Guidance Regarding Drug Shortages and Substitutions that Occur During the Conduct of Research Studies
Version date: July 16, 2012
The purpose of this guidance is to assist research teams in identifying the steps they need to take in relation to the IRB should a shortage of a drug used within a research study occur. The shortage of a drug and/or need to substitute a different drug is considered a potential unanticipated problem and thus needs to be reported to the IRB promptly (i.e., with 14 business days). Because it is expected that a substitution of a drug in a potentially therapeutic study is to prevent an apparent immediate hazard to subjects, such changes can be made prior to IRB review. If the drug shortage is not expected to affect subjects under UW-Madison purview, the drug shortage would not need to be reported to the IRB. If a study team initially judges that a drug shortage will not affect subjects under UW-Madison purview, but circumstances change such that these subjects may be affected, then the IRB should be informed of this information as soon as possible.
Drug shortages and/or substitutions should be submitted to the IRB via the Reportable Event mechanism within ARROW as a potential unanticipated problem. As part of this report, please describe:
- The actions taken to address the shortage (e.g., substitutions of a new drug)
- Whether study enrollment has been suspended
- Whether the drug(s) that will be substituted are considered standard of care or whether they are investigational
- Any change in risks to participants, especially any increase, that may occur as a result of the shortage and/or substitution
- Effect of potential study outcomes, if known (e.g., study may be closed prematurely)
- What information will be conveyed to participants, how the information will be provided, and when the information will be disseminated - a revised consent form or consent form addendum may be appropriate
- Any documentation received from the study sponsor related to the shortage and any actions recommended or required.
If a drug shortage and/or substitution is not temporary and expected to be in place for the life of the study, a change of protocol should be submitted to the IRB, regardless of whether such an amendment is provided by the sponsor. The IRB will review the report to determine if any additional action is required and convey its determination to the research team. If information about the drug shortage should be communicated to subjects, a change of protocol also would be needed for any revisions to the consent documents or the addition of a consent form addendum.