USE OF CENTRAL/COMMERCIAL IRBS:

Mount Sinai School of Medicine (MSSM) has contracts with Quorum Review IRB, Schulman Associates IRB, and Western IRB (WIRB) to oversee initial and continuing review of protocols for specific clinical trials conducted at MSSM.

Eligibility Criteria: Research Studies Eligible for Submission to a central/commercial IRB: The criteria for Research Studies to be eligible for central/commercial IRB review include:  The research is a multi-site Phase II/III/IV drug or medical device Research Study.  The research is designed by, and the protocol written by, the sponsor.  The sponsor is a pharmaceutical or medical device company.  The sponsor (pharmaceutical or medical device company) holds all INDs/IDEs.  The research has not previously been submitted to MSSM’s IRB for review.

Research Studies Not Eligible for Submission to a central/commercial IRB: The criteria for Research Studies that are not eligible for submission to a central/commercial IRB include:  Investigator initiated research.  Research where MSSM is a coordinating center, or otherwise has an oversight role for the overall research across multiple sites.  Research in which the Investigator holds an IND/IDE.  Research is being conducted at MSSM only (single-site study).  Planned emergency research.  Embryonic stem cell research.  Research that involves a request for approval for local non-affiliated sites.  Research that involves the use of recombinant DNA and its derivatives, such as vectors or infectious agents requiring IBC review.

The Role of the PPHS when using a central/commercial IRB: 1. All requests to submit a new research study to a central/commercial IRB must be sent to the PPHS Office using the HRP-229A. 2. The PPHS Office will determine whether the submission is eligible for submission to the central/commercial IRB and, upon confirming eligibility, will provide documentation required by the commercial IRB for you to proceed with the submission. 3. The PPHS Office will work with you to determine how the submission will be made (varies by Sponsor/CRO preference). a. The Sponsor/CRO be making the submission i. Use the downloaded submission forms b. You will make the submission directly i. Use the online system ii. Use the downloaded submission forms o The PPHS review will: . Confirm that all education requirements have been met . Confirm that other required institutional submissions have been made . Serve to coordinate the review process. For example, the PPHS Office will work with the FCOIR committee, the study team and the commercial/central IRB to ensure the information is gathered and communicated; the PPHS Office will work with the central/commercial IRB to obtain the ICF for the GCO Contract Specialists as early in the process as possible (before the ICF has been officially released for the site) so as to not delay contract negotiations. . The PPHS Office will work with the commercial IRB and Sponsor/CRO on any consent/HIPAA language negotiation required during the review process.

Submitting a New Study to a central/commercial IRB – MSSM process: The following must be completed as part of the MSSM process to use a central/commercial IRB: 1. FCOIR disclosure through Sinai Central 2. Submission to GCO and contract negotiation 3. HRP-229A-Request to Rely on an External IRB (this may trigger other institutional requirements) 4. IDS review, if applicable

Email new study submission packets (with HRP-229A) from a Mount Sinai email address to [email protected] with the subject line “Commercial IRB Submission – [Quorum, Schulman, WIRB]” or hand-deliver to the PPHS office.

The central/commercial IRB will not accept a submission for research to be conducted by an investigator at MSSM without signed authorization from the PPHS.

The administrative fee charged by the PPHS for the use of a central/commercial IRB is a one-time charge of $575.

Submitting a New Study to a central/commercial IRB – What the commercial IRBs have in common:

WIRB, Schulman Associates and Quorum Review each have:  A simplified application form to add a site to an approved research study. o These submissions do not require a copy of any documents on file from the Sponsor’s submission for approval, or a copy of the consent/HIPAA document  A more comprehensive application form for a study that has not ever been submitted to the commercial IRB o These submissions require in-depth information and documentation

Submitting a New Study to a central/commercial IRB – the CRO matters:  Some Sponsors/CROs will submit the site on your behalf.  Ask your contact at the CRO who will submit to the commercial IRB (you or them). o If the Sponsor/CRO will submit on your behalf, your contact at the CRO will provide you with guidance on what needs to be completed and in what format (commonly, the application form and all supporting documents need to be downloaded, completed and scanned to PDF and sent via email to the CRO; in these cases CC: [email protected]). o If you will submit directly, you may be able to use the commercial IRB’s online submission process.

If you are interested in submitting a research study to a different central IRB, please contact the PPHS Office for guidance. This may be possible, but the first time working with any new IRB takes time as contract negotiation and consent/HIPAA authorization forms need to be customized for the site. Schulman Associates IRB: http://www.sairb.com/Pages/home.aspx

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

Submission Type: Initial Submission: eSubmission 2.0 System, Research Site (if the study has already been approved by Schulman and you are adding a site only). Prior to submission, you will have the opportunity to view form summary and can print to PDF at this step to save a copy of your submission for your file, send to the PPHS with the HRP-229A form, upload it into InfoeEd, etc.

If you are not going to use the Esubmission system, you can download the forms you need from the Schulman website, complete them, scan them and send them as PDF attachments via email.

Upon Schulman’s receipt of a new study submission, a SiteAccess account will be established using the site contact email provided on the Schulman submission form. SiteAccess allows users to track review activities, as well as to download approval documents as soon as they become available. Quorum Review IRB: http://www.quorumreview.com/

Esubmission Login: www.quorumreview.com/submit

Quorum has a Smartform submission process for the Site Information Questionnaire to add the site to an approved sponsored protocol.

If you are not going to use the Esubmission system, you can download the forms you need from the Quorum Review website (right menu), complete them, scan them and send them as PDF attachments via email. Under the Site Forms, you will also find a checklist and some guidance documents with instructions on how to complete the forms for Quorum.

Quorum has partnered with the PPHS Office to develop an institutional cover sheet. This cover sheet must be completed by the PI, signed by a representative of the PPHS and submitted with your application or Quorum will not review your application. The information obtained on the cover sheet will be used by Quorum Review to customize the language in the consent/HIPAA authorization for the research study for MSSM.

Western IRB (WIRB): http://wirb.com Submission Process WIRB has an electronic submission system for adding a site. This enables you to use their Smart Form for New Research, upload supporting materials, save and print the application as a PDF, and to submit electronically. You will need to save and print the application as a PDF for submission to the PPHS office prior to submission to WIRB.

Using the electronic submission process allows you to copy the information from an application to use as a basis for a new application, in addition to providing you with alerts and study documentation online.

If you are not going to use the Esubmission system, you can download the forms you need from the WIRB website, complete them, scan them and send them as PDF attachments via email.

WIRB NET client log-in https://forms.wirb.com/utils/login.aspx

Choose online submission using a smart form, choose new research, Submission Type: Select New Investigator for a research study that has already been submitted to WIRB by the Sponsor/CRO and has been approved. This submission type allows you to add MSSM as a site to the study.

Tips for completing this form:

Under Site: Does this site have an obligation to use another IRB? Answer “Yes”

Under WIRB Consent: Would you like to use the previously approved consent form? Answer “Yes”. We have negotiated a site-specific consent/HIPAA authorization that will be generated by WIRB. You do not need to submit a consent form.

Under Billing Information: You should discuss this with the CRO/Sponsor prior to submission since you need to submit written verification.

Note: The Finalize Submission button is the submission button. Only click this if you are ready to submit your application to WIRB.