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Submissions :: Submitting a protocol :: Multi-phase/ multi-condition studies

Multi-Phase/ Multi-Condition Studies

Generally most of the studies that are submitted to the IRB-SBS describe one condition or study scenario.  However, some studies are more complex and involve multiple phases or conditions.  Instead of submitting multiple protocols for each condition, our office is willing to accept a protocol that covers multiple phases or conditions.  In order to submit a multi-phase or multi-condition study, we ask that you take some additional steps in your submission process so that the review can be both thorough and efficient. 

What is a multi-phase or multi-condition study?

Typically this type of study is conducted over a longer period of time and has a consistent study objective. It can include the same group of participants who are involved in various phases of the study, or it can include different groups of participants who participate in various conditions. Some studies may be covered under one grant, and for the grant documentation purposes, it is easier to have one IRB protocol approval as well. 

A multi-phase or multi-condition study should not be a blanket approval for a general topic you might be pursuing. These studies are complicated and require the same level of explanation as is in a basic protocol. If you have questions about whether your study qualifies as a multi-phase or multi-condition study, please contact our office.

How do I submit?

Overall, the submission process is the same as for a basic protocol.  Please see Submission Process for more information on the basic submission process. However, before you submit a protocol, it may be beneficial to contact our office and talk to a member of our staff about the protocol. We can go through your study with you and help you to develop your protocol so that it communicates to the Board what they need to know in order to review it.  Working with you directly can help us to be more aware of any issues that need special attention, etc.  As these protocols are more complicated, they require an additional degree of communication between all of the parties involved.

What do I submit?

In addition to the materials that you need to submit for a basic protocol, you may need to include additional information to help guide the reviewer through your protocol.  For example, if you have multiple instruments, consent forms, and appendices, you should provide a table of contents for the additional material.  Make sure that your materials are organized and well-labeled.  If you have multiple consent forms and instruments, make sure that the titles on the documents clearly indicate what condition or group of participants will use it. In the protocol, consider using tables, bulleted points, or other visual markers to help organize your descriptions. 

Sample Protocol Description

Group
What will participants do?
What instruments will
they use?
What consent forms will they use?

Group A

Sign a consent form
Complete a survey

Survey A (match the title used in this table to the title on the survey)

Consent Form A (match the title used in this table to the title on the consent form)

Group B

Sign a consent form
Complete a survey
Interview

Survey B
Interview Questions B

Consent Form B

Maintenance

Constructing a well-organized multi-phase or multi-condition study will be beneficial for maintaining the protocol over the life of the study.  As your study progresses, you may find that you need to add materials or modify procedures.  To do so, you will need to submit a modification.  Please see Modifications for more information about submitting a basic modification.  Provide a detailed description of the modification that you are making and provide adequate documentation so that our Board can review the change.  If the change is even moderately complicated, contact someone in our office (preferably the staff member who oversaw your original review) and go over the modification with them so that they can help you assess what needs to be included in your submission.

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