Human Research Protection Program (HRPP) Seminar: Research Involving Vulnerable Populations Nidal Najjar, Ph.D. Social and Behavioral Sciences, FAS Social and Behavioral Sciences, FAS Sawsan Abdulrahim, Ph.D. Health Promotion and Community Health, FHS Policies and Procedures Committee for Risk Management and Reduction, HRPP December 13, 2010
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Human Research Protection Program (HRPP) Seminar: Research
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Human Research Protection Program (HRPP) Seminar:
Research InvolvingVulnerable Populations
Nidal Najjar, Ph.D.Social and Behavioral Sciences, FASSocial and Behavioral Sciences, FAS
Sawsan Abdulrahim, Ph.D.Health Promotion and Community Health, FHS
Policies and Procedures Committee forRisk Management and Reduction, HRPP
� Justice; equitable selection of participants and distribution of benefits
45 CFR 46� Code of Federal Regulations (CFR)� Title 45: Public Welfare, Dept. of Health and Human Services� Part 46: Protection of Human Subjects (Subparts A-E)
The Belmont Report, Office for Protection from Research Risks (1979)45 CFR 46 (2009)
Introduction (cont’d)� Research involving vulnerable populations has to pertain to
those specific populations.� Not out of convenience.
� Biomedical and social-behavioral research involving
Introduction (cont’d)� IRBs reviewing research involving vulnerable populations
� “should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations.” (Justice)
selected contexts, based on potential for coercion, which is typically due to an asymmetry of power.
DuBois (2006)
Seminar Outline:Vulnerable Populations� Introduction and relevant terms
� Vulnerable populations� People with mental disorders or decisional impairments� People who are economically disadvantaged� People who are educationally disadvantaged
Protections should be broadly applied regardless of particulars� A person impaired by brain injury or diabetes.� A person impaired as a result of schizophrenia or depression.� Both are entitled to the same level of protection.
Delano (2006)
People with Mental Disorders or Decisional Impairments (cont’d)� IRB regularly reviews research involving adults with
decisional impairments � membership includes persons familiar with the nature of impairment.
� Does not regularly review this type of research �� Scientific/clinical expertise� Patient/consumer representative
� “may do so at a lower level than the general population of a given community”.
� The PI could use other materials (e.g., pictures, videos) that would help potential participants with educational vulnerability understand all information necessary for informed consent.
� Ethical concerns: Respect, Justice
Harvard policy on vulnerable populations
Students and Employees� Non-statutorily protected
� Reminder: Non-statutorily protected populations are vulnerable only in selected contexts, based on potential for coercion, which is typically due to an asymmetry of power.
� Research in settings/institutions providing employment or
who are higher in rank.� Employees may be recruited by researchers other than
their direct or indirect employer, supervisor, or other members within the same department.
The Ohio State University HRPP Policies & Procedures (2009)
Case Study� A professor asked her students to do her a favor by staying
after class for a few minutes to fill out a research questionnaire. She added that this task was voluntary, but when a student, Andy, began to leave, the professor said, “I’m certainly glad that the rest of you are willing to help me out.” Andy sat down, but was embarrassed and felt he had
Andy sat down, but was embarrassed and felt he had jeopardized his standing with the professor.
Koocher and Keith-Spiegel (1998)
Case Study� A professor asked her students to do her a favor by staying
after class for a few minutes to fill out a research questionnaire. She added that this task was voluntary, but when a student, Andy, began to leave, the professor said, “I’m certainly glad that the rest of you are willing to help me out.” Andy sat down, but was embarrassed and felt he had
Andy sat down, but was embarrassed and felt he had jeopardized his standing with the professor.
Koocher and Keith-Spiegel (1998)
Vulnerable Populations: Seminar Outline� Introduction and relevant terms
� Vulnerable populations� People with mental disorders or decisional impairments� People who are economically disadvantaged� People who are educationally disadvantaged
� If it presents more than minimal risk and holds out no direct benefit to the child, it promises to generate important scientific knowledge about conditions that affect the wellbeing of children
*Definition of minimal risk is presented on next slide
� “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”
case research poses more than minimal risk, unless one parent is not available*
� Parental consent can be waived in the case of neglected or abused children, provided a mechanism is in place to ensure protections to this group of children in research
*Deceased, unknown, incompetent
Assent
� In addition to consent, assent – a child’s agreement to participate in research – should be solicited and documented when appropriate*
the pregnant woman and/or fetus � It generates important scientific knowledge
which cannot be obtained by other means
* Appropriate studies have been conducted, on pregnant animals and non-pregnant women and reasonable evidence exists for assessing potential risk to pregnant
women and fetuses
Also …
� The researcher is not involved in any decisions related to determining the viability of the fetus or the timing or procedure to terminate a pregnancy
� If research promises benefit solely to the fetus, the consent of both the pregnant woman and the father should be obtained, unless father’s consent is not needed*
*In the case of unavailability, incompetence, incapacity or if the pregnancy resulted from rape or incest
origin involuntarily and who are unable to return “owing to a well founded fear of being persecuted for reasons of race, religion, nationality, membership of a particular social group, or political opinion”*
� Line between voluntary and involuntary is fine and distinctions are political
* UNHCR Article 2 (1951); as cited in Birman (2006)
Domains (traits)* of vulnerability
� Legal restrictions (refugees)/lack of protections by state institutions (immigrants)
� Economic – lack of access to benefits� Social – stigma, stereotyping, and discrimination