Who are “investigators”? The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. Other terms such as "researcher," "research team member," or "research personnel" may also be used and have the same meaning as an investigator.
For the purposes of the IRB, an “investigator” is any individual who is involved in designing, conducting, or reporting human subjects research activities. Such involvement can include:
- Obtaining information about living individuals by intervening or interacting with them for research purposes;
- Obtaining identifiable private information about living individuals for research purposes;
- Obtaining the voluntary informed consent of individuals to be subjects in research;
- And studying, interpreting, or analyzing identifiable private information or data for research purposes.
Investigators may include instructors, students, clinicians, scientists, coordinators, directors, and administrative staff, among others. Please contact the HSPP with any questions about who might be acting as an investigator in your research study.
In every study, one investigator should be designated as the “Principal Investigator” who assumes overall responsibility for the conduct of the study. MSU Denver's IRB requires that the Principal Investigator be a member of the University's faculty or staff. Multiple PIs are not allowed on an IRB submission. MSU Denver students may not serve as the Principal Investigator on a research study; this role should be assumed by the faculty or staff advisor.
In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects. Investigators play a crucial role in protecting the rights and welfare of subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB.
Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include, in summary:
- Obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research.
- Obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document.
- Ensuring that progress reports and requests for continuing review and approval are submitted to the IRB
- Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB
- Keeping study records as required by the HHS regulations for at least three years after completion of the study (other sponsor or federal oversight may extend this requirement)