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 January 21, 2019. 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?
  • Updates definition of a human subject
  • New definition of identifiable biospecimenadded
  • New definition of Public Health Authority added
  • New section on Activities Deemed Not to be Research added
  • Example sections on Oral History, SoTL and QA/QI activities removed
Researcher ResponsibiltiesChanges annual continuing review requirements for all research to re-review before the expiration date set forth by the IRB
Criteria for IRB ApprovalVulnerable 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
  • Updates exemption categories
  • Adds section on Exempt Categories Requiring Limited IRB Review
Limited IRB ReviewNEW POLICY defining the purpose, applicability, criteria, procedures and outcomes of the new Limited IRB Review Process
Expedited Review of Human Subjects Research
  • References updated expedited categories
  • Defines conditions under which a continuing review of expedited research will not be required
  • Requires reviewers to document rationale for forwarding research that meets expedited review categories for convened IRB review
Secondary Research Use of Identifiable Private Information and/or Identifiable BiospecimensNEW 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
  • New definition of written or in writing added
  • New requirements for key information and organization of consent document added
  • Defines and references requirements for new Broad Consent procedures
  • Adds references to biospecimens
  • Adds a new section on Screening, Recruiting, or Determining Eligibility Without Informed Consent
Prisoners as Research Subjects
  • Allows research involving prisoners to be exempt from IRB review ONLY when the research is aimed at a broader subject population that only incidentally includes prisoners
  • Removes the section on When a Non-Prisoner Subject Becomes a Prisoner
FDA Regulated Research
  • Adds a definition of clinical trial for the specific purpose of posting clinical trial consent forms
  • Adds the definition of minimal risk
  • Adds a section on Posting of Clinical Trial Consent Form
  • Adds a section on Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects
    Non-Exempt Cooperative Human Subject Research
    • Policy name and all references within changes from Multisite Research to Cooperative Research
    • Adds single IRB requirement for all federally funded cooperative research for all domestic institutions
    • Provides exceptions to single IRB requirement
    IRB MembershipEdited 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.

    Please contact Arita Winter-Potter or Michael Brown with any questions related to the upcoming changes.