Changes to the Continuing Review Procedures

Changes to the Continuing Review Procedures

Summary of Changes

Continuing review is no longer required for some minimal risk research such as Exempt and Expedited studies that were approved on or after January 21, 2019 unless the IRB explicitly justifies for each study why continuing review would enhance protection of research subjects.

Continuing Review Procedure Changes – Impact on Researchers

FULL BOARD PROTOCOLS

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Important: Continuing Review requirements for Full Board Protocols remain unchanged.

EXEMPT AND EXPEDITED PROTOCOLS

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Studies will continue to require submission of a renewal form annually until the study is completed at which time a final report form must be filed.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • Continuing Review/Renewal - NOT REQUIRED (CHANGED)
  • Continuing review will no longer be required as a general practice unless the IRB reviewer explicitly justifies why continuing review would enhance protection of human research subjects. Your IRB approval letter will indicate the designation as requiring or not requiring a continuing review/renewal.

NOTE: UMASS/HRPO may re-evaluate its decision of not requiring continuing review/renewal for a particular study that was approved ON or AFTER January 21, 2019 based on changes proposed in a revision that increase the risk(s) to subjects, or as an outcome of the IRB's review of unanticipated problems/adverse events/research-related complaints.

UMASS/IRB/HRPO will notify the research if there is any change in the designation.
 

The following research team responsibilities remain unchanged (for both Exempt and Expedited Protocols)

  1. Complete a final report form when all participants have completed all research-related interventions AND you are only doing data analysis of de-identified data.

  2. Submit a revision in the following instances prior to implementation (unless to eliminate an apparent immediate hazard to subjects):

    • Enrollment of additional participants beyond the number approved

    • Any changes to study design/methodology, questionnaires, etc.

    • Any changes to study personnel

    • Any changes to consent procedures/documents

    • Any changes to recruitment procedures/materials

  3. Report the following to the IRB:

    • Unanticipated problems

    • Adverse Events

    • Research-related complaints

    • Protocol deviations/violations