Roles & Responsibilities

The Principal Investigator (PI) is ultimately responsible for the ethical conduct of the research project. When designing the study, the PI must determine if the study constitutes research involving human subjects by comparing the proposed project to the following definitions:

RESEARCH is a systematic investigation designed to develop or contribute to generalizable knowledge.

A HUMAN SUBJECTS is a living individual about whom an investigator obtains data through interaction or intervention with the individual or obtains identifiable private information.

The PI should feel free to contact the Human Subjects Committee (HSC) to help with this determination. If the project is found to be research involving human subjects then the PI must submit a description of the project to the HSC. The procedure and forms for doing so can be found on this website under Guidebook and Forms.

HSC review of the project usually leads to a number of questions and/or corrections to which the PI must respond prior to study approval. Once these issues are resolved approval is granted and the project may begin.

In conducting the research, the PI is responsible for:

• Ensuring that appropriate informed consent is obtained from each participant.
• Reporting to the HSC any problems which arise in the course of the study.
• Submitting proposed changes to the HSC for approval prior to incorporating them into the study design.
• Providing an annual report to the Committee as outlined in the Annual Report Form.