Amending Exempt Research

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Investigators must self-assess that the proposed changes to a study previously determined to qualify for exemption continues to qualify for exemption. Minor changes are likely to qualify for exemption and more substantive changes have the potential to no longer meet the conditions of exemption. Therefore, some changes to Exempt protocols will require review by RCS to verify the self-assessment of exemption prior to implementing changes.  If the study no longer qualifies for exemption with the proposed changes, the study will require review by the IRB using the expedited or full board review procedures; this would require submission of a new initial application for IRB review.

Use the RCS Exempt Self-Assessment Tool to evaluate whether the amended study continues to meet exemption criteria.

 


Minor Proposed Changes to Exempt Studies

Minor changes to studies previously determined exempt are likely to continue to qualify for exemption. The investigator must self-assess that the study continues to qualify for exemption and whether further submission to RCS is required based on the types of changes detailed below. If the investigator self-assesses that the study no longer qualifies for exemption or if you have questions about the eligibility of a minor change, contact RCS for further instruction.
 
  • Minor changes include:
    • Editorial changes that clarify but do not alter the existing meaning of a document
      • e.g., grammatical corrections, wordsmithing, addition of clarifying questions, addition of very similar questions to those previously approved, or deletion of questions.
    • Minor revisions to recruitment materials and methods.
      • e.g., a change to a phone number, or the addition of a newspaper ad.
    • Minor revisions to survey, interview, or focus group instruments that do not fall outside the scope of the originally described instruments.
      • e.g., wordsmithing, addition of clarifying questions, addition of very similar questions to those previously described, or deletion of questions

Submission Requirements for Minor Changes to Exempt Research

Use the self-assessment tool to evaluate if the study is still exempt.

  • IF STILL EXEMPT, do NOT submit for RCS review. Investigators are responsible for documenting in their research records that the changes made to the protocol were self-assessed as continuing to qualify for exemption and that further submission to RCS was not necessary.
  • IF UNCERTAIN IF STILL EXEMPT, contact RCS to discuss the proposed changes.
  • IF NO LONGER EXEMPT, contact RCS for further instruction as it may be necessary to prepare an initial protocol submission for IRB review.

Substantive Proposed Changes to Exempt Studies

Substantive changes to studies previously determined exempt may continue to qualify for exemption but will require an amendment be submitted to RCS for review to verify continued eligibility for exemption or determine if IRB review is required. The investigator must self-assess that the study continues to qualify for exemption prior to submitting an amendment. If the investigator self-assesses that the study no longer qualifies for exemption, an initial application for IRB review may be necessary. 
 
  • Substantive changes include but are not limited to:
    • Adding or removing study personnel.
    • Changing the funding source.
    • Changing the study purpose or procedures.
      • e.g., adding a new method, adding a survey on a different topic than previously described, new data collection, etc.
    • Changes to the study population targeted for recruitment.
      • e.g., increasing number of participants, adding a new population or substantively revising the inclusion/exclusion criteria for the current population.
    • Changing the identifiability of the research data you will receive or record.
      • e.g., your exempt application states that you will not collect names with the surveys, but you now want to, or you now want to record identifiable data from an existing dataset.
    • Changes that alter the risks involved in the study.

Submission Requirements for Substantive Changes to Exempt Research

Use the self-assessment tool to evaluate if the study is still exempt.

  • IF STILL EXEMPT, prepare an Exempt Amendment using the Exempt Review Application and submit to RCS for verification of continued exemption. For studies that were initially granted exemption prior to January 2019, the Amendment Review Application may be used to request changes; include any previously reviewed protocol materials impacted by the changes.
  • IF UNCERTAIN IF STILL EXEMPT, contact RCS to discuss the proposed changes.
  • IF NO LONGER EXEMPT, contact RCS for further instruction as it may be necessary to prepare an initial protocol submission for IRB review.