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• How should informed consent handle sharing of study results?
  • Should participants be asked to specify either during the consent process or at a later time whether they would like to exercise the right NOT to be informed of study results?
  • Is there ever a case where informed consent or assent should be extended to family members so that they may also be informed of study results?
• Sharing study results introduces additional privacy risks due to additional data handling. What factors should IRBs consider when making determinations about return of results to patients? To family members?
• What policies and procedures should be in place for contacting and counseling participants, if analysis of their data reveals evidence of a health-related risk?
  • What obligations does the researcher have, if any, to inform participants of findings?
  • Are counseling resources required?
• What guidelines should researchers consider when informing participants of potential privacy risks that might have implications for family members? What are the potential tradeoffs of informing participants of possible risks to the privacy of family members?
• Should researchers have informed family members initially about the survey data repository collecting family history of health/disease?
• Would presence of genetic data (instead of family history) collected as part of initial patient contact change any of the required or recommended procedures for health or privacy?
• Given the policy gaps related to “big data,” what are the legal and privacy implications of “big data” collection and analysis?[i],[ii]
• How will anyone determine if study results are relevant to participants? Will all participants receive the same thing? Will individual choices be made so that one individual is told the results because the results have some relevance to him, but the next individual receives nothing because the findings are not significant to her? What if the findings are that some participants have a 5% greater risk than the population at large, but the absolute risk is actually 1 in 10000? Who will explain and answer questions? What if anything will the IRB do, and will it have any accountability for what it does (or doesn’t do)?
  
  

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