Protocol Modification Procedures

Any changes to the approved protocol, including procedures, consent forms, questionnaires, and advertisements, must be reviewed and approved by the IRB before implementation. The process for modifying a protocol is as simple as submitting a modification request.

Modification requests may be submitted using the optional request form or by including all the form information in a memo.

The following information is required in order for a modification request to be accepted for review:

1. Title of approved protocol and name of the Principal Investigator.
2. A brief project summary.  This summary should provide sufficient information for the IRB to evaluate the requested changes within the context of the overall project.
3. A complete description of the changes to be made; AND the reasons for each change.  Generally, the rationale for modifications should relate to the research goals of the project.
4. Your description of how the changes will affect the overall risk to participants in the study and the willingness of individuals to participate.
5. If the modification requires any changes to documents, such as the consent forms, questionnaires or advertisements, attach revised documents with the changes highlighted in some way.
6. Principal Investigator Conflict of Interest Statement: 
   (a) Do you have a conflict of interest on this project, according to the University ‘Conflict of Interest Policy for Officers of Instruction and Research’?       Yes    No

(b) If YES, has this conflict been previously disclosed to the IRB?             Yes   No

7. Principal Investigator’s signature

For full board protocols:  The review of modifications for full board protocols will be completed at a scheduled meeting. Therefore, the regular submission deadlines must be met. At the discretion of the IRB, changes that are minor, fit within the expedited categories, or don't increase the risk to participants may be reviewed by an expedited process.

For Expedited and Exempt protocols:  Modifications to expedited and exempt protocols do not require review at a convened meeting, so they may be submitted at any time and review is conducted on a rolling basis.

Helpful Hints

1. Familiarize yourself with your protocol. In order to determine whether it is necessary to submit a modification request, it is important to know what you already have approval to do. If you want to add a procedure that isn't already included in the protocol, or revise an approved procedure, then you will need to submit a modification request. A modification is any addition or alteration of protocol procedures (including recruitment, consent and assessment procedures), or documents (including advertisements, surveys, consent/assent documents).
2. Provide sufficient detail about the new/revised procedure and the rationale for the change for the Board to understand exactly what will be done, and why. Lack of sufficient information may prolong the review process.
3. When appropriate, describe protocol procedures in general terms to avoid the need to submit multiple modifications related to the same procedure. For example, if gift cards are offered as compensation for participation, the modification request may describe compensation as "gift cards to a local store" as opposed to "gift cards from Target." This way, if you decide to change vendors later on, a modification will not be necessary.
4. Do not submit foreign-language translations of study documents. The protocol should clearly state which documents will be translated into which languages.
5. Do not submit an entire revised protocol document. The modification request should be written in sufficient detail for the IRB to understand what is changing or being added to the protocol. The approved protocol is on file in our office and is reviewed with each submission along with all subsequently approved modifications.
6. Fasten all pages of your submission with only one clip or staple. It is not necessary to separate sections with additional fasteners.

More information about RPO policies and procedures can be found on the following web page: http://research.brown.edu/policies/hrpo.php.

Contact RPO staff if you have any questions about how to submit a change to your study, at 863-3050.