Does the Project Require IRB Review and Approval?

You need to answer the following three questions to determine if your project requires IRB review and approval.   Determination forms are located on our forms library.

1.  Is UVM or UVM Medical Center engaged in the activity?

2.  Is the activity in which you will be engaged RESEARCH?

3.  Will the activity involve HUMAN SUBJECTS?

1.  Engagement

An individual is considered engaged in human research when he/she for the purposes of the nonexempt research project, obtains: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. An institution is considered engaged when its employees or agents conduct the above activities, or when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor. 

The following two flows will assist you in making the next determinations. 

2.  Is the activity in which you will be engaged RESEARCH?

is it research

is it research notes

3.  Will the activity involve HUMAN SUBJECTS?

is it human subjects 

Grant Proposals Lacking Definite Plans for Involvement of Human Subjects

Certain types of applications may involve human subjects (within the funding period) but definite plans are not included in the application or protocol.  This type of application would include such activities as institutional grants, training grants, and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. The IRB must certify that all human subjects research contained within a grant application has been reviewed and approved prior to release of funds, even if the plans for human subject involvement is unknown.  Therefore, investigators should submit the Initial Administrative Review of an Umbrella Grant or Projects to be Developed form.  This will allow the IRB to certify what is in the grant with the caviat that not all activities specific to human subject involvement have been reviewed.  This will allow the release of grant funds so that work may begin.

However, no human subjects may be involved until a human subjects protocol has been reviewed and approved by the Committee.  This new certification would be the approval of record going forward and you may be required to obtain prior approval or submit the new certificate to the funder.