Appendix 4: Duties of the PI and Faculty Adviser

All researchers must complete Human Subjects Protection Training before signing an IRB application.

Principal Investigators (PIs)

1.                   The PI is the lead person who is responsible for the design, conduct, and reporting of a research project.

2.                   The PI is responsible for initiation of an IRB review, completing all required training, completing the IRB application form, and gathering all required documentation and signatures.

3.                   The PI is responsible for requesting IRB approval for any protocol changes after IRB approval.

4.                   The PI is responsible for the reporting of any adverse events taking place during the research.

5.                   The PI must apply for IRB renewal for projects lasting longer than one year.

Faculty Advisors

1.                   Faculty research advisors, or faculty members assigning research projects involving human subjects must take an active part in preparing students for the role of researcher, instructing them in the ethical conduct of research and assisting in the preparation of applications for human subjects research approval. Advisors shall take an active role in ensuring that the conduct of the research meets the highest ethical standards.

2.                   Faculty research advisors shall ensure that their advisees:

minimize the risk to human subjects,
understand the elements of the consent process,
develop a readable consent form,
plan and accomplish appropriate recruitment strategies for identifying subjects,
establish and maintain strict guidelines for protecting anonymity and confidentiality, and
conduct their research in accordance with these policies and procedures.
3.                   The faculty research advisor's signature is required on the IRB application form. By signing, the research advisor is stating that these essential aspects of research have been addressed, and that the advisor is ultimately responsible for the protection of human subjects in student research.

4.                   The faculty research advisor's signature affirms that:

The study purposes, rationale, design and methods are clearly stated and are scientifically sound;
the protocol conforms to the norms, ethical standards and methods of procedure of the scholarly discipline;
the proposed study involves no known risks to human subjects other than those specified;
the principal investigator and other researchers are qualified to conduct the proposed study;
the study facilities and resources are adequate for the safe conduct of the research; and
the subject population, sampling procedures, and data to be collected are justified and adequate to meet study objectives.