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 

 Policy 6: Continuing Review of Ongoing IRB-approved Research 

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 

 Policy 7: Vulnerable Populations 

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 8: Single-Patient Use of an Investigational Product or Agent 

 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 

IRB Links