Chin Lisa Judy, Rifai-Bashjawish Hoda, Kleinert Kelly, Saltman Alexandra, Leu Cheng-Shiun, Klitzman Robert
Columbia University College of Physicians & Surgeons & Mailman School of Public Health, 1051 Riverside Drive, New York, NY 10032, USA.
J Empir Res Hum Res Ethics. 2011 Sep;6(3):83-91. doi: 10.1525/jer.2011.6.3.83.
We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.
我们探究了由发达国家资助、在发展中国家开展的艾滋病研究的期刊文章提及两国研究伦理委员会(REC)批准的频率以及涉及哪些因素。在2007年发表于Medline上的、在四个发展中国家之一开展的此类文章(N = 154)中,仅有52%提及了这种双重批准。在有≥50%资助国作者的文章以及以美国为资助国的文章中,提及双重批准而非单一批准的可能性更大。此外,在提及知情同意和资金、有≥50%资助国作者、属于生物医学领域(而非社会心理领域)且发表在采用国际医学期刊编辑委员会(ICMJE)指南的期刊上的文章中,双重批准的可能性更大。因此,仅有一半的文章获得了双重批准,且这与伦理和后勤问题相关,这表明需要更清晰、更被普遍接受的指南。