Human Subjects in Research
Institutional Review Boards
The University's On-site Institutional Review Boards- Committees on Research Involving Human Subjects (CORIHS) a
- Committees on Research Involving Human Subjects (CORIHS) b
External Institutional Review Boards
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
- 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)
- Review the University Hospital's general HIPAA awareness training materials.
- Satisfy this HIPAA training requirement by sending an e-mail to Mary Ellen Herz.
- the subject reading: HIPAA RESEARCH TRAINING COMPLETED and 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."
Standard Operating Procedures
Ethical Principles
- Belmont Report: http://ohsr.od.nih.gov/guidelines/belmont.html
- Declaration of Helsinki: http://ohsr.od.nih.gov/guidelines/helsinki.html
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:
- FDA: 21 CFR Part 50 FDA - Protection of Human Subjects
- FDA: 21 CFR Part 54 FDA - Financial Disclosure by Investigators
- FDA: 21 CFR Part 56 FDA - Institutional Review Boards
- FDA: 21 CFR Part 312 FDA - Investigational New Drug Application
- FDA: 21 CFR Part 812 FDA - Investigational Device Exemptions
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
- Research Involving Human Subjects P202R
- Policy for Sponsor, IRB and Institutional Fees (eff. 7/1/2011)
CORIHS Members
| CORIHS A | CORIHS B |
| Prof. Harold Carlson, Medicine, Chair | Prof. Michael Pearl, Obstetrics and Gynecology, Chair |
| Ms. Elizabeth Baron, Member/ IRB Coordinator | Mr. Abdool Samad, Member/ IRB Administrator |
| Ms. Marijean Buhse, Nursing | Prof. Rishimani Adsumelli, Anesthesiology |
| Dr. James Droesch, Obstetrics and Gynecology | Ms. Gail Frankel, Community Member/ Patient Advocate |
| Mr. James Farrell, Community Member | Mr. Omar Gould, Community Member |
| Dr. Donald Harrington, Radiology | Prof. Robert Marmo, Prisoner Advocate |
| Dr. Andrzej Kudelka, Medical Oncology | Prof. Margaret McNurlan, Surgery |
| Prof. Leighann Litcher-Kelly, Psychiatry | Prof. Susan O'Leary, Psychology |
| Prof. Richard Morgan, Social Welfare | Prof. Philip Bao, Surgery |
| Ms. Stephanie Musso, UH Privacy Officer | Prof. Luis Gruberg, Cardiology |
| Prof. Ira Rampil, Anesthesiology | Prof. Stephen Vitkun, Anesthesiology |
| Dr. Jila Sharif, MD, Neonatology | Mr. Michael Wade, Health Outreach Educator |
| Prof. Michael Pearl, Obstetrics and Gynecology, (Alternate for Prof. H. Carlson) | Prof. Marie Marino, Nursing |
| Mr. Abdool Samad (Alternate for Ms. E. Baron) | Prof. Harold Carlson, Medicine (Alternate for Prof. M. Pearl) |
| Ms. Lu-Ann Kozlowski (Alternate for Ms. E. Baron) | Ms. Marie Varela, PharmD, Pharmacy |
| Dr. Sherry Courtney, Pediatrics | |
| Ms. Elizabeth Baron (Alternate for Mr. Abdool Samad) | |
| Ms. Lu-Ann Kozlowski (Alternate for Mr. Abdool Samad) | |
| Judy Matuk (ex officio), Assistant Vice-President for Research Compliance | Judy Matuk (ex officio non-voting), Assistant Vice-President for Research Compliance |
| Mary O'Neill (ex officio, non-voting), Assistant Director for Research Compliance | Mary O'Neill (ex officio non-voting), Assistant Director for Research Compliance |
| Updated 12/26/2011 |
CORIHS Deadlines
| CORIHS A | CORIHS B | ||
| Deadline for Materials | Meeting Date | Deadline for Materials | Meeting Date |
| 12/19/2011 | 1/12/2012 | 1/9/2012 | 1/26/2012 |
| 1/23/2012 | 2/9/2012 | 2/6/2012 | 2/23/2012 |
| 2/20/2012 | 3/8/2012 | 3/5/2012 | 3/22/2012 |
| 3/19/2012 | 4/12/2012 | 4/9/2012 | 4/26/2012 |
| 4/23/2012 | 5/10/2012 | 5/7/2012 | 5/24/2012 |
| 5/21/2012 | 6/14/2012 | 6/11/2012 | 6/28/2012 |
| 6/25/2012 | 7/12/2012 | 7/9/2012 | 7/26/2012 |
| 7/23/2012 | 8/9/2012 | 8/6/2012 | 8/23/2012 |
| 8/20/2012 | 9/13/2012 | 9/10/2012 | 9/27/2012 |
| 9/24/2012 | 10/11/2012 | 10/8/2012 | 10/25/2012 |
| 10/22/2012 | 11/8/2012 | 10/29/2012 | 11/15/2012* |
| 11/12/2012 | 12/6/2012* | 12/3/2012 | 12/20/2012* |
| * Exceptions to the 2nd and 4th Thursday rule due to Holidays | |||
