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After IRB Approval

Modifications

After IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation. This includes changes to the research team, recruitment process or material, consent procedures or materials, participant payment, data collection procedures, and target population. Protocol violations are changes in the approved IRB protocol that are under the investigator's control and made without prior IRB approval.

When changes to the IRB are necessary to immediately eliminate or reduce an apparent hazard to the safety of research participants or others, those changes may be initiated without prior IRB approval. This event must be reported to the IRB/HRPP within 10 working days of initiation. If there are subject safety concerns, contact the HRPP Director or IRB Chairs immediately.

Modifications are made and submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Then click on New Submission and Modification. Researchers must complete the modification summary section. They must also edit appropriate sections of the IRB and attach revised documents.

Incidents

During the research, researchers may encounter certain types of unanticipated problems, adverse events or protocol deviations. Researchers must report these incidents to the IRB.

A protocol deviation is any change, deviation, or departure from the approved IRB and is under the researcher's control and has not been approved by the IRB. Upon discovery, the Principal Investigator and research team is responsible for reporting protocol deviations to the IRB.

Incidents

    • Unanticipated problem is an incident or event that was unexpected by the research team. This incident or event has developed a new or increased risk to the participants and was possibly related to the research procedures. Anticipated problems are already described as potential risks in the consent form and described in the IRB.
    • Adverse events are any unpleasant or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the research participation. Adverse events encompass both physical and psychological harms.
    • A minor deviation or minor violation is viewed by the IRB as an event that does not impact subject safety, compromise the integrity of study data and/or affect a subject's willingness to participate in the study. Minor deviations or violations will be reviewed by the IRB Chair. The IRB Chair will determine whether the event is accepted as a minor deviation/violation and can recommend a corrective course of action.
    • A major deviation or violation is viewed by the IRB as an event that may impact participant safety, affect the integrity of study data and/or affect a participant's willingness to participate in the study. Major protocol deviations/violations are treated as noncompliance. These incidents will be reviewed by the IRB Chair, the IRB committee and the Institutional Official to determine the appropriate course of action.

Incidents are made and submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Click on New Submission and Incident. After submitting the Incident, additional information may be requested by the IRB.

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the researcher, appropriate institutional officials, and the department or agency head. (45 CFR 46.113)

Renewals

Renewals are conducted at least once a year and used to re-evaluate the research protocol and risk to participants. The IRB can determine the length of approval and timeline for renewal. The rationale for doing so must be documented in the IRB approval letter. Renewals are submitted on a yearly basis until the research has been completed and the IRB protocol has been closed.

Renewal based on Review Type:

  • Exempt – DOES NOT require renewal
  • Limited Review - DOES NOT require renewal
  • Expedited Approved before 1/19/2019 – REQUIRES renewal
  • Expedited Approved on or after 1/19/2019 – DOES NOT require renewal
  • Full Board – REQUIRES renewal

Renewals are submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Click on New Submission and Renewal. Complete the submission and attach all consent and assent documents with updated expiration dates. The renewal submission should be submitted no sooner than 60 days but no later than 30 days before the IRB's expiration date. Expired IRBs are in non-compliance and must stop immediately until a renewal is approved. During this time no recruitment and/or data collection can occur.

The HRPP office will email the PI and primary contact of all approved IRBs NOT requiring renewal on a yearly basis. The email will serve as a reminder to submit any modifications or incidents for the approved protocol. The PI must inform the HRPP office that the research is complete and can close. This can be done by responding to the annual email or submitting a closure submission in Cayuse IRB. IRBs that remain active are subject to audit by the IRB.

Closures

If all research interventions or interactions with participants have been completed and collection and analysis of identifiable private data/biospecimens are finished, the study should be closed with the IRB. Once a study has been closed, investigators may keep the data collected (including identifiable, private data) if consistent with the IRB-approved protocol. Investigators should continue to honor any confidentiality protections of the data. Investigators should also honor any other commitments that were agreed upon as part of the approved research. For example, providing information about the study results to research participants or honoring reimbursement commitments for participation. IRBs that remain active are subject to audit by the IRB.

Closures are submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Click on New Submission and Closure. Once the submission is approved, the study is considered Closed by the IRB and archived. If a researcher wishes to resume the research after the study has been closed or if the study is closed in error, a new study will have to be submitted.

The IRB Closure Guidelines can be used by the research team to assist with closing their IRB.  

Human Research Protection Program

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