VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

appropriate level of payment is contingent upon a variety of factors, including: the amount of inconvenience or time associated with participation, local economic and cultural factors, the socioeconomic status of prospective subjects and any other circumstance that may affect subjects’ ability to make a decision regarding their participation in the study. Payment should not depend on the degree of risk or amount of discomfort associated with participation. 16.4. Lotteries & Door Prizes Occasionally, investigators who are not in a position to offer equal compensation to each research subject may propose to substitute a drawing as an incentive. For example, an investigator with only $200 to compensate 100 subjects might propose a drawing for two $100 prizes rather than paying each subject $2.00. VCOM research projects may not include distribution of prizes to the research subjects via chances purchased by the human subjects or obtained by them in exchange for something of value including money, human tissues or blood samples, etc. The terms used for these purchased chance distributions include “lottery” and “raffle.” The prohibition is pursuant to state law and VCOM policy. A prize distributed by chance where the chance is obtained merely by attendance at an event (sometimes called a “door prize”) and not by the payment of any fee, donation or other consideration is not prohibited by law or VCOM policy. Regardless of the terminology used, College research should generally not include distribution of incentives to human subjects by chance. This method may represent coercion or undue influence if the incentive is sufficiently valuable. Additionally, the distribution of incentives via chance represents an unequal distribution of the incentive and may be unfair to subjects who will ultimately receive nothing. Generally, rather than conducting a drawing, researchers should provide equitable incentives to each subject, even if such a practice diminishes the value of the incentive. However, use of incentives structured as described above for “door prizes” may be considered by the IRB on a case-by-case basis for research studies of minimal risk and brief duration if the proposed incentives do not have potential for coercion or undue influence and clearly are not distributed in exchange for valuable consideration such as blood or tissue samples, significant time and effort in research participation, etc. If such an incentive is approved for a given study, consent form language describing the incentive should avoid terms like “lottery” or “raffle.” Acceptable terminology might include a reference to a “drawing based on chance in which each subject has equal odds of receiving [the incentive]. Participants should be informed of their odds of winning the lottery or raffle, and how they will be contacted for said prize to be awarded. 17. VULNERABLE SUBJECTS Vulnerable subjects include children, pregnant women, fetuses, prisoners, physically or cognitively challenged, economic or socially disadvantaged, and subordinate individuals (e.g. students and employees). The degree to which these potential subjects are vulnerable is directly related to the degree to which these individuals are capable of volunteering or providing informed consent to research participation. Specific federal regulations (DHHS 45 CFR 46 Subparts B – D and FDA 21 CFR 56) apply to conducting research with vulnerable populations. These regulations assure that the risks associated with participation are minimal or the research is of direct benefit to the subjects.

VCOM Institutional Review Board Policies and Procedures

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