IRB Initial Submission
Complete the Investigator Form (IF) in Sinai Central?
An IF number is required for your IRB application. This IF number is generated in Sinai Central for each study. For more information visit the Investigator Form (IF) page.
Exception – If you are using BRANY for both IRB review and contracting, this step is not required.
Start the GCO Application?
A GCO application must be started at the same time as your IRB application. The IRB will reject your submission if you have not started the GCO application and do not have an assigned InfoEd Project Development (PD) number.
For more information visit the GCO Application page.
Review the Program for the Protection of Human Subjects (PPHS) Information?
Please read the following information before submitting to the PPHS office for human research review.
The ISMMS Institutional Review Board (IRB) is responsible for assessing and approving all* research at the Mount Sinai Health System (MSHS) that is to be conducted in human subjects.
*All research includes:
- More than minimal risk studies
- No more than minimal risk (expedited) studies
- Requests for IRB exemptions
- Human subject research determinations
- Requests to rely (R2R) on an external IRB (commercial IRB, BRANY, SMART IRB)
- For more information, click here.
If you believe your research study is exempt from IRB oversight, see Worksheet HRP-320: Human Research Determination for more information. Note – Only PPHS can determine if your study is exempt from IRB review.
Types of Studies that Qualify as Human Subject Research
If you need a determination of whether your study qualifies as human subject research, see Worksheet HRP-309: Human Research Determination for more information. Note – PPHS makes the ultimate determination in cases as to whether an activity constitutes Human Research subject to IRB oversight.
Ideate Account Access
Click here for step-step instructions on how to access Ideate and upload a CV in Ideate. Note that all members of the research team must upload their CV into their Ideate profile.
Requests to Rely on External IRBs
To determine whether your protocol meets the criteria to rely on an external IRB, refer to "Commerical IRBs, BRANY and NCI CIRB".
Note, all human subject research protocols being reviewed by an external IRB, must first be submitted to the PPHS office through Ideate. For detailed guidance on the Request to Rely (R2R) process, click here.
When an external IRB is used, ISMMS only cedes study review to the external IRB. ISMMS remains responsible for review of local requirements including conflict of interest reviews, conditional office review, state law, institutional policy and education requirements.
The IRB submission should be concurrent with budget and contract negotiations. Final IRB approval is contingent on a fully-executed contract.
These are studies that were originally approved by the IRB before the Ideate system was implemented. They were submitted on forms via email to the IRB. Continual renewals, modifications and amendments for legacy studies do not go through Ideate, they continue to utilize FORMS and email IRB@mssm.edu for submission.
ISMMS Conditional Office Reviews
Depending on the type of research activities involved, PPHS may route applications to other Institutional committees for review. While these committee reviews are concurrent with IRB review, study teams should allow for additional time for the IRB review process.
Radiation Safety Committee – Review is required when research involves ionizing radiation for imaging or therapy, including:
- CT scans
- Nuclear Medicine Tests
- Radiation Therapy
Institutional Biosafety Committee – Review is required when research involves the use of hazardous materials including:
- Recombinant DNA
- Viral Vectors
- Bacterial Artificial Chromosomes
- Toxic Chemicals
- Potentially Toxic Medication/Carcinogens
- Autologous Cell Lines
Embryonic Stem Cell Research Oversight Committee (ESCRO) – Review is required when research involves the use of stem cells including:
- Induced Pluripotent Stem Cells (IPS )
- Human Embryonic Stem Cells (hESCs)
- Human Embryos
Investigational Drug Services (IDS) – Review is required for research involving the use of drugs or biologics including:
- Drugs or biologics are not part of standard practice (including FDA approved drugs/biologics when given in a way that differs from standard practice)
- Controlled substances
- Drugs or biologics supplied by the research sponsor or purchased with study funds
Financial Administration of Clinical Trials Services (FACTS) – The FACTS office conducts a review of all research applications to determine if a clinical trial requires a Medical Coverage Analysis (MCA). A MCA is required for trials in which tests, procedures and interventions will be billed to patients or third party payers. If a MCA is necessary the investigator will be notified and FACTS will coordinate the process of having BRANY complete the MCA. Note: There is a BRANY fee associated with the coverage analysis that must be built into the study budget. For more information see Medical Coverage Analysis.
Form HRP-231- International Research
Researchers who are travelling internationally to conduct any research activities that may include (but are not limited to) data collection and analysis, interaction with human subjects, access to identifiable health information of human subjects are required to submit form HRP-231-Form -International Research to the IRB. The form should be uploaded in the electronic IRB submission system.
IRB Continuing Review and Modifications
IRB Continuing Review
Before you submit your continuing review, a new IF# must be generated in Sinai Central and all research staff must make their annual FCOIR disclosure under the assigned IF#. Studies using an external IRB are also required to complete an IF form in Sinai Central (exception - studies using BRANY for both IRB review and contracting). When an external IRB is used, ISMMS only cedes study review to the external IRB. ISMMS remains responsible for FCOIR reviews, conditional office reviews (Biosafety, IDS, Radiation Safety etc.) and ensuring study teams meet the institutional training requirements.
For more information visit the Investigator Form (IF) Instructions page.
If the IRB has provided a three year approval and there is no external sponsored project funding (e.g., ISMMS, industry clinical trials negotiated by FACTS, and cooperative trial research projects), GCO submissions are also only then required every three years.
For more information visit the GCO Annual Submission page.
Please read the outlined information before submitting to the PPHS office for human research review.
All research studies are required to submit continuing review applications to the IRB. The frequency of review is determined by the IRB. Refer to the expiration date listed on your project’s most recent IRB approval letter.
Effective January 21, 2020, the PPHS has determined that certain minimal risk protocols will no longer require an annual continuation and will be granted a three year approval period. The PI/Research Team is responsible for ensuring CITI refresher training is completed every three years, and that Financial Conflicts of Interest are managed a by the FCOI committee in the Office of Industry Engagement and Conflict of Interest Office ("COI Office) independent of the project approval committee.
For studies using the ISMMS IRB, continuing review applications must be submitted at least 6 weeks prior to the study/project expiration date that is listed on the most recent IRB approval letter.
To coordinate your submission, refer to "2020 ISMMS IRB Review Deadlines & Board Meeting Dates."
Ideate: For studies that have been approved in Ideate, continuing review applications are required to be submitted in Ideate.
Legacy Studies: These are studies that were originally approved by the IRB before the Ideate system was implemented (also called paper submissions). Continuation renewals and, modifications for legacy studies do not go through Ideate, they continue to utilize HRP FORMS and email irb@mssm,edu for submission. Refer to FORM HRP-212 for the specific continuing review submission requirements.
To submit a modification along with your continuing review application in Ideate, you need to do the following:
- Create a modification application in Ideate
- Attach signed and completed form HRP-212 Continuing/Final Review Progress Report (see "Forms")
Note: This only applies if the study is not expired. Otherwise a continuing review must first be submitted, followed by the modification.
Studies using an external IRB are required to submit continuing reviews to the external IRB of record.
ISMMS PPHS Requirements: Once continuing review approval has been obtained from the external IRB, study teams are required to make a Continuation submission in Ideate. For more information, refer to "Continuations" under "Icahn School of Medicine at Mount Sinai IRBs and External IRBs.
Contact the PPHS at (212) 824-8200 or IRB@mssm.edu.
IRB Modifications and Reportable New Information
All proposed modifications to a study require IRB approval prior to implementation.
Exempt Studies: If the research is determined to be "exempt", and a proposed modification affects the design and conduct of the research in the approved protocol, a modification must be submitted to the IRB.
Note - if a modification is a study personnel change, you will be required to modify the Investigator Form (IF) in Sinai Central.
Ideate: For studies that have been approved in Ideate, modifications are required to be submitted in Ideate.
Legacy Studies: These are studies that were originally approved by the IRB before the Ideate system was implemented. Continuation renewals, and modifications for legacy studies do not go through Ideate, instead they continue to utilize HRP FORMS and email firstname.lastname@example.org for submission. Refer to FORM HRP-213 for the specific submission requirements.
Studies using an external IRB are required to submit all modifications and unanticipated problems to the external IRB of record.
ISMMS PPHS Requirements: Refer to Requests to Rely (R2R) on an External IRB.
IRB Study Closeout
IRB Study Closeout
The principal investigator is required to close out the study with the governing IRB when the following conditions have been met:
- Enrollment is closed and research related activities, interventions or interactions with human subjects have been completed
- All queries have been resolved
- PHI data, and records are no longer required by study team or sponsor (data locked)
- Sponsor has conducted a close out visit and issued a close out letter (sponsor grants permission to close the study with the IRB)
Reports should be submitted within 30 days of the completion of the study.
For studies that were initiated through Ideate, close out reports are required to be submitted in Ideate.
Legacy or Paper Studies
Legacy or Paper Studies are studies that were originally approved by the IRB before the Ideate system was implemented. They were submitted on forms via email to the IRB. Notification of closeout, terminations and suspensions for legacy studies do not go through Ideate, instead they continue to utilize FORMS and email email@example.com for submission. Refer to FORM HRP-212 for specific submission instructions.
Submit a close out report to the external governing IRB.
ISMMS PPHS Requirements: Study teams are also required to report the study closure to ISMMS PPHS via Ideate.
Study Termination or Suspension
If a study is terminated or suspended the study team is required to notify the governing IRB immediately.
Study termination or suspension is reported via Ideate.
Legacy or Paper Studies
These are studies that were originally approved by the IRB before the Ideate system was implemented. They were submitted on forms via email to the IRB. Notification of closeout, terminations and suspensions for legacy studies do not go through Ideate, they continue to utilize FORMS and email for submission.
Study termination/suspension is reported to the external governing IRB. Study teams are also required to report study termination/suspension to ISMMS PHHS.
Training, Ongoing Workshops & Office Hours
IRB Office Hours
The PPHS Office offers walk-in Office Hours providing ISMMS faculty and staff the opportunity to consult with the IRB. During these consultations the PPHS staff can assist with all questions related to the IRB submission process, etc.
Every Thursday: 2:00 – 4:00 pm
Icahn School of Medicine at Mount Sinai
345 East 102 Street
Second Floor, Ste. 200
Ideate Instructional Modules & Reference Guides
To access, click here.
The PPHS IRB University Program offers training courses for investigators and research teams who are involved in the design, conduct, and/or reporting of human subject studies at the Mount Sinai Health System. The courses provide hands-on training on the IRB submission requirements, protocol and consent writing, as well as useful tips to ensure documentation is complete and compliant.
- IRB 101: Basic Steps of the IRB Submission
- IRB 201: Document Analysis & Evaluation: Protocol and Consent
Upcoming training sessions are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.
Step Right Up
PPHS hosts monthly Step Right Up questions and answers sessions with the IRB. Principal investigators and their study teams are encouraged to come with their questions for one-one-discussions with the IRB.
Upcoming sessions are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.
Clinical Research Forum
PPHS hosts a monthly Clinical Research Forum to facilitate ongoing communication between research personnel and the administrative offices that regulate and process research projects (e.g., IRB, IACUC, GCO. Topics discussed at the forum include, NIH regulations, institutional processes and procedures, and research compliance. All clinical research personnel are encouraged to attend.
Date: First Wednesday of Every Month
Location: Hess Bldg., Davis Auditorium, 2nd floor
Upcoming forums are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.
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