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 ClinicalTrials.gov. 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 Miscellaneous 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
