Browsing by Author "Poland, Fiona"

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    Experiences of research ethics committee members and scientists of the research protocol review process in Uganda: a case study
    (International Health, 2020) Ssali, Agnes; Poland, Fiona; Seeleya, Janet
    We investigated how relevant and responsive scientists and research ethics committee (REC) members considered the research protocol review processes for health research practice in Uganda. Methods: Interviews were conducted with five scientists and five REC members. Data were analysed thematically. Results: How much to compensate for time, the amount of study information shared with volunteers and sample storage for future unknown research were areas of concern for REC members. Delays in getting feedback concerned scientists. Conclusions: Researchers and REC members need to hold regular discussions to ensure the review process is relevant and responsive.
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    Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda
    (BMC medical ethics, 2015) Ssali, Agnes; Poland, Fiona; Seeley, Janet
    Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team. Methods: Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis. Results: Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.