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.
As a rule, deception of subjects is not considered ethical in human subject research, especially in relation to the principle of informed consent. In certain circumstances, the IRB may approve the use of deception when it is deemed absolutely necessary for the study and does not put the subjects at inappropriate risk. In such instances, researchers may be asked to debrief subjects upon completion of their participation, and this debriefing should disclose the deception used and why the use of deception was necessary.
Financial conflict of interest in research is the existence of a significant financial interest on the part of researchers that an independent observer might reasonably determine could affect or compromise, or appears to affect or compromise, the design, conduct, reporting, or management of research. Financial conflicts of interest have the potential to skew or influence the collection, analysis, and interpretation of data, the hiring of staff, the procurement of materials, the sharing of results, the choice of protocol, the