When Do I List Persons on the IRB Protocol

Any individual engaged in the research project must be listed. This includes:

• Recruiting prospective participants;
• Consenting participants;
• Interacting or performing interventions/study procedures with participants; and
• Accessing identifiable information from participants.

Reviewing identifiable data, even with no interactions with the subjects themselves, is conducting human subjects research. These individuals will need to be listed on the IRB application.

The following factors have no bearing on the regulatory requirement that all persons who are engaged in human subjects research be listed and reviewed by the IRB to ensure they meet qualifications for conducting human subjects research:

• Undergrad students
• Graduate students
• Volunteers

Permitted time period students/volunteers can help with a project:

• One month
• One week
• One day

Yes. The faculty member, who is serving as your mentor to ensure you are fulfilling your obligations as a researcher, must be listed as the PI on the IRB application.

That’s ok. You can submit with just those individuals you know will be involved and get approved to start your research. Once the additional persons are identified, then submit an amendment to add research personnel.

NOTE: Added personnel cannot begin working on the research project until they are approved by the IRB.

That’s ok. You can submit with just those individuals who are compliant with requirements (like CITI training) and get approved to start your research. Once the additional person(s) has completed the requirements, then submit an amendment to add research personnel.

NOTE: Added personnel cannot begin working on the research project until they are approved by the IRB.

The school would be engaged and need an Assurance and IRB approval to cover the school employee’s activities if their involvement includes:

• Receiving an award to support the research as the prime awardee or subcontractor or
• Performing research activities involving human subjects.

Examples of performing research activities that would engage school employees:

• Administering the survey to students as part of the research initiative.
• Acting as authoritative representatives of the researchers and/or obtaining informed consent on behalf of the researchers.
• Obtaining, receiving, using, or possessing private information for research purposes.

Reference: ED Guidance on “Engagement” of Institutions in Research

If you cannot find the person in the directory to add in Section 3.0, this means they do not have an iRIS account. The individual needs to login through SSO for the first time and then an iRIS account will be created. Once they have an iRIS account, then you will be able to find them in Section 3.0 directory to add them to the submission.