Human Subjects In Research

Overview of Human Subjects

Institutional Information
  • SBU operates under Federalwide Assurance #00000125, expiration date January 3, 2017. The Department of Defense Addendum (DoD N-A3069) to our Federalwide Assurance expires January 3, 2017.
  • 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:

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.

CORIHS Submission Deadlines

CORIHS A CORIHS B
Deadline for Materials Meeting Date Deadline for Materials Meeting Date
10/19/2015
11/5/2015*
11/2/2015
11/19/2015
11/16/2015
12/3/2015*
11/30/2015
12/17/2015*
12/21/2015
1/14/2016
1/11/2016
1/28/2016
1/25/2016
2/11/2016
2/8/2016
2/25/2016
2/22/2016
3/10/2016
3/7/2016
3/24/2016
3/21/2016
4/14/2016
4/11/2016
4/28/2016
4/25/2016
5/12/2016
5/9/2016
5/26/2016
5/23/2016
6/9/2016
6/6/2016
6/23/2016
6/20/2016
7/14/2016
7/11/2016
7/28/2016
7/25/2016
8/11/2016
8/8/2016
8/25/2016
8/22/2016
9/8/2016
9/6/2016
9/22/2016
9/19/2016
10/13/2016
10/10/2016
10/27/2016
10/24/2016
11/10/2016
10/31/2016
11/17/2016*
11/21/2016
12/8/2016
12/5/2016
12/15/2016*
* Exceptions to the 2nd and 4th Thursday rule due to Holidays

Human Subject 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 TWO training requirements (along with obtaining IRB approval for the activity):
Training in Human Subjects Protection
Section 12.4 for training instructions
  • Training can be completed through 1 of 2 options:
    • For individuals, training can be completed through CITI OR
    • For groups of 20 or more, 'Live' training lectures for new or recertifying researchers can be scheduled. Contact Judy Matuk, 631-632-9036 if you are interested in this training option.

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

HIPAA in Research Training

  1. Review the SBU Policy and Procedure on Research Subjects' Right to Privacy.
  2. Review the University Hospital's general HIPAA awareness training materials.
  3. Satisfy this HIPAA training requirement by:
  • sending an e-mail to ORC_HS_Training_Documents@stonybrook.edu.
  • The subject line reading “HIPAA RESEARCH TRAINING COMPLETED”
  • The body of the text reading:  "I have read and understood the HIPAA awareness training materials and agree to comply with the SBU Policy and Procedures on Research Subjects' Right to Privacy."

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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