Institutional 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
Delegation of Authority 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 Instructions for registering your study are available here. Instructions for updating your registration are available here. FAQs are available here.
Emergency Preparedness Guidelines
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
International Research Procedure
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
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
Guidelines for the Recording of Research Subjects
Transportation of Subjects
Research Record Retention Policy
Required Documentation for the Conduct of Research Involving Human Subjects
Additional Protections
Enrollment of Children in Research
Enrolling Adults with Varying Decision-Making Capacity in Research
Pregnant Women, Fetuses, and Neonates
Enrollment of Subjects in Significant Pain
Research Involving Employees as Subjects
Participation of Research Personnel as Research Subjects
Research Involving Psychiatric In-Patients
Investigational Drugs and Devices
Investigational Device Procedure
Investigational Drug Procedure
Guidelines on Sponsor-Investigator Responsibilities
Emergency Use of Investigational Drugs, Devices, and Biologics
Treatment Use of Investigational Devices
Treatment Use of Investigational Drugs
Humanitarian Use Device Procedure
Storage and Dispensing of Investigational Drugs
Special Considerations
Fetal Tissue Research
Embryonic Stem Cell Research Policy
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
Certificate of Confidentiality Policy and Guidance and FAQ
NIH Regulations Regarding FDA Correspondence
Notes on Names for Einstein IRB and Albert Einstein College of Medicine