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

I. Training in Human Subject Protections (Click here for instructions)

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)

II. HIPAA in Research Training

a. REVIEW the SBU Policy and Procedure on Research Subjects’ Right to Privacy at: http://www.stonybrook.edu/research/HSG/HSGsec25.html

b. REVIEW the University Hospital's general HIPAA awareness training materials at: http://www.stonybrook.edu/research/humans/hipaa-train.pdf

c. SATISFY this HIPAA training requirement by sending an e-mail to Laura Wessels at lwessels@notes.cc.sunysb.edu with:

i. the subject reading:HIPAA RESEARCH TRAINING COMPLETED and the

ii. 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.'

UNIVERSITY POLICIES and PROCEDURES

CORIHS Policies and Procedures Handbook for Investigators - Updates to this Handbook are made regularly. Check back often for current policies and procedures.

Entire Handbook - print version (.pdf) updated 11/13/2007

Section	Title	Revised Date
Contents	Outline of Handbook Sections
General Information	Overview of CORIHS Activities	12/12/07
Section 1	Stony Brook University Definitions	06/28/07
Section 2	Categories of Research Requiring CORIHS Approval	12/12/07
Section 3	Materials Required for Submission to CORIHS	12/12/07
Section 4	Review Time Considerations
Section 5	Criteria for CORIHS Approval of Research
Section 6	Approval Periods
Section 7	Responsibility of Investigators Conducting Approved Research
Section 8	CORIHS Disapproval
Section 9	Vulnerable Populations: Pregnant Women, Nonviable Neonates and Neonates of Questionable Viability	1/31/06
Section 10	Vulnerable Populations: Minors	3/30/07
Section 11	Vulnerable Populations: Prisoners	2/01/06
Section 12	General Issues in Informed Consent	5/08/06
Section 13	Capacity to Provide Consent for Research (Including Research Involving Subjects with Diminished Capacity)	11/05/07
Section 14	Required Format for Consent Forms: Adult Subjects (18 years old and older)	06/28/07
Section 15	Consent (Permission)/Assent Requirements: Minor Subjects (less than 18 years old)	06/28/07
Section 16	Continuing Review Of CORIHS-Approved Activities - including Adverse Events and Amendments	08/27/07
Section 17	Training of Investigators in the Protection of Human Subjects in Research Activities	3/02/07
Section 18	Data/Tissue Registries	1/04
Section 19	Biological Specimens in Clinical (including Genetic) Research	05/01/07
Section 20	Exemptions from CORIHS Approval Requirement
Section 21	CORIHS Records
Section 22	Violations of CORIHS Policies	3/01/04
Section 23	IRB Fee Recovery from Industry Sponsored Research	2/09/06
Section 24	Conflict of Interest/Financial Disclosure Policy	3/02/07
Section 25	Policy and Guidance on HIPAA Compliance for Research Activities (Involving use of Health Information)	06/28/07
Section 26	QA/QI Activities vs. Research Activities	06/28/07
SBU Policy P202R	Research Involving Human Subjects

APPLICATIONS and FORMS

• Applications and forms REVISED 12/21/2007

Approval, Continued Approval, reporting Unanticipated Problems, Serious Adverse Events and HIPAA Compliance

NOTE: The applications and forms have been recently updated. Please begin using these forms and check back often to ensure you are submitting the most recent versions.

RELEVANT FEDERAL POLICIES and PROCEDURES

The Code of Federal Regulations (CFR) can be searched at: http://www.gpoaccess.gov/cfr/index.html.

• DHHS: 45 CFR Part 46 DHHS -- Protection of Human Subjects
• 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
• FDA: Good Cinical Practice in FDA Regulated Clinical Trials
• Guidance for Institutional Review Boards and Clinical Investigators 1998 Update
• Belmont Report
• Declaration of Helsinki

NIH / OHRP / DHHS Policies

NIH

• NIH statement on Certificates of Confidentiality
• NIH FAQ's about Certificates of Confidentiality
• Conflict of Interest
• NIH Statement on Financial CONFLICTS OF INTEREST and Research Objectivity
• BIOETHICS Resources at NIH
• Points to Consider When Planning a Genetic Study That Involves Members of Named Populations
• NIH Policy on Inclusion of WOMEN and MINORITIES
• NIH Guidelines on the inclusion of WOMEN and MINORITIES as subjects in clinical research - Updated August 1, 2000
• NIH Inclusion of CHILDREN Policy and Implementation
• NIH Policy for DATA and Safety Monitoring
• Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects (PDF - 96 pages)
• Recommendations to General Clinical Research Centers (GCRCs) for Patient Safety in Clinical Research

OHRP / OPRR

• Office for Human Research Protections (formerly, Office for Protection from Research Risks (OPRR)
• OHRP guidance document: (1) "Guidance on Continuing Review" 7/11/2002
• OHRP guidance document: (2) "Guidance on Written IRB Procedures" 7/11/2002
• OHRP has updated its November 16, 2001 guidance entitled, "Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles" (March 9, 2002)
• OHRP Issues Draft Interim Guidance on Financial Relationships in Clinical Research
• OPRR Human Subjects Workshop at Stony Brook - Proceedings
• Human Subject Protection and Financial CONFLICTS OF INTEREST

DHHS

• General DHHS links
• HHS OIG Reports (Suggested categories: IRB, Clinical Research)
• The recruitment of subjects in industry sponsored clinical research June 2000
• FDA Oversight of Clinical Investigators
• Recruiting Human Subjects

OTHER LINKS

• AAMC's Task Force on Financial Conflicts of Interest in Clinical Research
• FDA Documents on Research Involving Human Subjects
• PRIM&R Home Page (Public Responsibility in Medicine and Research)
• Clinical Trials Research Group
• Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct - published by the Institute of Medicine
• Bibliography of Publications and Links on Ethics in Research and Scholarly Effort
• National Bioethics Advisory Commission
• National Human Research Protections Advisory Committee (NHRPAC)
• International Conference on Harmonization (ICH)

Questions? Email Judy Matuk, Director of Research Compliance.

Office of the Vice President for Research

News

Accomplishments

Human Subjects Research at SBU