Consent and Community Engagement in Diverse Research Contexts

Overview

Journal J Empir Res Hum Res Ethics

Specialty Medical Ethics

Date 2013 Oct 31

PMID 24169417

Citations 98

Affiliations

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Abstract

Consent and community engagement (CE) in health research are two aspects of a single concern-that research is carried out in a respectful manner where social value is maximized. There are important overlaps and interdependencies between consent and CE; for example, CE can provide insights into how best to tailor consent to context and can be an important component of consent processes. Engaging communities can also have intrinsic and instrumental value beyond consent; for example, as a means of showing respect and identifying appropriate ways of working respectfully. In this paper we critically examine how CE and consent processes are characterized, conducted, and evaluated in diverse health research contexts, and propose a preliminary research agenda to support future learning in these critical areas.

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References

Quinn S . Ethics in public health research: protecting human subjects: the role of community advisory boards. Am J Public Health. 2004; 94(6):918-22. PMC: 1448363. DOI: 10.2105/ajph.94.6.918. View

Edwards S, Lilford R, Thornton J, Hewison J . Informed consent for clinical trials: in search of the "best" method. Soc Sci Med. 1999; 47(11):1825-40. DOI: 10.1016/s0277-9536(98)00235-4. View

Bandewar S, Kimani J, Lavery J . The origins of a research community in the Majengo Observational Cohort Study, Nairobi, Kenya. BMC Public Health. 2010; 10:630. PMC: 2978148. DOI: 10.1186/1471-2458-10-630. View

Pace C, Emanuel E, Chuenyam T, Duncombe C, Bebchuk J, Wendler D . The quality of informed consent in a clinical research study in Thailand. IRB. 2005; 27(1):9-17. View

Pace C, Talisuna A, Wendler D, Maiso F, Wabwire-Mangen F, Bakyaita N . Quality of parental consent in a Ugandan malaria study. Am J Public Health. 2005; 95(7):1184-9. PMC: 1449338. DOI: 10.2105/AJPH.2004.053082. View

Nyika A . Ethical and practical challenges surrounding genetic and genomic research in developing countries. Acta Trop. 2009; 112 Suppl 1:S21-31. DOI: 10.1016/j.actatropica.2009.07.034. View

Molyneux C, Peshu N, Marsh K . Trust and informed consent: insights from community members on the Kenyan coast. Soc Sci Med. 2005; 61(7):1463-73. DOI: 10.1016/j.socscimed.2004.11.073. View

Mtunthama N, Malamba R, French N, Molyneux M, Zijlstra E, Gordon S . Malawians permit research bronchoscopy due to perceived need for healthcare. J Med Ethics. 2008; 34(4):303-7. DOI: 10.1136/jme.2007.020461. View

Strauss R, Sengupta S, Quinn S, Goeppinger J, Spaulding C, Kegeles S . The role of community advisory boards: involving communities in the informed consent process. Am J Public Health. 2001; 91(12):1938-43. PMC: 1446908. DOI: 10.2105/ajph.91.12.1938. View

10.

Madhavan S, Collinson M, Townsend N, Kahn K, Tollman S . The implications of long term community involvement for the production and circulation of population knowledge. Demogr Res. 2010; 17(13):369-388. PMC: 2854818. DOI: 10.4054/DemRes.2007.17.13. View

11.

Lang T, Gould J, von Seidlein L, Lusingu J, Mshamu S, Ismael S . Approaching the community about screening children for a multicentre malaria vaccine trial. Int Health. 2013; 4(1):47-54. DOI: 10.1016/j.inhe.2011.10.003. View

12.

Barsdorf N, Wassenaar D . Racial differences in public perceptions of voluntariness of medical research participants in South Africa. Soc Sci Med. 2004; 60(5):1087-98. DOI: 10.1016/j.socscimed.2004.06.039. View

13.

Tekola F, Bull S, Farsides B, Newport M, Adeyemo A, Rotimi C . Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study. BMC Med Ethics. 2009; 10:13. PMC: 2736170. DOI: 10.1186/1472-6939-10-13. View

14.

Bull S, Lindegger G . Ensuring consent to research is voluntary: how far do we need to go?. Am J Bioeth. 2011; 11(8):27-9. DOI: 10.1080/15265161.2011.585272. View

15.

Morin S, Morfit S, Maiorana A, Aramrattana A, Goicochea P, Mutsambi J . Building community partnerships: case studies of Community Advisory Boards at research sites in Peru, Zimbabwe, and Thailand. Clin Trials. 2008; 5(2):147-56. DOI: 10.1177/1740774508090211. View

16.

Molyneux S, Kamuya D, Marsh V . Community members employed on research projects face crucial, often under-recognized, ethical dilemmas. Am J Bioeth. 2010; 10(3):24-6. DOI: 10.1080/15265161003708623. View

17.

Newman P . Towards a science of community engagement. Lancet. 2006; 367(9507):302. DOI: 10.1016/S0140-6736(06)68067-7. View

18.

Kass N, Maman S, Atkinson J . Motivations, understanding, and voluntariness in international randomized trials. IRB. 2006; 27(6):1-8. PMC: 3099429. View

19.

Dunn M, Sheehan M, Hope T, Parker M . Toward methodological innovation in empirical ethics research. Camb Q Healthc Ethics. 2012; 21(4):466-80. DOI: 10.1017/S0963180112000242. View

20.

Vallely A, Lees S, Shagi C, Kasindi S, Soteli S, Kavit N . How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Med Ethics. 2010; 11:10. PMC: 2893460. DOI: 10.1186/1472-6939-11-10. View