The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have issued final revisions to the Common Rule, which is the Federal Policy for the Protection of Human Subjects. The changes will go into effect on July 19, 2018. These changes to the federal policy will result in a number of changes to CUNY HRPP policies and procedures. The impact of Common Rule changes on CUNY HRPP policies and procedures is summarized in the table below.
CUNY HRPP Policy or Procedures
CUNY Changes Based on Common Rule Changes
|When is CUNY HRPP or IRB Review Required?|
|Researcher Responsibilties||Changes annual continuing review requirements for all research to re-review before the expiration date set forth by the IRB|
|Criteria for IRB Approval||Vulnerable populations section edited to remove references to pregnant women; replace cognitively impaired individuals with individuals with impaired decision making capacity; and to add economically or educationally disadvantaged individuals|
|Human Subjects Research Exempt from IRB Review|
|Limited IRB Review||NEW POLICY defining the purpose, applicability, criteria, procedures and outcomes of the new Limited IRB Review Process|
|Expedited Review of Human Subjects Research|
|Secondary Research Use of Identifiable Private Information and/or Identifiable Biospecimens||NEW POLICY defining mechanisms by which research involving the secondary use of identifiable private information and/or identifiable biospecimens may be permissable|
|Consent Process and Documentation|
|Prisoners as Research Subjects|
|FDA Regulated Research|
|Non-Exempt Cooperative Human Subject Research|
|IRB Membership||Edited to remove references to pregnant women and replace cognitively impaired individuals with individuals with impaired decision making capacity|
Updated CUNY policies and procedural documents will be available on the CUNY HRPP web page on July 19, 2018. Related information from the HHS Office for Human Research Protections (OHRP) is available here.