Ethical guidelines protecting medical research participants have been criticized for stripping the sociocultural contexts of research. This critique is urgent considering ongoing calls to account for participant diversity in recruitment and inclusion procedures. Our intersectional analysis of illness narratives explores how sociostructural factors might play a role in participants’ exposure to research-related harm in clinical trials. Although widening participation does respond to generalizability concerns, we argue that gendered, classed, and ableist processes of self-silencing could simultaneously enhance risk of harm for (...) participants with multiple oppressed identities. To prevent this, researchers might actively involve participants when designing trials. (shrink)

When conducting health and medical research it is important to do the research ethically and to apply for prior ethical approval from the relevant authorities. The latter requirement is true for developed countries as well as developing countries. The authors argue that simply applying for research ethics approval from an institutional review board at a university based in a developed country is not enough to start a health research project in a developing country. The paper also suggests a number of (...) reasons why researchers may fail to seek local research ethics permission in developing countries. The authors use a recent paper reporting research conducted in Nepal and published in an international journal as a case study to highlight the importance of being sensitive to local requirements regarding applying for and registering health and medical research. (shrink)

Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees reviewing them have the capacity to ensure that they are conducted to the highest ethical standards.Methods. The Kenya AIDS Vaccine Initiative Institute of Clinical Research and the Kenyan National Council for Science and Technology embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit of (...) all ERCs in the country, and performing training needs assessments to identify knowledge and capacity gaps. Information obtained was used to develop training materials for ERC members at workshops conducted in different parts of the country.Results. Five accredited and 13 non-accredited ERCs were identified. Four of the accredited ERCs were located in the capital city of Kenya, Nairobi. The most common challenges cited by participants during the needs assessments were excess workload, and a lack of co-ordination and/or communication between the ERCs. Subsequently, 140 ERC members from 17 institutions across the country were trained as follows: 36 from institutions in the western part of Kenya, 38 from institutions in the south-eastern coastal region, 38 from the eastern region and 44 from Nairobi.Conclusion. The KAVI-ICR and the NCST have developed training modules for training ERC members in Kenya and are in the process of developing a manual to train members. The Kenyan experience may be used to enhance the capacity of ERCs in the East African region. (shrink)