How to Submit Changes to an Approved IRB Protocol
By Donna Peters
Requesting changes to your approved Institutional Review Board (IRB) protocol takes just a few steps. The most important point to remember is that you need to have IRB approval before you implement any changes. The recruiting material, the procedure steps, and the surveys/measurements that are used in the research study must mirror the IRB protocol on file in the Human Research Protection Program (HRPP) office.
In the event an auditor from the Office of Human Research Protections, U.S. Department of Health and Human Services, visits Texas Tech and chooses to review your research study, all documentation will reflect exactly what you are doing.
Here are steps and instructions on how to request an amendment to your approved IRB protocol:
Amendment Request Instructions
Amendments to change an approved protocol can be requested at any time. An e-mail memo along with any revised documentation should be sent to the HRPP staff for processing and review. The following steps should be followed:
|Step 1||Step 2||Step 3|
|Submit an email to email@example.com with the following information;||Your amendment will take 3-to 5 days for administrative preparation and 10-working days for IRB review.||An amendment approval letter will be emailed as a PDF document to the researcher(s). If you are working with an expedited or full board protocol, the expiration date for data collection does not change with an amendment approval. The expiration date is noted in your amendment approval letter.|
|Include the IRB number, protocol title and name of the principal investigator. The email should come from the faculty PI rather than the graduate student.|
|List the requested changes/revisions in bullet form in the body of the email. It is helpful to reference the page number and location in the protocol where you are making these changes. You may include a document with tracked changes and then attach a clean version also. Changes to protocols often include additional recruiting measures, additional population sampling, deleting measures or adding measures or revisions, additional data collection methods, title changes and changes in the researchers involved.|
|Attach the revised protocol with the revised appendices (recruiting, consent/assent forms, fliers, etc.) to your email. Remember to make only one file document and include page numbers.|
Sometimes proposed amendments that involve multiple changes may require a new proposal submission. For example, if you propose to change your recruiting methods, recruit additional populations, add new procedures (such as interviews and focus groups), and change your measurements, your protocol amendment becomes complicated. These changes would have an impact on your rationale. The requested amendment changes to the original approved study morphs into a different document. In this case, submit a new proposal for review. You can continue collecting data from the active protocol and also collect data from the new protocol.
Amendments are one of the most time-consuming reviews. The more the amendment changes are identified and clarified, the easier the review.
As always, please contact the staff in the HRPP Office with questions on amendments. We are here to help.
Donna Peters is manager of Texas Tech's Human Research Protection Program