Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study

Abstract

Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

The willingness to participate in biomedical research involving human beings in low‐ and middle‐income countries: a systematic review

“…Additional reasons for participation mentioned were: ability to withdraw , advice from physician , community involvement , cultural acceptability , creating a feeling of community , low pressure decision , need for treatment , research involving a non‐invasive procedure , peer enrolment , low perception of risk , result availability , guarantee of confidentiality , being unaware of voluntariness of participation , research outcome, and finally seeing research participation as motivation to avoid risky behaviour .…”

“Hard to reach, but not out of reach”: Barriers and facilitators to recruiting Black African and Black Caribbean men with prostate cancer and their partners into qualitative research

“…Whilst acknowledging the autonomous power of gatekeepers at support groups and religious organisations to either hinder or promote access to their members or contacts (Singh & Wassenaar, ), there is need to also consider how this may possibly impact on the voluntary rights of potential participants to personally decide their participation or otherwise in a research study (Mamotte & Wassenaar, ; Wanat, ). Experience with participants in this study suggests that they may be willing to participate in research studies if they are asked, as many of them seemed to view their participation as a way of “helping others.” Although the researcher offered to volunteer at one of the support groups approached and all the support groups were also told they would be provided with summary of research findings as an “incentive” for their cooperation (Singh & Wassenaar, ), this strategy remained unsuccessful for the current study.…”

“…Hence such men did not give their partners the opportunity to make their own informed decision to participate or not. Whilst acknowledging the autonomous power of gatekeepers at support groups and religious organisations to either hinder or promote access to their members or contacts (Singh & Wassenaar, 2016), there is need to also consider how this may possibly impact on the voluntary rights of potential participants to personally decide their participation or otherwise in a research study (Mamotte & Wassenaar, 2017;Wanat, 2008). Experience with participants in this study suggests that they may be willing to participate in research studies if they are asked, as many of them seemed to view their participation as a way of "helping others."…”

“…Current available evidence has focused on participants’ perspectives and clinical research on CaP (Toms, Cahill, George, & Hemelrijck, ). Wider evidence relating to other “hard to reach” groups further highlights that participants’ opinions of the topic being investigated (Jones et al, ), and the nature of research being conducted (e.g., experimental studies) may also have an impact on recruitment outcomes (Mamotte & Wassenaar, ; Newington & Metcalfe, ). These suggest the need for qualitative researchers to be aware (through other researchers’ experiences) of strategies they can adopt to maximise recruitment for their studies.…”

“…Wider evidence relating to other "hard to reach" groups further highlights that participants' opinions of the topic being investigated , and the nature of research being conducted (e.g., experimental studies) may also have an impact on recruitment outcomes (Mamotte & Wassenaar, 2017;Newington & Metcalfe, 2014).…”