USING SMART IRB AND SINGLE IRB REVIEW

Transcription

1 USING SMART IRB AND SINGLE IRB REVIEW Jeannie Barone Director, HRPO

2 ATTRIBUTES Special thanks to Nichelle Cobb, PhD from University of Wisconsin-Madison for her permission to utilize her slides on SMART IRB

3 Presentation Agenda New NIH policy (and DHHS regulations) SMART IRB Other Reliance Mechanisms Pitt as IRB of Record External Site as IRB of Record

4 Terms you may hear Single IRB Review a legal arrangement that allows one IRB to review the research on behalf of other engaged institutions Also commonly referred to as Central IRB Reliance Agreement an agreement that outlines the responsibilities of each party IRB Authorization Agreement (IAA), IRB Agreement, Reciprocal Agreement, Master IRB Agreement

5 Terms you may hear Reviewing IRB the IRB that reviews and makes required regulatory determinations Also commonly referred to as IRB of Record or Single IRB Relying Institution the institution that cedes IRB responsibilities to the reviewing IRB Ceding site, Relying site

6 NIH Policy NIH funded or supported Competing grant applications (new, renewal, revision, or resubmission) Non-exempt, multi-site (more than one) research Conducted at domestic sites Receipt date on or after September 25, 2017

7 Roles and Responsibilities (Final NIH Policy) Single IRB: Conducts the initial and continuing reviews to ensure compliance with regulatory requirements. May also act as the Privacy Board for HIPAA purposes. Participating Sites: Rely on the Single IRB to carry out functions for institutional compliance. Meet other regulatory obligations obtaining informed consent, reporting unanticipated problems, communicate relevant local context and state regulations.

8 DHHS Regulation Conducted, supported, or other subject to regulation Non-exempt, cooperative research (more than one site) Conducted at domestic sites IRB determined by Federal agency Exclusions: Required by law Determined by Federal department or agency Effective date: January 18, 2020

9 Review Costs Pitt IRB of Record The primary activity of IRB review of the research protocol and template consent are covered by the grant s indirect costs. Secondary activities can be charged as direct costs with appropriate justification. Includes site-specific considerations for all of the participating sites. Contact HRPO when formulating budget

10 A Note of Caution Ceding oversight only covers the IRB review piece Institutional Review Board (IRB) Office for Investigator Initiated IND/IDE Support (O3IS) Radioactive Drug Research Committee/Human Use Subcommittee (RDRC/HUSC) Institutional Biosafety Committee (IBC) Education and Compliance Office (ECO) Conflict of Interest (COI) Study Initiation Stem Cell Research Oversight Committee (SCRO)

11 REVIEW MECHANISMS

12 SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board) was developed under an NIH grant and is responsive to new NIH policy requiring the use of a single IRB for multi-site research funded by the agency.

13 A master agreement to support collaboration across the nation 8 CTSAs came together to develop a national IRB reliance agreement Public & private universities Academic healthcare centers Shared with 72 Institutions + 25 CTSAs in 19 states + Community hospitals + Independent/commercial IRBs Shared with 115+ Institutions + 64 CTSAs in 33 states + NIH agencies Collaboratively developed with broad stakeholder input 13

14 SMART IRB: More than a Master Agreement

15 Any eligible institution may join 1. FWA or IRB Organization: Unless it is an IRB organization, an institution must maintain a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP) AND provide institutional oversight of all its human subjects research. 3 Eligibility Criteria 2. Quality Assessment: If an institution has an IRB or is an IRB organization, it must have undergone or initiated assessment of the quality of its human research protection program (HRPP) within five years prior to joining. 3. Point of Contact: An institution must establish a Point of Contact (POC) who will be responsible for, and communicate on behalf of, the institution regarding initial and ongoing implementation of the SMART IRB Agreement.

16 Federal-Wide Assurances Each institution engaged in federally funded research provides written assurance that it will comply with human subject protections regulations

17 Separate FWA = Separate Agreement Considerations: Where does the PI reside Which sites are engaged in research Which office is handling the money Pitt, UPMC, Magee Women s Research Institute and Foundation, Children s Hospital of Pittsburgh of UPMC (UPMC Cancer Center pending)

18 Using the Agreement Human Research 18Protection Office

19 The SMART IRB Online Reliance System For Investigators and Participating Institutions Provides a single point of entry to standardize reliance processes Serves as communication portal to eliminate tracking requests via or other methods Guides investigators and institutions through the workflow, making clear when action is required Facilitates reliance arrangements on a study-by-study basis

20 The Reliance System Is For Investigators (or their designees) A centralized mechanism to request single IRB review for their studies and track the status of those requests For Institutions A platform to review reliance requests and determine and record appropriate reliance arrangements for each study The Reliance System Is NOT A mechanism to submit an application for IRB review and approval A document storage system Note: the SMART IRB Exchange Portal (SIEP) is a different system than the SMART IRB Online Reliance System; SIEP is used by the NCATS Trial Innovation Network (TIN) central IRBs to manage TIN studies.

21 Facilitating Communication

22 Reviewing IRB and Overall PI (or designee) The Reviewing IRB POC should reach out to the Overall PI (or designee, such as a Lead Study Team/Coordinating Center) to: Communicate when the IRB application should be submitted for review Explain how to request approval for relying institutions (e.g., by creating separate applications vs. adding each new site as an amendment) Use of a combined consent/ authorization form vs. separate documents Develop a communication plan

23 Communication Plan Clarifies and documents key responsibilities, such as who will: Provide confirmation to the Reviewing IRB that relying site study teams have completed relevant training and are qualified to conduct the proposed research Provide information to the Reviewing IRB about relying site study team conflicts of interest (and applicable management plans) Provide relying site study teams with key policies of the Reviewing IRB The Reviewing IRB (e.g. reportable events policy) POC reaches out to Communicate local the Lead context Study information to the Reviewing IRB regarding state laws and institutional Team to: requirements that pertain to the review of the ceded study Submit study-wide initial application and amendments to the Reviewing IRB Prepare site-specific applications and site-specific amendments and Continuing Reviews to the Reviewing IRB Use of a combined consent/ authorization form vs. separate documents Distribute IRB determinations and IRB-approved study documents to relying site study teams

24 Collecting Local Context & Site Information The Reviewing IRB (or designee, such as the lead study team) identifies a mechanism to collect local context information about the Relying Institutions (e.g. demographics of populations served) and variations in the conduct of the research study across sites. POCs at Relying Institutions are expected to provide local context information to the Reviewing IRB about: Study team training and qualifications Study team member conflicts of interest related to the study and any applicable management plans State laws and institutional requirements that pertain to the research, including any institutionally required language about availability and type of compensation for research injury and contact information for local PI Variations in study conduct may be collected by the Reviewing IRB (e.g., directly from relying site study teams as part of its own application) or delegate this to personnel responsible for preparing the IRB application on behalf of sites (e.g., Lead Study Team or coordinating center).

25 Communication Touchpoints After Initial Review for Relying Institutions Relying Institutions must have processes in place to provide information to the Reviewing IRB after their site is approved, including mechanisms for: Ensuring any personnel added to the study after initial approval are qualified and have completed required training. Providing the Reviewing IRB with information regarding any new or updated management plans for their personnel related to the ceded study audits of ceded research any information/events that could affect have an impact on the ceded research (e.g., complaints or serious noncompliance findings for the PI or team on other studies)

26 Local Oversight Considerations How will fiscal issues be handled? Timing and monitoring for ancillary reviews Radiation safety IBC Pharmacy Ensuring compliance with state laws that touch about human subjects research

27 Process at Pitt

28 Requesting Use of a Single IRB Contact us early in the process letter of support in RFAs if requested New request forms under A-Z guidance Submit to irb.reliance@pitt.edu (NEW) Determinations made on case-by-case basis Funding source - Number of sites Number of studies - Level of risk Approval by Institutional Official Discussions with IRB reps from sites Drafting of template agreement and SOPs

29 Outside institution is Reviewing IRB An registration application is submitted via external pathway OSIRIS Ensures completion of other institutional requirements Allows tracking of approved studies at institution Research cannot begin until we provide acknowledgement

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31 PI/Research Team Responsibilities Complying with the reviewing IRB s policies and procedures Registering through OSIRIS Maintaining a current and accurate protocol file Including correspondence from reviewing IRB Only limited information is submitted to Pitt IRB Time of continuing review If the PI or study staff changes If any procedure related to an ancillary review changes If the Reviewing IRB makes a determination of serious or continuing non-compliance or an unanticipated risk to subjects or others

32 Pitt as Reviewing IRB Normal submission through OSIRIS We will work with relying sites to negotiate agreement Relying sites supply local context information Our IRB issues a template consent for all sites Consents will be watermarked once local required language is inserted

33 PI/Research Team Responsibilities Assisting IRB with obtaining contact information from local IRBs Presenting study to all sites and addressing any issues identified Submitting study into OSIRIS Complete workflow not yet developed Site PI/study team will need access to system Following provisions of agreement

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35 COMING ATTRACTIONS

36 New System to Replace OSIRIS Coming in 2018! Simplified submission system Improved questions Ideas to name the new system? Let us know!

37 Common Rule Did you know that the Federal policy for the protection of human subjects (The common rule, subpart A) has major changes coming? HRPO will keep you posted on the revisions and policies

38 RCCO Learning Center Classroom with distance learning Specialized Education Sessions Coming Soon! Check

39 When in Doubt Call us: Set up a consultation appointment us: askirb@pitt.edu