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This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to convey information and enhance research participants' understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified.

Introduction: While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. Methods: A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. Results: There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. Conclusion: Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication. [ABSTRACT FROM AUTHOR]

Background The Makerere University Faculty of Medicine Research and Ethics Committee reviews and approves more than 100 new research protocols a year, yet its activities had never been evaluated as far as the researchers are concerned. Methods and results This was a cross sectional study at Makerere University Faculty of Medicine and Mulago Teaching Hospital. The survey population included all staff involved in research at the post graduate level and faculty. Most of the respondents agreed that decisions of the REC were binding 53 (75.7%),15 (21%) hold that were variable and 2(2.9%) biased. The biased attitudes of researchers regarding protocol review reduces as researchers present more protocols to the REC. Most of the respondents do agree that the REC makes researchers more aware of ethical issues (52.9%), that ethical review is important for protection of human subjects (55.8%), and that the system of ethical review protects human research participants (65.7%). 48.6% believed that the REC ensures that researchers adhere to elements of the consent process which help to protect the autonomy of research participants. However 51% doubt the ability of the REC to ensure that researchers adhere to elements of the consent process during conduct of research More than 97% of the respondents believe that the REC is either average or very good, while 2.8%rank it below average. Conclusion The Research and Ethics Committee sticks to the scientific design and ethical issues to ensure protection of research participants. Some respondents reported bias during review, delay in approval of protocols as well as lack of follow up of on going research. However, majority of respondents ranked the committee as average or above average. [ABSTRACT FROM AUTHOR]