Albert Einstein College of Medicine, Inc. & Montefiore Medical Center

Albert Einstein College of Medicine, Inc. & Montefiore Medical Center

Reliance Request/Protocol RegistrationRequired Information

Principal Investigator Information

AECOM/MMC PI:Click here to enter text.

PI Phone Number:Click here to enter text.

PI Email: Click here to enter text.

PI Payroll: Choose an item.

AECOM/MMC Study Contact Information

Study Contact Name:Click here to enter text.

Study Contact Phone Number:Click here to enter text.

Study Contact Email: Click here to enter text.

External or Individual Investigator Information

External Investigator Name:Click here to enter text.

External Investigator Phone: Click here to enter text.

External Investigator Email: Click here to enter text.

External Investigator Home Institution (please write N/A if not applicable): Click here to enter text.

Study Information

Study Title (please be sure the study title is the same on this form, in iRIS, and on the grant, if applicable): Click here to enter text.

iRIS ID#: Click here to enter text.

Which IRB will serve as the IRB of record? Choose an item.

Which research procedures will occur at Einstein/MMC? (Select all that apply. You must select at least one.)

☐Consenting

☐Einstein/MMC is receiving funding

☐Einstein/MMC is providing funding for research occurring elsewhere

☐Use of ancillary services (e.g. radiology, labs, etc.)

☐Reviewing medical records (including record review for identification and recruitment)

☐Sending coded or de-identified data outside of the institution

☐Sending or receiving specimens

☐Sending a limited data set outside of the institution

☐Administering surveys, questionnaires, interviews, or conducting focus groups

☐Recruiting subjects (students, faculty, staff, patients)

☐Design of study/protocol

☐Other – Please describe: Click here to enter text.

Which research procedures will occur at the external institution? (Select all that apply.)

☐Consenting

☐Use of ancillary services (e.g. radiology, labs, etc.)

☐Reviewing medical records (including record review for identification and recruitment)

☐Sending coded or de-identified data outside of the institution

☐Sending or receiving specimens

☐Sending a limited data set outside of the institution

☐Administering surveys, questionnaires, interviews, or conducting focus groups

☐Recruiting subjects (students, faculty, staff, patients)

*If you are requesting that the Einstein IRB serve as the IRB of record for more than one external site, please email or call us at 718-430-2237 and ask to speak with someone about reliance agreements.

External IRB Information (if applicable)

Name of External IRB: Click here to enter text.

IRB Contact Name and Title: Click here to enter text.

IRB Contact Phone Number: Click here to enter text.

IRB Contact Email: Click here to enter text.

HIPAA Information

If the study has already been reviewed and approved by an external IRB, has that IRB or other privacy board issued a waiver of HIPAA Authorization? Choose an item.

Ancillary Approvals

Please check all that apply:

☐This study has a corresponding grant or contract that has already been reviewed by the Office of Grant Support.

☐This study involves the Office of Clinical Trials.

☐This study involves a DUA or MTA.

☐This study requires Radiation Safety Committee approval.

☐This study requires Institutional Biosafety Office approval.

☐This is a cancer protocol, requiring scientific review by the Protocol Review and Monitoring Committee.

☐This study involves the Clinical Research Center.

☐This study involves the use of an investigational drug and, therefore, review by the Research Pharmacy.

Attestation

I attest to the following:

• I understand that ceding requests are reviewed on a case-by-case basis and that Einstein/MMC may choose not to enter into a reliance agreement for a particular study.
• All key personnel have been listed on the Einstein IRB application and I will submit all changes to key personnel to the Einstein IRB (and to the overseeing IRB, if required.)
• I will submit progress reports to the Einstein IRB 30 days prior to the study expiration date listed on the protocol acknowledgement letter. I understand I will receive the protocol acknowledgement letter once the Einstein IRB has reviewed and made a determination on my ceding request.
• I will promptly report to the Einstein IRB all local unanticipated problems, study terminations and/or suspensions, data breaches, local serious adverse events, local non-compliance, systematic data collection errors that impact the integrity of the research, any action taken to prevent apparent immediate hazard to a research subject, incarceration of a research subject, suspension or restriction of any local investigator’s clinical license, and any other reportable events required by Einstein for ceded protocols or as specified in the protocol acknowledgement letter.
• If Einstein/MMC are ceding IRB review to an outside institution, I understand that I do not need to submit reports of external events to the Einstein IRB. I will abide by the reporting requirements of the Lead IRB regarding external events.
• I will familiarize myself with the reporting requirements of both Einstein/MMC and the Lead IRB (if applicable) and will adhere to both Einstein/MMC’s and the Lead institution’s policies and procedures governing human subjects research.
• I will submit a closure report to the Einstein IRB upon study completion.

INSTRUCTIONS

Please submit this form in iRIS along with the additional required documents indicated on the next page.

You should select protocol registration as your application type if you are requesting that the Einstein IRB rely on an external IRB.

If you are requesting that Einstein serve as the lead IRB of record on behalf of another/other site(s), please call the IRB Office at 718-430-2237 before submitting in iRIS.