Jerry Menikoff 2 2 Disclaimer The views expressed in this presentation and those of the presenter and do not necessarily represent the views of the Department of Health and Human Services or any subdivision thereof ID: 642980
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Updating the Common Rule Governing Human Subjects Research Protections
Jerry MenikoffSlide2
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Disclaimer
The views expressed in this presentation and those of the presenter and do not necessarily represent the views of the Department of Health and Human Services or any subdivision thereof.Slide3
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I.
Background
Twenty years have passed since the “Common Rule” was adopted
Nature of research activities has changed dramatically.
Multi-site studies; genomics; internet and information technology
Time to update the Common Rule: goal of improving protections for subjects, while making the rules function more effectively
Thus, an
Advance Notice of Proposed Rulemaking Slide4
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I.
Background
Current rules on
secondary use of data
:
If stripped of identifiers, no human subject, thus not subject to these rules.
Can even keep one-way link to original data source, and collect new information
Genomic data is not
per se
identifiable
No consent needed
under those
scenarios
Even if a study uses “human subjects,” it can still be found exempt from needing to follow these rules.Slide5
II. Ensuring Risk-Based Protections
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II. Ensuring Risk-Based Protections
Goal is to better target time and effort spent on reviewing a study to the risk of the study. Slide7
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II. Ensuring Risk
-
Based Protections
Current
framework has tiers of review:
Review by a convened IRB
—
Studies with
greater than minimal risk
Expedited
review
–commonly single IRB reviewer
Exempt
--six categories exempted from IRB review altogetherSlide8
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II. Ensuring Risk-Based Protections
Currently, no specific standards for protecting privacy and confidentiality
IRBs currently must, where appropriate, determine that there are adequate protections
New
standards for data security and information protection that would apply to appropriate studies
IRB would no longer be responsible for reviewing this aspect of protocolsSlide9
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II. Ensuring Risk-Based Protections
Convened IRB Review
— Only change: continuing review not required if only analyzing data or collecting new data from standard clinical follow-upSlide10
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II. Ensuring Risk-Based Protections
Eligibility for
Expedited Review
:
Regular updates to list of research activities that qualify for expedited review
Presumption that a study which includes only activities on the list is a minimal risk study and should receive expedited review (reviewer option to send to convened IRB)
Considering whether a study eligible for expedited review should be required to meet all of the current criteria for IRB approvalSlide11
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II. Ensuring Risk-Based Protections
Eliminating Continuing Review of
Expedited
Studies
Default -- no continuing review for studies that qualify for expedited review
Reviewer could make a specific determination (with justification) that continuing review is appropriate for a studySlide12
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II. Ensuring Risk-Based Protections
Streamlining Documentation Requirements for
Expedited
Studies
T
emplates for protocols and consent formsSlide13
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II. Ensuring Risk-Based Protections
Revising and expanding current
exempt
category:
No longer fully “exempt”—adhere to data security rules, some consent rules
Requiring brief registration form to be filed with institution
Research could generally begin immediately after filing
Eliminate current routine review of almost all exempt studies; audit some to verify qualificationSlide14
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II. Ensuring Risk-Based Protections
Expansions of
“
exempt” categories
:
Surveys conducted with competent adults would qualify, even if “risky” identifiable data
Perhaps a new category for social and behavioral research involving specified types of benign interventions that are known to involve virtually no risk to subjects
“Secondary” research with existing
biospecimens
and data would qualify, even if identifiers retained; consent rulesSlide15
III. Streamlining IRB Review of Multi-site Studies
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III. Streamlining IRB Review of Multi-site Studies
Mandating that all domestic sites in a multi-site study rely upon a single IRB as their IRB of record for that study. Slide17
IV. Improving Informed Consent
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IV. Improving Informed Consent
Goal is to produce consent forms that do a much better job in informing prospective subjects by:
Prescribing how information should be presented in consent forms
Providing more specifics about content that should be in the forms, and about what should not be in them (vs. in appendix)
Reducing institutional “boilerplate”Slide19
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IV. Improving Informed Consent
Written consent for
biospecimens
collected after effective date
Open-ended standard consent form for giving consent to broad future useSlide20
V. Strengthening Data Protections To Minimize Information Risks
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V.
Strengthening Data Protections To Minimize Information Risks
As mentioned earlier: new data security protections that would apply to research involving identifiable informationSlide22
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V.
Strengthening Data Protections to Minimize Information Risks
Common Rule definition of when data is “identifiable” would be harmonized with definition in HIPAA Privacy RuleSlide23
VI. Data Collection To Enhance System Oversight
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VI. Data Collection To Enhance System Oversight
Create a web-based portal for investigators to submit safety data and automatically have it delivered to appropriate agencies
Harmonize safety reporting guidance across all Federal agencies
Central repositorySlide25
VII. Extension of Federal Regulations
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VII. Extension of Federal Regulations
Require domestic institutions that receive some Federal funding from a Common Rule agency for research with human subjects to extend the Common Rule protections to all research studies conducted at their institution. Slide27
VIII. Clarifying and Harmonizing Regulatory Requirements and Agency Guidance
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VIII. Clarifying and Harmonizing Regulatory Requirements and Agency Guidance
Request for Comments
How do
differences in guidance from different agencies either strengthen or weaken protections for human subjects or the ability to conduct research?
Should these differences be reduced?Slide29
How to find the Advance Notice of Proposed Rulemaking:
www.hhs.gov/ohrp Click the big blue button!Check out the 1,100 comments!
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