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Non-Compliance with Regulations of Institutional Research Committees

F3 - DU Policy Document 9/1/2006

PURPOSE

The institutional research committees of the University of Denver – Institutional Review Board for the Protection of Human Subjects in Research (IRB), Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC) – are charged with the protection and safety of the university community according to federal regulations. To mitigate risk and liability, it is critical that staff, subjects, and all interested parties have a means of communicating information about the conduct of a researcher or research project directly to the appropriate institutional officials. It is vital that IRB, IACUC, and IBC members, department heads, and other institutional officials with responsibility for oversight of research have access to the highest levels of authority within the institution and can count on ethical handling of research misconduct and non-compliance.

The purpose of this policy is to describe guidelines on review of non-compliance allegations, what administrative bodies will perform reviews, and what may be the possible consequences of such non-compliance with policies, procedures and/or decisions of the institutional committees.

This policy applies to all research submitted to Institutional Committees.

DEFINITIONS

Adverse event: Occurrence or situation during the course of a research project that was (1) harmful or (2) increases the probability of harm to subjects.

Assurance: Authority granted to the Institutional Committees from the appropriate federal agency to oversee research activities within the university.

Chair: Chair of the pertinent institutional committee. The Chair is responsible for directing events from the inquiry though resolution of the situation.

Compliance Committee: The university committee charged with resolving allegations of serious non-compliance. At the beginning, the Compliance Committee works with the University Institutional Committees in developing action plans when noncompliance is detected. The Compliance Committee will meet as necessary. Voting members shall include the Institutional Official (Vice Provost for Graduate Studies and Research, who will chair the Compliance Committee), the appropriate Dean, the appropriate department Chair, and the Chair of the appropriate institutional committee. Non-voting members shall include the Manager of Research Compliance, the Director of the Office of Research and Sponsored Programs (ORSP), a representative from the Office of Institutional Compliance and Internal Audit, and University Counsel. Decisions of the Compliance Committee must be supported by positive vote of all voting members, with signature of the Provost.

Institutional Committee: The institutional research committees of the University of Denver – Institutional Review Board for the Protection of Human Subjects in Research (IRB), Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC).

IRB: Institutional Review Board for the Protection of Human Subjects in Research. The committee mandated to review all research involving human subjects in research.

IBC: Institutional Biosafety Committee. The committee charged with review of research involving recombinant DNA as well as other biological materials that may represent hazards to individuals and/or the environment.

IACUC: Institutional Animal Care and Use Committee. The committee overseeing activities involving any live, vertebrate animal used or intended for use in research, research training, teaching, experimentation or biological testing or for related purposes.

I.O.: Institutional Official. The signatory on the Assurances submitted to the federal offices in charge of research compliance activities of the Committees, and Chair of the Compliance Committee.

Non-compliance: Conducting research in a manner that disregards or violates federal regulations governing such research as approved by the Institutional Committees. This can include but not limited to willful failure to comply with federal requirements and guidelines, failure to obtain Institutional Committee approval for research involving human or animal subjects or Biosafety procedures, inadequate procedures for obtaining informed consent from human subjects, inadequate supervision of research, failure to report adverse events or proposed protocol modifications to insure safety of subjects, and ongoing failure to provide progress reports.

OBA: Office for Biotechnology Activities, the federal unit responsible for regulating the IBCs.

OHRP: Office of Human Research Protection, the federal unit responsible for regulating the IRBs.

OLAW: Office of Laboratory and Animal Welfare, the federal unit responsible for regulating the IACUCs.

ORSP: Office of Research and Sponsored Programs, the university office responsible for providing administrative support for the Institutional Committees.

P.I.: Principal Investigator, the person (staff, student, or faculty member) responsible for the conduct of a research project, whether funded or not.

Protocol: The plan presented to the Institutional Committee for the conduct and methodology of the proposed research project.

VPGSR: Vice Provost for Graduate Studies and Research (VPGSR). Also the Institutional Official (IO) for all institutional committees.

POLICY

  • Institutional Committees shall review all relevant research regardless of funding source, to ascertain that rights, welfare and regulations are protected and/or followed according to federal regulations and university policies. The authority of the Institutional Committees is derived on federal regulations, university policies, community standards, etc., and is based on the approved assurances on file with the appropriate federal agencies. Institutional Committee authority is independent of other university authority.
  • PIs shall be required to certify compliance with the submission of each protocol for Institutional Committee review. In addition, an annual certification shall be made and returned to the Research Compliance Manager. This signed from explains the responsibilities of faculty who conduct, or advice students who conduct said research as agents of the University of Denver. (See Appendix A)
  • Anyone conducting and/or supervising such studies or experiments without approval of the appropriate Institutional Committee(s) may be personally responsible for legal or other liabilities that may consequently arise. In addition, the research may be subject to disciplinary action by the University.
  • Allegations of non-compliance with the approved protocol shall be directed to the following:
    • For incidents of an administrative nature only: Chair, IO, Research Compliance Manager.
    • For incidents involving adverse events or continuing disregard of approved protocols: Full Compliance Committee
    • The Chair shall inform and discuss non-compliance incidents with the appropriate Institutional Committee
  • Resolutions of non-compliance shall be signed by the IO and the Provost.
  • The Research Compliance Manager shall report such incidents and their resolutions to the appropriate federal agency and sponsor (if funded).

PROCEDURES

Investigator non-compliance may often be the result of communication difficulties, therefore the Institutional Committee will attempt to resolve apparent instances of non-compliance without interrupting the conduct of the study, especially if the rights and welfare of subjects may be jeopardized.

If it becomes known that a P.I. has deviated from approved protocols, the following will occur:

  • The Institutional Committee Chair shall request a written explanation from the P.I. regarding the non-compliance issue.
  • In the Chair’s absence, an Acting Chair will be designated and will initiate the process.
  • The Chair of the appropriate Institutional Committee will review the written explanation and the protocol and report conclusions and recommendations in writing to the Research Compliance Manager. The Manager will contact the ORSP Director, the Vice Provost, the P.I.’s Chair and Dean. In the case of a student researcher, the advisor (and department, school, or college) bears the burden of the responsibility and discipline of the student.

If it becomes known that a P.I. has not submitted an application to the Committee prior to conducting research, the same procedure is followed. In addition, the Chair determines:

    • The level of risk posed from the research activity.
    • The consent procedures followed, if any.
    • The details of the conduct of the research.

Following the Institutional Committee Chair’s review, a memo is sent stating the conclusions of the review, along with recommendations to the Manager. The Manager then contacts the ORSP Director, the Vice Provost, the P.I.’s Chair and Dean.

Depending on the seriousness of the non-compliance, the Institutional Official, in consultation with the Compliance Committee, communicates recommendations or requirements that may include one or more of the following:

    • If the data are intended for publication, the investigator must disclose to the publication editor(s) that the data were collected without the approval of the appropriate Institutional Committee.
    • If the study is ongoing, experiments must cease until the Institutional Committee has reviewed and approved all study procedures.
    • Investigator may be required to complete a training program.
    • The investigator may be required to inform subjects of lack of compliance with DU procedures.
    • The P.I. agrees NOT to publish the results of the research.
    • The P.I. agrees to discard data collected during the period of noncompliance.
    • The P.I. agrees NOT to present the research as having had IRB approval.
    • Student is required to fulfill degree requirements without a publication option.
    • If there are multiple instances of noncompliance in a specific department, college or school, the unit will be required to formulate a plan to assure that its investigators comply with compliance regulations and procedures, and inform the Institutional and Compliance Committee of the plan in place.
    • When the lack of compliance results in risk of, or actual harm to subjects, the Manager is required to report the situation to OHRP, OLAW, and/or OBA as required by Assurances. This action may result in investigation of the University’s management of research compliance and possible suspension of all funded research until resolution.

REFERENCES

Protection of Human Subjects in Research

  • PHS policy IV-B
  • University of Denver Federal-Wide Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects,

http://www.du.edu/orsp/multipleproject.html

Humane Care and Use of Laboratory Animals

  • 45CFR46.113
  • University of Denver Animal Welfare Assurance of Compliance with PHS Policy on Humane Care and Use of Laboratory Animals,

http://www.du.edu/orsp/animal.html

Research Involving Recombinant DNA Molecules

  • NIH Guidelines, Section 1-D.