External Institutional Review Boards
Use of external institutional review boards (IRBs), such as that of the Biomedical Research Alliance of New York (BRANY), is permitted on a case-by-case basis. If you’re interested in enlisting the services of an external IRB, whether commercial or academic, please contact the External Review Unit at IRBemail@example.com.
Using the Biomedical Research Alliance of New York Institutional Review Board
BRANY is an Association for the Accreditation of Human Research Protection Programs–accredited IRB available for use as a central IRB of record for certain NYU School of Medicine research studies. Please note the following critical points:
- There are fees associated with BRANY IRB, and they must be approved by the study sponsor before the study is submitted to BRANY. Our Clinical Research Support Unit or the Laura and Isaac Perlmutter Cancer Center Clinical Trials Office contacts the study sponsor to confirm that the fees are accepted. Email Ryan Washington, program manager for Clinical Research Operations, at firstname.lastname@example.org, or call 646-501-2724 for more information.
- MyStudies, a module available within Research Navigator, and all other pertinent forms relating to clinical trials, ancillary committees, service providers, and protocol review and monitoring committees (if applicable) must be completed in Research Navigator, in addition to any required BRANY IRB forms. The study protocol, financial disclosures, CVs, budget, and investigator’s brochure (if applicable) must be uploaded to the MyStudies module.
- An institutional clearance by the external review unit and BRANY IRB approval are required before research involving human subjects is undertaken. No research with human subjects may commence without the approval of an authorized IRB.
To use BRANY IRB, your study must meet one of the following criteria:
- The study is industry initiated (for example, an industry sponsor is directly responsible for the study).
- The study is a federally sponsored, multicenter trial that requires the use of a central IRB.
- The study is a multicenter trial where NYU School of Medicine is the clinical coordinating center.
If you would like to consider using BRANY IRB for a cancer clinical trial, email Denise Rodriguez, manager of the Laura and Isaac Perlmutter Cancer Center Clinical Trials Office Regulatory Affairs Unit, at email@example.com.
Initial Study Submission Requirements
To submit an initial study to BRANY or another external IRB, you must meet the following requirements:
- Your study team completes registration of the study in the MyStudies module of Research Navigator, naming “BRANY IRB” the IRB of record, and upload the protocol, budget, completed NYU School of Medicine financial disclosure forms, CVs for all study team members, investigator’s brochure (if applicable), and National Institutes of Health grant (if applicable). This is done for the following purposes:
- It assigns an NYU School of Medicine study number.
- It allows for submission to Perlmutter Cancer Center, if applicable
- It allows for submission to the External Review Unit for institutional review.
- It allows for submission to NYU School of Medicine’s Clinical Research Support Unit for review of the study budget and coverage analysis and to initiate the creation of billing grids in the Clinical Research Management System (CRMS) and the Epic system.
- It allows for submission to NYU School of Medicine ancillary review committees and services providers (such as radiology, investigational pharmacy, or feasibility)
- It allows for Research Finance to track enrollment and request payments from sponsors.
- The study is to be reviewed administratively by the Clinical Research Support Unit for confirmation that the study sponsor accepts the fees associated with using BRANY IRB. The Clinical Research Support Unit notifies the principal investigator if the study cannot be submitted to BRANY IRB.
- The submission is cleared administratively by the External Review Unit to confirm that all institutional requirements are addressed in the materials and documents before the principal investigator submits the study to BRANY IRB.
- BRANY IRB will send the study team instructions on how to complete the IRB application through BRANY IRB’s IRBManager™ system.
- If a financial conflict of interest is indicated, the External Review Unit notifies NYU Langone’s Conflicts of Interest Management Unit, which conducts its review and assigns a management plan, if necessary. The review occurs concurrently with the BRANY IRB review, and the Conflicts of Interest Management Unit notifies both the principal investigator and BRANY IRB of the outcome.
- The principal investigator is responsible for ensuring that all institutional approvals and clearances are obtained before initiating the study.
- The External Review Unit issues institutional clearance when all ancillary and local context reviews are complete and BRANY IRB has issued its approval. When institutional clearance is issued, the status of the study becomes “External IRB” in Research Navigator.
- IRB-approved documents are available in IRBManager™.
Access to the BRANY IRB System
IRBManager™ is BRANY IRB’s web portal used for making submissions, managing IRB information, and tracking study-related events. It must be used to electronically complete “xForms” for the following:
- research application (new research studies)
- continuing review applications
- requests for IRB review (related to changes in study personnel, amendments, updated or new study materials, or advertisements)
- reports of study site status change
- reportable events
Principal investigators and research staff wishing to obtain access to IRBManager™ must complete a one-time request for user access form and email it to Svetlana Abramova, senior adverse event assistant, at firstname.lastname@example.org. Within 48 hours, you should receive an email notification with your username and password. Note that you have the option to schedule training sessions for IRBManager™ and xForms.
It is important to note that your study cannot begin until you have received BRANY IRB approval, as well as all pertinent institutional approvals and clearances. These include the following:
- Conflicts of interest disclosures. Regardless of the use of BRANY IRB, financial conflict of interest disclosures for all investigators and research staff must be reported to NYU Langone’s Conflicts of Interest Management Unit by uploading completed forms into the MyStudies module of Research Navigator.
- CITI Human Subjects Protection Training. All investigators and research staff must complete Collaborative Institution Training Initiative (CITI) training on human subjects protection. Certificates of completion should be printed and maintained with the study’s regulatory binder.
- NYU Langone ancillary reviews and service providers. The use of BRANY IRB does not replace the need for applicable internal reviews and approvals related to the conduct of your study at NYU Langone and its facilities. Examples include radiation safety, Department of Radiology, Center for Biospecimen Research and Development, Department of Pathology, and others. The principal investigator ensures that all such approvals are obtained before beginning the study.
- If the study is conducted by the Laura and Isaac Perlmutter Cancer Center, the study team must obtain approval from the Protocol Review and Monitoring Committee.
- Research billing and contracts. All clinical research studies must be submitted for review by the Clinical Research Support Unit through the CRMS module of Research Navigator. They determine whether the study requires a billing grid, and if so, perform a prospective reimbursement analysis of procedures and services performed within NYU Langone. Approval through the CRMS must be obtained before you begin the study, even if you have already received BRANY IRB approval. Additionally, clinical trials agreements for industry-sponsored studies must be fully executed.
- Institutional clearance. The External Review Unit is situated within NYU School of Medicine’s IRB office and provides final institutional clearance of the study. It confirms that the study has been approved by BRANY IRB, uploads all approved documents to Research Navigator, and verifies that all institutional review committees and service providers have provided their approvals and clearances.
Continuing Review, Study Modifications, and Study Closures
The study team submits study modifications, continuing reviews, and study closures directly to BRANY IRB through IRBManager™.
The study team submits personnel changes through Research Navigator only.
Unanticipated Problems or Serious or Continuing Noncompliance Issues
All unanticipated problems or serious or continuing noncompliance issues should be reported first to BRANY IRB. BRANY IRB reviews all reports and escalates any possibly serious issues by sending an email to the principal investigator, research team, sponsor liaison (if applicable), NYU School of Medicine’s IRB director, NYU School of Medicine’s External Review Unit, and NYU School of Medicine’s designated institutional official. The email summarizes the reported problem, specifies whether any additional information is required, and notes when the convened BRANY IRB will review the matter.
Following the IRB’s review and determination, a response to that aforementioned email is sent to all parties, providing the following:
- notification of the IRB’s determination
- requests for further information and/or corrective and preventive action plan, if applicable.
BRANY IRB generates notifications to regulatory authorities, when required, and sends them within 30 days of the determination, copying the principal investigator, sponsor, and institutional liaisons. During this 30-day period, BRANY IRB regularly provides updates, as well as a draft of the notice to review before it is sent.
Conducting Research at NYC Health + Hospitals/Bellevue
Before applying to conduct research at NYC Health + Hospitals/Bellevue, investigators should review the NYC Health + Hospitals/Bellevue guidance document to determine whether to list NYC Health + Hospitals/Bellevue as a site in Research Navigator.
If you determine that Bellevue is a research site, complete the following steps:
- Contact Andy Veeraraj, Bellevue Research Director, to confirm that you have chosen NYC Health + Hospitals/Bellevue as a research site. Call 212-562-4176 (office) or 646-676-9691 (mobile), or email email@example.com.
- Submit your study using the System to Track and Approve Research (STAR). All investigators conducting research at NYC Health + Hospitals/Bellevue must obtain approval from the Bellevue Research Review Committee and the Health + Hospitals Central Office Research Administration via STAR.
- Wait until you receive your approvals. Your study may begin at NYC Health + Hospitals/Bellevue upon the receipt of Health + Hospitals Central Office approval letter, sent to you via the STAR system. Please note that annual renewals are required.
If you have questions regarding the STAR process or applying at NYC Health + Hospitals/Bellevue, please contact Mr. Veeraraj.
If you have NYU Langone-related questions regarding conducting research at NYC Health + Hospitals/Bellevue, please contact Bien Lee, MPA CCRC, senior research project manager in the Office of Science and Research. Call 646-754-7201 or email firstname.lastname@example.org.