Reporting Changes to Research and Reportable Events due to COVID-19
BRANY IRB is monitoring the COVID-19 epidemic and has been notified that organizations conducting research have implemented guidelines to ensure the health and safety of employees, visitors, patients and research participants. In some cases, such guidelines may impact a research team’s ability to carry out study procedures and visits as required. We recognize that this might result in protocol deviations, as well as the need for protocol amendments.
Be sure to follow your organization’s requirements in response to the COVID-19 epidemic.
Regulations require the IRB to follow written procedures to ensure prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.
If you need to make a change in order to eliminate apparent immediate hazards to the subject, this can be done prior to BRANY IRB review and approval. Such safety-related changes may include procedures to minimize potential exposure to COVID-19, or to continue medically necessary study interventions. BRANY IRB policy requires you report such changes within 5 days. Changes may be reported in the form of a protocol amendment, letter, memo, or other document containing sufficient detail for the IRB to assess the risk associated with the change. BRANY IRB is available to promptly review such changes prior to implementation as well.
BRANY IRB defines a protocol deviation as any temporary alteration/modification to the IRB-approved protocol. The protocol may include the detailed protocol, protocol summary, consent form, recruitment materials, questionnaires, and any other information relating to the research study. Deviations can be major (affect subject safety, rights, welfare, or data integrity) or minor (do not affect subject safety, rights, welfare, or data integrity).
Examples of minor deviations may include use of telemedicine and other modifications to minimize in-person visits when feasible, changes to study visit schedules, or a decision to temporarily pause enrollment of new participants. Minor protocol deviations should be reported in aggregate to BRANY IRB at continuing review or with notification of study closure, using the Minor Deviation Log. Please review the Information Sheet for Researchers – Reportable Events for more information.
BRANY IRB encourages researchers to consider the potential benefit of study participation versus the risk of potential exposure to COVID-19, and act accordingly. Researchers should also confer with study sponsors in all cases.
If you have any questions, please contact a BRANY IRB representative.