1  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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5 DHHS/OHRP Proposed New Rule Making

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66  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 time of collection and  study results are not ret’d to participants (not excused if ret’d)

67  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

68  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

69  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).

70  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)

71 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)

72  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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75  Center For Scholarly and Creative Excellence  Research Protections Program  Human Research Review Committee   RPP Office:  Seth Galligan (GA)  Jordan Fink (student worker)  Christina Moord (Research Protections Coordinator)