Human Research Protection Program: Policy

Equitable Selection of Research Participants

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: January 22, 2009

Purpose:  This document describes how the UW-Madison IRBs evaluate whether the selection of research participants is equitable.

Policy

I.      To approve research submitted for initial review, continuing review, or change of protocol, UW-Madison IRBs must make a specific determination that the selection of subjects is equitable. Belmont Report; 45 CFR 46.111(a)(3); 21 CFR §56.111(a)(3).

Procedure

II.     When reviewing research submitted for initial review, continuing review, or review of modifications, UW-Madison IRBs systematically evaluate whether the selection of participants is equitable. Belmont Report; 45 CFR §46.111(a)(3); 21 CFR §56.111(a)(3)].

III.    Investigators are asked to describe the subject population and recruitment methods in the Application for Initial Review:

 

Health Sciences IRB and Health Sciences Minimal Risk IRB: HS IRB and MR IRB Application for Initial Review.

 

Social and Behavioral Sciences IRB and Education Research IRB: SBS IRB and ED IRB Application for Initial Review.

IV.   In assessing whether selection of participants is equitable, the IRBs will consider:

A.  The purposes of the research

 

1.  Whether the nature of the research requires or justifies using the proposed participant population

 

2.  Whether there is an intention for that population to benefit from the research.

B.  The setting in which the research will be conducted

C.  The inclusion/exclusion criteria described in the protocol

 

1.  Investigators are required to justify any proposed involvement of institutionalized persons, disproportionate numbers of participants of a particular gender or ethnic or racial group, individuals with impaired decision-making capacity or persons at the lower end of the socioeconomic scale.

D.  The manner in which subjects will be recruited, i.e., whether recruitment processes and/or advertisements affect the equitable selection of participants

E.  Whether the amount of payment to participants and the proposed method and timing of disbursement are coercive or present undue influence.

F.  Whether potential participants are vulnerable to coercion or undue influence, and what measures are being proposed to minimize the risks to these vulnerable participants.  In reviewing the selection criteria in research involving vulnerable participants, the IRB may consider such issues as:

 

1.  The extent to which a proposed subject population is already burdened by poverty, illness, poor education, or chronic disabilities in deciding whether they are a suitable subject population.

 

2.  When determining whether the burdens of research are being distributed equitably, such things as inconvenience (i.e., the time required, travel involved, restrictions on diet, or other activities), discomfort, and embarrassment in addition to the risks associated with the research procedures.

 

3.  Whether it would be possible to conduct the study with other, less vulnerable participants, and whether that would entail additional expense or inconvenience.  Whether the convenience of the researcher or possible improvement in the quality of the research justifies the involvement of participants who may either be susceptible to pressure or who are already burdened.

 

4.  Whether means exist for reducing the pressures on certain classes of subjects to participate in research, e.g., consulting beforehand with representatives of the proposed participant group.

 

5.  Whether the selection process overprotects potential participants who are considered vulnerable (e.g., children, cognitively impaired, economically or educationally disadvantaged persons, patients of researchers, seriously ill persons) so that they are denied opportunities to participate in research.

 

6.  Whether recruitment materials and consent documents are in language appropriate for the population in terms of reading level and language used.  If participants are illiterate or non-English speaking subjects, the IRB may require an oral consent process, translation of documents into subjects’ language or the use of a subject advocate.

G. In clinical trials, the IRBs generally require that someone involved in the individual’s care to approach the potential participant first about study participation.

H.  Generally, the IRBs do not allow the release of names of potential participants to investigators without prior permission from the potential participants, especially in the case of medical research.

I.   Whether there were insufficient veterans available to complete the study so that non-veterans could be entered into VA-approved research studies.

 

For additional information, see UW-Madison’s guidance on Equitable Selection of Participants on the Human Research Protection Program website (http://www.grad.wisc.edu/research/hrpp/submissioninstructions.html) and OHRP’s IRB Guidebook Chapter III: Basic IRB Review.