Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-8

Title 8:

Equitable Subject Selection

Effective Date:

06-21-06

Revision History:

12-06-04

Objective

To provide the VCU human subject research community with guidance regarding equitable subject selection as it pertains to ensuring justice the fair selection of research subjects.

Description

Both the risks and the potential benefits of research should be spread fairly among potential individual subjects and subject groups. Study design and selection should avoid bias for or against particular social, racial, sexual, or ethnic groups.

  1. Sharing Research Risks:

    The guiding principle in the ethical selection of subject groups is that any risks of the research should fall equitably upon the groups who might benefit from the research. If the results of a risky protocol might benefit the general population, it would be unethical to focus subject recruitment on vulnerable or disadvantaged groups (e.g., institutionalized people or prisoners, the uninsured, patients using government-run clinics). Groups already burdened by other factors should not also be burdened by an undue share of research risks.

    In addition, groups folly able to consider research risks and informed consent should be asked to face research risks before more vulnerable populations. For example, investigational drugs usually are tested with consenting, capable decision makers before considering research on the decisionally impaired.

  2. Sharing Research Benefits:

    Attention is now being paid to the rights of various groups to be included in research. Many research subjects, in search of the best medical care available, have come to insist on having access to experimental treatments. For many others, an experimental treatment may be the only type of potential treatment available. It is important to note that, in the past, many clinical trials have focused primarily on white male middle class subject groups, at times leading to results of questionable value to members of other social, racial, gender, and ethnic groups.

    As a result, both the Food and Drug Administration and the National Institutes of Health now require that study design include as broad a range of subjects as feasible and ask that data be analyzed to uncover responses that differ between groups. Where women of child-bearing potential and pregnant or nursing women previously were routinely excluded from new drug trials, it is now required that, whenever possible, these women be asked to make their own choices after being folly informed of the risks of the research. While in the past, participation was sometimes viewed as a burden, it is now can also be viewed as a right.

  3. Individual and Social Justice:

    The selection of subjects of research occurs at two levels of justice: social and individual. Individual justice in the selection of subjects requires research to exhibit fairness between and among potential research participants. Potentially beneficial research or risky research ought to be offered to and made available to as varied a subject population as possible. Social justice requires that inclusion and exclusion criteria for research participation consider the equitable dissemination of research benefit and risk among the represented constituencies within the targeted community(ies).

  4. VCU Guidance:

    To adequately assess the risks and benefits of participation in research, the VCU IRB requires accurate information regarding the number of subjects to be recruited and tested. In addition, the VCU IRB will closely examine the characteristics of the subject population, such as age, gender, and population diversity outlined in the protocol and the procedures for identifying and recruiting subjects.

    The VCU IRB will ask for a clear and compelling justification if women and/or minorities are not appropriately represented or are excluded from the research. Similarly, the VCU IRB will ask for a clear and compelling justification if it is found (e.g., at continuing review) that the research has enrolled an unusual number of minority subjects, women, or uninsured.

    In order to ensure that the burdens of research are evenly distributed, the VCU IRB is required to consider more than the risks associated with the research procedures. The VCU IRB will also consider the impact participation in research poses on the daily life of the potential subject. For example, the IRB will consider reimbursement of subjects for inconvenience posed by the research, such as: the time required to participate; travel involved and/or parking costs; restrictions on diet or other activities; etc. Investigators should include provisions in the protocol for addressing these concerns, especially for research that poses little or no direct benefit for the subjects.

    Recruitment should not be restricted to certain populations of potential participants simply on the basis of convenience or efficiency, or by exploiting vulnerable individuals or communities.

Responsibility

It is the responsibility of the principal investigator to plan recruitment strategies that target a broad range of members of the community. It is also the responsibility of the principal investigator to monitor ongoing recruitment to ensure equitable subject selection as well as equitability in subject retention. Concerns or issues should be reported to the IRB.

It is the responsibility of the IRB to consider the equitability of subject selection, including the inclusion and exclusion criteria, recruitment plan, language barriers, and compensation.

References

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. April 18, 1979.