506. New Projects: Submitting for Human Research Determination
Updated July 1, 2019
Determining if a project or activity constitutes human subject research can be challenging. When uncertain about the status of a project/activity, University and affiliate faculty, students, and staff may wish to review IRB policy for projects that may or may not be human subject research and are advised to create a new project in IRBNet and submit a Request for a Human Research Determination.
Submission Requirements for Administrative Review of New Project: Determination of Not Human Subjects Research
- Add Part I, Cover Sheet
- Add Request for Human Subject Research Determination researcher form
- Sign electronically through IRBNet
Study-Specific Submission Requirements for Administrative Review New Project: Determination of Not Human Subjects Research
- Add grant proposal, contract, or scope of work: Required for sponsored projects/activities
- Add supplemental materials (e.g., invitations, surveys, data collection logs)
The request should describe the proposed project/activity with enough detail for the person reviewing the application to determine if the project meets both definitions. Determination requests for projects/activities involving existing data or specimens should describe the procedures for the new project/activity, not how the data were originally obtained.
NOTE: Determination requests may only be submitted for projects/activities that have not yet been implemented.
To require RI (for exempt research) or IRB oversight, projects/activities must qualify both as research and involve human subjects as defined in the federal regulations (see IRB Policy Manual Definitions).
Assessment of Human Subject Research Determination Requests
Experienced RI staff assess human research determination requests as described in 45 CFR 46.101 and through use of DHHS OHRP's decision Chart #1 Is An Activity Research Involving Human Subjects?
The staff determination will 1) consider the purpose of the activity and uses of the data; and evaluate the project to determine if 2) private information will be obtained from or about individuals, or 3) researchers will interact with the persons involved in the project to obtain information about the person (as opposed to obtaining general information about a business or event).
- If staff determine the activity is not research or does not involve human subjects, the submitter will be notified of the determination in IRBNet and time the project/activity may commence.
- If staff conclude the activity is human subject research, she/he will send the researcher an email from within IRBNet letting the submitter know of the determination (i.e., research is exempt, or requires expedited or full committee review). The email will indicate which additional materials must be submitted for the required review. No research activities may be initiated until the research is notified of exempt or IRB approval.