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 with Limited English Proficiency
             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       Unanticipated Problems Involving Risk to Subject or Others (Including Adverse Events)
             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: Emergency Use Exemption from Prospective IRB Approval for Use of Unapproved Drugs, Biologics or Devices

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  Specimen and Data Repositories
              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