In light of the current COVID-19 epidemic, the MaineHealth Office of Research Compliance would like to provide you with information on the requirement for IRB review of changes in research made in response to this situation.
The FDA regulations require that:
Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects. 21 CFR 56.108(a)(4).
The Common Rule requires that:
In order to fulfill the requirements of this policy each IRB shall… Establish and follow written procedures for… (iii) Ensuring 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. 45 CFR 46.108(a)(3)(iii)
Both the Common Rule and FDA regulations require that prospective IRB approval be granted for changes in research except where necessary to eliminate apparent immediate hazards to the human subjects.
Eliminating immediate hazards may include actions to reduce potential exposure to COVID-19, or to continue to provide medically necessary study care (including study drug) to participants who have been placed in isolation or quarantine because of suspected or known exposures. You may consider shipping study drug directly to research participants, and/or replacing in-person study visits with phone calls, home visits, or telemedicine. MaineHealth encourages sponsors and investigators to take such steps as necessary to eliminate apparent immediate additional risks to participants.
If a sponsor or investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported to the IRB of record.
If your study is under the purview of MaineHealth IRB, you must report the changes in research as soon as possible, as per MaineHealth IRB policy.
If your study in under the purview of a commercial IRB (WIRB, Advarra, Sterling, etc.), you must report the changes in research per that IRB’s policy.
If reporting to the MaineHealth IRB, you may submit a full protocol amendment, but the changes may also be communicated via memo, letter, or other document that explains the changes being made, and provides enough information for the IRB to assess the relative risks resulting from the changes. The amendment (or change in research) document must be submitted for review in IRBNet.
If you have any questions about changes in research to eliminate apparent immediate hazards to subjects, please contact the Office of Research Compliance by calling 207-661-4474, or writing to MMCIRB@mmc.org.