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Resources for Investigators

FAQs IRB Submissions

Submission of Protocols

 

Continuing Review Issues

Decision Letters

Mandated Education

Informed Consent

Progress/Termination Reports

Serious Adverse Events (SAEs)

 

Submission of Protocols

When is the next IRB committee meeting?
Click here to access meeting and submission deadline dates for Committees A and B.

Can I fill in the IRB forms by hand?
No. All IRB forms must be typed so that they are clear and legible for reviewers.

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What are the categories of research that qualify as exempt?
Research that could qualify as exempt includes the following:

  • Test, surveys, interviews or public observation
  • Research on existing public or anonymous data or specimens

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.


 

For further guidance, click on Policy 1: IRB Review and Approval: Categories of Research

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What are the categories of research that qualify for expedited review?
Research that could qualify for expedited review includes:

  • Research that presents no more than minimal risk to human subjects, and
  • Involves only procedures listed in one or more of the categories listed by OHRP as eligible for expedited review.

For further guidance, click on Policy 1: IRB Review and Approval: Categories of Research

How many copies of protocol packets need to be submitted for exempt and/or expedited protocols?

One copy of the entire submission packet - with all required signatures - must be emailed to the Office of the IRB (OIRB) at: irb@nshs.edu.

Your email should include the following attachments:

  • Study protocol and (if applicable) consent form in Word format
  • All IRB submission forms with required signatures in PDF format
  • All IRB submission forms not requiring signatures as Word or PDF documents

- or -

If you do not have access to email, you may submit your protocol packet by one of the following methods:

  • Fax your protocol to the OIRB at 516-562-3105.
  • Mail your protocol packet to the Office of the Institutional Review Board, 350 Community Drive, Manhasset, NY 11030.
  • Hand-deliver your protocol packet to the OIRB. See: Directions to the Office of the IRB.

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 will be reviewed by the full board.

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How many copies of protocol packets need to be submitted for full board review?

One copy of the entire submission packet - with all required signatures - must be emailed to the Office of the IRB (OIRB) at: irb@nshs.edu.
 

Your email should include the following attachments:

  • Study protocol and (if applicable) consent form in Word format
  • All IRB submission forms with required signatures in PDF format
  • All IRB submission forms not requiring signatures as Word or PDF documents

- or -

If you do not have access to email, you may submit your protocol packet by one of the following methods:

  • Fax your protocol to the OIRB at 516-562-3105.
  • Mail your protocol packet to the Office of the Institutional Review Board, 350 Community Drive, Manhasset, NY 11030.
  • Hand-deliver your protocol packet to the OIRB. See: Directions to the Office of the IRB.

What should I do if the forms I have filled out show tracked changes that were made when the forms were developed by the IRB?
Call the OIRB for assistance (516-562-3101). This is a formatting quirk that some users encounter based on the version of Windows being used when completing the forms. We are working on solving this problem. In the meantime, the IRB will accept your forms with the tracked changes showing.

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Continuing Review Issues

How do I submit a progress report?
Click here for guidance on submitting progress reports.

What forms are needed with a modification to the consent form or protocol, is a memo needed?
All study modifications must be summarized and reported to the IRB using IRB Form 8a. This form should accompany the complete revised version of the modified document (e.g. revised protocol, revised consent form, etc.) with an explanation, written by the PI, of the modification and its impact on the risk/benefit assessment. Include any supporting documentation from the sponsor or collaborators as appropriate. The explanation can be in the form of a memo. Click here for further guidance.

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How many copies are necessary when submitting a modification?
One copy of the signed modification request must be submitted to the IRB. Click on How to Submit a Modifications Request to the IRB for further guidance.

How do I add a person to the protocol?
Submit the following to the IRB:

  • IRB Form 8a. Check "Personnel Changes" and list name(s) of person(s) you wish to add to protocol. Indicate whether he/she will be obtaining informed consent.
  • IRB Form 3. Include a separate COI for each person you are adding to the protocol
  • IRB Form 1a. List required education dates for each added individual.

How do I remove a person from the protocol?
Check the "Personnel Changes" category on IRB Form 8a. Click the box next to "Remove" and enter the name of the person you want to remove from the protocol. Submit original document with PI's signature to the IRB. (If necessary, delete the person's name from the consent form and submit the revised consent form for approval.)

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Can I change the PI on a study?
Yes. If the new PI is currently listed on the protocol as a sub-investigator, submit the following to the IRB:

  • IRB Form 8d
  • If appropriate:
    • Revised consent form reflecting change of PI and contact information
    • Revised FDA Form 1572

If the new PI is not currently listed on the protocol, submit the following to the IRB:

  • IRB Form 8d
  • IRB Form 1a - List required education dates
  • IRB Form 3
  • If appropriate:
    • Revised consent form reflecting change of PI and contact information
    • Revised FDA Form 1572

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How do I report protocol violations?
If the protocol violation is major, it must be submitted to the Office of the IRB using IRB Form 8c immediately upon discovery. Click on How to Report a Major Protocol Violation to the IRB for further guidance.

If the protocol violation is minor, it may be reported and detailed on the Study Progress Report form at the time of continuing review.

Note: Violations 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.

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Can I ever deviate from the protocol?
Yes, under certain circumstances, but only after you obtain IRB approval.

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 request form (IRB Form 8b) gives investigators the opportunity to request a change in procedure and/or protocol activity for a single, isolated event.

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.

In order to obtain approval for a protocol exception, the PI must submit a request to the IRB using IRB Form 8b. The form should include:

  • A description of the requested exception
  • Justification for deviating from the protocol

All protocol exceptions should be listed on the progress report.

For further guidance, click on: Policy 6.7: Protocol Exceptions

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How do I submit a recruitment ad, flyer, etc. for approval?
Submission of recruitment ads depends on their intended use.

For recruitment outside the Health System:

  • If you want to recruit through mass media (print media such as newspaper or television and/or radio air time) you must contact the NSLIJHS Marketing Department. The Marketing Department will make sure your recruitment materials are designed and presented according to Health System guidelines.
    • For new studies: Once approved by Marketing, the investigator should submit the advertisements, scripts, etc. as part of the initial submission packet.
    • For ongoing, approved studies: Investigators should complete IRB Form 8a. Enter a description of the recruitment item and its intended use in the "Other" category. Attach a copy of the ad, flyer, etc. to IRB Form 8a and submit to the IRB.

For recruitment within the Health System:

  • Flyers and other items for recruitment intended for use within the Health System may be submitted directly to the IRB for approval. If you wish to include a logo on the flyer, contact the Marketing Department for the appropriate logo.

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Decision Letters

What does "contingent approval" mean?
"Contingent approval" means minor revisions are needed that do not affect the safety of the research subject. The IRB Chair/designee may approve the study upon receipt of the satisfactory revisions without further review by the convened IRB. It is important to know that the study is not approved and cannot be initiated until the response is reviewed and the approval letter is issued. If revisions are not received by the IRB within 120 days, the protocol will be withdrawn from consideration.

What does "tabled" mean?
"Tabled" means substantive issues regarding the protocol and/or consent form must be addressed. The investigator's response to the issues raised must be reviewed by the IRB at a convened meeting. If the PI does not respond within 120 days, the protocol will be withdrawn from consideration.

What does "expedited approval" mean?
"Expedited approval" is approval given to issues/items that meet the criteria in the Federal regulations for review outside of a fully convened meeting(i.e., minor modifications, change of personnel, etc.).

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What does "acknowledged" mean?
"Acknowledged" means the IRB has noted receipt of the item(s) (i.e., investigator's brochure, protocol violation, SAEs, etc.) which do not require approval.

How do I resubmit a project that has been tabled/ deferred?
Submit a memorandum that includes a point-by-point response to all questions/concerns/issues raised in the decision letter. Include a highlighted revised protocol and consent (both including revision dates), and/or any other additional information requested or needed to justify your responses.

How should I respond to the IRB's issues when a protocol has contingent approval?
Click on How to Respond to a Decision Letter: Contingently Approved Study for guidance.

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Mandated Education

Click on Researcher Registration and Education for updated information on education requirements.

How long after taking the CITI program will I receive my completion report?

You may print your completion report from your computer immediately after you successfully complete the CITI program.

Do I need to keep my certificates from the IRB's mandated education programs?
Yes. It's important that you keep your certificate on file as documentation that you have completed this training. If you are audited you will be asked to provide this information

Dr. X doesn't obtain informed consent, but he sees subjects in our study. Does he need to take the CITI program?
Yes, all staff involved in research with human subjects should complete the CITI program and the Researcher Registration Form.

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Informed Consent

Do I need to include sub-investigators names on the consent form?
No. You only need to list the Principal Investigator's name on the consent form.

If I submitted a revised consent form to the IRB, but haven't yet received an approval letter, can I use it for enrolling new subjects?
Not yet. You must wait until you receive written approval from the IRB before you use the revised consent form. Until then, continue to use the latest approved consent form version with incoming subjects.

I submitted a modified consent form to the IRB. It was approved on the 15th but I received my approval letter on the 30th. During that interval, I enrolled five subjects using the old version of the consent form. What should I do?
All subjects currently undergoing research-related activities must be notified immediately of any new risks or changes in study procedures. If the revised consent form contained such information, every subject must sign a new consent form when they are seen at the next visit. If appropriate, based on the new information, subjects who have completed research activities may need to be notified as well. If, however, the changes were administrative (i.e., change of phone number, personnel change, etc.), subjects do not need to sign new consent forms.

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Last week, my study participant took a consent form home to read it and he signed it at home. He came in today - should I keep the date that he first signed the consent form?
No. The study participant should sign the consent on the day he/she comes in and is consented by the staff (with some exceptions including mailed consents). If he/she has pre-dated the consent, the subject should cross out that date and initial it, and then write down the date that they were consented by the research staff. It's preferable that the staff member makes a note on the consent regarding the situation - it's better to document everything.

Upon review of the consent forms, I noticed that a subject didn't date the consent form. Is this okay?
No - Look in the subject's medical record to confirm his/her date of participation in the study. Place a note to file attached to their consent form with the date of their participation. Do not add the date to the consent form. This should also be reported as a minor protocol violation on the next Progress Report that is submitted to the IRB.

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Progress/Termination 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 Study Progress Report Form, 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 terminate 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 for whom you have data is an enrolled subject.

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My study is completed. Do I need to do anything?
Yes. Complete a Termination Report and submit it to the IRB.
 

How long do I have to keep my study records?(Revised 3/2/07)
Study records must be kept permanently.

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.
 

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 Termination Report and submit it to the IRB.
 

If the study is still continuing, you must request approval from the IRB to replace the PI. With your memo, submit the following forms described under A or B as appropriate:

A. If the new PI is currently listed on the protocol as a sub-investigator, submit the following to the IRB:

IRB Form 8d
If appropriate:

  • A revised consent form reflecting change of PI and contact information
  • A revised FDA Form 1572

B. If the new PI is not currently listed on the protocol, submit the following to the IRB:

IRB Form 8d
IRB Form 1a
IRB Form 3
If appropriate:

  • A revised consent form reflecting change of PI and contact information
  • A revised FDA Form 1572

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Serious Adverse Events (SAEs)

What is the difference between an internal and external serious adverse event (SAE)?
An internal serious adverse event is one that involves a subject enrolled by a NSLIJHS investigator in a protocol that has been approved by a NS-LIJHS IRB.
An external serious adverse event is one that involves a subject enrolled at a facility that is outside the jurisdiction of the NS-LIJHS IRB (e.g., safety report from sponsor, collaborating site).

How do I submit an internal SAE?
Submit form IRB Form 7a to the IRB. This form must be completed and signed by the Principal Investigator. Include progress notes/reports from hospitalization and discharge or death reports where applicable. Click here for further guidance.
 

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How do I submit an external SAE?
IRB Form 7b should be used to report external serious adverse events. The investigator's report should include:

  • A detailed description of the event
  • Any resultant changes to the consent form
  • NS-LIJ investigator's assessment of event
  • Site of incident

Click here for further guidance.
 

What should I do with DSMB reports that I receive?
Submit them to the IRB.

I found some old SAEs that were never submitted to the IRB. The study is now closed, do I still have to submit them?
Yes, it's better to submit than not to submit. Complete IRB Form 7a or IRB Form 7b (or IRB Form 7c if applicable). A memo can be attached, explaining the situation, if necessary.

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Last Update

February 1, 2012
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