This section of the Investigator Manual provides information about who is considered engaged in human subjects research, who can serve as the PI, responsibilities of those conducting research, training requirements, and financial interest/disclosure information.

Study Team Member Engagement

UW-Madison requires all individuals engaged in human subjects research that fall under the purview of its IRBs to be listed as part of the study team. Individuals who generally fall under UW-Madison IRB purview are individuals conducting human subjects research as UW-Madison faculty, staff, or students or under an appointment or affiliation with the Madison VA Hospital, University of Wisconsin Hospital and Clinics or University of Wisconsin Medical Foundation.

Individuals who fall under UW-Madison IRB purview are generally considered study team members engaged in human subjects research if they:

  • design research
  • direct research or serve as the principal investigator for the study
  • enroll research subjects (including obtaining subjects’ informed consent or screening potential subjects)
  • make decisions related to eligibility to participate in research
  • conduct study procedures
  • analyze or report research data
  • analyze or report adverse events

For additional details on what constitutes engagement in human subjects research, please see HRP-311 – WORKSHEET – Engagement Determination.

Who Can Serve as a Principal Investigator

Every research study requires a Principal Investigator (PI). This person takes full responsibility for the conduct of the study. To be able to serve as a PI, individuals must meet certain criteria. For more details, see the Principal Investigator Status for UW-Madison Studies Involving Human Participants policy.

Principal Investigator Responsibilities

A PI is responsible for the overall conduct of a study. Some of these responsibilities include, but are not limited to, the following:

  1. Conducting the study in compliance with relevant regulations (e.g., 45 CFR 46/the Common Rule, FDA, other federal agencies, state law) as well as ethical principles described in the Belmont Report.
  2. Completing required human subjects research trainings.
  3. Providing adequate training to and oversight of study personnel
  4. In the case of certain types of clinical trial research, ensuring the protocol complies with applicable Good Clinical Practice requirements.
  5. Obtaining legally effective informed consent, when required.
  6. Obtaining permission for the use and disclosure of protected health information in compliance with the HIPAA Privacy Rule, as applicable.
  7. Comparing contracts with consent documents.
  8. Submitting follow-on applications as required for approved or exempt studies, including changes, continuing reviews, and reportable events.
  9. Submitting a closure report when a study is completed.
  10. Complying with all institutional requirements related to human subjects research, including conflict of interest.
  11. Assuring participant privacy and confidentiality according to institutional and regulatory requirements including HIPAA and FERPA (as applicable).

Study Team Member Responsibilities

While the PI bears overall responsibility for the conduct of a study, study team responsibilities include, but are not limited to:

  1. Completing of required human subjects research trainings.
  2. Complying with all institutional requirements related to human subjects research, including conflict of interest.
  3. Adhering to the federal regulations, state and local laws, institutional policies and procedures surrounding the safety and protection of human participants.
  4. Assuring participant privacy and confidentiality according to institutional and regulatory requirements including HIPAA and FERPA (as applicable).

Student Research, Advisor, & Course Instructor Responsibilities

Depending on the nature and purpose of the project, student research may require IRB review as described below.

All UW–Madison undergraduate and graduate students engaged in human participants research must obtain UW-Madison IRB approval or exemption before beginning the research (except for some class-related projects; see below). The research of a graduate student involving human participants for inclusion in a master’s thesis or doctoral dissertation must be approved or determined to be exempt by a UW-Madison IRB before beginning the research.

Student projects conducted within an academic course involving data, samples, or images collected from or about people may meet the federal definition of human participants research if the project is systematic and develops or contributes to generalizable knowledge.

If the data, sample, or image collection and interpretation are for pedagogical purposes only and gathered without the intention of dissemination beyond the scope of the course, the student project should be categorized as a course assignment rather than human participants research and thus IRB review is not required. For example, IRB review is not required when course work may be presented to a group beyond the course as part of the pedagogical process, such as an event showcasing the work of students in the class. In these situations, this limited dissemination is not considered to constitute developing or contributing to generalizable knowledge and thus the requirement for IRB review is not triggered.

Course Instructor and Advisor Responsibilities

Course instructors and faculty/staff members who serve as the formal advisor to a student on a project are responsible for the following:

  1. Ensuring that the student is aware of the requirement to obtain IRB approval or exemption prior to any engagement in human participants research.
  2. Determining prior to assigning a project, whether the project is a course assignment or constitutes human participants research and ensure that any students engaged in human participants research obtain IRB approval or exemption prior to commencing that project.
    1. If a student research project is originally conducted as a course assignment, but develops into human participants research, the faculty member or instructor overseeing the course or project must ensure IRB approval or exemption is obtained before the project can continue.
  3. Monitoring student projects conducted as part of coursework for the impact on human participants, especially maintaining participant confidentiality, assuring freedom of participants to withdraw from the project without penalty, and obtaining consent for participation in the project when reasonable.
  4. Ensuring student researchers give due consideration of the University’s ethical and legal responsibility to protect participants and their data, especially when participants are exposed to more than a minimal risk or participants include those who are considered a vulnerable population.
  5. Ensuring any changes in the research project, adverse events, or incidents which may affect the conduct of research will be reported to the IRB.
  6. Reviewing the proposed research study, including assessing whether the topic and design are appropriate for student research.
  7. Ensuring the student researcher has the necessary experience and training to conduct the research.
  8. Meeting with the student researcher on a regular basis to monitor study progress.
    1. If the study procedures are carried out in a location away from the University or regular channels of communication are not feasible, you will make alternate arrangements to continue communication with the student-investigator;
  9. If you will be unavailable, you will arrange for an alternate faculty advisor to assume the above responsibilities and will advise the IRB of this change.

Training Requirements

Training requirements are described in HRP 066-SOP-Human Research Education and Training. All members of the research team listed on an IRB submission classified as exempt or non-exempt research, must complete the required training. Although recommended, research team members listed on submissions determined “Not Human Research” will not be required to complete the IRB training requirements.

All members of the research team involved in the design, conduct, or reporting of the research must complete training. Members of the research team who have not completed human research protections training may not take part in aspects of the research that involve human subjects. All required training must be completed before IRB final approval can be granted. Instructions on how to complete the training requirements can be found on the Training page.

Financial Interests and Disclosures

All faculty, regardless of appointment, all academic staff with 50% or greater appointment, and all individuals listed as participants on human subject protocols or on federal grants are required to fill out an annual Outside Activities Report (OAR) and update whenever new outside activities are undertaken. This includes any financial interests related to the research in accordance with University of Wisconsin policies on Conflicts of Interest and Institutional Conflict of Interest.

In the event a study team member (including the PI) has a conflict of interest management plan for a specific study, the IRB will consider this as part of its review process and, if deemed necessary to protect the rights and welfare of study participants, may require additional measures be implemented (e.g., consent monitoring) beyond those included in the management plan. For more than minimal risk studies, a conflicted individual cannot serve as key personnel without the exception to the management plan (approved by COI Committee).

We recommend reaching out to the Conflict of Interest office directly for assistance with questions regarding the OAR process, potential conflicts of interest, and conflict of interest training requirements.

See HRP 055-SOP-IRB Review of Financial Conflicts of Interest.