1. 11/15/2018 4:51 PM
Ethical Issues: Proposed changes to the Common Rule Personalized Medicine in particular populations
Lisa S. Parker, PhD
Center for Bioethics & Health Law
Department of Human Genetics
© 2007 Microsoft Corporation. All rights reserved. Microsoft, Windows, Windows Vista and other product names are or may be registered trademarks and/or trademarks in the U.S. and/or other countries.
The information herein is for informational purposes only and represents the current view of Microsoft Corporation as of the date of this presentation. Because Microsoft must respond to changing market conditions, it should not be interpreted to be a commitment on the part of Microsoft, and Microsoft cannot guarantee the accuracy of any information provided after the date of this presentation. MICROSOFT MAKES NO WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, AS TO THE INFORMATION IN THIS PRESENTATION.

2. Notice of Proposed Rulemaking (NPRM) Proposed changes to the Common Rule, September 8, 2015
Relevant to quality improvement activities (vs. research)
Relevant to storage & use of biospecimens
Relevant to use of identifiable private information in research

3. Notice of Proposed Rulemaking (NPRM) Proposed changes to the Common Rule, September 8, 2015
Shorten & simplify consent forms
Exempt from IRB review some research now requiring review; exclude some as outside IRB’s purview
Implement investigator-employed decision tool
Require (“broad”) consent for (secondary) research with (even de-identified) biospecimens
Only rarely grant waiver of consent

4. Require privacy safeguards for biospecimens & identifiable private information, but exempt …
Secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given
Storing or maintaining biospecimens & identifiable private information for future, unspecified secondary research studies, or conducting such studies, when a broad consent template to be promulgated by the Secretary of HHS is used & IRB approves consent process
Surveys, interviews, or observations of public behavior even when sensitive information may be collected

5. Concerns about the NPRM
Although activities related to public health surveillance, program improvement activities, survey procedures, use of existing data, demonstration projects, and other “low-risk” activities are excluded, the definition of QI employed would result in many current QI activities being classified as research
The intention to assess the outcomes related to a QI activity—or to disseminate QI results—should not necessarily make the activity subject to the Common Rule

6. Both # 2 & 3 are administratively complex & costly
Requiring consent, even broad consent, for use of de-identified biospecimens
Granting patients the option to opt-out of secondary analysis of identifiable private information collected for non-research purposes (e.g., EHR or insurance claims data)
Blurring of ‘biospecimens’ and ‘identifiable private information’ re: #3 is inconsistent with requiring consent only for use of biospecimens
Both # 2 & 3 are administratively complex & costly
Both may lead to unrepresentative samples

7. IRBs and informed consent
 Particular populations
Developing and practicing PM
Consent for biobanking/big data research

9. PM: population person
The ways that individuals are grouped together determine the genetic frequencies that are attributed to particular populations.
Historically, it has not been genetic frequencies that determine how to group individuals into populations.
Phenotype/self-report “race” continental ancestry variation in genotype
Imprecision in, imprecision out.
slippage

10. Lessons from BiDil
Trust & transparency are critical to success of any intervention that stratifies or singles out particular populations.

11. Biobank/big data research: consent
Challenges of trust, reach, representativeness
Broad consent acceptable, but being informed desirable
Consent model vs. governance model for biobank and data mining research
Pediatric populations
Who gives permission?
To whom & how are actionable findings returned, and when?

12. Child’s right to “an open future”
Autonomous individuals consent/refuse
Parents give/refuse permission
Concern about the autonomy of the child
Overrides child’s right to know / not-know
Allegedly forecloses the RTOF
Concern should be about the child’s well-being
Living in the shadow of personalized risk
Shifting focus/control to person, not context
Uncertain value of personalized knowledge

13. Return of results: challenges
Beyond immediately and “easily” actionable
Value of many results is behaviorally & socially mediated
Even “easy” actions have consequences
Shifting of liability/responsibility
Lab clinician patient
All the more challenging in pediatric patients who did not consent
Pediatric patient as the familial “canary in the coal mine” of reproductive planning, healthcare