Returning Individual Information – A Complex Calculus

1. Returning Individual Information – A Complex Calculus Ellen Wright Clayton, MD, JD Center for Biomedical Ethics and Society Vanderbilt University

2. Who is the research participant? • Recruited for specific project • Healthy volunteer • Control • Affected • Not recruited for specific project • Secondary uses • Never recruited – general patient populations • What was s/he told about return of results? • Implications of lack of consent

3. Who is the investigator? • Patient’s physician • Original investigator • Other investigator

4. What is the finding? • Preexisting • Missed/overlooked clinical result • Emerge in the research • Incidental finding – “finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.” JLME 2008; 36(2):219 • Research result • When was finding made relative to the time of collection of data and samples?

5. What is the potential clinical significance for the finding? • Analytic and clinical validity • Level of risk • Severity of health risk • Likelihood that risk will occur • Potential efficacy of intervention

6. What is the process -- • For assessing significance of the finding? • General consensus that review is required • For communicating results? • More complex if investigator had no prior interaction with research participant

7. Legal and regulatory issues • Is there a duty to report? • Knoppers et al argue that there is an international consensus that there is ethical duty to report • Eur J Hum Genet 2006; 14:1170-78 • Possible legal bases • Regulation, tort, property • Practice creates duty • Concerns about scope

8. Legal and regulatory issues • CLIA 42 USC § 263a & 42 CFR § 493 • “Laboratory means a facility for . . .examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” • Does not apply to “Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients” • But people want results so they can act on them • Unclear that reporting as “research results” avoids the problem

9. Fundamental tensions • Individual information arises in many different ways in research • Legal barriers to reporting some information which may need to be addressed • Many, but not all people want this information • Right to know v. right not to know • Optimal to address this question beforehand • Increases the desirability of obtaining informed consent before research begins • Lack of consent may require different schemes for reporting results