Colorado PROFILES, The Colorado Clinical and Translational Sciences Institute (CCTSI)
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Ethical Issues in Broad Data Sharing for Addiction Research: Best Research Practi


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The objective of this project is to facilitate the ethical conduct of addiction research with broadly shared biobanks and promote opportunities for persons with addictions to participate in research that could lead to treatments for their disorders. We will develop best practice recommendations for informed consent and Institutional Review Boards to guide genetic addiction research. Aim 1 will collect data regarding current, foreseeable and speculative risks of participation in broadly shared biobanks. To identify the risks, there will be a two-day workshop with 30-35 participants from diverse perspectives. The workshop will analyze case studies and participate in mock exercises. The workshop discussions will be recorded, transcribed and analyzed to identify the risks. The product will be: (1) a list of up to 25 risks of broadly shared biobanks, and (2) one paper summarizing the risks to the addiction research community. Aim 2, stage 1 will measure and compare the saliency and comprehension of up to 25 risks across 6 groups of participants: 100 adolescents with addiction, 100 parents of adolescents with addiction, 75 adolescent controls, 75 parents of adolescent controls, 100 adults with addiction, 75 adult controls. We will measure saliency via a visual analogue scale and comprehension via a multiple choice and true/false written test. Aim 2, stage 2 will develop, pilot and then test enhanced disclosure forms compared to the general disclosure form through a written comprehension test in additional subjects; 100 adolescents with addiction, 100 parents of adolescents with addiction, 75 adolescent controls, 75 parents of adolescent controls, 100 adults with addiction and 75 adult controls. The product will be data regarding how differences in risk taking propensity in persons with addictions impact disclosure in informed consent. Aim 3 will incorporate the findings of Aims 1 and 2 to make recommendations for best practices for addiction research with broadly shared biobanks. Specifically, the ethical analysis will: (1) describe the ethically relevant information about risks to participants in broadly shared biobanks; (2) attain as much insight as possible about how persons with addictions process information and make decisions about enrolling in risky research; (3) make recommendations for informed consent and Institutional Review Boards that take into account the risk- taking propensity of this population. We will produce one paper recommending strategies addiction researchers can implement to mitigate those risks, one paper recommending guidelines for Institutional Review Boards, and present the findings at professional meetings. PUBLIC HEALTH RELEVANCE: Ethical Issues in Broad Data Sharing for Genetic Research on Addiction: Best Practices Project Narrative The objective of this project is to facilitate the ethical conduct of addiction research with broadly shared biobanks and promote opportunities for persons with addictions to participate in research that could lead to treatments for their disorders. We will: (1) identify risks to participants in broadly shared biobanks; (2) attain as much insight as possible about how persons with addictions process information and make decisions about enrolling in risky research; (3) make recommendations for informed consent and Institutional Review Boards that take into account the differences in risk taking propensity in persons with addictions.
Collapse sponsor award id
R01DA029258

Collapse Time 
Collapse start date
2010-03-15
Collapse end date
2013-08-28

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