National Institute for Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina, USA.
Account Res. 2011 Nov;18(6):382-97. doi: 10.1080/08989621.2011.622172.
Assessing and managing risks to participants is a central point of contention in the debate about disclosing individualized research results. Those who favor disclosure of only clinically significant results think that disclosing clinically insignificant results is risky and costly, and that harm prevention should take precedence over other ethical considerations. Those who favor giving participants the option of full disclosure regard these risks as insubstantial, and think that obligations to benefit participants and promote their autonomy and right to know outweigh the obligation to prevent harm or financial considerations. The risks of disclosing clinically insignificant research results are currently not quantifiable, due to lack of empirical data. The precautionary principle provides some insight into this debate because it applies to decision-making concerning risks that are plausible but not quantifiable. A precautionary approach would favor full disclosure of individualized results with appropriate safeguards to prevent, minimize, or mitigate risks to participants, such as: validating testing methods; informing participants about their options for receiving tests results and the potential benefits and risks related to receiving results; assessing participants' comfort with handling uncertainty; providing counseling and advice to participants; following-up with individuals who receive tests results; and forming community advisory boards to help investigators deal with issues related to disclosure.
评估和管理参与者的风险是关于披露个体化研究结果的争论中的一个核心问题。那些赞成只披露有临床意义结果的人认为披露无临床意义的结果是有风险和代价的，预防伤害应该优先于其他伦理考虑。那些赞成让参与者有选择充分披露的人则认为这些风险微不足道，认为有义务使参与者受益，并促进他们的自主权和知情权，这比预防伤害或财务考虑更为重要。由于缺乏经验数据，目前还无法量化披露无临床意义的研究结果的风险。预防原则为这场争论提供了一些启示，因为它适用于涉及有合理但无法量化的风险的决策。谨慎方法将倾向于充分披露个体化结果，并采取适当的保障措施来预防、最小化或减轻对参与者的风险，例如：验证测试方法；告知参与者有关接受测试结果的选择，以及与接受结果相关的潜在益处和风险；评估参与者处理不确定性的舒适度；为参与者提供咨询和建议；对接受测试结果的个人进行随访；并组建社区咨询委员会，帮助研究人员处理与披露相关的问题。
