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July 26, 2011
60 day public comment period ends:
Monday, October 26, 2011 !!
Paul J. Reitemeier, Ph.D., Chair
Human Research Review Committee
Note: Slides used courtesy of PRIM&R webinar with permission
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DHHS/OHRP
Proposed New Rule Making
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RISK ASSESSMENT: framework refined (Section II);
Replace the “exempt” category with "excused" category.
 Excused research:
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Expanded and clarified list of categories
Would not require IRB review, only filing notices + audit system
Would be subject to DHHS regulation and oversight
Would require registration with & auditing by the institution
Expand EXCUSED category 101(b)(2) (surveys, interviews) to
include all research on competent adults, incl. w/personal
identifiers & sensitive data
 Expand EXCUSED category 101(b)(4) (research on existing data
sets) to include all data sets if:
 New initial consent standards are met @ time of collection and
 study results are not ret’d to participants (not excused if ret’d)
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 EXPEDITED REVIEW:
 Federal panel to expand and clarify categories
 No Continuing Review req’d for most studies
 FULL BOARD REVIEW:
 No Continuing Review req’d for data analysis or routine
clinical follow-up
 Up/AE:
 Timely PI reports still req’d for UP/AE and proposed
protocol changes.
 Federal collection/analysis of all UP/AE reports proposed
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MULTI-SITE STUDIES: Require using a single IRB
review for all domestic sites (Section III);
CONSENT: Revised consent process and forms (Sec. IV);
 May require verbal consent for some excused
research studies, e.g., educational surveys, tests
 Require some language, incl. boilerplate sections for
common types of research
 Proscribe some language, esp. institutional
 Limit length of some sections in consent document
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BIOSPECIMENS: Require documented informed
consent to collect, bank or conduct research on human
tissue specimens. Applies to all clinical collections.
EXPANDED COVERAGE: Extend federal regulatory
protections to all research, regardless of funding
source, if conducted at US institutions receiving any
federal funding from a Common Rule agency for
research with human subjects (Section VII); (in for a
penny, in for a pound)
HARMONIZATION: Improve consistency of
regulations and agency guidance for all Common Rule
subscriber agencies (Section VIII).
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DATA SECURITY: Require that HIPAA
Privacy rule standards (for defining Personally
Identifiable Information, limited data set and
de-identification) be applied to all research
regardless of whether the research was conducted as
part of a HIPAA Covered Entity for all studies
that involve identifiable or potentially
identifiable data (Section V);
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No IRB review for informational risk of any study
(per institution adopting HIPAA data standards
universally)
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DATA SECURITY: For research involving personal
identifiers, human biospecimens, and limited data
sets, the security standards could require the use of:
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encryption for archiving and transmitting in electronic
form,
strong physical safeguards for paper forms, audit trails, and
access controls
Researchers required to adhere to breach notification
standards modeled on HIPAA stds.
Researchers using limited data sets or de-identified
information, strictly prohibited from attempting to reidentify the subjects of the information.
No IRB review for informational risk of any study (per
institution adopting HIPAA data stds universally)
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LIMITING IRB CREEP: Require reporting to DHHS of
any IRB protocol review upgrades: i.e., determinations
that override default review requirements
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Conducting full-board reviews of research that may have
otherwise qualified for expedited review,
Conducting expedited review of research that would have
qualified as exempt/excused.
Emphasis is to limit autonomy of IRB to “creep” or overreach
its authority under the regulations. Allows unspecified
independent institutional ethics review which may be IRB
based.
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Center For Scholarly and Creative Excellence
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Research Protections Program
 Human Research Review Committee
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HRRC@gvsu.edu
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RPP Office: 331-3197
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Seth Galligan (GA)
Jordan Fink (student worker)
Christina Moord (Research Protections Coordinator)
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