00000ctm a22000003a 4500 UP-1685523046126236532 Buklod 20120919102427.0 a r |||| u| ta 120919s xx d r |||| u| (iLib)UPMNL-00012502229 UPM-Main eng LG 995 2012 B5 M66 Montoya, Jaime C. Perceptions of selected Filipino participants on undue inducement for participation in clinical trials Jaime C. Montoya. Thesis (Master of Science in Bioethics) -- University of the Philippines Manila. xxv, 180 leaves. The main concern of this study was to describe the issue of undue inducement from the perspective of selected Filipino respondents that included clinical investigators and ethics review board (ERB) members. It specifically intended to determine the respondents' perceptions about appropriate and inappropriate monetary and in-kind compensation for clinical trials, the social factors associated with their perceptions, their knowledge and assessment about current compensation packages in the country, their undue inducement concepts and assessment of selected drug trials, as well as their views about Emanuel's four criteria on undue inducement. Descriptive research design utilizing the triangulation of methods particularly survey, focus group discussion, and review of literature were used for the study. The survey had 44 respondents (34 females and 10 males) while the three focus groups had 16 participants. These respondents were purposively drawn from among the participants of the Philippine Council for Health Research and Development's (PCHRD) ethics training workshops which were conducted in three cities from October 2007 to March 2008. A self-administered survey questionnaire and an FGD interview guide served as the research instruments. The survey respondents' mean age was 39 (range, 23-72) and they were mostly Catholics, married, Tagalog, Cordillera, and Cebuano. Only 18 were medical doctors. Close to three quarters (31 respondents) had no formal training in ethics. The majority were not ERB members. Only 19 have conducted clinical trials. Monetary and in-kind compensation in clinical trials are considered appropriate if: they are not excessive (payment too high that would make it difficult for participants to refuse from joining the study), the participants' opportunity costs (lost time and income) and expenditures are reimbursed, the participants safety is assured during and beyond the clinical trial period, sufficient information is provided regarding the risk and whatever invasive procedures is going to be performed, and informed consent is obtained from clinical trial participants. In other words, when the health, welfare and rights of the participants are taken into account, then compensation of whatever form is assessed as appropriate. A monetary or in-kind compensation is considered inappropriate or an undue inducement if the abovementioned elements are ignored or violated. If the participants' health, welfare and rights are not considered by the clinical trial researcher, then a compensation of whatever form, becomes an inappropriate inducement. Few respondents knew about monetary or in-kind compensation packages for clinical trial participants in the Philippine setting. Daily, per visit, and lump sum payment were the mode of monetary payment cited. Free medication, diagnostic/laboratory tests, medical care, meals, transportation, food/groceries, gift certificates, and T shirts are the in-kind inducement to entice potential participants to join clinical trials. Those who agreed that monetary compensation is always appropriate were mostly under 40 years old, female, unmarried, medical doctors, non-ERB members, and have conducted clinical trials. Ethnicity, religious affiliation, and formal training in ethics did not show marked differences among the respondents' answers. Those who agreed that compensation in kind should always be appropriate for clinical trials participants were mostly also below 40 years old, married, Catholics, medical doctors with formal training in ethics, ERB members, and who were engaged in clinical trials. Ethnicity showed no marked differences in the respondents' answer. The respondents' views about appropriate and inappropriate compensation for clinical trial participants provided the framework in assessing the drug trial cases presented to them. Emanuel's four criteria of what comprise an undue inducement appear to be similar to respondents' perceptions about this issue. The Emanuel criteria are perceived as useful for the Philippine setting and the respondents intend to use them in their work. The study recommended a list of topics for future research studies. Perception. Undue Inducement. UPMNL MED LG 995 2012 B5 M66 Thesis