Office of Human Research Affairs

Policies and Procedures

NOTE: The policies below are being updated on an ongoing basis. In the meantime, references to "Committee on Clinical Investigations," "CCI," or "MMC IRB" refer to the Einstein IRB.

 
Institutional Policies 

Human Research Protection Program Policy 

Principal Investigator Requirements 
Principal Investigator Responsibilities 

IRB Chair and Member Responsibilities 

Disclosing Financial Conflicts of Interest to the Einstein IRB 
Training and Education 

Single IRB Reliance Procedure 

sIRB PI Responsibilities 

Single IRB Guidelines  
Guidelines for registration of studies on ClinicalTrials.gov. Instructions for registering your study are available here. Instructions for updating your registration are available here. FAQs are available here.
 
IRB Review Procedures  

Initial Full Board Review 

Expedited Review 

Exempt Research 

Exemption Categories (Revised Common Rule, effective January 21, 2019) 

Exempt Determination Decision Chart (Revised Common Rule, effective January 21, 2019) 

Expanded Guide to Exempt Category 3 

Studies that do not meet the Definition of Human Subjects Research 

Continuing Review 

Amendments to Previously Approved Research 

Documentation of IRB Meeting Minutes 

IRB Membership and Appointment 

Consultant Reviewers 

IRB Member and Consultant Conflicts of Interest 

IRB Record Retention 
 
Compliance and Reporting  

Research Noncompliance 

Unanticipated Problems 

Other Reportable Events 

Suspension or Termination of IRB Approval 

Reporting to Institutional Officials, Sponsors, and Federal Agencies 

Protocol Exception Requests 

Audit and Inspection Guidelines and Audit Policy 
HRPP Quality Improvement 
 
Conduct of Research
Informed Consent Guidelines 
Short Form Procedure for Enrolling Non-English Speaking Subjects 
Subject Compensation Guidelines 
Recruitment Guidelines 
Data and Safety Monitoring Guidelines 
Use of Protected Health Information (PHI) in Research (replaces Policy for the Use of Patient Medical Record Information in Research and Recruitment of Research Participants)
Guidelines for the Recording of Research Subjects 
Compensation Language Policy 
Use of Epic in Research  
Transportation of Subjects 
Policy for Informing Research Participants of Protocol Amendments and/or New Risk Information 
Research Record Retention Policy 
Required Documentation for the Conduct of Research Involving Human Subjects 
 
Additional Protections 
Enrollment of Children in Research 
Research Involving Adults with Diminished Capacity 
Pregnant Women, Fetuses, and Neonates 
Enrollment of Subjects in Significant Pain 
Participation of Research Personnel as Research Subjects Policy 
Research Involving Psychiatric In-Patients 
Placebo-Use and Washout in Psychiatric Research 
Inclusion of Children in NIH Research Protocols 
 
Investigational Drugs and Devices 

Investigational Device Procedure 

Investigational Drug Procedure 

Emergency Use of Investigational Drugs, Devices, and Biologics 

Treatment Use of Investigational Devices 
Treatment Use of Investigational Drugs 
Humanitarian Use Device Procedure 
Guidelines for Storage and Dispensing of Investigational Drugs 
 
Special Considerations

Fetal Tissue Research 

Cell Line and Dataset Policy 
Radiation/Radioisotope Guidelines 
Case Report Guidelines (Authorization Form - English, Authorization Form - Spanish)
HIV Guidelines 
Collection and/or Study of Human Specimens Policy 
 
Miscellaneous 
Certificate of Confidentiality Policy and Guidance and FAQ 
Non-Pregnant Women Research Policy 
NIH Regulations Regarding FDA Correspondence 
Policy and Procedure for National Cancer Institute CIRB 
Notes on Names for Einstein IRB and Albert Einstein College of Medicine  
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