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

December 13, 2010

Seminar Outline

� Introduction and relevant terms

� Vulnerable populations

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� Q&A

Seminar Outline:Introduction and Relevant Terms

� Introduction and relevant terms� Research ethics and human participants

� The Belmont Report and 45 CFR 46� Relevant terms

� Vulnerable

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� Vulnerable � Statutorily protected� Non-statutorily protected

� Vulnerable populations

� Q&A

IntroductionEthical conduct in teaching and research

The Belmont Report� Respect for persons; autonomy and informed consent� Beneficence� Justice; equitable selection of participants and distribution of

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� 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

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� Biomedical and social-behavioral research involving vulnerable populations should adhere to � general guidelines of research included under the

45 CFR 46, Subpart A� extra protections outlined in Subparts B, C, and D

45 CFR 46DuBois (2006)

Introduction (cont’d)� IRBs reviewing research involving vulnerable populations

� include “one or more individuals who are knowledgeable about and experienced in working with these [populations].”

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45 CFR 46DuBois (2006)

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)

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research involving vulnerable populations.” (Justice)

45 CFR 46DuBois (2006)

Relevant Terms: Vulnerable� In the context of research, vulnerable persons or vulnerable

populations are� “those who are relatively (or absolutely) incapable of

protecting their own interests.”� vulnerable to coercion or undue influence.

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� vulnerable to coercion or undue influence.

Levine (1988)

Relevant Terms: Statutorily and Non-Statutorily Protected

� Statutorily protected populations are vulnerable in the research context, irrespective of research question or setting.

� Non-statutorily protected populations are vulnerable only in selected contexts, based on potential for coercion, which is

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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

Students

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� Students� Employees� *Children� *Pregnant women and fetuses� *Prisoners� Immigrants and refugees

� Q&AStatutorily Protected; Non-Statutorily Protected; *45 CFR 46

People with Mental Disorders or Decisional Impairments� Statutorily protected

� Mental disorder vs. decisional impairment

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People with Mental Disorders or Decisional Impairments (cont’d)

Mental disorder is� a clinically significant psychological syndrome that occurs in

an individual and is associated with distress, disability, or with an increased risk of suffering death, pain, or an important loss of freedom;

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important loss of freedom;� must not be an expected and culturally sanctioned

response to a particular event.

American Psychiatric Association (2000)

People with Mental Disorders or Decisional Impairments (cont’d)

Decisional impairment� The ability to reason and make sound choices is affected. � Not a chronic condition; it might be temporary, permanent,

progressive, or fluctuating.

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Delano (2006)

People with Mental Disorders or Decisional Impairments (cont’d)

Lacking the ability to provide valid informed consent.� Parent, legal guardian, legally authorized representative (LAR)

Ethical concerns: Respect, Justice, Beneficence.

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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

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� Patient/consumer representative� Family member (spouse, parent, LAR)� Advocacy group member

� As complexity and risks of procedures increase, the required level of capacity should also increase.

Delano (2006)

People Who are Economically Disadvantaged� Statutorily protected� Economic vulnerability refers to the lack of “access to

adequate income, housing, or health care”.� A Principal Investigator (PI) may not recruit an individual who

is economically vulnerable when research participation “appears to offer benefits that are badly needed and only

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“appears to offer benefits that are badly needed and only available to the individual through research participation”.

� Ethical concerns: Respect, Justice

DuBois (2006)

People Who are Educationally Disadvantaged� Statutorily protected� Educational vulnerability refers to having

� “limited education,”� not being able to read or write, or� “may do so at a lower level than the general population of a

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� “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

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� Research in settings/institutions providing employment or services (e.g., medical care or education).

� Ethical concerns: Respect, Justice, Beneficence

DuBois (2006)The Ohio State University HRPP Policies & Procedures (2009)

Students� Students should not be recruited by their professors when

those professors are the PIs.� Students may be recruited through student participant

pools� E.g., Psyc 202 participant pool

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� E.g., Psyc 202 participant pool� Such recruitment may be facilitated by the students’

professors, provided that those professors are not the PIs.

Employees� Non-statutorily protected

� Employees may not be recruited by their direct or indirect supervisors or directors, or by others of their department who are higher in rank.

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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

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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

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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

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� People who are educationally disadvantaged� Students� Employees� Children� Pregnant women and fetuses� Prisoners� Immigrants and refugees

� Q&A

Children, pregnant women/fetuses, and prisoners

� Researcher has to follow:� General guidelines for research with human

participants outlined in 45 CFR 46, subpart AANDAND

� Specific guidelines for each one of these vulnerable groups as outlined in 45 CFR 46, subparts B, C, and D

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Children

� Statutorily protected� (45 CFR 46, Subpart D)� “ … persons who have not attained the legal

age of consent to treatment or procedures

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age of consent to treatment or procedures involved in the research”

� Cognitive/developmental vulnerability� Children may be unable to protect their own

interests and/or to provide informed consent

Exemptions from IRB review

� Research on educational tests or the effectiveness of instructional strategies

� Research on the behavior of children in public settings, which does not involve

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public settings, which does not involve interference by the researcher

� Note: research on children in school settings is *NOT* necessarily exempted

Research on children may take place provided that …

� It presents no more than minimal risk*� If it presents more than minimal risk, it holds

out the prospect of direct benefit to the childIf it presents more than minimal risk and

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� 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”

http://www.aub.edu.lb/irb/Pages/SocialApplicationsForms.aspx

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Consent

� Consent for participation should be provided on behalf of the child by a parent (biological or adoptive) or a legal guardian

� Consent from both parents is required in the case research poses more than minimal risk,

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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*

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appropriate*� Information about the study in the assent

form should be presented at an appropriate level for the child participant

*Age, maturity, psychological state

Pregnant women and fetuses

� Statutorily protected� (45 CFR 46, Subpart B)� Pregnancy is “ … the period of time from

implantation until delivery”

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implantation until delivery”� The fetus is “ … the product of conception

from implantation until delivery”

Changing regulations

� Exclusion of women of childbearing potential from biomedical research

� Ensuring that women (and ethnic/racial minorities) were not unjustifiably excluded

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minorities) were not unjustifiably excluded from research

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Research on pregnant women/fetuses may take place provided that …

� It presents no more than minimal risk*AND

� It holds out the prospect of direct benefit to the pregnant woman and/or fetus

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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

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terminate a pregnancy� The researcher does not offer any

inducement, monetary or otherwise, to terminate the pregnancy

Consent

� If research promises benefit to the pregnant woman and the fetus, consent by the pregnant woman is sufficient

� If research promises benefit solely to the

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� 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

Prisoners

� Statutorily protected� (45 CRF 46, Subpart C)� “ … individuals involuntarily confined or detained

in a penal institution”*

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in a penal institution”*� Institutional vulnerability� Persons incarcerated may be unable to make truly

voluntary or uncoerced decisions to participate in research

*Confined pending arraignment, trial, or sentencing; sent by court order to rehabilitation facilities; minors in correctional facilities

Research on prisoners may take place provided that …

� It presents no more than minimal risk� Its intent is to understand the prison as an

institution; conditions that affect prisoners; causes and consequences of incarceration;

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causes and consequences of incarceration; the behaviors and/or wellbeing of prisoners

� Advantages of research should not be of such a magnitude to impair decision-making in a “limited choice environment”

� Participants are fairly selected

Consent and IRB Composition

� Consent should clearly state that the participation of the prisoner in research will not affect decisions

� Invite a prisoner or prisoner representative to provide expertise during IRB deliberations

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not affect decisions regarding his/her parole

deliberations� The majority of IRB

members should not be affiliated with the prison system

Immigrants and Refugees

� Non-statutorily protected� Immigrants are individuals who leave their country of

origin voluntarily primarily for economic reasons (documented or undocumented)

� Refugees are individuals who leave their country of origin involuntarily and who are unable to return “owing

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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

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� Circumstantial vulnerability – consenting to participate in research during crisis (refugees)

� Communicative vulnerability – language and culture

*National Bioethics Advisory Committee, NBAC; cited in DuBois (2006)

Cultural norms

� Respecting the cultural norms of the immigrant/refugee community; appropriate or ethical behavior may be defined differently by participants

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participants� Seeking feedback from “cultural insiders” on

issues related to consent and voluntariness� Acknowledging diversity within an immigrant

or a refugee groupBirman (2006)

Migrant Domestic Workers

in Lebanon

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in LebanonFair selection; legal issues;

informed consent; and stigma

Fair selection� Women who work as

free-lancers exercise more autonomy and are

Legality� However, Free-

lancing is technically illegal in Lebanon

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more accessible to participate in research

illegal in Lebanon under the kafala system� Certificate of non-

disclosure

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Consent� Translating the consent

form� Recruiting women to

participate through “gate-

Stigma� Can (well-meaning)

research further stigmatize immigrants/refugees?

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participate through “gate-keepers”

immigrants/refugees?� Research that portrays

immigrants/refugees as:�Less intelligent�Passive and accepting

Vulnerable Populations: Seminar Outline� Introduction and relevant terms

� Vulnerable populations

� Any questions?

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� Any questions?

Thank you!