Human Subjects In Research

 

NEW -  Proposal Submission Deadline Policy  

NEW - Inventor Portal - Now Available

Overview of Human Subjects

Institutional Information

  • SBU operates under Federalwide Assurance #00000125, expiration date November 18th, 2021.
  • Our human research protection program has been accredited by the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP) since September 2010.

Federal Regulations

Stony Brook Standard Operating Procedures

In order to ensure ethical research performance on human subjects, Stony Brook issues this Human Subjects Standard Operating Procedures Manual and expects researchers to be familiar with its policies.

Principles and Guidance

Which Institutional Review Board (IRB)?

Stony Brook IRBs

The University’s on-site Institutional Review Board (IRB) is used for all reviews except for studies as defined below as being reviewed by Advarra or National Cancer Institute’s Central IRB Adult and Pediatrics Initiative.

Non-Stony Brook (External) IRBs

​In addition to our partnership with Advarra and the NCI CIRBs (as described below), Stony Brook abides by the NIH ‘Policy on the Use of a Single Institutional Review Board for Multi-Site Research’, and encourages such single IRB review for non-NIH funded multi-center studies as well. In general, SBU will only cede IRB review to an external entity if that entity is AAHRPP accredited.

Note that Stony Brook is a participating institution in the SMART IRB National IRB Reliance Initiative. All participating sites have signed the SMART IRB agreement that enables them to accept each other's IRB as the IRB of record for a multi-site study, if so desired. Investigators are encouraged to review http://smartirb.org to see if their other collaborating sites are participating too.

Advarra

SBU investigators wishing to conduct industry-funded, industry-initiated biomedical research studies must use the IRB services provided by our associate, Advarra. All other studies (e.g. investigator-initiated, etc.) must be reviewed by the local SBU IRB. There is one exception to this requirement. If the following criteria is met, review will need to be conducted by our local IRB:  when the industry sponsor will not accept direct invoicing from Advarra and/or allow direct payments to Advarra. 

National Cancer Institute’s Central IRB Adult and Pediatrics Initiative

Stony Brook University is a participant in the National Cancer Institute’s Central Institutional Review Board (CIRB) Initiative. Local investigators who wish to enroll patients onto CIRB-approved protocols are encouraged to utilize this service. Such investigators should first contact Ms. Lu-Ann Kozlowski so that she may complete paperwork to secure a username and password for the PI and study coordinator. NCI requires that investigators wishing to do so must first submit CIRB review materials (along with minimal local paperwork) to their local IRB for a facilitated review (similar to our expedited review process), to confirm the acceptability of CIRB as the IRB of record for that particular study.

myResearch IRB

Regarding studies already approved or submitted in IRBNet as of February 26, 2019: All submissions related to these studies will continue to be reviewed in IRBNet until the time of continuing review. From the time of continuing review and onward, these studies will be reviewed in myResearch. 

All studies with an expiration date after February 27, 2019 will be imported into myResearch and available to the Principal Investigator and study team members in their myResearch Inbox. These studies will be imported as a “shell,” which means that some but not all of the study data will be transferred into the myResearch application. The Principal Investigator and study team members are responsible for reviewing all automatically imported information for accuracy and completing the remainder of the application prior to submission for continuing review.  In order to submit a continuing review application for a study imported into myResearch, see the continuing review submission instructions below. 

Note: If you do not see one of your studies in your myResearch Inbox, please send an email with the IRBNet ID# to OVPR_myresearchIRB@stonybrook.edu for assistance.

Sign Up for a Training Class

Click here or paste the following into your browser: https://stonybrookuniversity.co1.qualtrics.com/jfe/form/SV_7OGP7YWwfp5U9mt

Instructions for myResearch IRB - How To:

Create a submission

Create a continuing review submission

Create an external IRB submission

Close a study

Complete/submit an ancillary review

In lieu of the electronic signature requirement as in IRBNet, departmental representatives (e.g. Department Chairs/designated signatories, University Hospital administrators, etc) complete ancillary reviews in myResearch. Ancillary reviewers must complete a brief form prior to submitting the review certifying approval or disapproval of the proposed submission. 

Checklists for myResearch IRB

New Study Submission Requirements Checklist

Continuing Review Submission Requirements Checklist

Modification Submission Requirements Checklist

 

Submission Guidelines for External (non-SBU) IRBs

Chesapeake Research Review, Inc.

Complete Your CRRI Application at the CRRI CIRBI™ Website

Satisfy SBU Application Requirements for CRRI Studies (Using IRBNet)

What Are SBU Responsibilities Re: CRRI-Reviewed Protocols

PI Responsibilities post-CRRI approval

National Cancer Institute’s Central IRB Adult and Pediatrics Initiative

Submission

When your Protocol has been Approved for CIRB Oversight

External IRBs (not covered above)

1. Contact the Office of Research Compliance when you are first considering using an IRB that is not one of SBU's internal committees. If acceptable, an agreement (or individual reliance arrangement, if part of the SMART IRB Initiative) between the Institutions will be necessary.

2. Satisfy SBU Application Requirements for other External IRBs

IRB Submission Deadlines

Deadline for Materials Meeting Date Deadline for Materials Meeting Date
5/20/2019 6/13/2019 9/23/2019 10/2/2019
6/3/2019 6/19/2019 9/30/2019 10/10/2019
6/17/2019 6/27/2019 10/7/2019 10/16/2019
7/1/2019 7/11/2019 10/14/2019 10/24/2019
7/8/2019 7/17/2019 10/21/2019 11/6/2019
7/15/2019 7/25/2019 11/4/2019 11/14/2019*
7/22/2019 8/8/2019 11/11/2019 11/21/2019
8/5/2019 8/14/2019 11/18/2019 12/4/2019
8/12/2019 8/22/2019 12/2/2019 12/12/2019
8/19/2019 8/28/2019 12/9/2019 12/18/2019*
8/26/2019 9/4/2019 12/23/2019 1/9/2020
9/2/2019 9/12/2019 1/6/2020 1/15/2020
9/9/2019 9/18/2019 1/13/2020 1/23/2020
9/16/2019 9/26/2019 1/20/2020 2/5/2020

   *Exceptions to the 2nd and 4th Thursday rule due to Holidays

For a list of Committee Members, please click here

Human Subjects Training

Human Subjects Training

In order for you to be certified to conduct research involving human subjects, you must satisfy the following training requirement (along with obtaining IRB approval for the activity):

Training in Human Subjects Protection, see Section 12.4 for training instructions

Training is completed through the CITI web-based courses in Human Research Protections (either biomedical or social behavioral).  In order to see your training in myResearch, please make sure to link your CITI program account to your netID.  To find more information on how to link your account, please click here.

For those who must certify training to the NIH, the this template is acceptable for your Certification of Completion of Human Subjects Training letter.

Note: HIPAA Training will now be satisfied within the CITI curriculum or through attendance at the HSC HIPAA/Live Lecture training. Exceptions will be reviewed upon request.

Questions

Email questions to ORC_HS_Training_Documents@stonybrook.edu.

Linking your SBU NetID to CITI

Stony Brook NetID Single Sign On (SSO) has recently been enabled for CITI Program training. However, existing CITI Program accounts were not automatically matched to Stony Brook NetID credentials.

To link your Stony Brook NetID and NetID password to your existing CITI Program account:

  • navigate to www.citiprogram.org/?pageID=668
  • click Log In Through My Institution
  • select SUNY - University at Stony Brook
  • log in using your NetID and NetID password

 

You should receive the following message:

 

You will then be asked if you have an existing CITI Program account:

Please select the first option, I already have a CITI Program account.  You will then be asked for your CITI Program username and password:

Once this step is complete, your CITI account should be linked to your Stony Brook credentials.

 

If you have any questions regarding this process, please contact University Information Systems/Research at ovpr-it@stonybrook.edu.

 

Human Subjects Standard Operating Procedures

In order to ensure ethical research performance on human subjects, Stony Brook issues this Human Subjects Standard Operating Procedures Manual and expects researchers to be familiar with its policies.

Learn about existing protection programs, review boards and processes, informed consent, and other governing regulations in order to allow research to be conducted as smoothly as possible.

   

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