HRPP Manual Section 9-2

Noncompliance

The investigator and the research study team are required to comply with all ethical standards, institutional policies, governmental regulations, and conditions placed on the conduct of the human subject research.  The Principal Investigator (PI) is responsible for supervising all research staff and is held accountable for their actions and/or omissions.

Noncompliance with human subject protection requirements (e.g., U.S. Department of Health and Human Services (DHHS) regulations, Institutional Review Board (IRB) requirements) is a violation of Michigan State University's (MSU) Federal Wide Assurance (FWA-00004556). Noncompliance presents a serious challenge to the IRB. Regardless of the  investigator’s intent, unapproved research activities involving human subjects may place those subjects at an unacceptable risk.

Any incident of noncompliance with human subject protection requirements must be reported to the IRB immediately. Allegations of noncompliance may be reported to the IRB office, IRB chair, or  IRB members by anyone, including investigators, research staff, research subjects, students, faculty, staff, administrators, external parties, etc. See the Human Research Protection Program (HRPP) Manual 9-4 “Subject Complaints.” This section applies to allegations of noncompliance with IRB requirements. Allegations of noncompliance with other regulatory requirements are referred to other individuals or offices as appropriate (e.g., covered entity for protected health information).

The IRB chair and others when appropriate (e.g., HRPP director, IRB, HRPP compliance analyst) will investigate allegations and instances of noncompliance, determine immediate actions to protect subjects, report serious or continuing noncompliance to appropriate authorities (including government agencies), require modifications to, suspension or termination of research activities, and take other actions as needed to protect human subjects or to comply with institutional policies and procedures.

Individuals assigned to review allegations and instances of noncompliance in a human research study in which they have a conflict of interest cannot review the incident. The policy and procedure described in HRPP Manual 10-1 “Conflict of Interest” shall be followed.

Definitions

Noncompliance

The failure of any person or organization involved in a human research project to act in compliance with a federal or state law, regulation, policy or the requirements and/or, determinations of an IRB.

Serious Noncompliance

Those actions that demonstrably or potentially materially result in substantial harm to subjects by violating their rights or welfare.

Continuing Noncompliance

Noncompliance that continues after the IRB has notified the investigator of a finding of noncompliance, including failure to respond and comply with IRB directives.         

Reporting Incidents or Allegations to the IRB

Noncompliance or potential noncompliance may be self-reported by researchers, staff, employees, or research subjects, may be discovered by the HRPP (e.g., through monitoring visits or other routine review or quality control activities), and may be reported to the IRB by any individual. See HRPP Manual 5-6 “Contact Information” for multiple mechanisms to report incidents to the IRB. The university will take reasonable steps to protect persons who file reports in good faith from retaliatory actions based on such filing.

Procedures for Immediate Action

The IRB chair determines if immediate actions are necessary and may consult with others (e.g., members of the IRB, HRPP director) as needed.  Immediate issues to consider will be whether to:

At any other time during the inquiry or investigation process the IRB chair or IRB may determine that it is necessary to act to protect subjects by terminating or suspending IRB approval according to HRPP Manual 9-3 “Termination or Suspension of IRB Approval.”

Investigation of Allegations of Noncompliance to Determine if Allegation has Basis in Fact

The IRB chair will perform an initial investigation of the alleged noncompliance, in order to determine whether the allegation is substantiated or has a basis in fact. Materials reviewed by the IRB chair include all relevant materials (e.g., report in the MSU IRB online system, IRB study submission or upon request, the complete file for legacy studies, communications, relevant research materials such as survey or consent, audit reports). The IRB chair may gather more information through discussions or correspondence with the principal investigator and/or others.

The IRB chair may request review by others (e.g., HRPP compliance analyst, IRB member(s), the IRB). If the IRB chair determines that such review is necessary, the individual will receive all relevant materials (e.g., report in the MSU IRB online system, IRB study submission or upon request, the complete file for legacy studies, communications, relevant research materials such as survey or consent, audit reports). If any individual feels that they are not qualified to review the research study, the IRB staff should be notified. The IRB chair will be consulted to determine an appropriate replacement. If additional expertise is not available, the policy and procedures for obtaining additional expertise will be followed, HRPP Manual 5-4 “Additional Expertise.”

The investigator(s) may submit in writing their account and explanation of the events possibly constituting noncompliance.  At their request, the investigator(s) may also appear before the IRB. For the process to request attendance at an IRB meeting, see HRPP Manual 5-5 “Meetings.”

The IRB chair, alone or in consultation with the IRB, determines whether the allegation is substantiated or has a basis in fact (incident involved noncompliance). If the allegation has a basis in fact, the procedures for substantiated noncompliance will be followed to determine whether the noncompliance is serious or continuing.

Procedures for Substantiated (or Self-Reported) Noncompliance

If a reported incident involved noncompliance, a determination of whether the noncompliance was serious or continuing is made promptly based on the definitions in the section “Definitions” above.

Incidents of noncompliance that do not clearly meet the definition of serious or continuing should be documented in the MSU IRB online system and corrected as appropriate.  The IRB chair, IRB staff, or the HRPP compliance analyst will communicate with the investigator(s) and/or others to determine the appropriate corrective action when necessary. See section “Procedures for Corrective / Protection Actions,” below for possible corrective actions.  The actions taken will be appropriate for the type, severity, and frequency of the noncompliance.

Incidents of noncompliance that may meet the definition of serious or continuing noncompliance must be reported to the IRB chair.  Any incident that may meet the definition of serious or continuing noncompliance must be brought to the convened IRB to determine whether the incident is serious and/or continuing noncompliance. Before being brought to the convened IRB for a determination, an investigation may be necessary to gather additional information.

Investigation

The IRB chair reviews all relevant materials (e.g., report in the MSU IRB online system, IRB study submission or upon request, the complete file for legacy studies, communications, relevant research materials such as survey, consent, audit reports) and may gather additional information through discussions or correspondence with the investigator(s) and/or others, if needed.

The IRB chair may request review by others as needed before being brought to the convened IRB (e.g., IRB members, HRPP compliance analyst). If the IRB chair determines that such review is necessary, the individuals will receive all relevant materials (e.g., report in the MSU IRB online system, IRB study submission or upon request, the complete file for legacy studies, communications, relevant research materials such as survey, consent, audit reports). If any individual feels that they are not qualified to review the research study, the IRB staff should be notified. The IRB chair will be consulted to determine an appropriate replacement. If additional expertise is not available, the policy and procedures for obtaining additional expertise will be followed, see HRPP Manual 5-4 “Additional Expertise.”

Convened IRB Review

The IRB chair, or another IRB member or individual (e.g. HRPP compliance analyst) designated by the IRB chair, presents the potentially serious or continuing noncompliance to the convened IRB for review.  Materials provided to IRB members include all relevant materials, e.g., communications, relevant research materials such as survey, consent, audit reports and the report in the MSU IRB online system, IRB study submission or upon request, the complete file for legacy studies. 

Further Investigation

The IRB may require further investigation prior to making a determination of whether the noncompliance was serious or continuing. If further investigation is required, the IRB may:

  • Request the individuals continue their investigation

  • Impanel an investigative sub-committee of the IRB to review all relevant materials, e.g., report in the MSU IRB online system, IRB study submission or upon request, the complete file for legacy studies, communications, relevant research materials such as survey, consent, audit reports, etc.

  • Request that the HRPP compliance analyst perform an investigation

  • Obtain additional expertise (See HRPP Manual 5-4 “Additional Expertise”)

The IRB chair or the investigative sub-committee will report back to the convened IRB with recommendations (e.g., severity and frequency of noncompliance, corrective/protective actions). 

The convened IRB will then make the determination of whether the noncompliance is serious and/or continuing.

IRB Determinations

The IRB determines whether the noncompliance is serious and/or continuing. This is based on the definitions provided above.

The IRB will determine whether the investigator satisfactorily resolved the noncompliance, if applicable, and whether corrective/protective or other actions are needed.

The IRB is required to consider the range of actions that include:

  • Suspension of IRB approval of the research

  • Termination of IRB approval of the research

  • Notification of current subjects’ when such information might relate to subjects’ willingness to continue to take part in the research

Corrective/protective actions which may be taken include, but are not limited to:

  • Require research study specific corrective action

  • Require plan for corrective action, based on the type and nature of the issues

  • Require education of the investigator(s) and research team

  • Require modification of the protocol

  • Require that subjects be re-contacted and provided with additional or updated information or re-consent to participation

  • Notification of current subjects when such information may relate to subjects’ willingness to continue to take part in the research

  • Modification of the information disclosed during the consent process

  • Providing additional information to past subjects

  • Requiring current subjects to re-consent to participation

  • Suspension or termination of IRB approval

  • Suspension of other affected research study(ies)

  • Pause IRB review of affected new IRB study submissions

  • Require periodic monitoring or auditing, such as modification of the continuing review schedule (when required) or monitoring of the research or consent process

  • Referral to other organizational entities

  • Other actions as needed

Corrective/protective actions taken will be appropriate for the type, severity, and frequency of the noncompliance.

The IRB may decide that the investigator(s) found in serious and/or continuing noncompliance should not be allowed to submit new protocols or renew or revise current research studies until all concerns have been addressed taking into account the best interests of the subjects currently enrolled. See HRPP Manual 9-3 “Termination or Suspension of IRB Approval” for requirements.

Corrective / protective actions may also be required by others with oversight responsibilities such as other university offices or individuals, federal departments or agencies, sponsors, etc.

Reporting

Serious and/or continuing noncompliance will be reported (e.g., to appropriate institutional officials, federal agencies) pursuant to HRPP Manual 4-8 “Reporting Policy.”

Coordination with Other Institutional Officials

Any possible research misconduct discovered during the IRB’s noncompliance investigation can be reported to the MSU Research Integrity Officer (RIO) as an allegation of misconduct. 

  • These allegations can be presented to the RIO by the chair, member or staff of the IRB, staff of the HRPP Compliance Office, human subjects of the research, or any other individual. 

  • The misconduct investigation will be performed independently of IRB procedures and the IRB’s noncompliance investigation will be performed independently of the misconduct investigation (i.e., the IRB will conduct the noncompliance investigation and the RIO will conduct the research misconduct investigation). See HRPP Manual 3-1 “MSU HRPP Plan” for more information about interactions with the RIO.

If possible noncompliance with IRB requirements, university policies and/or federal regulations protecting human subjects of research is discovered during a misconduct investigation, the RIO will notify the appropriate individuals as outlined by the Faculty Handbook, VI. Research and Creative Endeavors, “Procedures Concerning Allegations of Misconduct in Research and Creative Activities.”

No one in the university may approve research that has been disapproved by the IRB (45 CFR 46.112).  Investigators who believe that the IRB has acted contrary to provisions of 45 CFR 46 or contrary to terms of its Assurance to the federal government (FWA-00004556) may contact the MSU Office of Regulatory Affairs, 517-432-4500 or the DHHS Office for Human Research Protection, (240) 453-6900.  Investigators who believe that the IRB has acted contrary to provisions of 21 CFR 50 and 56 may contact the MSU Office of Regulatory Affairs, 517-432-4500 or the U.S. Food and Drug Administration (FDA), 301-796-8340.

Communications with Investigators

An investigator who believes that the IRB has erred in its finding of noncompliance may submit a written request asking the IRB to reconsider within 30 days of when the noncompliance determination letter was made available through the MSU IRB online system.  The request should clearly indicate the facts or the interpretation in dispute, providing supporting evidence where applicable. This process follows the appeal process described in the Disapproval section of HRPP Manual 8-3 “Committee Review Procedure.” See HRPP Manual 8-3 “Committee Review Procedure” and 5-5 “Meetings.”

The IRB provides notice to investigators of its determinations and corrective/protective actions, if any.

Additional Considerations

For research subject to the requirements of the U.S. Department of Defense, see HRPP Manual 2-2-A “U.S. Department of Defense.”

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 2-1-2006. Revision 2 approved by VP Research & Graduate Studies on  3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 5-6-2008. Revision 4 approved by VP Research & Graduate Studies on 7-22-2011. Revision 5 approved by VP Research & Graduate Studies on 3-27-2017. Revision 6 approved by Assistant VP Regulatory Affairs on 12-11-2021.

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