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.

 
Organizational Policy 

Human Research Protection Program Policy 

Principal Investigator Requirements 
Policy on Disclosing Financial Conflicts of Interest to the Einstein IRB 
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 

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

Expanded Guide to Exempt Category 3 

Amendments to Previously Approved Research 

IRB Membership and Appointment 

 
Compliance and Reporting  

Research Noncompliance 

Unanticipated Problems 

Other Reportable Events 

Suspension or Termination of IRB Approval 

Reporting to Institutional Officials, Sponsors, and Federal Agencies 

Audit and Inspection Guidelines and Audit Policy 
 
Conduct of Research
Informed Consent Guidelines 
Guidelines for Compensation of Research Subjects 
Advertisement Policy 
Data and Safety Monitoring Policy 
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 Minors in Research – Principles and Guidelines 
Research Involving Adult Persons with Diminished Capacity 
Pregnant Women or Fetuses Research Policy 
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 

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

Fetal Tissue Research 

Cell Line and Dataset Policy 
Radiation/Radioisotope Guidelines 
Case Report Policy (Authorization Form)
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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