OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

This RAMS Gif Guide is intended for researchers and research teams using the RAMS-IRB system to manage IRB submissions. This guide will walk users through the different processes for adding and removing personnel, as well as adding or removing protocol editors.

You can access more RAMS Gif Guides made for researchers by using the researcher gif guide tag on our blog. View all gif guides by using the RAMS Gif Guides tag on our blog.

Key Personnel, Non-Key Personnel, and Protocol Editors

The VCU IRB uses three different terms to refer to different types of personnel who may be involved in a study. It is crucial to understand the differences between these types of personnel in order to understand which process to use to add/remove that type of personnel.

Key Personnel

Key personnel are defined as the following:

  • Anyone designated as a “Conflict of Interest (COI) Investigator” which includes, at minimum:
    • The Principal Investigator (PI)
    • The Lead Student/Trainee Investigator
    • The Medically/Psychologically Responsible Investigator
  • Anyone else whose roles are essential to the conduct of the research

When thinking about Key Personnel, consider whether the individual has specific, unique expertise that could not be supplied by anyone else. For example, when working with Limited English Proficiency individuals, translators/interpreters may be considered Key Personnel, because their language skills are not replaceable.

Key Personnel must be listed in the “Personnel” section of the IRB submission itself. Thus, updates to Key Personnel can only be made in an amendment (discussed below).

Non-Key Personnel

Non-Key Personnel are any personnel who are not Key Personnel. Non-Key Personnel are often research assistants or coordinators, students workers, etc. Think about those whose work contributes to the completion of the research, but who are under direct supervision and who have limited decision-making capacity for the study, and/or who do not possess specialized skills or knowledge that cannot be replaced by another individual.

Non-Key Personnel do not need to be listed on the “Personnel” page of the IRB submission, and instead can be added, removed, and tracked using the “Study Roster.” Updates to Non-Key Personnel can be done outside of an amendment, using the “Study Roster” button in the study workspace (discussed below).

Protocol Editors

Protocol Editors are individuals who have access to and the ability to edit the IRB submission, and who are copied on correspondence from the IRB. Protocol editors may or may not also be Key or Non-Key Personnel. Some research teams have regulatory coordinators who manage IRB submissions for a study, but who do not have any other role in conducting the study. These individuals would be Protocol Editors but not also Personnel.

Some study teams will have individuals who are Protocol Editors who manage IRB submissions for the study, but who also have other personnel duties, such as obtaining informed consent, interacting or intervening with study subjects, and/or who have access to identifiable study data. If a Protocol Editor also has any of those three duties, they are likely also Key or Non-Key Personnel and should be listed in the Study Roster or on the Personnel page, as appropriate.

Protocol Editors are initially designated on the Study Identification page of the SmartForm when a study is first created. Once a study is approved, Protocol Editors can be modified by using the “Update Protocol Editors” button in the main study workspace, outside of an amendment (discussed below). Protocol Editors may be modified during an amendment, but if you wish to modify Protocol Editors but do not have any other changes that require an amendment, using the “Update Protocol Editors” button will be preferable.

Updating Key Personnel

Since Key Personnel must be listed within the IRB submission itself, the only way to add, remove, or update Key Personnel is through submitting an amendment, and modifying the entries on the Personnel page.

Use the Navigating RAMS-IRB to Create an Amendment to a Study gif guide to learn more about how to open and submit an amendment to a study.

NOTE: if the Key Personnel being changed in an amendment is the PI, then the PI Change Instrument must also be used and uploaded to the amendment for IRB review. The PI Change Instrument can be found under “Supplemental Submission Forms” on the IRB section of the OVPRI Forms page.

Updating Non-Key Personnel

Non-Key Personnel can be updated outside of an amendment by using the “Study Roster.”

To do this, first locate the study you wish to update Non-Key Personnel for within RAMS-IRB. You can use the Navigating RAMS-IRB to Locate My Studies gif guide to learn how to find your studies.

Once you locate the study you wish to update Non-Key Personnel for and are in the main study workspace, locate the “Study Roster” button under the “My Activities” menu on the left side of the screen. Click this button to open a pop-out window.

Next, in the pop-out window, click the “Add” button. This will open another pop-out window, where you will select the name of the person being added as Non-Key Personnel by beginning to type their name and selecting from the options that populate.

Complete the rest of the information requested in the pop-out window, and then click “OK” to close the pop-out window and return to the Study Roster.

Once someone is added to the Study Roster, you can edit their information by clicking “Update” to the left of their name. You can remove someone from the Study Roster by clicking the small X button that appears on the far right when hovering over an entry. Confirm the deletion by clicking “OK” in the dialogue that pops up in the browser.

Once you click “OK” within the Study Roster, the changes you make will update, and the fact that the Study Roster was modified will appear in the study’s History tab.

Viewing the Study Roster

To view the study roster, navigate through the study’s History and locate an entry that says “Study Roster.” Click on “Study Roster” in the History and it will open a list of the Non-Key Personnel entered in the Roster.

To return to the study workspace from the Roster view, click “Return to Workspace” at the top left or bottom left of the screen.

Updating Protocol Editors

Protocol Editors can be added or removed during an initial submission and during amendments. Protocol Editors can also be updated without submitting an amendment, by using the “Update Protocol Editors” button.

First, click the “Update Protocol Editors” button under the “My Activities” menu on the left side of the main study workspace.

Just like the Study Roster, this will open a pop-out window. In the pop-out window, in question #1, select the individual you wish to add as Protocol Editor by typing their name in the text field and selecting the appropriate person from the suggestions made by the system.

To delete a protocol editor, click the small “X” button that appears on the far right of an entry when hovering over it.

Once you click OK in the pop-out window, the new list of Protocol Editors can be found in the main study workspace, under the heading “Protocol Editors,” below the Principal Investigator field.

Categories IRB Education and Training
Tagged , ,