Table of Contents
General
Information
Section 1 Stony
Brook University Definitions
A. Human Subject
B. Minimal Risk
C. Research
Section 2 Categories of Research Requiring CORIHS Approval
A. Exempt Review Category, Review Procedure
B. Expedited Review Category, Review Procedure
C. Full Review Category, Review Procedure
Section 3 Materials Required For Submission to CORIHS
A. CORIHS Application
B. Project Description
C. Grant or sponsor protocol
D. Consent/Permission/Assent Forms
E. Investigator Brochures/Package Inserts
Section
4 Review Time Considerations
Section 5 Criteria
for CORIHS Approval of Research
Section 6 Approval
Periods
Section 7 Responsibility
of Approved Investigators
Section 8 CORIHS
Disapproval
Section 9 Vulnerable
Populations: Pregnant Women, Nonviable Neonates And Neonates of Questionable
Viability
A. Definitions
B. Research Involving Pregnant Women or Fetuses
C. Research Involving Neonates (non-, or questionably viable)
Section 10 Vulnerable Populations: Minors
A. Additional Protections of Minors
B. Types of Activities Involving Minors Qualifying for Exempt or Expedited review
C. When enrollment of minors is possible, but rarely anticipated
D. Involvement of Minors in the Departmental Subject Pools
Section
11 Vulnerable Populations: Prisoners
Section 12 General
Issues in Informed Consent
A. Criteria for a Waiver of Obtaining Informed Consent
B. Criteria for a Waiver from the Documentation of Informed Consent
C. Differences between consent, permission and assent
D. Obtaining Consent from Non-English Speaking Subjects
E. Circumstances Under Which Consent Must be Sought
A. Introduction
B. CORIHS Review
C. Required procedures to be followed by the Person Obtaining Consent for All Studies, All Subjects
D. What determines a potential subject’s capacity to consent to research?
E. What characteristics of research subjects may suggest a diminished capacity to provide consent?
F. If a study proposes to include a subject populations where all or some of the individuals will lack the capacity to consent…
G. Who can provide consent for a patient to participate in a research study if a patient is incapable of doing so?
H. Conclusion
Section
14 Required Format for Consent Forms: Adult Subjects (18 years old and older)
Section 15 Consent
(Permission)/Assent Requirements: Minor Subjects (less than 18 years old)
A. Required format for Permission (addressed to the parent/legal guardian
B. Assent (and Documentation of Assent) Requirement
Section 16 Continuing Review Of CORIHS-Approved Activities
A. Observation of Research by CORIHS
B. Oversight Compliance
C. Renewal Procedures
D. Amendments to Approved Studies
E. Unanticipated Problems and SAE Reporting
F. Amendment- or Serious Adverse Event-related changes to consent/permission/assent forms
Section 17 Training of Investigators in the Protection of Human Subjects in Research Activities
A. Training Policy
B. What does ‘successful completion’ mean?
C. What is the lecture series?
D. Lecture Registration
E. What is the CITI Program?
F. CITI Registration
G. What if you fail?
H. Continuing Education
I. Re-certification
Section
18 Data/Tissue Registries
Section 19 Biological
Specimens in Clinical (including Genetic) Research
A. Introduction
B. Definitions
C. Consent/Review Guidelines
D. Points to be Addressed in the Protocol and Consent Form when Proposing Research on Biological Specimens (including Tissue Banking for Future, Unspecified Research
Section
20 Exemptions from CORIHS Approval Requirement
Section 21 CORIHS
Records
Section 22 Violations
of CORIHS Policies
Section 23 IRB Fee
Recovery from Industry Sponsored Research
Section 24 Conflict
of Interest/Financial Disclosure Policy
Section 25 Policy
and Guidance on HIPAA Compliance for Research Activities (Involving use of Health
Information)
SBU Policy
P202R: Research Involving Human Subjects
Return to Human Subjects Research at SBU
Last Updated: 2007-03-30