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.  


Revision Date  Policy 



Categories of Research
  - Research Eligible for Exemption (prior to January 21, 2019)
  - Research Eligible for Exemption (Revised Common Rule, effective January 21, 2019)
  - Expanded Guide to Exempt Category 3
  - Exempt Determination Decision Chart (Revised Common Rule, effective January 21, 2019)
  - Research Eligible for Expedited Review
  - Research Requiring Full Board Review 

1/14/11 Cell Line and Dataset Policy 
7/6/13  Case Report Policy (Authorization Form)
(Posted 11/21/14)
Research Involving Adult Persons with Diminished Capacity 
1/17/18 Humanitarian Use Device Policy and Procedure 
3/25/15  Reportable Events Policy (replaces Internal Adverse Event Policy, External Adverse Event Policy, and Protocol Deviation Policy and Procedure) 
2/5/10 Principal Investigator Requirements 
5/07 Research Record Retention Policy 
2/07 Participation of Research Personnel as Research Subjects Policy 
3/07 Data and Safety Monitoring Policy 
7/12/02 Research Involving Psychiatric In-Patients 
12/17/12 Amendment Policy and Procedure 
3/7/12 Policy on Disclosing Financial Conflicts of Interest to the Einstein IRB 
6/30/15   Informed Consent Guidelines 
7/31/16  Use of Epic in Research  
 2/1/19  Single IRB Guidelines  
9/27/2017   Certificate of Confidentiality Policy and Guidance and FAQ 
1/12/01 Policy and Procedure for Reporting Protocol Non-Compliance 
 11/17/17  Required Documentation for the Conduct of Research Involving Human Subjects 
5/21/07 Collection and/or Study of Human Specimens Policy 
5/8/03 Investigational Drug, Biologic and Device Policy 
5/8/03 Emergency Use of an Investigational Drug or Biologic Policy and Procedure 
5/8/03 Emergency Use of an Investigational Device Policy and Procedure 
10/12/04 Guidelines for Storage and Dispensing of Investigational Drugs 
3/01 Compensation Language Policy 
5/12/05 Radiation/Radioisotope Guidelines 
2/08 Non-Pregnant Women Research Policy 
11/22/13 HIV Guidelines 
06/2017  Fetal Tissue Research Policy 
2/8/07 Pregnant Women or Fetuses Research Policy 
1/24/05 Enrollment of Subjects in Significant Pain 
12/6/11 Guidelines for the Recording of Research Subjects 
1/08 Transportation of Subjects 
9/18/02 Advertisement Policy 
12/15/11 Guidelines for Compensation of Research Subjects 
10/23/09 Inclusion of Children in NIH Research Protocols 
10/23/09 NIH Regulations Regarding FDA Correspondence 
5/8/03 Enrollment of Minors in Research – Principles and Guidelines 
(Posted 9/30/14)
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)
2/5/10 Policy for Informing Research Participants of Protocol Amendments and/or New Risk Information 
8/5/05 Placebo-Use and Washout in Psychiatric Research 
1/31/11 Policy and Procedure for National Cancer Institute CIRB 
06/28/17  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.
1/13/12 and 04/2017  Audit and Inspection Guidelines and Audit Policy 
01/2019   Notes on Names for Einstein IRB and Albert Einstein College of Medicine  
Click here to log in