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Continuing Reviews
The IRB must conduct a review of ongoing research at intervals that are appropriate to the level of risk for each research protocol, but not less then once per year. During the IRB review process, the board determines the level of review necessary for the project. A project that is particularly risky or an investigator who has recently had a protocol suspended by the IRB for compliance concerns might be subject to a re-review of the project only after a couple of months after the approval of the project. The approval date(s) and approval expiration are clearly noted on all IRB notifications sent to the PI and must be strictly adhered to. Investigators should allow sufficient time for development and review of renewal submissions.

What research must be reviewed?
Continuing review must occur as long as the research remains active for long-term follow-up of participants even when the research is permanently closed to the enrollment of new participants and all participants have completed all research-related interventions. It is also must occur for research activities even though activities are limited to the analysis of private identifiable information.

Can a continuing review be expedited?
Yes. A project may be expedited review in the following circumstances: (1) The protocol falls under the limited circumstances described by the expedited review categories [8] and [9] at 63 FR 60364-60367 (see: Categories Research Eligible for Expedited Review. (2) the protocol was originally approved by the expedited reviewer in the initial review process.

A project that can not be reviewed in an expedited manner are those projects that fall under the following: (1) the research did not qualify for expedited review at the time of initial review of the application or (2) the research activities that previously qualified for review in accordance with 45 CFR 46.110 changed or will change, such that expedited review would no longer be permitted for continuing.

When should I submit my continuation request?
Approximately 120 days before the approval period expires, the principal investigator will receive an e-mail reminder notice of the expiration of the approved project. A reminder will be provided monthly until the project is submitted or expires.

Renewals should be submitted as early as possible to ensure the continuation review does not occur after the expiration date. Continuations to be reviewed at a convened IRB meeting may be submitted any time prior to the posted deadline dates on the NYU SoM website.  Ensure the meeting date you are submitting on the appropriate deadline for is before the project’s expiration date. It is important to provide enough time in case your renewal is deferred or provided a conditional approval.

Continuations that qualify for expedited review are accepted one week prior to posted submission deadlines or one week after the deadline. Full board review continuations take preference on the deadline dates. Expedited projects submitted on the deadline date will be delayed.
Submissions are accepted during the IRB Office’s hours: 8 am to 5 pm. It is preferred at this time documents be hand delivered. The office is located at the VAMC, 423 East 23rd Street, 10th Floor, West Side, NY, NY.  The main number is (212) 263-4110.

If the project is not reviewed and approved by the expiration date, new enrollment to the project must cease. Current study subjects who remain in follow-up or active therapy may continue to do so only, if they are placed at an increased risk.

Study Renewal
The following information must be submitted for continuing review:

• The current consent document
• Any newly proposed consent document
• Completed Application for Continuation Review
• Complete most recently approved protocol
• Protocol Summary updated with any changes
• The complete Application for Initial Review updated with any changes

Investigators must provide complete answers to all questions on the Request for Continuation form. Subject Counts should be organized in the form as follows; Screened equals the number of subjects that have signed consent. Enrolled equals the number of subjects that have signed consent and entered the study. Enrolled subjects are not counted as screen failures. In order to screen subjects, the subject must sign an informed consent document or verbally consent for studies where waiver of documentation of consent has been granted.  A subject is considered enrolled once it has been determined that the subject meets the inclusion/exclusion criteria for enrollment in the study.

Additional Reports/Information Required
The following are sections of the Continuation form where additional information is required for review.

Adverse Events/Withdrawal from Study
Along with this Continuation Application you must submit a SUMMARY of all events that have occurred since the commencement of this study.(Summaries should be in aggregate #s. Do not submit detailed reports)

Additional information that may be required:

1. Ensure to explain if there is an increase of the frequency of serious but expected side effects that the Principal Investigator or others involved in the research anticipated.
2. Complaints about the research project must be attached in a summary describing the number and nature of the complaints.
3. If any subjects were withdrawn from the study due to adverse reactions, noncompliance or other reasons please attach a summary. If this is a multi-center trial, attach a summary of all reports.
4. If a subject withdraws from the study voluntarily for medical or non-medical reasons, provide a description of any known reasons for why each subject withdrew.

Protocol Modifications
Any changes in a research protocol (such as changes in subject population, recruitment plans, advertising materials, research procedures, study sites, study instruments, or to investigators who are instrumental to the design or execution of the study) must be approved by the IRB before implementation of the change.

Investigators must submit requests for such changes listed above in a Application for Amendment form. If the study protocol has been modified, information must be conveyed in the form that the modification was approved by the IRB and the date the amendment was approved. Protocol changes proposed at this time and that require re-evaluation and approval, a highlighted and clean copy, along with the justification for the revision must be provided.

Study Results
If subjects have experienced any benefits, please provide a summary of the benefits experienced. The Principal Investigator must provide information regarding a change in the protocol’s description of the risks and/or potential benefits. If the risk/benefit relationship has been altered in anyway, please attach a summary and describe the changes.

It is important that study approval not be allowed to lapse; an expired study cannot be renewed.

Response after IRB review
After the application has been reviewed and approved, the approval letter and one copy of the approved consent form is sent to the researcher. The consent form will include the dates of the new approval period at the bottom of the page. Keep one copy of the study renewal in your file along with the application materials that were previously approved by the IRB.

What if my continuation was not submitted on time and approval has lapsed?
If the IRB has not reviewed and approved a research study by the end of the approval period specified by the IRB, all research activities must cease, including recruitment and enrollment of subjects, consent, interventions, interactions and data collection, unless the IRB concludes it is in the best interests of individual subjects to continue participation in the research interventions or interactions. This will occur even if the investigator has provided the continuing information before the expiration date because, the IRB was unable to review due to the time of receipt, non-inclusion of required information or other delays ensue.

Failure to submit continuing review information on time is considered non-compliance.

If the study is FDA regulated, the IRB Director and IRB Chair must follow FDA requirements set forth in 21 CFR 56.108(b)(3)in reaching their decision.

The sponsoring agency, private sponsor or other federal agencies must be informed of any lapse in research via the Office of Clinical Trials or Sponsored Programs Administration as appropriate.

The procedure for obtaining approval to continue subject participation after expiration of IRB approval is as follows:

• The PI will submit to the IRB Chair a written list of research subjects for whom stopping of the research would cause harm;
• The IRB Chair will review written requests from investigators who wish to continue with the study.
• The IRB Chair will further determine the specific procedures that may continue to be performed when ceasing such procedures will harm the subject.
• The IRB Chair will either orally communicate the decision to the investigator(s) or communicate such decisions via electronic mail. The IRB Chair will also provide a written response.

Final Closures

The completion or termination of a research protocol is a change in activity and must be reported to the IRB. A final report to the IRB allows the closure of all files as well as providing information that may be used by the IRB in the evaluation and approval of related studies.

NOTE: Closure of a study means that no further research, follow-up or data analyses will be performed. If any subjects are ongoing, the study may not be closed. A study is not closed simply because no additional subjects will be enrolled.

If your study has closed, complete the Application for Study Closure form and complete all information requested. The investigator must submit a final report with the closure application.