Human Subjects In Research

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 Boards (IRB) are used for all reviews except for studies as defined below as being reviewed by Chesapeake Research Review, Inc. or National Cancer Institute’s Central IRB Adult and Pediatrics Initiative.
The University has two on-site IRBs:

Non-Stony Brook (External) IRBs

​In addition to our partnership with CRRI 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.

Chesapeake Research Review, Inc.

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

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. Judy Matuk 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 (CORIHS) 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.

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

CORIHS Submission Deadlines

CORIHS A CORIHS B
Deadline for Materials Meeting Date Deadline for Materials Meeting Date
7/24/2017 8/10/2017 8/7/2017 8/24/2017
8/21/2017 9/14/2017 9/11/2017 9/28/2017
9/25/2017 10/12/2017 10/9/2017 10/26/2017
10/23/2017 11/9/2017 10/30/2017 11/16/2017*
11/20/2017 12/7/2017* 12/4//2017 12/21/2017*
12/26/2017 1/11/2018 1/8/2018 1/25/2018
1/22/2018 2/8/2018 2/5/2018 2/22/2018
2/19/2018 3/8/2018 3/5/2018 3/22/2018
3/19/2018 4/12/2018 4/9/2018 4/26/2018
4/23/2018 5/10/2018 5/7/2018 5/24/2018
5/21/2018 6/14/2018 6/11/2018 6/28/2018
6/25/2018 7/12/2018 7/9/2018 7/26/2018
7/23/2018 8/9/2018 8/6/2018 8/23/2018
8/20/2018 9/13/2018 9/10/2018 9/27/2018
9/24/2018 10/11/2018 10/8/2018 10/25/2018
10/22/2018 11/8/2018 11/5/2018 11/15/2018*
11/19/2018 12/6/2018* 12/3/2018 12/20/2018*

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

Human Subjects Training

Human Subjects Training

In order for you to be certified to conduct research involving human subjects, you must:

  1. Be registered in IRBNet
  2. And then 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)

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: HIPPA 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.

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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