You’ve received good news that your grant to support existing research has been funded. Congratulations! Before you get started, you will need to link this new grant to the research that is currently approved by the OHSU Institutional Review Board. The IRB will help you make sure that your previously approved protocol still meets all criteria for approval as you incorporate activities of the new grant.
To add your new funding to a currently approved research project, you’ll need to prepare and submit a modification request. Avoid having to resubmit your modification request by considering these tips:
1. Write a detailed memo. An informative memo is valuable to the IRB reviewers. Use non-technical language to answer key questions appropriate to the changes that the new grant will make to your protocol. For example:
- What elements of the approved research are being altered by the new grant activities? That is, how have the design, subject population, study procedures, or follow-up changed with the addition of the new grant while still addressing the approved purpose? If there are no substantive changes to the main protocol, of if the grant is covered by the previously approved protocol, it is helpful to explain why. Provide detail about how the proposed grant activities fall under the scope of the previously approved research aims and activities.
- Are the risks of the study changed by the incorporation of the new grant? It is helpful to explain reasons that the new grant activities do not change the risks of the study.
- Do the activities of the new grant add benefits that were not part of the previously approved research?
- What new surveys or interviews are you adding and what are topics? If you have many new surveys, it is helpful to add a table that maps content of the survey to the file-name of the uploaded document containing that survey (e.g. Montreal Pain Questionnaire, Survey_MPQ).
2. Update your main protocol document with your new grant’s aims, scientific rationale and methods. Be sure to describe any changes to recruitment, enrollment, consent, and follow-up procedures in both the main protocol document and in the Consent and Authorization forms. If appropriate, increase the number of subjects to cover the new recruitment.
3. Determine if new forms are required for the revised research. For example, will you need a Prep to Research or Waiver of Authorization form. Also, check that you’ve uploaded any new surveys, questionnaires or interview items.
4. Review all revised documents for completeness, accuracy and consistency.
We know you are eager to receive your new funding. Help us help you get the green light by carefully and thoroughly preparing your modification request. If you need guidance or have questions, give us a call. 503-494-7887, option 1.