ALL INVESTIGATORS ENGAGED IN CLINICAL RESEARCH WITHIN THE NSLIJ HEALTH SYSTEM MUST CONDUCT THEIR RESEARCH IN STRICT ACCORDANCE WITH THESE POLICIES AND STANDARD OPERATING PROCEDURES.*

TABLE OF CONTENTS

General Information
Introduction to the Institutional Review Board
What Type of Activity is Considered Research?
What is a Human Subject?
When Must a Submission be Made to the IRB?
The Distinction Between Research and Clinical Care

Policy 1:   IRB Review and Approval: Categories of Review

1.1  Exempt Review
1.2  Expedited Review
1.3  Full Board Review
1.4  The Appeal Process

Policy 2:    How to Prepare a Protocol for IRB Review (*Note: Only applicable when using a NSLIJ IRB)
2.1  IRB Submission Forms
2.2  Guidance and contacts: consultations and/or Approvals for Research Projects

Policy 3:    Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and Research
3.1  Protected Health Information
3.2  Authorization from the Research Subject  (Revised 02/2007)
3.3  Waiver of Authorization
3.4  Reviews Preparatory to Research


Policy 4:    Recruitment of Study Subjects
4.1  Recruitment Mechanisms
   Recruitment by Clinician or Treatment Staff - Acceptable Methods
   Recruitment by the Researcher

4.2  Recruitment Methods
   Recruitment through Chart Reviews
   Using Letters to Contact Potential Research Participants
   Optional Authorization for Research Contact
   Advertising
   Recruitment of NS-LIJHS Employees and Students as Research Subjects
   Recruitment Incentives and Conflict of Interest
   Payment to Research Subjects
   Recruitment on the Internet

Policy 5:    Informed Consent
Federally Mandated Elements of Informed Consent
5.1  Documentation of Informed Consent
5.2  Waiver of Informed Consent Requirements
5.3  Waiver of Documentation of Informed Consent
5.4  Persons Authorized to Obtain Informed Consent from Research Participants
5.5  Persons authorized to give permission for a subject (other than themselves) to participate in research
5.6  Waiver of the Assent Requirement
5.7  Re-consenting Subjects
5.8  Expiration of Consent
5.9  Obtaining a Witness Signature
5.10  Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
5.11  Obtaining and Documenting Informed Consent of Illiterate Subjects
5.12  Mailed/Emailed/Faxed Consent/Authorization Forms

6.1  Progress Reports
6.2  Re-activation of Terminated Protocols
6.3  For-Cause Compliance Audits
6.4  Routine Audits
6.5  Modifications
6.6  Protocol Exceptions
6.7  Protocol Violations
6.8  Adverse Events / Unanticipated Problems
6.9  Termination of a Protocol
6.10  Withdrawal of a Protocol
6.11  Other Activity as Determined by the IRB

7.1  Research Involving Children
7.2  Research Involving Pregnant Women, Human Fetuses, and Neonates
7.3  Research Involving Prisoners
7.4  Research Involving Incapacitated or Decisionally Impaired Subjects
7.5  Additional Special Classes of Subjects
   Terminally Ill Patients
   Elderly/Aged Persons
   Minorities
   Normal Volunteers
   Students
   Employees
   International Research Participants
   HIV Testing

Policy 9:    Medical Devices

Significant Risk And Non-significant Risk Medical Device Studies

Policy 10:    Genetic Research and Tissue Banking

10.1 Research Using Prospectively Collected Samples
10.2  Retrospective Studies of Existing Samples
10.3  Tissue Banking
10.4  Disclosure of Results to Subjects
10.5  Protocol/Consent Requirements for Genetic Research or Tissue Banking

Policy 11:    Research Investigators

Appendix A
Exception From Informed Consent for Studies Conducted in Emergency Settings

Appendix B
Federal Wide Assurance

Appendix C
Certificates of Confidentiality

Appendix D
IRB Standard Operating Procedures

Additional Information on FDA Regulated Research

Investigational Products in Clinical Investigations (Clinical Trials)

Expanded Access to Investigational New Drugs
   Open Label Protocol or Open Protocol IND
   Treatment IND
   Group C Treatment IND
   Parallel Track
   Emergency Use IND

“Off-Label” and Investigational Use of Marketed Drugs, Biologics and Medical Devices
“Off-Label” Use of Marketed Drugs, Biologics and Medical Devices Investigational Use of Marketed Drugs, Biologics and Medical Devices

Use of Investigational Products when a Subject Enters a Second Institution

Personal Importation of Unapproved Products

Food and Drug Administration (FDA) Classification of Drug Studies
   Phase I Studies
   Phase II Studies
   Phase III Studies
   Phase IV Studies