IRB approvals. Although most of us dread the process of submission, edits, resubmission and waiting for approval, IRB review is a very important step in the clinical trial process.
An IRB, or Institutional Review Board, is meant to protect the rights and welfare of human research participants by ensuring that recruitment materials (among other things) are not coercive, misleading or promising treatment.
A lot of the sites we work with often have questions about when things need approval and when they don’t. To dive deeper into the topic of IRB approvals, we asked the staff at Advarra IRB to answer some commonly asked questions.
Read on to find out the answers!
- Why do you think IRB approval is important? IRB approval ensures that the recruitment and study-related materials used follow the United States Food and Drug Administration (FDA) guidelines, the International Conference on Harmonization (ICH) Guidelines and the Board’s standard operating procedures. The IRB has the authority to approve, require modification, or disapprove research activities before it is seen or heard by prospective or current subjects.
- Are there some terms or phrases that can be avoided in recruitment materials that can help eliminate edits? Any term or phrase that promises improvement or a cure is to be avoided. Anything that references a “free” medical treatment or examination is not acceptable as it must include that it is “study-related”. Also, any emphasis on subject compensation like bolding, italicizing or underlining is not allowed. The content cannot express that the investigational drug is FDA approved or express that it is a “new” drug without mentioning that the drug is investigational or experimental. The word “patient” should not be used to avoid therapeutic misconception but instead to use the word “subject” or “study participant”. Any language that waives the subject’s legal rights or appears to release the investigators/institution from liability for negligence is not acceptable.
- How long does approval usually take? Standard turnaround time is 2-3 days.
- When is approval optional vs mandatory? Anything that will be used to recruit potential subjects and/or any material that will be given to subjects requires approval. Minor changes to previously approved material may not require additional review. It is best practice to ask the IRB if the proposed changes require additional review.
- Do live TV interviews need to go through an approval when mentioning general study information? While there may not be an exact script for TV interviews, it is best practice to submit the talking points that will be discussed.