Human Research Protection Program (HRPP) Operations

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Policy Number:
UW-4143
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

This policy supplements the requirements and procedures for HRPP Operations outlined in the University of Wisconsin Madison Human Research Protection Program (HRPP) Toolkit. The policy statements below describe additional requirements and considerations related to HRPP Operations that are not described in the Toolkit.

Policy:
  1. Institutional Research Board (IRB) Authority and Independence
    1. UW-Madison maintains the independence of its IRBs.
      1. Attempts to unduly influence IRB staff, IRB Members, or IRB Chairs should be reported to the IRB Chair, IRB Director, or Institutional Official (IO), as appropriate.
      2. Attempts by the IO to influence IRB Chairs, Members, and/or Staff should be reported to the Vice Chancellor for Research. 
    2. The Chancellor of UW-Madison grants, recognizes, and maintains the IRBs’ Authority.
  2. Institutional Official in Charge of the HRPP
    1. The Associate Vice Chancellor for Research Policy and Compliance in the Office of the Vice Chancellor for Research is the IO for the protection of human research participants at UW-Madison.
  3. Creation and Dissemination of Policies
    1. Campus-wide HRPP policies are developed and revised by the Office of Research Compliance in conjunction with the IRB Office Director and Assistant Directors, the Office of Legal Affairs, and other stakeholders. Campus-wide HRPP policies and revisions are then reviewed and modified by the Cross Campus HRPP Advisory Committee and approved by the Institutional Official.
    2. Requirements outlined in the HRPP Toolkit are maintained by the Toolkit Management Team with input from the parties listed above.
  4. Engagement in Human Subjects Research at UW-Madison
    1. The UW-Madison HRPP Toolkit outlines when UW-Madison employees and agents are engaged in human subjects research and when that research and other non-human subjects research activities are subject to IRB oversight.
  5. HRPP and IRB Resources
    1. UW-Madison assures that it has a sufficient number of Institutional Review Boards (IRBs) to review studies in a thorough and timely manner and that its Human Research Protection Program (HRPP) has adequate resources for conducting the activities under its jurisdiction.
  6. HRPP Education and Training
    1. UW-Madison ensures that its research teams, IRB members and staff, and other personnel maintain continuing knowledge of, and comply with, their legal and ethical obligations to protect human participants when conducting research.
  7. Obtaining and Documenting the Informed Consent Process
    1. The University of Wisconsin-Madison follows applicable federal regulations and state laws governing informed consent and requires investigators conducting non-exempt human subjects research to obtain legally effective written documentation of informed consent from each prospective participant or the participant’s legally authorized representative, unless the IRB has granted a waiver of informed consent or a waiver of documentation of informed consent.
    2. UW-Madison IRBs systematically evaluate whether informed consent will be sought from each prospective participant (or the participant’s legally authorized representative).
    3. UW-Madison IRBs systematically evaluate whether informed consent will be documented as required by the federal, local and state law, University policies, and, if applicable, Food and Drug Administration (FDA) regulations.
  8. Monitoring the Consent Process
    1. The UW-Madison HRPP may observe the consent process to assure that research teams satisfy all federal, state and institutional requirements for obtaining informed consent from participants in human participants research.
      1. If the UW cedes IRB oversight of a human participants research study to another institution or entity, the reviewing IRB also may require consent monitoring and designate a monitor for the informed consent process. In addition, the institution providing IRB oversight may observe the consent process as part of its auditing and monitoring program.
  9. Reporting of Suggestions and Concerns
    1. Suggestions and concerns regarding the protection of research participants or regarding HRPP function or performance can be brought to the attention of the relevant UW-Madison IRB Office, the Office of Research Compliance, or the IO, as appropriate.
    2. Individuals with suggestions and concerns that wish to remain anonymous should make their comments via the Anonymous Human Research Protection Hotline (608-890-1273).
      1. While efforts will be made to maintain anonymity, anonymity cannot be guaranteed.
  10. Compliance Monitoring and Quality Improvement
    1. The UW Madison HRPP Toolkit describes the methods used to monitor the quality, efficiency, and effectiveness of the HRPP.
  11. Suspensions and Terminations
    1. UW-Madison IRBs and the IO have the authority to suspend or terminate previously approved research.
    2. An IRB cannot suspend an investigator's privileges to conduct human participants research. The IRB must bring any recommendation to suspend research privileges to the Institutional Official (IO).
  12. Clinical Trial Agreements (CTA)
    1. UW-Madison's standard clinical trials agreement is the university's preferred document for CTA's.
  13. Conflicts of Interest of Non-UW Madison Key Personnel
    1. UW-Madison handles conflicts of interest of non-UW-Madison key personnel listed on human participants studies under the purview of a UW-Madison IRB.
    2. If a researcher listed on a human participants research study reviewed by one of the UW-Madison IRBs discloses a Significant Financial Interest in the IRB application, but does not provide a management plan, one of the following actions will be taken.
    3. Individual investigators (not affiliated with any institution) or investigators affiliated with an institution that does not have a Conflict of Interest (COI) management process are subject to UW-Madison’s COI policies and processes.
    4. Individuals affiliated with an institution that has a COI process are subject to their institution’s COI policies and must submit their management plan to the UW-Madison IRB.
      1. Regardless of the management plan put in place by the individual's home institution, the IRB may determine that additional measures are needed to protect the rights and welfare of research participants, including not permitting the individual to be engaged in the research as an investigator or key personnel.
  14. ClinicalTrials.gov
    1. UW-Madison Principal Investigators are required to follow all federal laws and policies regarding registration, results reporting, and submission of other required information for clinical trials on a publicly accessible database such as ClinicalTrials.gov.
      1. The FDA, NIH, and CMS impose specific timelines for initial registration and results reporting for trials subject to each agency’s oversight. If a clinical trial is an Applicable Clinical Trial, an NIH-funded Clinical Trial, or a Qualifying Clinical Trial, researchers must follow FDA, NIH, or CMS requirements, as applicable. If a research project is subject to regulation by more than one agency, the most stringent requirements must be applied.
      2. Changes to the research project must appear in the ClinicalTrials.gov record within 30 calendar days of IRB approval. Active ClinicalTrials.gov records must be reviewed and verified annually by the PI or delegated study team member, even if nothing has changed.
    2. UW-Madison PIs are also required to fulfill any registration requirements imposed by the International Committee of Medical Journal Editors (ICMJE) or other publishers as a condition of publication, as well as any registration or reporting obligations specified in UW-Madison’s agreement with the sponsor of a clinical trial
Related UW-Madison Policies:
Related UW–Madison Documents, Web Pages, or Other Resources:

Policy Administration

Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Associate Vice Chancellor of Research Policy and Compliance
Contact:
Associate Director, HRPP -- Travis Doran, TRAVIS.DORAN@WISC.EDU, (608) 890-4399
Effective Date:
05-27-2021
Date Issued:
05-27-2021
Revised Dates:

10-27-2023

Retrieved:
05-30-2025 18:58:38