1 july 26, 2011 60 day public comment period ends: monday, october 26, 2011 !! paul j. reitemeier,...
TRANSCRIPT
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DHHS/OHRPProposed New Rule Making
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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SUMMARY
RISK ASSESSMENT: framework refined (Section II); Replace the “exempt” category with "excused" category. Excused research:
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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SUMMARY
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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SUMMARY
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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SUMMARY
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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SUMMARY
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); No IRB review for informational risk of any
study (per institution adopting HIPAA data standards universally)
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SUMMARY
DATA SECURITY: For research involving personal identifiers, human biospecimens, and limited data sets, the security standards could require the use of:
1. encryption for archiving and transmitting in electronic form,
2. strong physical safeguards for paper forms, audit trails, and access controls
3. Researchers required to adhere to breach notification standards modeled on HIPAA stds.
4. Researchers using limited data sets or de-identified information, strictly prohibited from attempting to re-identify the subjects of the information.
5. No IRB review for informational risk of any study (per institution adopting HIPAA data stds universally)
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SUMMARY
LIMITING IRB CREEP: Require reporting to DHHS of any IRB protocol review upgrades: i.e., determinations that override default review requirements 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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DHHS/OHRPProposed New Rule Making
Center For Scholarly and Creative Excellence Research Protections Program
Human Research Review Committee [email protected]
RPP Office: 331-3197 Seth Galligan (GA) Jordan Fink (student worker) Christina Moord (Research Protections
Coordinator)