Feedback of Research Findings for Vaccine Trials: Experiences from Two Malaria Vaccine Trials Involving Healthy Children on the Kenyan Coast

Developing World Bioethics

Volumn 13, Issue 1, 2013, Pages 48-56

  Gikonyo, Caroline ^a   Kamuya, Dorcas ^a   Mbete, Bibi ^b   Njuguna, Patricia ^a   Olotu, Ally ^a   Bejon, Philip ^a   Marsh, Vicki ^c   Molyneux, Sassy ^a  

^a KERMI ^*  (Kenya)

^b MASENO UNIVERSITY   (Kenya)

^c UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Benefit sharing; Clinical trials; Empirical ethics; Research ethics; Sub Saharan Africa

Indexed keywords

MALARIA VACCINE;

ADAPTIVE BEHAVIOR; ARTICLE; CHILD; ETHICS; FEMALE; FOLLOW UP; HUMAN; HUMAN RELATION; INFANT; KENYA; MALARIA; MALE; PARTICIPATORY RESEARCH; PHASE 2 CLINICAL TRIAL (TOPIC); PRESCHOOL CHILD; STANDARD; TREATMENT OUTCOME;

CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS, PHASE II AS TOPIC; COMMUNITY-BASED PARTICIPATORY RESEARCH; FEEDBACK, PSYCHOLOGICAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT; INTERPERSONAL RELATIONS; KENYA; MALARIA; MALARIA VACCINES; MALE; TREATMENT OUTCOME;

EID: 84876074787     PISSN: 14718731     EISSN: 14718847     Source Type: Journal    
DOI: 10.1111/dewb.12010     Document Type: Article

References (13)

1. K. Hede . Efforts To Communicate Clinical Trial Results to Patients Face Uphill Climb. Journal of the National Cancer Institute 2007; 99: 11-13; CIOMS. 2002. International Ethical Guidelines for Biomedical Research involving Human Subjects. Council for International Organsiations of Medical Science; G. Moutel, etal. Communication of pharmacogenetic research results to HIV-infected treated patients: standpoints of professionals and patients. Eur J Hum Genet 2005; 13: 1055-1062; Nuffield Council on Bioethics. 2005. The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics. Available at: http://www.nuffieldbioethics.org/sites/default/files/HRRDC_Follow-up_Dis cussion_Paper.pdf [Accessed 2 Nov 2012]; World Medical Association (WMA). 2000. Ethical Principles for Medical Research Involving Human Subjects-Declaration of Helsinki. Ferney-Voltaire: WMA. Available at: http://www.wma.net/en/30publications/10policies/b3/17c.pdf [Accessed 2 Nov 2012].
2. See for example M. Dixon-Woods, etal. Receiving a summary of the results of a trial: qualitative study of participants' views. Bmj 2006; 332: 206-210
3. C.V. Fernandez, etal. Considerations and costs of disclosing study findings to research participants. Cmaj 2004; 170: 1417-1419
4. A.H. Partridge & E.P. Winer . Informing Clinical Trial Participants About Study Results. JAMA: The Journal of the American Medical Association 2002; 288: 363-365
5. D.I. Shalowitz & F.G. Miller . Communicating the Results of Clinical Research to Participants: Attitudes, Practices, and Future Directions. PLoS medicine 2008; 5: e91
6. L. Wang . Researchers Push for Sharing of Trial Results with Participants. Journal of the National Cancer Institute 2002; 94: 1049-1050.
7. See for example L.M. Beskow & W. Burke . Offering Individual Genetic Research Results: Context Matters. Sci Transl Med 2010; 2: 38cm20; R.R. Fabsitz, etal. Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group. Circ Cardiovasc Genet 2010; 3: 574-580.
8. See Bejon etal., 2006 & 2008; Lusingu, etal., 2010 and Olutu, etal. 2011 for further reading on the FFM ME-TRAP & RTS, S/ASO1E vaccine trials.
9. See Molyneux etal., 2006 & 2008; and Gikonyo etal., 2008 for further reading on the community engagement and informed consent processes and post vaccination quizzes and discussions with parents of children enrolled in the FFM ME-TRAP trial.
10. C. Gikonyo, etal. Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med 2008; 67: 708-720; S. Molyneux, etal. Incorporating a quiz into informed consent processes: Qualitative study of participants' reactions. Malaria Journal 2007; 6: 145.
11. This suggestion is clearly problematic, and illustrates how on-going social relations influence participants' hopes and expectations regarding findings, as discussed further later in the paper.
12. See also V.M. Marsh, etal. Working with Concepts: The Role of Community in International Collaborative Biomedical Research. Public Health Ethics 2011; 4: 26-39.
13. H.L. Meltzer . Undesirable Implications of Disclosing Individual Genetic Results to Research Participants. American Journal of Bioethics 2006; 6: 28-30.