In Part 2: Recruiting Quality Patient Volunteers For Medical Research, we’re going to discuss the topic of payments and its relevance to the recruitment effort.
FDA Policy On Payments.
The FDA is committed to the welfare of subject volunteers in clinical trials. As has already been stated, many participants are willing to expose themselves to great risk in order to secure a possible health advantage to their persons. Still others are willing to participate for chiefly altruistic reasons. If you wish to recruit quality patient volunteers, the National Center of Biotechnology lists several reasons attractive remuneration packages can enhance volunteer participation.
First, the promise of payment will increase participation levels because it removes the financial barriers that keep economically disadvantaged individuals away. Secondly, timely and adequate remuneration will increase participation from a diverse cross-section of the population. This will ensure that racial, gender, and ethnic diversity goals are met in the area of bio-medical research. Third, the promise of payment may also remove other barriers to participation such as lack of interest, low awareness levels, and inherent distrust of researchers.
For the payment scheme to be effective, research companies should stress that participants will be paid regardless of their ability to finish the entire process. Also, specific dollar amounts and/or non-monetary compensation should be listed for each research activity, whether it is a blood study, drug trial, or survey. According to Dickert and Grady’s 1999 survey of research organizations, 68% paid for travel expenses, 84% paid for the inconvenience to subjects, and 87% paid for the time subjects spent on the research. In the same study, 58% of the organizations list payment as an effective method of recruiting participants.
Concerns About Using Payment As An Inducement.
Some health experts worry that the prospect of monetary compensation could cloud the judgment of individual participants. Many argue that payments exceeding $500 could prove to be the downfall of unsuspecting, low-income participants. However, experts at the National Center For Bio-Technology (NCBI) maintain that depriving these economically disadvantaged individuals of fair payment will do little to protect them against actual, predatory organizations that seek to take advantage of their economic vulnerability. Interestingly, this is where the IRB comes in.
The Benefits of IRBs.
The IRB stands for the Institutional Review Board. In the United States, IRBs are organizations that consistently monitor and review the clinical projects of research organizations. IRBs are committed to the physical and mental health of research participants and as such, are responsible for ensuring that payment options to participants are fair and ethical. The boards also evaluate the health risks of specific clinical trials, review eligibility criteria for participants, and explore the vulnerabilities of potential participants from economically-disadvantaged areas.
According to NCBI guidelines, every participant is entitled to claim all the privileges of informed consent. This means that no participant can be forced to participate in any clinical trial against his/her better judgment. The IRBs are central to the clinical trial review process. A 2010 study showed that monetary compensation tops the list of reasons 77% of IRB chairpersons routinely authorize paying organizations to pursue their projects. With that said, it is worth noting that payment is one of many effective ways to recruit and retain quality patient volunteers.
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