When to Amend a Protocol

The file for each protocol maintained by the IRB must be an accurate record of how the study is being conducted. Thus, changes must be recorded in the file and in most cases (see below), receive prior written approval.

The federal regulations governing research with human subjects have this to say about the prior review of minor changes:

"An IRB may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized."

This directive leaves the IRB with the task of defining which changes are "minor," which are "major," and which fall below the threshold altogether, for example, a change in contact information. Given the complexity of the research enterprise, it is not possible to offer finite descriptions of categories of change, but only general guidelines. When in doubt, please contact the IRB staff.

Classification of Changes

As a general guideline, major changes would affect the experience of the subjects in some way, for example:

1. Introducing a new procedure or instrument
2. Revising the consent process
3. Changing the risk/benefit analysis
4. Adding a new subject population
5. Changing the investigator

Examples of minor changes would include:

1. Adding questions to an approved instrument (providing the questions don't change the experience or risk to the subjects)
2. Revising a consent form to improve readability without changing the content
3. Adding one more iteration of a previously approved interview procedure to a longitudinal study
4. Adding HIPPA language to a consent form
5. Deleting an instrument

Examples of changes that are less than "minor" and that would not require IRB approval might include:

1. Changing contact information
2. Including an example to clarify a question

Although IRB approval is not required for less than "minor" changes, investigators should forward documentation of the changes to the IRB so that the protocol file can be made current.

Type of Review

As noted above, minor amendments to approved protocols may always be approved using the expedited review process.

Determining the type of review required for major changes is more complex. Major changes may be reviewed through the expedited review procedures or may need review by the full IRB, depending upon the type of initial review and the level of risk. Please consult the IRB staff.


The Form

A Request to Amend an Approved Protocol may be submitted at any time. If full review is required, check the timetable for deadlines for submission and review dates.