It is important for the researchers to understand that the IRB reviewers are not in any way criticizing the study but they are only trying to make the proposal to comply with the federal guidelines.  It is also important to understand that the reviewers' comments are based on the information provided to them by the investigators and the IRB will not by default use prior submissions or any information they may have received through an existing or previously approved protocols.  The investigators must demonstrate compliance in order to secure approval.

The researchers must bear in mind that the reviewers are MTSU faculty members who have volunteered to serve on the IRB and they have tremendous work committments that include teaching, advising students, conducting research, serve on other committees and much more.  Therefore, it is essential that the investigators respond to the questions in most efficient manner.  Providing all of the information needed for the reviewers to make a swift determination is crucial for a quick turnover of the IRB approval process.  

 

Review Comments by Email

In most instances, reviewers would seek clarification or raised concerns on the protocol that they could not understand based on the protocol application.  The investigators must also bear in mind that the reviewers may not share the field of expertise with the investigators.  Besides, the reviewers are more concerned about the ethical aspects of the research than the actual research project itself.  In such instances where the reviewer seeks minor clarification, the investigators would simply respond to the same email with "reply" or "reply to all" mode by providing adequate clarification.  

Please be aware that any response or clarification you provide may require an appropriate change to the protocol application.  Although the email correspondences are tracked as much as possible, the protocol application is a more appropriate legal document that binds the investigators to their proposed activities.  Therefore, the investigators should be ready to make appropriate revisions to meet the reviewers' comments if required by the Office of Compliance even if the designated reviewer did not make recommendations to modify the protocol. 

Responding in a point-by-point manner if more than one clarification question was posed by the reviewer would add clarity to your response.  On many occasions, the designated reviewer may forward the responses from the researchers to other IRB members or the Compliance staff to seek additional feedback when needed.  Therefore, it is essential that your responses are elaborate enough to address the IRB's broader concerns.  Clarity of your responses can be greatly enhanced by responding to the original email in a different font or a text color to adequately distinguish your rebuttal.  The IRB recognizes that their concerns are based on the documentation presented to them.  Therefore, they are also open to alternative courses of action if a certain reviewer recommendation is either impractical or would cause more risk to the participants. The researcher would then explain clearly why the recommended action would not be implemented but rather reviewer concern would be addressed by an alternative course of action. 

If the reviewer listed revisions to be incorporated in the application or in attached documents, then respond to the email in a point-by-point manner, in a distinguishable font if possible, detailing what course of action was taken.  Even if you agreed and did exactly what the reviewer recommended, it is crucial that each point is responded separately.  Ensure you first make the recommended changes to the appropriate documents and resubmit along with the email.  Preferably, complete all the recommended revision before responding to the email.   Any iterative back-and-forth discussion should be continued in the same email thread.  This way, the reviewer will be able to forward a single email thread to the Office of Compliance for records keeping.  Multiple email threads make the documentation process inefficient and the reviewer has to spend additional time to track and forward any iterative discussions causing delays to the approval process. 

Document Comments

In addition to gathering project information using the protocol application, the Office of Compliance is moving towards using extending the same document for  capturing review and discussion as well.  The correspondences are expected to be more effective.  There are options in the exempt application for the reviewer to open a new text field and write their concerns and questions directly in the application.  The reviewer questions will be highlighted, so they can be clearly distinguished, and the application will be sent back by email to the investigators.   The researcher would then respond in the box provided to them under the reviewer questions and return the revised application by email.  This single-document information exchange is expected to allow the IRB to track the discussion between the researcher and investigating team.  Also, revisions made by the investigator will be captured in "track" mode.  The reviewer will simply send the approved application and associated documents to the IRB office for subsequent action and record keeping.  The investigators will receive an uneditable version of the approved protocol in addition to the approval notice.    

This document comments format is available only for exempt application as of now. Therefore, changes to the expedited or full committee review applications, informed consent, recruitment tools, instruments and other documents have to be done through email.  

Responding to Reviewer Comments

As described above, write your response to the email in a different font under each review point raised by the reviewer.  The researchers may copy all the questions by the reviewer to a word document and send the document to the reviewer with their responses for each concern.  Although this sounds laborious, it makes the review process much swifter by enhacing clarity to the dialogue.  Another mode of correspondence would be to set up a face-to-face meeting with the reviewer(s) depending on everyone's availability or have a teleconference.  Nonetheless, it is important that the investigators respond to the original review email after the meeting/teleconference to create document record for the agreed terms and conditions.  

Responding to Action Requests

These could span several types of tasks that the reviewer may have asked the researchers to perform before an approval can be granted.  For instance, the tasks may be as routine as making alterations to the documents originally presented by the investigator or other action items such as, completing a training/certification, obtaining additional documentation to demonstrate compliance (like letter of support), provide participant debriefing, and other attachments to the application.  Ensure that all action items indicated in the review email are met before sending any revised documents.  Investigators should bear in mind that the reviewers would prefer to complete their evaluation in a single step than iteraritively.  Multiple iterations lead to more complications.