- Perceptions on Undue Inducement for Participation in Clinical Trials in the Philippines
There are few published literature dealing with the topic of appropriateness of compensation for clinical trial participants as well as the current modes of compensation in clinical research. Most of them, whenever available, were done in the developed countries such as the United States and Europe and therefore does not take into consideration the cultural context of developing countries like the Philippines. Based on historical records of clinical studies done in the past, inducements for research participants in clinical research through payments may have been a predominant practice for a long time even without the existence of proper guidelines on whether or not the practice of inducement is appropriate and how and in what manner this should be done in clinical research.1, 2 Currently, the issue has even become more complicated with the onset of cyber technology and the internet. There are now websites that advertise clinical studies with promises of significant compensation for willing subjects. One would therefore ask whether the ethical, moral and legal issues of inducement were ever considered or discussed by the research sponsors and investigators.
There was a study done by Grady et al. in the US involving a review of 467 clinical research studies that offered payment to research subjects and approved by 11 Institutional Review Boards (IRBs) across the US composed [End Page 8] of 7 academic IRBs in medical centers and 4 independent IRBs.3 Independent IRBs are commissioned by pharmaceutical companies to review their protocols based on the list of accredited IRBs by the Health Industry Manufacturers Association (HIMA, USA), as compared to academic IRBs which are based in universities or medical centres. Money was offered in a variety of studies, from short-term physiologic studies to large clinical trials of therapeutic interventions, to patients (61%), healthy (24.4%) subjects or both (14.6%). Dollar amounts varied widely and were infrequently explicitly described as based on time (19%) or procedures (12%). Although the amount varied considerably ($5–$2,000), total amounts were usually low by US standards (median $155), and almost always described in the consent form (94.4%) and usually prorated based on time spent in the study (73%).3 It is important to note that at least 23% of the 467 clinical researches approved by the 11 IRBs paid subjects. Payments to research subjects were generally higher for clinical trials reviewed by independent IRBs and clinical trials funded by pharmaceutical companies.3
A similar study was done in Australia to examine current research payment practices using an email-based questionnaire.4 A total of 100 completed questionnaires were received with respondents covering a range of research organisational types, research target groups, and research methods.
Based on this study, payment practices were found to be highly variable. Payment was standard practice for around one-third (34%) of the respondents and not standard for just over half (54%). The remaining 12 per cent of respondents indicated that practices varied according to factors such as research type, demand characteristics and the target group. Examination of organisation type (e.g. hospital, government, university, etc.), research target group (e.g. children/youth, health professionals, patients, etc.), and research method (e.g. epidemiology, clinical research, market research, etc.) revealed no clear pattern to payment practices. Where reimbursements were provided at all, the monetary amount varied between AUD$15 and AUD$200.
In another study by Dickert et al. (2002), only 8 of the 32 institutions in the US included in the study have any standard payment scheme, which explains the wide differences in payments even within institutions. Only 37.5% of organisations (12 of 32) reported having written policies or guidelines about payment of research subjects. Only 8 of these 32 organisations reported using a particular formula to calculate amount of payment.5
There are very few studies that attempted to explain why research participants are being paid for participation in research. Grady et al. (2005) presented some of the possible reasons for paying research participants:6 [End Page 9]
1). To recruit adequate numbers of research subjects
2). To overcome opportunity costs, inertia and distrust, and...