5,000 of ownership in any single public entity/company. $25,000 and 5% of ownership in any single entity/company. Greater than $2,000 or 2% of ownership in any single entity/company. Greater than $10,000 or 5% of ownership in any single entity/company.Greater than $5,000 of ownership in any single public entity/company.
The most important ethical concerns related to conflicts of interest in research are: Maintaining a supply of volunteers for research studies and their active involvement in research Ensuring the objectivity of research and the protection of human subjects Protecting proprietary information and fidelity to contracts with sponsors Establishing open dialog with sponsors and security of study recordsEnsuring the objectivity of research and the protection of human subjects
A conflict of interest implies: The elimination of bias. The actual involvement of bias. An awareness of bias. The potential for bias.The potential for bias.
What are the 3 principles discussed in the Belmont Report?Respect for Persons Beneficence Justice
What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?Determining that the study has a maximization of benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT:The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.
The history of ethical regulations in human subjects research began with theNuremberg Code
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?Faculty Advisor/Research Mentor IRB Office
Which of the following elements must be included in an informed consent?All foreseeable risks and discomforts.
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?Exempt
How can faculty researchers avoid coercion of student subjects?Avoid using their own students in their research
A student is conducting a research project that involves using a survey. The survey asks participants about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?Exempt Review
A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?Full Board Review
A master's degree candidate needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stock and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?Not Human Subjects
Which of the following studies need IRB approval?Studies collecting data about living individuals.
What is the Institutional Review Board (IRB) charged with?- Protecting the rights and welfare of human subjects. - Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. - Reviewing subject recruitment materials and strategies.
Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. B. Stanford Prison Experiment (Zimbardo). C. Tearoom Trade Study (Humphreys). D. The Harvard T3 study.A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
The Belmont principle of beneficence requires that: A. The study makes a significant contribution to generalizable knowledge. B. Subjects derive individual benefit from study participation. C. Risks are managed so that they are no more than minimal. D. Potential benefits justify the risks of harm.D. Potential benefits justify the risks of harm.
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: A. Justice. B. Beneficence. C. Respect for persons.C. Respect for persons
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: A. Beneficence. B. Justice. C. Respect for persons.B. Justice
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? a. Providing detailed information about the study to potential subjects. b. Ensuring that risks are reasonable in relationship to anticipated benefits. c. Ensuring that the selection of subjects is fair. d. Ensuring that subjects understand that participation is voluntaryb. Ensuring that risks are reasonable in relationship to anticipated benefits.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? a. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS. b. A researcher conducts a linguistic study of comments posted on a local public blog. c. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the US between1820-1845 to track the numbers of immigrants from certain ethnic groups. d. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.d. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? a. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership. b. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. c. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department. d. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.b. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? a. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches. b. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques. c. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine. d. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.d. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? a. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs. b. The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided. c. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. d. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.c. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: a. Identifiable public information. b. De-identified private information. c. Identifiable private information. d. Observations of public behavior.c. Identifiable private information.
According to the federal regulations, research is eligible for exemption, if a. All the subjects are adults and the risk is minimal. b. The investigator is experienced in the field of inquiry. c. The research falls into one of six categories of research activity described in the regulations. d. Participation in the research will involve 10 minutes or less of the subjects' time.c. The research falls into one of six categories of research activity described in the regulations.
In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations? a. College students. b. Adults with decisional impairments. c. The elderly. d. Prisoners.d. Prisoners.
According to federal regulations, the expedited review process may be used when the study procedures pose: a. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting. b. More than minimal risk, but the study replicates previously approved research. c. Any level of risk, but all the subjects are adults. d. No more than minimal risk and the research activities fall within regulatory categories identified as eligible.d. No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
Continuing review of an approved and ongoing protocol a. Is limited to review of unanticipated problems. b. Must be conducted by a convened IRB. c. Is not required unless additional risks have been identified. d. Must occur within 12 months of the approval date.d. Must occur within 12 months of the approval date.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? a. Institutional priorities take precedence over all IRB determinations. b. Department chairs can overturn an IRB disapproval. c. Officials of the institution may overrule an IRB approval. d. Officials of the institution may overturn an IRB disapproval.c. Officials of the institution may overrule an IRB approval.
An investigator wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: a. Experience emotional or psychological distress. b. Lose their legal status. c. Lose their employment. d. Feel that their privacy has been invaded.a. Experience emotional or psychological distress
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: a. Have the subject sign the consent form under an assumed name. b. Obtain a Certificate of Confidentiality. c. Code the subjects' responses. d. Obtain a waiver of documentation of informed consent.d. Obtain a waiver of documentation of informed consent.
The primary purpose of a Certificate of Confidentiality is to: a. Prevent subjects from knowing the purpose of a study. b. Allow law enforcement to investigate abuse cases. c. Protect researchers from disclosing conflicts of interest. d. Protect identifiable research information from compelled disclosure.d. Protect identifiable research information from compelled disclosure.
Risk should be evaluated solely by the magnitude or severity of expected harm, not probability. True FalseFalse
What statement about risks in social and behavioral sciences research is most accurate: a. If a study offers potential benefits, it is not necessary to minimize risks. b. Anonymizing data effectively manages the risk of creating emotional distress. c. There are never any risks. d. Risks are specific to time, situation, and culture.d. Risks are specific to time, situation, and culture.
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? a. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes. b. If it is the best interests of the community that the children participate in the study, parental permission is optional. c. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission. d. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.d. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? a. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. b. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. c. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out. d. In the event of any distress you may have related to this research, you will be given access to appropriate resources.b. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: a. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material. b. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. c. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects. d. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.b. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
A waiver of the requirement for documentation of informed consent may be granted when: a. The subjects are literate in their own language; however, they do not read, write, or speak English b. Potential subjects might find some of the research questions embarrassing, personal, or intrusive c. The investigator has no convenient place to store signed consent forms separate from the research data d. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.d. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
As part of the consent process, the federal regulations require researchers to: a. Describe penalties that may be imposed for non-participation. b. Recommend that potential subjects discuss their decision to participate with family members. c. Provide a list of the IRB members who reviewed the protocol. d. Provide potential subjects with information at the appropriate reading comprehension level.. d. Provide potential subjects with information at the appropriate reading comprehension level.
Which of the following are the three principles discussed in the belmont report?Respect for persons, beneficence, Justice
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?Determining that the study has a maximization of benefits and minimization of risks
All of the following are true regarding the belmont report except:The belmont report indicates that it is necessary to rigorously avoid conflicts of interest.
The history of ethical regulations in human subjects research began with...Nuremberg code
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?faculty advisor/research mentor or the IRB office
Which element is to be included in informed consent?all foreseeable risks and discomforts
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or and IRB designeeexempt
How can faculty researchers avoid coercion of student subjects?Avoid using their own students in their research
A student is conducting a research project that involves using a survey. it asks participants about their highest level of education, political affiliation, and views on various social issues. No identifiable info will be collected. What is this?exempt review (no consent)
A student working on his dissertation plans on interviewing 15 principles in neighboring high schools. The student will collect data about personal experiences they had with disruptive students, disciplinary action and feelings/thoughts. Identifiers will be collected. What is this?full board review
A masters degree candidate needs to conduct a research project for her masters thesis. She is interested in junk food available to public. She plans on going to the grocery stores and asking for highest sellers. Identifiers will not be collected. What is this?no human subjects
Which of the following studies needs IRB approval?studies collecting data about living individuals
What is the IRB charged with?protecting the rights and welfare of human subjects assuming that all applicable institutional policies and federal regulations related to research with human subjects are followed reviewing subjects recruitment materials and strategies
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?Ensuring that risks are reasonable in anticipated benefits
Which of the following studies is linked most directly to the est. of the national research act in 1974 and ultimately to the belmont report and federal regulations for human subject protection?The public health service tuskegee study of untreated syphilis in the negro male
the researchers failure to protect subjects from deductive disclosure is the primary ethical violation in which of the following studies?Harvard, "tasts ties and time (t3) study (2006-2009)
The belmont principle of beneficence requires that...potential benefits justify the risks of harm
According to federal regulations, which of the following studies meets the definition of research with human subjects?a cognitive psych enrolls undergrad students for comp. based study about the effect of mood on problem solving behaviors
According to the federal regulations, which meets criteria for human subjects?A study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessment for each for three months another answer: a developmental psych videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggressions
Researcher gains info through...identifiable private info
which of the following statements about the relationship between an institution and an institutions IRB is correct?officials of the institution may overrule IRB approval
According to federal regulations, research is eligible for exemption if..the research falls into one of the six categories of research activity described in the regulations
Continuing review of an approval and ongoing protocol...must occur within 12 months of approval
DHHS regulations provides protection for...pregnant women, fetuses, prisoners, and children
Expedited review process may be used when the study procedures pose..no more than a minimal risk and research activities fall within regulatory categories identified as eligible
What statement about risks in social and behavioral sciences research in most accurate?risks are specific to time, culture, situation
If disclosure of a subjects involvement is risky and the consent form is the only one thing linking the subjects...obtain a fee waiver of documentation of informed consent
certificate of confidentiality?protect identifiable research from compelled disclosure
Risk of harm should be evaluated by...both magnitude and the probability
Studying coping with adults who experienced abused as a child. There will be a consent form, the most likely additional risk is...experience emotional or psych distress
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for s case based research project. Which of the following research statements about parental permission is correct?The parents of the children might feel pressure to give permission to use their child's data so that she will continue to provide services
A general requirement for informed consent is that no informed consent may include any exculpatory language. Waives or appears to wave the subjects leg l rights or releases or appears to release those conducting the research from liability from negligence. Which is an example of exculpatory language?taking part in the research voluntary, but if you choose to take part, you waive your right to legal redress for any related injuries
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent info after the study. In which of the following studies would it not be appropriate to provide subjects with info about missing elements of consent:A study in which subjects were assigned to study activities based on an undesirable physical characteristic as assessed by members of research team
A waiver of the requirement for documentation of informed consent may be granted when...the only record linking the subject and the research is the consent document and the principal risk is a breach if confidentiality
As part of the consent process, the federal regulations require some researchers to...provide potential subjects with into at the appropriate reading comprehension levels
In a longitudinal study that will follow children from K to HS and collect info about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable info?securing a certificate of confidentiality
When a focus group deals with a potentially sensitive topic, providing confidentiality means:the researchers cannot control what participants repeat about others outside the group
Data are made anonymous by...destroying all identifiers relating to the data
Which constitutes a breach of confidentiality and a violation of subjects privacy?making identifiable data about sexual behavior available to grad students, although subjects were told it would be de-identiable
A researchers data is stolen from her car. Files contained aggregated data. Consent form said no identifying info would be retained ad researchers adheredThere was neither violation of privacy or breach of cofidentiality
A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed b interviews. The IRB must ensure that:confidentiality of the prisoners health status maintained
If a grad student speaks to a super (family friend)for a prisoner population. This students IRB should...not approve this project because the prisoners are merely a population of convenience for the student
A researchers uses a data set of prisoner demographic characteristics/ No interaction with prisoners. The IRB chair agrees that the study is exempt from IRB review.This review is wrong because 45 CFR 46.101 (B) states that prisoner research MAY NOT be exempt
Respect for Persons, Beneficence, Justice.Which of the following are the three principles discussed in the Belmont Report?
maximization of benefits and a minimization of risksan example of how the Principle of Beneficence can be applied to a study employing human subjects
Respect for personsincorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
autonomous personan individual capable of deliberation about personal goals and of acting under the direction of such deliberation.
BeneficencePersons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
complementary expressions of beneficent actions(1) do not harm and (2) maximize possible benefits and minimize possible harms.
JusticeWho ought to receive the benefits of research and bear its burdens? These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.
Informed Consent.Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.
Information.These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.
Examples of Justified incomplete information.(1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.
Comprehension.Making sure the the manner and context in which information is presented is easily understandable to the research subjects.
Voluntariness.An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.
Assessment of Risks and Benefits.requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research.
The Nature and Scope of Risks and Benefits.Accordingly, so-called risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits.
The Systematic Assessment of Risks and Benefits.It is commonly said that benefits and risks must be "balanced" and shown to be "in a favorable ratio." (i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. (iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation).(iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated.v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.
3. Selection of Subjects.it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.
Three principles of Belmont ReportRespect for Persons Beneficence Justice
The Belmont Report Principle of BeneficenceMAXIMIZATION of benefits and MINIMIZATION of risks
T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interestTRUE
The Belmont Report Respect for PersonRequires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent)
The Belmont Report defines and delineates..."Practice" and "Research"
The Belmont Report The Principle of JusticeResearch benefit and burden distribution and that selection of subjects is fair.
T/F The Belmont report describes the necessity to effectively manage conflicts of interestFALSE
Students in Research The history of ethical regulations in human subjects research began with theNuremberg Code
Nuremberg CodeHuman subjects research guidelines and regulations
Year of the Nuremberg Code1949
Additional resources regarding IRB approval processFaculty advisor/Research Mentor IRB office Human subjects research websites
What element must be included in an informed consent?All foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB?If the study qualifies for EXEMPTION
Another name for the "Exempt" statusthe Common Rule stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects?Avoid using their own students in their research
Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information.Exempt Review category 2
Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects.Full Board Review
Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimalExpedited review
Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a businessNot Human Subjects
Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components)"1.data through intervention or interaction with the individual 2. identifiable private information"
Name the 3 responsibilities the IRB is charged with1. Protecting the rights and welfare of human subjects 2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed 3. Reviewing subject recruitment materials and strategies
T/F IRB's investigate scientific misconductFalse
T/F IRB's do not review manuscripts prior to submission for publicationTrue
DHHS FDADepts. IRB's review for current policies -Department of Health and Human Services -Food and Drug Administration
Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately the Belmont Report and Federal regulations for human subject protectionThe Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle?The principle of beneficence: Potential benefits justify the risks of harm
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:Respect for persons Belmont Report
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:Justice
How is the principle of beneficence applied to a study involving human subjects?Ensuring that risks are reasonable in relationship to anticipated benefits.
Human subject study or not? Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggressionYes
Human subject study or not? The study of a list with deceased passengersNo:Human subject is a living individual
Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases?No: 'what' question rather than 'who' question
Human subject study or not? Conducting linguistic analysis of comments posted on a public blogNot: involves neither interaction with individuals nor collecting private identified info
Human subject study or not? A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledgeYes: humans
Human subject study? A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviorsYes: Interacting w/ living individuals.
Human subject study or not? Questioning a superintendent of schools to acquire data about the ethnic composition of a schoolNo: it is an "about what" question rather than "about whom" question
Human subject study or not? Study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over 3-month periodYes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation
Human subject study or not? Info collected by play ground designerNo: does not involve info about human subjects even though there is interactions between designer and school staff.
Human subject study or not? An analysis of aggregate dataNo: doesn't involve interactions w/ living individuals nor collection of private identifiable data
Human subject study or not? An economic feasibility studyNo: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer "about what" ? rather than "about whom" ?
According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or:identifiable PRIVATE information (Public info does not meet criteria)
Subpart of DHHS regulations provides additional protections for which vulnerable populations?1. Pregnant women 2. Fetuses 3. Neonates 4. Prisoners
Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations?1. elderly 2. students 3. for persons whose decision-making capabilities are impaired
The expedited review process may be used when the study procedures pose:No more than minimal risk and the research activities fall within regulatory categories identified as eligible
The expedited review process may NOT be used when the study procedures pose:-more than minimal risk, even if the subjects are adults, -the sponsor is in a hurry -the study replicates previously approved research
Continuing review of an approved and ongoing protocol...?Must occur within 12 months of the approval date (even if no additional risks have been identified)
Continuing review process must include:-unanticipated problems -number of subjects accrued -recent relevant literature -copy of current consent form
T/F Officials of the institution may overrule an IRB approvalTrue, however no one may overrule if an IRB disapproved a protocol
An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate meausre will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:Experience emotional or psychological distress
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful?Obtain a waiver of documentation of informed consent
The primary purpose of a Certificate of Confidentiality is to:Protect identifiable research info from compelled disclosure
Certificates of Confidentiality protect sensitive info provided by research subjects from:civil, criminal, or administrative subpoena
T/F Risk should be evaluated solely by the magnitude or severity of expected harm, not probabilityFalse: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered.
Risks are specific to:Time, situation, and culture
A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will:Not affect future care
T/F The fact that a therapist has access to her clients' records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assentFalse: S/he needs both parental permission & child assent
T/F School authority's permission to conduct research replaces the need for permission and assentFalse
T/F Children's right to choose cannot be overridden in the pursuit of an indeterminate community interestTrue, it cannot be overridden
Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the studyinforming participants they were assigned to a study based on undesirable or unflattering physical characteristics for example, or anything that may be judged negative or distressing would be considered appropriate criterion
A waiver of the requirement for documentation of informed consent may be granted when:The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality
As part of the consent process, the federal regulations require researchers to:Provide potential subjects with information at the appropriate reading comprehension level.
Data are made anonymous byDestroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which confidentiality procedure would protect against compelled disclosure of individually identifiable information?Securing a Certificate of Confidentiality.
When a focus group deals with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct?The researcher cannot control what participants repeat about others outside the group.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?There was neither a violation of privacy nor a breach of confidentiality
Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:Confidentiality of the prisoners' health status is maintained
Which of the following statements about prison research is true?Researchers may study the effects of privilege upgrades awarded by the prison.
An investigator is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:Not an excessive incentive.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:Not approve this project because the prisoners are merely a population of convenience for the student.
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in researchFederal regulations do not require the documentation of minors' assent.
According to Subpart D, research with children may be eligible for exemption when:The research involves the use of educational tests
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?The research must pose no more than minimal risk.
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
Parental notification, in lieu of active parental permission, is allowed when:An IRB has approved a waiver of the requirement for parental permission.
According to Subpart D, which of the following research activities with children would qualify for an exemption?Research about educational testing
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:Provide parents certain rights over their children's educational records.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?The Family Educational Rights and Privacy Act.
Which of the following is the LEAST important activity when protecting human subjects in international research?Assessing transportation conditions
The age of majority in international research is determined by theLaws, customs, and norms in the area in which the research will be conducted.
Which of the following activities constitutes engagement in research?Obtaining informed consent and conducting research interviews.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?Designing the survey so that subjects are not forced to answer one question before going to the next.
To minimize potential risks of harm, a researcher conducting an on-line survey can:Design the survey so that no direct or indirect identifiers are collected.
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
A HIPAA authorization has which of the following characteristics:Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...must be more detailed for disclosures that involve fewer than 50 subject records
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
Recruiting into research ...can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.
HIPAA's protections for health information used for research purposes...supplement those of the Common Rule and FDA.
HIPAAHealth Insurance Portability and Accountability Act of 1996
HIPAA privacy protections supplement those ofother federal regulations (viz., the Common Rule and FDA), state law, and certification/accreditation requirements.
HIPAA protectsprotects identifiable health information (PHI) originating or held in covered entities. De-identified data is not protected, and not all identifiable health information is considered PHI either
Under HIPAA, research activity using PHI generally requiresauthorization. However, there are several alternatives that allow bypassing the authorization requirement.
Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must beunderstood by researchers when HIPAA applies
If you're unsure about the particulars at your organization or have questions,consult with your organization's IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization's Security Official.
specified identifiers1.Names 2.All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: a.The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and bThe initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. 3.All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; 4.Telephone numbers; 5.Fax numbers; 6.Electronic mail addresses; 7.Social security numbers; 8.Medical record numbers; 9.Health plan beneficiary numbers; 10.Account numbers; 11.Certificate/license numbers; 12.Vehicle identifiers and serial numbers, including license plate numbers; 13.Device identifiers and serial numbers; 14.Web Universal Resource Locators (URLs); 15.Internet Protocol (IP) address numbers; 16.Biometric identifiers, including finger and voice prints; 17.Full face photographic images and any comparable images; and 18.Any other unique identifying number, characteristic, or code.
Vulnerable persons arethose who are less able to protect themselves than other persons in a given situation.
The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations,Pregnant Women, Human Fetuses and Neonates (Subpart B), Prisoners (Subpart C) and Children (Subpart D).
T/F Workers are considered vulnerable populationsFalse
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:pressure from their co-workers, unions and employers. Pressure can be applied to workers in subtle ways such as an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs, etc.
T/F When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.True
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:Conflict of interest
Significant financial interest can be defined as:- Equity/stock interests (regardless of value) in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000.
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) isGreater than $5,000 of ownership in any single public entity/public company.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:Any equity interest in a publicly held company that exceeds $50,000
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:Designated institutional officials
What constitutes "research" according to HIPAA?HIPAA defines research as any "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge
Who enforces HIPAA's protections?IRB Privacy Board Privacy Officer
Waivers and alterations of authorization requirementUse or disclosure of the PHI involves no more than minimal risk to the privacy of the research subjects, based on the following elements: oAn adequate plan to protect any data identifiers from improper use and disclosure. oAn adequate plan to destroy data identifiers at the earliest opportunity consistent with conduct of the research (unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law). oAdequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by HIPAA. oThe research could not practicably be conducted without the PHI. oThe research could not practicably be conducted without the waiver.
Activities preparatory to research, decedents' information exceptionsWhere the PHI will be used solely for reviews preparatory to research (e.g., for protocol development) and will not leave the covered entity. Where the PHI refers solely to deceased persons (the covered entity may ask for documentation of death of all data subjects
T/F A researcher may use fully "de-identified" health data without any authorization from data subjectsTrue
Grandfatherd researchif all informed consents and other legal permissions required at the time were in place before HIPAA took effect (April 2003 in most cases), and have not changed since, no new HIPAA authorization is required.
minimum necessary standardthe uses/disclosures must be no more than the minimum required for the described research purpose
accounting of disclosuresA list of all protocols for which their PHI may have been disclosed, along with the timeframe for those disclosures. The purpose of those protocols, and the types of PHI sought. The researcher's name and contact information for each study
Characteristics of authorizationsIn "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision. Executed in writing, and signed by the research subject (or an authorized personal representative).
T/F revocations for HIPAA authorizations for research can be revoked at any timeTrue Provided that the revocation is in writing
T/F It is permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriateTrue
Retrospective" researchuse or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board
what statement
studybud

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