Version Date: November 19, 2015
UW–Madison IRBs evaluate whether the selection of research participants is equitable when determining whether to approve research, or any changes to research. To make this assessment, IRBs will consider the following:
- Whether the purpose/nature of the research requires or justifies using the proposed population.
- The setting in which the research will be conducted.
- Whether there is an intention for the population to benefit from the research.
- Whether recruitment of participants, including any advertisements or payments, will be coercive or present undue influence.
- The inclusion/exclusion criteria for participants.
- Whether potential participants are vulnerable to coercion or undue influence, and what measures are being proposed to minimize the risks to these vulnerable participants.
Additional General Consideration for Participant Selection
When research involves vulnerable participants, or those vulnerable to coercion or undue influence, the IRB may consider the following to determine whether the population is suitable, and whether the burdens of research are being distributed equitably.
- The extent to which proposed participants are already burdened by poverty, illness, poor education, or chronic disabilities.
- Inconvenience to participants (i.e., the time required, travel involved, restrictions on diet, or other activities), and any discomfort, or potential embarrassment in addition to the risks associated with the research procedures.
- 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 be susceptible to pressure or who are already burdened.
- Whether it is possible to reduce pressure on certain groups of participants to participate in research (such as by consulting with a representative of the group beforehand)
- Whether the selection process overprotects vulnerable participants, such that they would be denied opportunities to participate in research.
- Whether recruitment materials and consent documents are appropriate for the population, and do not include exculpatory language.
Additional Considerations When Recruiting Participants for Clinical Research
When designing recruitment plans for participants involved in clinical research, Investigators should also be aware of the following:
- IRBs generally require that someone involved in the individual's care approach the potential participant first about study participation.
- Generally, IRBs do not allow the release of names of potential participants to investigators without prior permission from the potential participants, unless a waiver of consent for this activity is approved by the IRB.