Common Stipulations Across IRBs


To assist with preparing submissions to the IRB, below please find a table of frequent stipulations from the IRB on the left and suggestions on how to prevent these stipulations on the right.

Issue

Solution

Inaccurate references to facility name(s) - i.e. reference to the Medical Center should be AU Medical Center (not GR Health or Augusta University Medical Center).

Obtain informed consent documents or other available templates from the Forms and Templates Library in IRBNet.

The project as described in the protocol does not match what is presented in the Core Data Form or the consent form.  For example, the protocol may describe surveys but the consent form includes interviews and focus groups.

Another example is that the protocol may describe a retrospective chart review, but there is a consent form describing prospective collection of data from subjects.

Complete a thorough review of all of your study documents, or have someone else review the documents for you.

The data collection instrument is incomplete.  For example the protocol states that data will be collected on sociodemographic and lifestyle changes but there are no questions on these topics in the survey.

Complete a thorough review of all of your study documents, or have someone else review the documents for you.

The consent form and survey instruments are poorly worded or have numerous typos and grammar errors that make it impossible to assess the documents.

Use spellcheck and other tools to help you ensure your documents are worded and spelled correctly.

Complete a thorough review of all of your study documents, or have someone else review the documents for you.

The protocol does not have an adequate description of the study design including recruitment, the consent process, data collection, and any follow up.

The protocol should encompass all study components.

Complete a thorough review of all of your study documents, or have someone else review the documents for you.

There is no data collection form uploaded in the IRB submission.

Each study is required to have a data collection form of some type. This could be questionnaire, survey, excel spreadsheet, Word document with a list of data elements, etc.  This helps the IRB access what type of information is being gathered.