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dc.contributor.authorBagenda, Godfrey
dc.date.accessioned2021-05-06T07:56:29Z
dc.date.available2021-05-06T07:56:29Z
dc.date.issued2020-06-25
dc.identifier.citationBagenda, G. (2020). Compensating health research participants : Research Ethics Committee members’ perspectives and ethical guidance (Unpublished master’s dissertation). Makerere University, Kampala, Uganda.en_US
dc.identifier.urihttp://hdl.handle.net/10570/8538
dc.descriptionA dissertation submitted in partial fulfillment of the requirements for the award of the Degree of Master of Health Science in Bioethics of Makerere University.en_US
dc.description.abstractBackground: Research participants in resource-poor settings face a risk of exploitation due to widespread poverty and their limited experience and understanding of research. Researchers have an obligation to protect research participants, for instance by appropriately compensating them and also ensure that any form of compensation offered does not affect their decision-making capacity. Few studies have explored perspectives, experiences of REC members and practices regarding compensation of research participants in Uganda. Objective: To assess REC member’s perspectives on compensation, examine provisions on compensation in local and international guidelines, and to review amounts in protocols that are approved as compensation for research participants. Methods: This was a cross-sectional mixed-methods study conducted at the Makerere University College of Health Sciences and Mulago National Referral Hospital in 2018. Key informant interviews were conducted with 20 Research Ethics Committee members. Document review of national and international research guidelines was carried out. A retrospective analysis of 152 studies approved by five RECs in February, March and April 2017 examined researchers’ compensation practices. Qualitative data were analyzed using thematic analysis. STATA version 15 was used to analyze quantitative data. Data were presented using descriptive statistics and displayed in tables. Results: Research Ethics Committee members expressed various views on compensating participants for time, effort and inconvenience. UNCST, CIOMS and ICH GCP guidelines had specific provisions on compensation for participation in research. Unlike the UNCST and ICH GCP, the CIOMS guidelines provide clear additional explanation as to how provisions on compensation should be interpreted. The CIOMS guidelines give a lot of discretion to local Research and Ethics Committees to assess how much should be offered to research participants. Money was the major form of compensation in all studies. Compensation for time and reimbursement were the main reasons for giving money to research participants. The median amount offered to participants in all the studies that were reviewed ranged from 10,000–25,000, with a median of 20,000 Shillings. While for clinical trials, the range was 10,000–50,000 with a median of 30,000 shillings. Conclusion: Most guidelines give generic guidance on the provision of compensation to research. Only the CIOMS guidelines provide clear additional guidance on how participants should be appropriately compensated. Research Ethics Committee members also emphasized that the national guidelines do not provide clear guidance on compensation research participants in Uganda. There was a wide variation in compensation practices ranging from no compensation to high compensation. A high proportion of studies reviewed did not compensate research participants. Regular research ethics training for researchers is required. Regular research ethics training for researchers is required and RECs should conduct routine on-site monitoring to ensure compliance with research ethics guidelines.en_US
dc.description.sponsorshipFogarty International Center, U.S. National Institutes of Healthen_US
dc.language.isoenen_US
dc.publisherMakerere Universityen_US
dc.subjectCompensatingen_US
dc.subjectHealth research participantsen_US
dc.subjectResearch Ethics Committeeen_US
dc.subjectEthical guidanceen_US
dc.titleCompensating health research participants : Research Ethics Committee members’ perspectives and ethical guidanceen_US
dc.typeThesisen_US


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