Frequently Asked Questions

Below are frequently asked questions about the IRB submission and review process.

  • Specific Submission Instructions (how to submit a modification, new study, SAE, etc.) can be found on the Submission Instructions page.
  • For FAQ’s on HIPAA in Research, please click here.

Submission of New Protocols

What are the categories of research that qualify as exempt?

Please refer to the IRB Toolkit, which is available online here.
Note: Research involving prisoners is not eligible for exempt review.
Only the IRB has the authority to determine if a protocol fits the exempt categories.

What are the categories of research that qualify for expedited review?

Please refer to the IRB Toolkit, which is available online here.

What does “expedited review” mean? Does this mean my study will be reviewed more quickly?

Expedited review refers to research that involves only procedures detailed by the Office of Human Research Protection (OHRP) as eligible for expedited review.  Research that falls into expedited review categories as set forth by OHRP normally do not have to be reviewed by the full committee. An expedited submission is delegated to one or more IRB committee members for review. Hence, expedited review is not necessarily quicker than full board review. It can alternately be thought of as a form of delegated review.

What types of research need to be reviewed by the full board?

All research involving human subjects that does not qualify as exempt or for expedited review as set forth in the federal regulations (regardless of level of risk) will be reviewed by the full board. If you are unsure whether you are conducting research involving human subjects, please click here for guidance.

How do I know if my study needs a Data Safety Monitoring Board?

Please refer to detailed guidance available on the Tools and Guidance webpage, under the Design subsection of Guides for Investigators and the Research Team.

Issues Regarding Previously Approved Research

Can I change the PI on a study?

Yes. This would be considered a Modification, and you should follow the instructions for How to Submit a Modification on the Submission Instructions page. Don’t forget to update the study documents, and if applicable, a revised FDA Form 1572. If your study has been deemed greater than minimal risk by the IRB, also submit a copy of the investigator’s CV, which must detail experience working on greater than minimal risk protocols

Can I ever deviate from the protocol?

Investigators must seek IRB approval before making any changes in approved research—even though the changes are planned for the period for which IRB approval has already been given.

The only time a change may be implemented without IRB approval is when the change is necessary to eliminate an immediate hazard to the subject (in which case the IRB must then be notified within 3-5 business days).

All other deviations (which are not to eliminate immediate hazards) are considered to be protocol exceptions. A protocol exception is any temporary protocol deviation that is approved by the IRB prior to its initiation (e.g., enrollment of a subject who does not meet the eligibility criteria).

An exception gives investigators the opportunity to request a change in procedure and/or protocol activity for a single, isolated event. It should be submitted as detailed below.

Note: The PI should only request approval for exceptions that could affect a subject’s safety, welfare, comfort or rights. For example, a minor scheduling change does not need to be approved prior to implementation.

 

How do I submit a Protocol Exception?

In order to obtain approval for a protocol exception, submit the Application for Requested Modifications located on our IRB Forms page. Complete the section called “Protocol Exception.”  All protocol exceptions should be listed on the progress report at continuing review.

For further guidance, view IRB Policy.

How do I report protocol deviations (i.e., violations)?

If the protocol deviation is major, it must be submitted to the Office of the IRB immediately upon discovery via the Reportable Event Form located on our IRB Forms page.

If the protocol deviation is minor, it may be reported and detailed on the Study Progress Report form at the time of continuing review, along with the submission of the Protocol Deviation Log located on our IRB Forms page.

For more details, please click here.

Note: Deviations may be grouped if appropriate. For example, if you have 3 subjects who missed a visit due to scheduling issues, you can submit one form for these 3 violations.

 

Progress/Study Closure Reports

What is the status of my study? We’re not enrolling any new subjects, but the subjects in our study are still receiving active treatment.

According to the Application for Continuing Approval located on our IRB Forms page, it would qualify as “research-related interventions ongoing” until the last participant completes active treatment.

Nothing has changed – I haven’t really done anything with my study over the past year, do I still need to submit the progress report?

Yes. Every researcher who has an open study (that has been approved by expedited or full-board review) is required to submit an annual progress report. Otherwise, the IRB will close the study.

How do I calculate the number of enrolled subjects in my study?

If your study requires subjects to sign a consent form, anyone who signs that consent form is enrolled in the study.

If your study has been given a waiver of informed consent (i.e., retrospective chart reviews, surveys, etc.), anyone from whom you have collected data is an enrolled subject.

How long do I have to keep my study records?

While the study is ongoing, records must be kept available at the study site. After the study has ended (all interventions, analyses, queries, follow-up, etc. have been completed) records may be archived with a System-approved vendor.

It is recommended that original data be retained indefinitely where feasible. For health system policy on record retention, and how long records must be kept, see Northwell Health Policy #GR052, accessible here.

I am leaving the health system. What should I do if I am the Principal Investigator on a study?

  • If you want to close the study, complete a Final Report form located on our IRB Forms page and submit it to the IRB.
  • If the study is still continuing, you must request approval from the IRB to change the PI. For information on how to add a new PI to a study, see above under “Can I change the PI on a study?” for details.
  • If the previous PI will remain on the study as a co-investigator, please contact the IRB at irb@northwell.edu or 516-321-2100 to determine what other documents may be needed.

What adverse events need to be reported to the IRB?

  • Internal and external adverse events which in the opinion of the principal investigator meet the criteria for  an unanticipated problem involving risk to subjects or others (unanticipated, related to the research and increase risk to subjects) should be reported to the IRB.
  • Serious adverse events (internal and external) which in the opinion of the principal investigator are both unanticipated and related to the research should also be reported.
  • Unrelated events should NOT be submitted to the IRB.
For further guidance, and for specific definitions, review IRB Policy.

 

In what time frame should I submit DSMB reports to the IRB?

DSMB reports should be submitted within 90 days of their receipt. If the DSMB meets more often than yearly, DSMB reports for all meetings should be submitted to the IRB so that the committee can determine the Data Safety Monitoring Plan is being followed.

Note: when completing a Progress Report/Application for Continuing Review, be sure to include the most recent DSMB report, if it has not been submitted to the IRB previously.  DSMB reports are an important part of continuing review. If they have not been submitted, they will be requested.

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