Stony Brook University
CORIHS Policies and Procedures Handbook for Investigators
Table of Contents
General
Information
Section 1
Stony Brook University Definitions
A.
Human
Subject (for studies not under FDA jurisdiction)
B.
Human
Subject (for studies under FDA jurisdiction)
C.
Minimal
Risk
D.
Quality
Assurance/Quality Improvement (QA/QI) initiatives
E.
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. Required Forms
B. List of Materials
required for Submission
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: Research Involving Pregnant Women, Fetuses, 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. 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
Section 13
Capacity to Provide Consent for Research (Including Research Involving Subjects
with Diminished Capacity)
A. Introduction
B. CORIHS Review
C. Required procedures
to be followed by the Person Obtaining Consent for All Studies
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 the patient is
incapable of doing so?
H. Conclusion
Section 14 Required
Format for Consent Forms: Adult Subjects (18 years old and older)
A. Introduction
B. Purpose/Procedures
C. Risks/Discomforts
D. Benefits
E. Payment to You/Institution
F. Confidentiality
G. Costs to you / Alternative / In Case of Injury
H. Removal from Study
I. Subject Rights
J. Questions about the study
Section 15
Consent (Permission)/Assent Requirements: Minor Subjects (less than 18 years
old)
A. Introduction
B. Purpose/Procedures
C. Risks/Discomforts
D. Benefits
E. Payment to You / Your Child / Institution
F. Confidentiality
G. Costs to you / Alternative / In Case of Injury
H. Removal from Study / Subject Rights
I. Questions about the study
J. Assent Requirements
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. Adverse Event
Reporting
F. Amendment- or 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. First time Trainees at SBU
C. How long does first time training take?
D. What’s the passing grade for the CITI training?
E. How long is my training certification good for?
F. Who can use the CITI program?
G. What if I fail?
H. I trained through SBU already, and I need to renew my training. How do I
do that?
I. Can I get CME/CEU credits for my training in human subject protections?
J. I’m confused. Who can help me?
Section 18
Data/Tissue Registries
Section 19
Biological Specimens in Clinical (including Genetic) Research
A. Introduction
B. Definitions
C. Will Consent need to be obtained?
D. Levels of Physical and Non-physical Risk/Types of IRB Review associated
with Biological Specimen Research
E. What about the information generated from specimen analysis?
F. General Issues to Consider in Biological Specimens 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
A. Enrollment Incentives
B. IRB Requirements regarding Financial Disclosure from Investigators
C. Investigator Conflict of Interest Unrelated to Current Financial Interest
(New Policy).
Section 25 Policy
and Guidance on HIPAA Compliance for Research Activities (Involving use of
Health Information)
A. Introduction
B. SBU Definitions pertaining to privacy in Research
C. Policy
D. Procedures
E. Confidentiality/Protecting the Privacy of Health Information - Consent
Form Instructions
F. Policy Violations
Section 26 Quality
Assurance/Quality Improvement (QA/QI) Activities Vs.
Research Activities (June 2007)
A. QA/QI initiatives
B. Research Activities
C. Activities
that have a mix of both QA/QI and Research Components
SBU Policy
P202R: Research Involving Human Subjects