Stony Brook University Office of Research Services

Contact

  • Office of Research Compliance
    Phone: 631-632-9036

About the Program

  • 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.

Useful Links

External IRBs

Community and Research Participants

Human Subjects in Research

Institutional Review Boards

The University's On-site Institutional Review Boards
  1. Committees on Research Involving Human Subjects (CORIHS) a
  2. Committees on Research Involving Human Subjects (CORIHS) b
Members | Meeting Dates | IRBNet

 

External Institutional Review Boards
  1. Chesapeake Research Review, Inc. (CRRI)
  2. NCI's Central IRB Adult Initiative (CIRBI)
  3. NCI's Central IRB Pediatrics Initiative (CIRBI)

IRBNet

IRBNet is SBU's electronic system for the administration and management of IRB records for investigators and CORIHS.

Go to http://www.irbnet.org and begin the simple process of registering with IRBNet by clicking on 'New User registration', in the top right corner. Then start creating your studies!

If you have any questions, or would like to schedule in-person training, please contact the Office of Research Compliance, at 631-632-9036.

 

Training

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

a. first be registered in IRBNet. Follow directions at http://www.stonybrook.edu/research/orc/human-subjects.shtml#irbnet-tab and

b. satisfy the following TWO training requirements (along with obtaining IRB approval for the activity):

1. Training in Human Subject Protections


Click here to read Section 12.4 for training instructions.

'Live' training lectures for new or recertifying researchers can be scheduled for groups of 20 or more. 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.

Click here to download Word Template

2. HIPAA in Research Training

  1. Review the SBU Policy and Procedure on Research Subjects' Right to Privacy at: http://www.stonybrook.edu/research/orc/humans/HSG.shtml (See Section 16 of the Standard Operating Procedures)
  2. Review the University Hospital's general HIPAA awareness training materials.
  3. Satisfy this HIPAA training requirement by sending an e-mail to Mary Ellen Herz.
  1. the subject reading: HIPAA RESEARCH TRAINING COMPLETED and the
  2. 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."

Standard Operating Procedures

1. Human Research Protection Program (HRPP)
2. Institutional Review Boards
3. CORIHS Review Process
4. Documentation and Records
5. Obtaining Informed Consent from Research Subjects
6. Vulnerable Subjects in Research
7. Investigational Drugs & Devices in Research
8. Unanticipated Problems Involving Risks to Subjects or Others
9. Protocol Exceptions or Deviations
10. Complaints and Non-compliance
11. Reporting to Regulatory Agencies and Institutional Officials
12. Investigator Responsibilities
13. Sponsored Research
14. Conflict of Interest in Research
15. Participant Outreach
16. Health Insurance Portability and Accountability Act (HIPAA)
17. Special Topics

Policies

Department of Health and Human Services (DHHS)/Office for Human Research Protections (OHRP)
Website: http://www.hhs.gov/ohrp/
Regulations: DHHS: 45 CFR Part 46 DHHS -- Protection of Human Subjects
Guidance: http://www.hhs.gov/ohrp/policy/index.html#topics

Food and Drug Administration (FDA)
Website: http://www.fda.gov/
Regulations:

Guidance:

Office of Civil Rights (HIPAA: Privacy Law)
Website: http://www.hhs.gov/ocr/hipaa/
Regulation: http://www.hhs.gov/ocr/hipaa/finalreg.html
Guidance (Research-related): 

SBU Policies

 

CORIHS Members

CORIHS A CORIHS B
Dr. Harold Carlson, Medicine, Chair Dr. Michael Pearl, Gynecologic Oncology,  Chair
Dr. Rishimani Adsumelli, Anesthesiology Dr. Philip Bao, Surgery
Ms. Elizabeth Baron, IRB Administrator Dr. Patricia Eckardt, Nursing
Dr. Marijean Buhse, Nursing Ms. Gail Frankel, Community Member
Dr. Turhan Canli, Psychology Mr. Omar Gould, Community Member
Dr. Kathleen Gambino, Nursing Dr. Luis Gruberg, Cardiology
Dr. Donald Harrington, Radiology Dr. Marie Marino, Nursing
Dr. Jeffrey Hom, Pediatrics Dr. Robert Marmo,  Prisoner Advocate
Dr. Andrzej Kudelka, Medical Oncology Dr. Margaret McNurlan, Surgery
Dr. Evan Leibner, Emergency Medicine Dr. Susan O'Leary, Psychology
Ms. Aimee Minton, IRB/COI Administrator Mr Abdool Samad, IRB Administrator
Dr. Richard Morgan, Social Welfare Dr. Marie Varela, PharmD, Pharmacy
Ms. Lynn Perry, Community Member Dr. Stephen Vitkun, Anesthesiology
Dr. Mary Saltz, Radiology Mr Michael Wade, IRB Assistant
Dr. Jila Sharif, MD, Neonatology  
ALTERNATE MEMBERS ALTERNATE MEMBERS
Dr. Michael Pearl, Gyn. Onc. (Alternate for Chair) Dr. Harold Carlson, Medicine (Alternate for Chair)
Ms. Lu-Ann Kozlowski (Alternate for Ms. Baron) Ms. Elizabeth Baron (Alternate for Mr. Samad)
Mr. Abdool Samad (Alternate for Ms. Baron) Ms. Lu-Ann Kozlowski (Alternate for Mr. Samad)
Mr. Michael Wade (Alternate for Ms. Minton) Ms. Aimee Minton (Alternate for Mr. Wade)
Updated February 27, 2014

CORIHS Deadlines

CORIHS A CORIHS B
Deadline for Materials Meeting Date Deadline for Materials Meeting Date
7/22/13 8/8/2013 8/5/2013 8/22/2013
8/19/13 9/12/2013 9/9/2013 9/26/2013
9/23/13 10/10/2013 10/7/2013 10/24/2013
10/21/13 11/14/2013 11/4/2013 11/21/2013*
11/18/13 12/12/2013 12/9/2013 12/19/2013*
12/23/2013 1/9/2014 1/6/2014 1/23/2014
1/20/2014 2/13/2014 2/10/2014 2/27/2014
2/24/2014 3/13/2014 3/10/2014 3/27/2014
3/24/2014 4/10/2014 4/7/2014 4/24/2014
4/21/2014 5/8/2014 5/5/2014 5/22/2014
5/19/2014 6/12/2014 6/9/2014 6/26/2014
6/23/2014 7/10/2014 7/7/2014 7/24/2014
7/21/2014 8/14/2014 8/11/2014 8/28/2014
8/25/2014 9/11/2014 9/8/2014 9/25/2014
9/22/2014 10/9/2014 10/6/2014 10/23/2014
10/20/2014 11/6/2014* 11/3/2014 11/20/2014*
11/17/2014 12/11/2014 12/1/2014 12/18/2014*
* Exceptions to the 2nd and 4th Thursday rule due to Holidays