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OHRP Update. Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP Ivor.Pritchard@hhs.gov April 26, 2014. La connexion historique entre Montréal et Washington. Upcoming Events. Internet Research Webinar (May 8 and following) Research Community Fora: Cincinnati, Ohio: May 21

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ohrp update

OHRP Update

Ivor Pritchard, Ph.D.

Senior Advisor to the Director of OHRP

Ivor.Pritchard@hhs.gov

April 26, 2014

upcoming events
Upcoming Events

Internet Research Webinar (May 8 and following)

Research Community Fora:

  • Cincinnati, Ohio: May 21
  • Seattle, Washington: July 31
  • Philadelphia, Pennsylvania: October 23-24
secretary s advisory committee on human research protections
Secretary’s Advisory Committee on Human Research Protections
  • Internet Research
  • Randomized Cluster Trials
  • Engagement in Research
  • Big Data Research and Protections (TBD)
  • Informed Consent (TBD)
ongoing activities
Ongoing Activities
  • Follow-up to the SUPPORT Trial compliance determination and subsequent controversy
  • Follow-up to the Advance Notice of Proposed Rulemaking (ANPRM), “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators”(July, 2011)
should the regulations be changed
Should the Regulations be Changed?
  • The Common Rule got it wrong, and it’s time to change it.
  • The Common Rule no longer suits the research enterprise well, and so it should be changed.
changes in life expectancy u s a
Changes in Life Expectancy (U.S.A.)

1900: 49

1950: 68

1971: 72

1991: 75

2008: 78

changes in the research practice relationship institutions
Changes in the Research/Practice Relationship: Institutions
  • Patient-Centered Outcomes Research Institute (2010)
  • The National Center for Advancing Translational Sciences (2011)
  • The National Institutes of Health (NIH) NIH Collaboratory (2012)
changes in the research practice relationship research design
Changes in the Research/Practice Relationship: Research Design
  • Comparative Effectiveness Research
  • Randomized Cluster Trials
  • Pragmatic Clinical Trials
  • Community-Based Participatory Action Research
changes in law regulation a case example
Changes in Law/Regulation? A Case Example

“A well-regulated militia being necessary to the security of a free state, the right of the people to keep and bear arms shall not be infringed.” (1791)

how should the regulations be changed

How should the regulations be changed?

The regulations could be changed in numerous ways, some for the better, some for the worse.

a proposal for change
A Proposal for Change

Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (Advance Notice of Proposed Rulemaking (ANPRM), July, 2011)

anprm proposals
ANPRM Proposals
  • Scope of regulatory jurisdiction
  • Single IRB review for domestic multi-site studies
  • Informed Consent improvements
  • Single set of security/confidentiality standards
  • Data Reporting
  • Uniformity of regulatory guidance
  • Biospecimen research
  • Revised tiers of review
simple vs complex1
Simple vs. Complex
  • Single IRB review for domestic multi-site studies Simple
  • Informed Consent improvements Simple
  • Single set of security/confidentiality standards Simple
  • Data Reporting Simple
  • Uniformity of regulatory guidance Simple
  • Biospecimen research Complex
  • Revised tiers of review Complex
review tailored to be commensurate with risks
Review Tailored to be Commensurate with Risks
  • Single or Multiple Review?
  • Convened or Expedited Review?
  • Continuing Review or Not?
  • Biospecimen Research?
  • Excused so long as conditions are met?
  • No Review?