Use of Vulnerable Populations

The IRB Process

Risk


Introduction

The protection of human subjects is the paramount consideration of the IRB. Each project is reviewed to determine whether some or all of the subjects are likely to be vulnerable to coercion or undue influence to participate. These vulnerabilities may be subtle but may limit the ability of certain subjects to refuse to participate or to continue to participate in the research. The IRB must assure that due consideration of this issue is addressed in the research plan. Additional safeguards may need to be included in the study to protect the rights and welfare of these subjects.

The federal regulations provide that additional safeguards to protect subjects' rights and welfare must be included in any study where "some or all of the subjects are likely to be vulnerable to coercion or undue influence." Examples of such vulnerable subjects are children, prisoners, pregnant women, mentally disabled persons, and persons who are economically or educationally disadvantaged.

The consent process must be conducted only under circumstances that provide the prospective subject sufficient opportunity to consider whether or not to participate. Research conditions must also minimize the possibility of coercion or undue influence to give consent.

Persons with acute and/or severe physical or mental illness may be overly compliant with requests to participate in research due to the effects of their illness or due to the prospect of relief from suffering. Clinical studies must be specially designed to assure that patients are able to consent freely. Additional safeguards may include such requirements as the co-consent of relatives, parents, or impartial observers. In acute illness, patients may need to be treated before being entered into research protocols as subjects. This may mean that subjects are sometimes lost to the research protocol.

Occasionally, the institutional setting in which the consent is sought will pose the possibility of coercion. Conducting research at institutions that provide services to subjects may be perceived as implying that continued service is dependent upon participation in the research. Students in the educational setting may be concerned that refusal to participate will affect their grades. These institutional pressures should be addressed in the research design. The protocol must adequately preserve the right to refuse participation.

There are many other examples of possible sources of undue influence on subjects. It may not be possible to remove all sources of influence, but the IRB must examine each project to assure the elimination of coercion and minimization of other influences.

The requirement to obtain informed consent should be seen as not only a legal obligation, but also as a moral obligation. The research design must adequately address how informed consent will be obtained and what information will be given to prospective subjects. IRBs must look at the coercion issue in each proposal and insist on experimental designs that protect against undue influence to participate.

Points To Consider

  • Are recruitment procedures designed to assure that informed consent is freely given?
  • What special safeguards are included to protect the rights and welfare of subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, persons with physical or mental illness, and persons who are economically or educationally disadvantaged)?
  • Does the nature of the disease or behavioral issue to be studied permit free consent?
  • Are any incentives offered for participation likely to unduly influence a prospective subject's decision to participate?
  • Is there an adequate procedure for monitoring the consent process, and should the IRB or its representative observe the process?