dhhs/ohrp proposed new rule making

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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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SUMMARYDATA 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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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)

mailto:[email protected]

dhhs/ohrp proposed new rule making

Documents

new initial consent

excused research

exempt category

existing data sets

irb review

framework refined section

courtesy of primr webinar

day public comment period