Institutional Review Board (IRB): Tips for a Successful Review
Protocols that come to the IRB offices with all the information the boards need typically make it through the review process quickly and easily. The offices for the Tufts University health sciences and Tufts Medical Center (the Health Sciences Campus IRB) and for Tufts University social, behavioral and educational research (the Medford/Somerville Campus IRB) have prepared the following tips to assist investigators. Although many policies, procedures, contacts, and forms are campus specific, these tips are common to both IRBs.
If you have questions about research involving human subjects, please check the following: Federal Rules & Regulations AND Health Sciences Campus Information & Policies OR Medford/Somerville Campus Information & Policies.
Staff in both offices are available for individual consultation. Call the IRB office and schedule a meeting to go over questions or prepared documents: Health Sciences Campus IRB office (617) 636-7512 OR Medford/Somerville Campus IRB office (617) 627-3417. Office staff can discuss your application with you before it is formally submitted for review and help identify areas to address that might otherwise slow down the review.
Please ensure that all members of the research team have completed the program of the Collaborative Institutional Training Initiative (CITI): Health Sciences Campus IRB required CITI training OR Medford/Somerville Campus IRB required CITI training.
Regarding ancillary materials:
Please be sure that you have submitted all required materials, including informed consent forms, information sheets, survey instruments, a copy of the grant submission, supporting documentation for drugs such as investigator’s brochures or package inserts, supporting documentation for medical devices such as the operator’s manual.
Check that all documents have been proofread for consistency. Protocols containing information that conflicts with what is stated in the informed consent form, for example, can delay the approval process.
Regarding the Informed Consent Form (ICF):
Please ensure that all ICF documents contain the required elements of informed consent: see Health Sciences Campus ICF OR Medford/Somerville Campus ICF. The IRB must verify that all required elements are present in consent forms before approving the protocol.
Confirm that the ICF is written in simple language that those not familiar with the research can understand. This is required to make it easier for a broader group of research participants to understand, as well as to facilitate the IRB process.
The ICF should use the terms “subject” or “study subject” rather than “patient,” and the word “intervention” instead of “treatment.” This is important to distinguish research from clinical care and to help assure that study participants understand the difference.
Regarding the entire application:
Please ensure that you send the IRB office the most up-to-date version of all documents. Note all changes to previously submitted documents in some manner, such as with the Microsoft Word tool “Track Changes.” A version date or number on all documents is required by the Health Sciences Campus IRB and optional for the Medford/Somerville Campus IRB.
Check that the entire application and all ancillary materials convey consistent information. For example, if the protocol states that the research requires weekly interaction, verify that the ICF states the same thing. If the protocol states that the participant population includes minors, for example, verify that parental permission and assent forms are attached.
Verify that the entire application is complete and that all sections of forms have been filled out. If something is not applicable, please write “N/A” instead of leaving a field blank.
Please also ensure that you have adequately addressed issues of confidentiality, data monitoring, and safety monitoring.
Review your application to ensure that it clearly conveys the details of your research and provides all information for reviewers. The reviewers need to understand from reading the protocol exactly what you will be doing.
Verify that all required signatures are present, such as principal investigator, department chair, faculty advisor.
Please plan your submission so that there is sufficient lead time for review prior to the research start date.
The staff of both IRB offices are available to meet with investigators and answer questions to ensure an efficient and successful experience. Ask early! Ask often!