Principal Investigators (PI) Guide for Human Research
Investigator Qualifications and Provision of Medical Oversight
OHRP Investigator Responsibility Frequently Asked Questions (FAQs)
FDA Requirements for Investigators Who are Also Sponsors
FDA Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
Research involving the investigation and/or collection of data from living human subjects requires review by the Institutional Review Board prior to initiation of a project. The IRB focuses its principal attention on human subjects protection when evaluating a research proposal. In the full, expedited, and exempt IRB applications, there is a requirement for the Department Chair’s Assurance Statement/signature, or that of an authorized designee. The IRB assumes that research conducted as part of the University's mission is designed and carried out in a manner that meets the highest scientific standards and with a commitment to human subjects protection. Each academic department is free to choose a mechanism to ensure human study proposals or protocols meet these rigorous scientific and human protection guidelines. By reviewing the IRB application and signing the Assurance statement, a Department Chair or designee has assumed certain responsibilities and signifies that the science is meritorious and deserving of conduct in humans.
The following is a list of the responsibilities reflected by signing the Assurance statement:
The Department Chair or designee has reviewed the research proposal submitted to the IRB and ensured that the science represented in the research protocol is valid and is likely to achieve its aim. They have also ensured that the knowledge expected as a result of the research has importance.
The Department Chair or designee has ensured that the researcher(s) has sufficient time to conduct and complete the research and that persons listed as study personnel on the research protocol have the proper expertise and training necessary to carry out the research being proposed. The Chair or designee has also ensured that the investigator has an appropriate number of qualified staff who are adequately informed about the protocol and their research-related duties and functions.
The Department Chair or designee has ensured that the investigator has access to a population that will allow recruitment of the required number of participants within the proposed recruitment period. The Chair or designee also has ensured that if participants need ancillary resources as a consequence of taking part in the research (psychological counseling or emergency treatment), the researcher has a process to make these available.
The Department Chair or designee has ensured that the facilities and equipment necessary to conduct the research study are adequate and appropriate for the type of research proposed to the IRB.
The Department Chair or designee has and will continue to provide guidance to the researcher(s) during the course of study conduct ensuring adherence to established standards of scientific integrity, as appropriate.
Students acting as a Principal Investigator (PI) on a protocol application are required to add a faculty advisor as study personnel. Below are FAQs and resources to help student investigators and faculty advisors understand and fulfill their responsibilities in conducting and supervising student-led human subjects research.
A student investigator (undergraduate, graduate, and postdoctoral students) must add a faculty advisor as study personnel to their protocol to meet the requirement of a University of Kentucky academic program. Additionally, faculty advisors must sign the Assurance Statement on the protocol to certify the scientific merit of the study, the qualifications of investigators, and the adequacy of the facility and resources needed to conduct the research.
As a student’s faculty advisor, you accept a supervisory role in guiding the student in conducting regulatory-compliant research. You must be certified in HSP and RCR training. You will sign the protocol assurance statement certifying that you have reviewed the research and attest to the scientific merit of the study, qualifications of the personnel, and adequacy of the facility and resources needed to conduct the research. For full review protocols, you are encouraged to accompany the student to the IRB meeting. Keeping an eye on requested revisions can enhance your IRB knowledge for the benefit of current and future students. See the ORI video training “Faculty Advisor Responsibilities,” which includes ORI tools to help your students succeed with human subject research.
If the Principal Investigator is completing this project to meet the requirements of a University of Kentucky academic program, in addition to Department Authorization, the student's faculty advisor should sign the Assurance Statement. The student's faculty advisor is accepting a supervisory role in guiding the student in conducting regulatory-compliant research and, therefore, must be certified in human research protection training throughout the life of the protocol.
Assurance Statement:
"This is to certify that I have reviewed this research protocol and that I attest to the scientific merit of this study; to the qualifications of the investigator(s) to conduct the project; that facilities, equipment, and personnel are adequate to conduct the research; and that continued guidance will be provided as appropriate."
A Faculty Workshop (Video, 44:22 minutes)
