Central IRBs: Where Does the UR Fit into the Picture?? Kelley O Donoghue Tiffany Gommel Emily Flagg April 15 th 2015

Transcription

1 Central IRBs: Where Does the UR Fit into the Picture?? Kelley O Donoghue Tiffany Gommel Emily Flagg April 15 th 2015

2 University of Rochester Office for Human Subject Protection (OHSP) Director OHSP: Kelley O Donoghue Research Education & Training Director: Kelly Unsworth Research Subjects Review Board (RSRB) Director: Tiffany Gommel Quality Improvement Director: Kathleen Wessman Regulatory Systems Director: Thai Nguyen

3 History

4 NIH DRAFT Policy What s the history??? National Cancer Institute s IRB Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) Network for Stroke Research (NIH StrokeNet) Release Date: December 3, 2014 Purpose: to increase the use of single IRB for multi-site studies funded by the NIH

5 NIH DRAFT Policy Represents the current climate where review by a single IRB, rather than multiple, will: Increase the speed by which research gets approved Save time and resources Not have an effect on human subject protection

6 NIH DRAFT Policy UR Concerns Mandatory Nature does not recognize the complexity and variation across NIH-funded multi-site studies Might be appropriate in some cases Large study groups Multiple studies by the same group of sites Might be inappropriate in other situations Single study with a few sites Expedited or Exempt

7 NIH DRAFT Policy UR Concerns Liability Common Rule and assurance regulations (45 CFR 46) hold the IRB of record responsible for site conduct (compliance) Requires a federal change in accountability and regulatory liability of IRBs and institutions The Institution of the Single IRB could risk losing or restriction of their FWA for compliance problems at other sites, even if the single IRB performed their responsibilities adequately

8 NIH DRAFT Policy UR Concerns Selection of Central IRB Very little insight on the selection process for identifying the single IRB, only that the PI of the multi-site study would propose the single IRB. Allowing an investigator to select the single IRB would risk IRB shopping Requires minimum standard of qualifications AAHRPP Accreditation Restructuring of IRB Office staff (or additional)

9 NIH DRAFT Policy UR Concerns Institutional Review Institutional policy Conflicts arise between institutional policy and the protocol as drafted Need coordination with other regulatory review entities within the institution (HURC, IBC, etc.) Not impossible, but infrastructure needed to support, both at the Single IRB and the relying IRB

10 UR Institutional Process What is the process for getting approval for the use of a central IRB, reliance agreement, IRB authorization agreement? UR employee conducting human subject research requests the UR become the IRB of record for an non-ur institution or investigator RSRB wants to defer another IRB

11 Policy 504 RSRB Reliance for Review

12 Reliance Agreement or IAA Reliance or IRB Authorization Agreement (IAA): A formal, written document that provides a mechanism for an institution engaged in research to delegate Institutional Review Board (IRB) review to another IRB, such as an independent IRB or another institution s IRB. The agreement may apply to a single study or to certain categories of studies. Institutions may use different descriptive terms, e.g., reliance agreement, cooperative agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU).

13 Reliance Agreement or IAA The IRB Authorization Agreement (IAA) is used for studies with minimal subject engagement or studies with limited data access or data analysis. The Reliance Agreement is used for research where the study conduct (consent, study procedures, etc.) will take place at an non-ur site by non-ur people. Policy 504: IRB Authorization Agreement Sample Template Reliance Agreement Sample Template

14 Process for Making the Decision UR Investigator makes the request to the RSRB Director Who decides? Institutional Official (IO), with consultation from the OHSP Director and RSRB Director, is responsible for deciding when the UR will become the IRB of Record or defer to another IRB

15 When the RSRB is the IRB of Record UR PI must provide a plan for oversight of collaborating site(s) The plan should: 1. Outline the specific research activities that will occur at the collaborating site(s) 2. Ensure study and regulatory compliance, including notification to the non-ur researcher in writing of the RSRB review determinations 3. Uploaded as an amendment to an already approved protocol or included with the initial protocol submission

16 When the RSRB is the IRB of Record The RSRB conducts a regulatory and institutional review per operating procedures for the activities of the UR researcher. Ensure that plan is adequate. UR will enter into an IRB Authorization or Reliance Agreement with the non-ur institution to defer IRB review to the RSRB. The non-ur institution should conduct an institutional review of the research prior to approval of the study by the RSRB to provide any local context to the RSRB, as appropriate.

17 When the RSRB defers to another IRB Institutional Review: Education Requirements Institutional policy (erecord, Decisional impairment) Compensation for Injury Language Conflicts of Interests

18 Institutional & Investigator Considerations Type of research and the activities conducted IRB is not AAHRPP accredited May take longer to complete paperwork for IAA or reliance agreement to defer to another IRB then to get RSRB approval Institutional approval could take a month or longer

19 Central IRB Application Reason for Changes No longer just using Western IRB (WIRB) To accommodate submissions reviewed locally by RSRB and those reviewed by another IRB of record To ensure basic information about the study submission is captured for all submissions (i.e., a few more sections apply to all studies)

20 Overview of Application Pathway Section 1 Protocol & Measures Section 2 Conflict of Interest Section 90 erecord and Research Section 3 Source of Funding/Sponsorship Section 4 Nature of Study Part 1 Section 5 Nature of Study Part 2 Section 6 Sponsorship Part 2 Section 7 (Part 1 and Part 2, if applicable) Just in Time Section 95 Determine IRB of Record NO Central IRB Section 10 Central IRB Application Section 62 Institution Oversight Section 83 Informed Consent Final Instructions YES RSRB Section 8 Coordinating Ctr, Concept, etc. Section 9 Exempt..etc.

21 Central IRB Screen Shots The following slides are screen shots to show information that may be new when completing the Central IRB application

22 ***NEW*** If not using the RSRB as the IRB of record, select No Note: An IRB Reliance Agreement or an IRB Authorization Agreement is required to use another IRB as the IRB of Record. See RSRB Policy 504 RSRB Reliance for Review.

23 ***New*** Indicate if IRB Agreement in place If Yes upload copy of agreement NOTE: Documentation not required if using WIRB

24 Institutional Oversight added so applicable ancillary reviews can be managed in ROSS

25 Informed Consent section now available so consent documents may be added for RSRB review.

26 Final Instructions pertain to any central IRB submission

27 Review Level will indicate Central IRB New Field to indicate the central IRB of record

28 Additional Changes New State Names, *Activity function buttons, and Tab labeling *RSRB Only

29 Questions