The IRB Process

Design Issues

Compensation/Incentives for Participation

Introduction

Each year, thousands of individuals are paid for participating in biomedical and behavioral research funded either by federal departments and agencies or private institutions. Although payments are usually monetary, both patients and normal healthy volunteers may be offered other rewards in lieu of or in addition to money. Free medical care, extra vacation time, and academic rewards (in the form of a grade or a letter of recommendation) are examples of alternative rewards. Regardless of the form of remuneration, the issues for the IRB remain the same. The IRB must consider whether paid participants in research are recruited fairly, informed adequately, and paid appropriately. Taking into consideration the subjects' medical, employment, and educational status, and their financial, emotional and community resources, the IRB must determine whether the rewards offered for participation in research constitute undue inducement.

IRB Considerations

The IRB must attempt to make sure that prospective subjects realize that their participation is voluntary, and that choosing not to participate will not adversely affect their relationship with the institution or its staff in any way. To make this determination, the IRB needs to know who the subjects will be, what incentives are being offered, and the conditions under which the offer will be made.

Determining the appropriateness of the incentive is another matter. For research that requires subjects to undergo only minor inconvenience or discomfort, a modest payment will usually be adequate. Reimbursement for travel, babysitting, and so forth may also be provided. In more complex research projects, the IRB tends to base their assessment on the prevailing payment practices within the institution or general locale.

Another point which is often ignored is the fact that participants must be able to withdraw from the study without any penalty. This includes subject payments, incentive gifts, and extra credit. Thus, the research methodology need to be designed in such a manner to allow participants to withdraw and still receive payment.

This issue is most pronounced in educational institutions. Participants are often recruited from classrooms or "subject pools." In most cases, students are given the opportunity to participate in research for extra credit points. Researchers need to ensure that students who do not or cannot participate will be given an alternative method to obtain extra credit (see the section on the use of students in research for more information). Researchers may need to work with instructors to ensure that students are aware that options exist.

Points To Consider

• Are all conditions in keeping with standards for voluntary and informed consent?

• Are the incentives offered reasonable, based upon the complexities and inconveniences of the study and the particular subject population?

• Is coercion or undue influence is a problem in recruitment strategies?