RPOHuman Subjects ResearchElectronic Submission Guide

 

Introduction

You need to answer the following three questions to determine if your project requires IRB review and approval.

1. IS UVM or UVMMC engaged in the activity?

An organization is considered engaged in human research when its employees or agents, for the purposes of the nonexempt research project, obtain:

  1. Data about the subjects of the research through intervention or interaction with them;
  2. Identifiable private information about the subjects of the research;
  3. The informed consent of human subjects for the research; or
  4. When the institution receives a direct federal award to conduct human subjects research, even when all activities involving human subjects are carried out by a subcontractor (that is, employees or agents of another institution).

See section 3.7 of the IRB Policies and Procedures Manual for more information about engagement.

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

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Whereas quality improvement projects or program evaluation projects systematically collect data for administrative, clerical, or reporting purposes.

See section 3.6 of the IRB Policies and Procedures Manual for more information about not research determinations.

The IRB does not review projects that do not meet the OHRP's definition of research. 

Please use our Self-Determination Tool to assist you in determining if the project requires IRB review.

3. Will the activity involve HUMAN SUBJECTS?

Research projects that do not involve human subjects as defined by the regulations under 45 CFR 46.102(e)(1) do not require submission to the IRB for review.  To reduce researcher burden, the IRB has developed this easy self-determination tool to allow researchers to make their own determinations as to whether the proposed activity involves human subjects and thus needs IRB review. 

The tool will either provide a final determination of research not involving human subjects to your email or it will direct you to submit the project to the IRB for review and approval.   Please review the Research Not Involving Human Subjects Determination Tool (PDF) in its entirety to prepare yourself for the questions that will posed to you. 

Research Not Requiring Human Subjects Tool

Grant Proposals Lacking Definite Plans for Involvement of Human Subjects