earning extra credit, the possibility of undue influence is minimized.
In addition to undue influence that can arise with the offering of rewards, undue influence also can be subtle. For example, students might feel pressure to participate in research if everyone else in the class is doing so. Because influence is contextual, and undue influence is likely to depend on an individual's situation, it can be difficult for IRBs to distinguish undue influence. It is up to the IRB to use its discretion in determining which circumstances give rise to undue influence. For example, an IRB might consider whether the informed consent process will take place at an appropriate time and in an appropriate setting, and whether the prospective subject may feel pressured into acting quickly or be discouraged from seeking advice from others.
Because of their relative nature and lack of clear-cut standards on the boundaries of inappropriate and appropriate forms of influence, researchers and IRB members must be vigilant about minimizing the possibility for coercion and undue influence. Reasonable assessments can be made to minimize the likelihood of undue influence or coercion occurring. For example, the IRB may recommend restricting levels of financial or nonfinancial incentives for participation and should carefully review the information to be disclosed to potential subjects to ensure that the incentives and how they will be provided are clearly described. Known benefits should be stated accurately, and potential or uncertain benefits should be stated as such, with clear language indicating how much is known about the uncertainty or likelihood of these potential benefits.
The IRB should be especially attentive to reviewing research protocols when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. In these instances, additional safeguards are to be included in the study to protect the rights and welfare of these subjects. Thus, inducements that would ordinarily be acceptable in some populations may become undue influences for these vulnerable subject groups.
It is not uncommon for subjects to be paid for their participation in research. Payments to research subjects for participation must not be considered a benefit. Researchers seeking IRB approval for a project involving payments to research subjects will present the amount and schedule of payments to the IRB at the time of the initial review. The IRB will review both the amount of the payments and the proposed method and timing of disbursement to assure that neither are coercive nor present undue influence.
In no case should remuneration for participation in research be viewed as a way of offsetting risks; that is, it should not be considered a benefit to be weighed against study risks. The level of remuneration should not be so high as to cause a prospective subject to accept risks that they would not accept in the absence of the remuneration.