Moutel Grégoire, Duchange Nathalie, Raffi François, Sharara Lama I, Théodorou Ioannis, Noël Violaine, de Montgolfier Sandrine, Callies Ingrid, Bricaire François, Hervé Christian, Leport Catherine
Laboratoire d'Ethique Médicale et Médecine Légale & Institut International de Recherche en Ethique Biomédicale, Faculté de Médecine Paris 5. 45 rue des Saints-Pères, Paris 75006, France.
Eur J Hum Genet. 2005 Sep;13(9):1055-62. doi: 10.1038/sj.ejhg.5201450.
The aim of pharmacogenetic studies is to adapt therapeutic strategies to individual genetic profiles, thus maximising their efficacy and minimising the likelihood of adverse side effects. Since the advent of personalised medicine, the issue of communicating research results to participants has become increasingly important. We addressed this question in the context of HIV infection, as patients and associations are particularly concerned by research and therapeutic advances. We explored the standpoints of both research professionals and participants involved in a pharmacogenetic study conducted in a cohort of HIV-infected patients. The setting of the research protocol was followed over a 2-year period. Participants' standpoints were collected through a questionnaire and interviews were conducted with research professionals. Of 125 participants, 76% wished to receive individual results and 71% wished to receive collective results; 39% did not know when results might be expected. Communication of global research results is a principle that is generally accepted by professionals. Concerning individual feedback, the professionals felt that it was necessary if it could be of direct benefit to the participant, but they expressed doubts for situations with no recognised benefit. Our results highlight the necessity to consider this issue in greater detail. We suggest the need to anticipate the debates concerning individual feedback, to differentiate between situations and the importance of further investigations on the opportunities and modalities of communication. Finally, our work emphasised the opposite pressures between the pursuit of scientific knowledge and the therapeutic orientation of clinical trials.
药物遗传学研究的目的是使治疗策略适应个体基因特征，从而最大限度地提高其疗效，并将不良反应的可能性降至最低。自个性化医疗出现以来，向参与者传达研究结果的问题变得越来越重要。我们在艾滋病毒感染的背景下探讨了这个问题，因为患者和协会对研究和治疗进展尤为关注。我们探究了参与一项针对一组艾滋病毒感染患者进行的药物遗传学研究的研究专业人员和参与者的观点。研究方案的实施持续了两年。通过问卷调查收集参与者的观点，并与研究专业人员进行访谈。在125名参与者中，76%希望收到个人结果，71%希望收到总体结果；39%不知道何时能收到结果。传达总体研究结果是专业人员普遍接受的一项原则。关于个人反馈，专业人员认为如果对参与者有直接益处则有必要，但他们对没有公认益处的情况表示怀疑。我们的结果凸显了更详细地考虑这个问题的必要性。我们建议需要预见有关个人反馈的争论，区分不同情况以及进一步研究沟通机会和方式的重要性。最后，我们的工作强调了追求科学知识与临床试验治疗导向之间的相反压力。
