Volunteer Experiences & Perceptions of the Informed Consent Process: Lessons from Two HIV Clinical Trials in Uganda

Background

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.

Conclusion

Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.

Full article at:  http://goo.gl/N43pgl

By:  Agnes Ssali^1*, Fiona Poland² and Janet Seeley¹³

¹Medical Research Council/Uganda Virus Research Institute (MRC/UVRI) Uganda Research Unit on AIDS, Kampala, Uganda

²University of East Anglia, Norwich, UK

³London School of Hygiene and Tropical Medicine, London, UK

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Getting Involved: Exploring Latino GBT Volunteerism and Activism in AIDS and LGBT Organizations

The purpose of this paper is to investigate the community involvement (e.g., volunteerism, activism) of Latino gay and bisexual men and transgender persons (GBT) in two areas: AIDS/GLBT and other general causes. Drawing from volunteering and identity theories, we explore: Who is likely to get involved? What factors affect variation in the levels of involvement? Where do Latino GBT participate and what do they do? Data come from a cross-sectional sample (N=643) of Latino GBT in Chicago and San Francisco. We find high levels of involvement, but primarily focused on AIDS/GLBT. Involvement appears to be driven by income, early involvement, role modeling, and childhood stigmatization of gender nonconformity...

...Forty percent of the total sample have ever been involved specifically in HIV/AIDS areas (See Table 1), while 30% have been involved in GLBT issues, and 23% (n= 146 of 643) have been involved in both causes. Yet, as noted earlier, in actuality, it is difficult to distinguish between the two, as many GLBT organizations in both cities undertake HIV/AIDS activities and vice versa. Hence, we grouped these two categories together (n= 309; 48% of the sample) for the purpose of analyzing the correlates of community involvement. This leaves 29% (n= 188) of the total sample as the group (exclusively) involved in areas other than AIDS/GLBT causes.

Seventy percent (n= 216; 34% of the overall sample) of those who have participated in AIDS or GLBT organizations were involved in the previous 12 months. The Gay Pride Parade is the most popular organization in which Latino GBT get involved in both cities (46% in Chicago and 31% in San Francisco). However, in Chicago, involvement generally takes place in AIDS-related organizations (e.g., CALOR, which serves HIV-positive Latinos) and the AIDS Walk. In San Francisco, there is greater involvement in gay organizations (e.g., AGUILAS-El Ambiente, Hermanos de Luna y Sol). Notably, almost all the reported organizations, except for Gay Pride Parade and the AIDS Walk, are run by, and devoted to, Latinos, according to the authors’ observations....

Full article at: http://goo.gl/aSI7dq

By: Jesus Ramirez-Valles, Lisa M. Kuhns, Raquel Vázquez, and Gregory D. Benjamin

University of Illinois at Chicago;

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