Presentation Transcript

1. My Sponsor Wants to Know if I Can Use a Central IRB

   An Introduction to Using a Central/Commercial IRB at MSSM
2. When Can I Use a Commercial IRB? A multi-site clinical trial (Phase II-IV or medical device) The protocol was written by a pharmaceutical or device company The company that rote the protocol holds the IND or IDE The research has not been submitted to MSSM’s IRB previously MSSM does not have oversight over other sites (not coordinating center, not the main study PI)
3. Commercial IRBs* that MSSM has contractual agreements with: Quorum Review Schulman Associates Western IRB (WIRB) If you wish to use a different commercial IRB, contact the PPHS office to discuss. Negotiating a contract with a commercial IRB takes time. * Listed in alphabetical order
4. What Do I Need to Do for MSSM? Financial Interest in research disclosures through Sinai Central PPHS FORM- HRP-229A – Request to Rely on an External IRB GCO (and contract negotiation) IDS review, if applicable Device review through Inna Bender, if applicable Any other institutional requirements (such as Radiation Safety Committee review)
5. What is the involvement of the PPHS? The PPHS office will confirm eligibility to use commercial IRB, and will provide the PI with the commercial IRB-required sign off to proceed within 2 business days The PPHS review will: Confirm education requirements have been met Confirm other required in-house submissions have been made Coordinate the review process (get ICF to the Contracts Specialist; get COI management plan to the commercial IRB when needed, etc.) Work with the commercial IRB and Sponsor/CRO to negotiate consent/HIPAA language Serve as MSSM Liaison to the commercial IRB The PPHS charges a one-time administrative fee of $575 for research that will use a commercial IRB
6. Basic Information on submitting to the commercial IRB:(once you have the PPHS-signed document to proceed) Each commercial IRB requires sign-off from the PPHS prior to submission Some Sponsors/CROs will submit on your behalf – find out who will ultimately make the submission Each commercial IRB website features an area to download forms and an online submission system with smart forms Each commercial IRB will accept an online submission or an email (with PDF file forms) A few basic screenshots for each site follow
7. Basic Tips while completing the commercial IRB forms to add a site For the question about a local IRB –answer “Yes” For the question about using the model consent form –answer “Yes” (MSSM has negotiated site-specific consent/HIPAA language in place)
8. After Initial Approval from the commercial IRB: You will still need to make annual submissions to the GCO and submit Financial Interest in research disclosure forms through Sinai Central
9. QUORUM REVIEW IRB http://www.quorumreview.com/ www.quorumreview.com/submit
10. X X X X
11. SCHULMAN ASSOCIATES IRB www.sairb.com https://portal.sairb.com/esubmission/Registration.aspx
12. Click here for online submission Click here to find out what forms you need Click here if you know what forms you need to download
13. Click here to start new site submission
14. WESTERN IRB (WIRB) http://wirb.com https://forms.wirb.com/utils/login.aspx
15. Use this if the study has not ever been submitted to WIRB (by the Sponsor) Use this to add MSSM as a site to a study already approved at WIRB