We discuss issues applicable to pay-to-participate trials, make recommendations appropriate for case-by-case review, and provide questions for potential subjects to ask about pay-to-participate trials.īroadly speaking, there are two variations of pay-to-participate trials. We begin from the position that whenever possible, it is best to avoid charging for research participation use of traditional funding models increases access to clinical trials, helps ensure the generalizability of the knowledge generated from research, honors subjects’ contributions to the socially valuable endeavor of research, and accords with the ethical standards normally applied by the regulated research community. Our intent is to identify considerations that can be used to balance the benefits and harms of this research funding model. SACHRP acknowledges that there may be legitimate reasons to charge research subjects, and that prohibiting pay-to-participate trials could in some instances preclude valuable research. SACHRP’s goal is to provide IRBs, sponsors, investigators, institutions, and prospective subjects with points to consider in the assessment of pay-to-participate research. NIH has asked SACHRP to consider whether there are questions that prospective subjects should ask, or objective criteria that they should consider, that are unique to pay-to-participate trials and that would facilitate understanding of any implications of participating. Prospective subjects considering pay-to-participate trials are also in need of guidance.
Investigators and sponsors conducting pay-to-participate trials may also face conflicts between optimal study design and conduct and the expectations of those subjects who, because they are bearing the financial costs of the research, consequently expect individual benefit. However, the relevant issues are not limited to those contexts. IRBs may face the greatest difficulty in review and oversight when pay-to-participate trials involve medical products that are not clearly regulated by FDA as drugs, biologics or devices – for example, nutritional supplements, surgical procedures, autologous stem cell transplants meeting minimal manipulation and homologous use criteria, and novel applications of standard treatments. For the purposes of this recommendation, SACHRP will use the terms “pay to participate” and “pay-to-participate trials” to describe this situation.Īnecdotally, SACHRP is aware that IRBs are increasingly asked to review pay-to-participate trials, but lack clear guidance about their ethical and regulatory acceptability, as well as how best to systematically examine the ethical and regulatory issues. Sometimes, however, potential subjects are asked to pay to participate in research. Rather, subjects generally participate without being charged for research interventions and associated care, and conversely, are often reimbursed for study-related expenses, offered compensation for time and burden, and/or paid incentives to encourage enrollment and retention. In these clinical trials, it is unusual for the sponsor, institution, or investigators to ask subjects to bear costs beyond those associated with usual care. Most clinical trials conducted in the United States are funded either by the federal government, particularly the National Institutes of Health (NIH), or by private drug and device companies.
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