IRB Reliance Models: Workshop for OSU Researchers Collaborating with External Partners

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1 IRB Reliance Models: Workshop for OSU Researchers Collaborating with External Partners Jessica Evans, MHA, CHRC, CIP Office of Responsible Research Practices August 8, 2017

2 Workshop Overview Regulatory context Definitions IRB reliance models-examples BuckIRB and Agreements How to SMART IRB navigation Current External IRB Relationships 2

3 The Regulations are Changing 3

4 Important Terminology IRB of Record = IRB that Reviews Single IRB (sirb) of Record=central IRB=IRB that Reviews Relying IRB Individual Investigator Agreement (IIA) IRB Authorization Agreement (IAA) Ceded review 4

5 OSU Active Protocol Data Summary June 2017 Who is Reviewing OSU Research? 5

6 OSU Active Protocol Data Summary June

7 3 IRB Review Model Options When OSU is conducting research with an external collaborator OSU IRB External IRB IRB Agreements OSU IRB Reviews External IRB Reviews None OSU IRB Reviews OSU IRB Relies on External Collaborator s IRB External Collaborator Relies on OSU IRB External IRB Reviews IAA or IIA IAA 7

8 IRB Review Models OSU IRB Reviews (IRB of Record) Primary IRB for OSU faculty, staff and students OSU is prime awardee on the award/contract OSU is designated as the sirb of Record (e.g., per the NIH policy) 8

9 OSU IRB reviews (IRB of Record) IRB of Record-reviews, approves, and oversees research for external researchers and institutions. 9

10 IRB Review Models OSU IRB review is always an option-except NIH sirb of Record mandates an External IRB OSU/NCH longstanding reciprocity agreement applies Western IRB (WIRB)-industry-sponsored clinical trials Sponsor-mandated central IRB (e.g., NCI cirb) 10

11 OSU Relies on an External IRB OSU is a Relying Institution when an External IRB oversees research conducted by OSU faculty, students & staff 11

12 IRB Review Models OSU IRB may rely on an External IRB-except Research determined EXEMPT by External IRB Planned emergency research Xenotranplantation research Gene transfer research Embryonic stem cell research 12

13 IRB Review Models What does an External IRB review cover? Initial Review Modifications (amendments) Continuing Reviews Reportable Events Noncompliance 13

14 IRB Review Models When an External IRB is the IRB of Record OSU is still responsible for ancillary committee reviews Human Subject Radiation Committee (HSRC) Institutional Biosafety Committee (IBC) Maternal Fetal Welfare Committee Cancer Scientific Review Committee (CSRC) 14

15 IRB Review Models When an External IRB is the IRB of Record OSU is still responsible for researcher training, compliance, and the conduct of research Training-Human Subjects Protection-CITI program Conflict of Interest (ecoi) Informed Consent: template/language, subject injury language, OSU contacts, and HIPAA 15

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17 Ohio State is acting as the IRB of Record- Regular Buck-IRB application to OSU IRBs In Buck-IRB note: Location of Research Buck-IRB Considerations Domestic Research Sites-Non-Ohio State Locations International Research Sites 17

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19 Ohio State is acting as the IRB of Record- Regular Buck-IRB application to OSU IRBs In Buck-IRB note: Buck-IRB Considerations External Co-Investigators & Key Personnel Affiliated Organization vs independent investigator? Activities Performed? CITI/COI required for independent investigators 19

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21 Ohio State is acting as the IRB of Record- Regular Buck-IRB application to OSU IRBs In Buck-IRB note: Buck-IRB Considerations Is this a multi-site study? (often YES for collaborative research) Is the Ohio State PI the lead investigator or is Ohio State the lead site for collaborative research? (usually YES if OSU is IRB of Record) 21

22 Buck-IRB Considerations 22

23 Buck-IRB Considerations OSU Relying on External IRB Short Buck-IRB Application To request a ceded review, start a new application in Buck- IRB Select Create a New Study Select Type of Review Must be Expedited or Convened Review for IRB reliance Reminder: Exempt research cannot be ceded to an external IRB 23

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25 Buck-IRB Considerations OSU Relying on External IRB Short Buck-IRB Application Next steps Select an external Review Board per the following choices: National Cancer Institute IRB NCH IRB WIRB (several other choices) Other external IRB 25

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27 Buck-IRB Considerations Next steps OSU Relying on External IRB Short Buck-IRB Application Selecting Other External IRB will require point of contact information for two individuals Collaborating external investigator (lead PI) External IRB point of contact 27

28 Buck-IRB Considerations 28

29 Buck-IRB Considerations Next steps OSU Relying on External IRB Short Buck-IRB Application Upload a copy of the IRB approval and/or IRB application form from the external institution as well as the protocol and any other documents relevant to Ohio State s participation ORRP will reach out to the external IRB when the application is received 29

30 IRB Agreements 30

31 IRB Agreements Important notes Contact OSU IRB to determine if a master agreement with the External IRB already exists Contact OSU IRB early if a new central IRB Agreement is needed (takes time) New External IRB IAA templates need OSU legal review (takes time) IRB staff will draft an IAA using an approved OSU template, or fill in OSU info on External IRB template 31

32 Example OSU IRB Authorization Agreement (IAA) Template 32

33 Individual Investigator Agreement (IIA) An external collaborator is an individual investigator if: Not a faculty, student, or staff of Ohio State May be conducting research activities outside of OSU Not acting as an employee or agent of ANY institution or Acting as an employee or agent of a non-assured institution (no Federalwide Assurance #, likely no IRB) Examples: former student, volunteer, consultant/selfemployed, local business/clinic, international researcher, survey firm 33

34 Individual Investigator Agreement (IIA) To obtain an IIA for an external collaborator Upload individual s CV in Buck-IRB with an Initial submission or amendment Eligibility for IIA is determined during IRB screening IIA template is prepared and sent by IRB staff to the PI for signatures 34

35 Example Individual Investigator Agreement Template 35

36 Individual Investigators Individual Investigators (IIA) are required to have OSU CITI training and Conflict of Interest (ecoi) Steps for external collaborator to access OSU CITI / ecoi Acquire an Ohio State guest account from orhelpdesk@osu.edu (or call (614) ) 36

37 Individual Investigators Individual Investigators (IIA) are required to have OSU CITI training and Conflict of Interest (ecoi) The researcher registers for CITI training using OSU guest address Instructions: To access CITI, log on 37

38 Individual Investigators Individual Investigators (IIA) are required to have OSU CITI training and Conflict of Interest (ecoi) ecoi disclosure will also need to be completed by the external researcher using their guest . Log on at: 38

39 Master IRB Agreements Consortia CReATe-via U of South Florida IRB Jaeb Center for Health Research Foundation MARCH (Midwest Area Research Consortium for Health) Northeast ALS Consortium (NEALS)-via Partners IRB NeuroNEXT Consortium-via Partners IRB PCORI LHSNet-via Mayo Clinic IRB PETAL cirb-via Vanderbilt IRB StrokeNet-via University of Cincinnati IRB 39

40 Master IRB Agreements Commercial / Government IRBs Western IRB (WIRB) Quorum IRB NCI CIRB-National Cancer Institute Academic Institutions Nationwide Children s Hospital Ohio CTSA (8 Ohio institutions & hospitals) SMART IRB-National reliance with 250+ participating institutions 40

41 SMART IRB OSU is a SMART IRB participating institution A national reliance agreement signed by 250+ institutions and growing. Designed to harmonize and streamline the IRB review process for multisite studies by using a single agreement and a process to designate and document the IRB of Record 41

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44 FAQs and References ORRP Website Frequently Asked Questions: OHRP Guidance: NIH Policy on the Use of a single IRB for Multi-Site Research: olicy_multi_site_research_updated2016.pdf 44

45 Who to Contact IRB general assistance: phone: press 2 for collaborative research, IRB agreements IRBInfo@osu.edu IRB reliance and investigator agreement help: Jessica Evans, MHA, CHRC, CIP Office of Responsible Research Practices 1960 Kenny Road, 3 rd Floor evans.309@osu.edu and IRBAgreements@osu.edu direct phone:

46 Questions? 46