Shared responsibility for ensuring appropriate management of incidental findings: a case study from South Africa

被引:1
作者
Sookrajh, Yukteshwar [1 ]
Naidoo, Sarita [1 ]
Ramjee, Gita [1 ,2 ]
机构
[1] South African Med Res Council, HIV Prevent Res Unit, ZA-3630 Durban, South Africa
[2] London Sch Hyg & Trop Med, Dept Epidemiol & Populat Hlth, London WC1, England
基金
英国医学研究理事会;
关键词
CLINICAL-RESEARCH; PREVENTION; RECOMMENDATIONS; TRIALS; CARE;
D O I
10.1136/medethics-2013-101561
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
We report the case of an HIV prevention clinical trial participant who was referred to a local hospital for investigation and management of an incidental finding unrelated to her study participation. This case illustrates the complexities in the management of incidental findings within the context of clinical trials and highlights the importance of ethical oversight of trials.
引用
收藏
页码:281 / 283
页数:3
相关论文
共 14 条
[1]  
[Anonymous], PLOS MED
[2]  
[Anonymous], 2008, Mapping the standards of care at microbicide trial sites
[3]   Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network (GARNET) [J].
Bookman, Ebony B. ;
Din-Lovinescu, Corina ;
Worrall, Bradford B. ;
Manolio, Teri A. ;
Bennett, Siiri N. ;
Laurie, Cathy ;
Mirel, Daniel B. ;
Doheny, Kimberly F. ;
Anderson, Garnet L. ;
Wehr, Kate ;
Weinshilboum, Richard ;
Chen, Donna T. .
GENOME MEDICINE, 2013, 5
[4]   What makes clinical research in developing countries ethical? The benchmarks of ethical research [J].
Emanuel, EJ ;
Wendler, D ;
Killen, J ;
Grady, C .
JOURNAL OF INFECTIOUS DISEASES, 2004, 189 (05) :930-937
[5]   Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research [J].
Haire, Bridget G. .
JOURNAL OF MEDICAL ETHICS, 2013, 39 (04) :231-235
[6]  
Health Professions Council of South Africa (HPCSA), 2008, GUIDELINES FOR GOOD
[7]   Empirical analysis of current approaches to incidental findings [J].
Lawrenz, Frances ;
Sobotka, Suzanne .
JOURNAL OF LAW MEDICINE & ETHICS, 2008, 36 (02) :249-255
[8]  
MacQueen KM, 2008, PARTNERING CARE HIV
[9]   PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial [J].
McCormack, Sheena ;
Ramjee, Gita ;
Kamali, Anatoli ;
Rees, Helen ;
Crook, Angela M. ;
Gafos, Mitzy ;
Jentsch, Ute ;
Pool, Robert ;
Chisembele, Maureen ;
Kapiga, Saidi ;
Mutemwa, Richard ;
Vallely, Andrew ;
Palanee, Thesla ;
Sookrajh, Yuki ;
Lacey, Charles J. ;
Darbyshire, Janet ;
Grosskurth, Heiner ;
Profy, Albert ;
Nunn, Andrew ;
Hayes, Richard ;
Weber, Jonathan .
LANCET, 2010, 376 (9749) :1329-1337
[10]   Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa [J].
Ramjee, Gita ;
Coumi, Nicola ;
Dladla-Qwabe, Nozizwe ;
Ganesh, Shay ;
Gappoo, Sharika ;
Govinden, Roshini ;
Guddera, Vijayanand ;
Maharaj, Rashika ;
Moodley, Jothi ;
Morar, Neetha ;
Naidoo, Sarita ;
Palanee, Thesla .
AIDS RESEARCH AND THERAPY, 2010, 7