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My Sponsor Wants to Know if I Can Use a Central IRB. An Introduction to Using a Central/Commercial IRB at MSSM. 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

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My sponsor wants to know if i can use a central irb

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

An Introduction to Using a Central/Commercial IRB at MSSM


When can i use a commercial irb
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)


Commercial irbs that mssm has contractual agreements with
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


What do i need to do for mssm
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)


What is the involvement of the pphs
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


My sponsor wants to know if i can use a central irb
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


Basic tips while completing the commercial irb forms to add a site
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)


After initial approval from the commercial irb
After Initial Approval from the commercial IRB: a site

  • You will still need to make annual submissions to the GCO and submit Financial Interest in research disclosure forms through Sinai Central


Quorum review irb
QUORUM REVIEW IRB a site

http://www.quorumreview.com/

www.quorumreview.com/submit


My sponsor wants to know if i can use a central irb

X a site

X

X

X


Schulman associates irb
SCHULMAN ASSOCIATES IRB a site

www.sairb.com

https://portal.sairb.com/esubmission/Registration.aspx


My sponsor wants to know if i can use a central irb

Click here for online submission a site

Click here to find out what forms you need

Click here if you know what forms you need to download



Western irb wirb
WESTERN IRB ( a siteWIRB)

http://wirb.com

https://forms.wirb.com/utils/login.aspx


My sponsor wants to know if i can use a central irb

Use this if the study has not ever been submitted to a siteWIRB (by the Sponsor)

Use this to add MSSM as a site to a study already approved at WIRB