Procedure 1: Addressing Noncompliance in Human Subjects’ Research

Effective Date: 23 April 2026
Responsible Office: Office of the Vice Provost for Research
Last Updated: 03 August 2026

I. Scope & Purpose

This procedure applies to all faculty, staff, students, and affiliated researchers who, within the scope of their roles at William & Mary (W&M), conduct research involving human subjects that is overseen by the W&M Institutional Review Board (IRB).

The purpose of this procedure is to outline W&M’s process for addressing allegations of noncompliance in research involving human participants that is overseen by the W&M Institutional Review Board (IRB).

II. Definitions

• Allegations of Noncompliance: An allegation of noncompliance is an unconfirmed report of possible noncompliance.
• Federally Funded Research: research that is directly or indirectly funded by any federal agency.
• Federally Regulated Research: research that is subject to federal regulations regardless of funding relationships, such as research subject to regulation by the Food and Drug Administration (FDA) or the Department of Defense (DoD).
• Finding of Noncompliance: An occurrence or determination of noncompliance that does not require further confirmation or investigation.
• Noncompliance: failure (regardless of intentionality) to comply with any federal, state, or local regulation governing human research, including university policies and procedures for research with human participants. Noncompliance includes completing any research with human participants without prospective IRB approval, any deviation from an IRB-approved protocol, or deviations from stipulations imposed by the IRB as a condition of approval. Noncompliance may be “serious,” "non-serious” (minor), and may be “continuing.”
  • Exempt Noncompliance: when research activities eligible for exemption under this policy are completed without IRB review from W&M’s IRB, and the activities or deviations from an approved protocol do not increase the risk to research participants, compromise participants' rights or welfare, affect the integrity of the research, the data, or the human research protection program. Exempt noncompliance can become serious or continuing noncompliance based on activities that occurred or patterns that develop.
  • Non-Serious (Minor) Noncompliance: noncompliance that does not increase the risk to research participants, compromise participants’ rights or welfare, or that does not affect the integrity of the research, the data, or the human research protection program.
  • Serious Noncompliance: noncompliance where participants were harmed due to researcher noncompliance, if there was the risk of harm due to noncompliance, or if the risk to participants was increased due to noncompliance. Serious noncompliance may increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research or data, or the human research protection program. The committee may consider the level of risk of the research in determining if noncompliance is serious.
  • Continuing Noncompliance: noncompliance where a researcher continues to deviate from the procedures, regulations, or directives of the William & Mary IRB after prior intervention by the IRB. Continuing noncompliance may be found if a researcher repeats an action determined to be noncompliant by the IRB, and it may also be found if a researcher commits different forms of noncompliance at different times.
  • Protocol Deviation: a variation from the IRB-approved protocol that happens without prior review and approval from the IRB. Protocol deviations can be major or minor. Protocol deviations may or may not be intentional and may or may not be under the control of the study team. Depending on the details, protocol deviations may be determined to be non-compliance.

III. Procedure

All William & Mary researchers conducting human participants research are expected to comply with the provisions of the IRB-approved study as well as all related federal regulations, university policies, and state and local laws. If a researcher becomes aware of any noncompliance, it must be reported to the William & Mary IRB office within 2 business days of discovery.

If any allegations of noncompliance are made to the William & Mary IRB office, those allegations must be investigated. During the investigation, it must be determined whether the allegation has a basis in fact and whether the noncompliance is deemed serious and/or continuing. The procedures for this investigation are described in the sections detailed below.

A. Handling Allegations of Noncompliance

1. Noncompliance reports may come from any source such as a William & Mary IRB committee member, an investigator, faculty or staff, a participant or their family members, the public, or institutional personnel.
2. Allegations of noncompliance must remain confidential to the extent permitted by law and consistent with the need to conduct an investigation. William & Mary must take reasonable steps to protect persons who file reports in good faith from retaliatory actions based on such filing.
3. Actions undertaken in response to an allegation or finding of noncompliance must be completed in a timely manner based on the circumstances and seriousness of the potential noncompliance.
   1. Factors influencing the timeline for investigating noncompliance include participant safety and welfare, type of possible noncompliance, funding, contractual obligations, or other related factors.
   2. Under federal regulations and state law, the William & Mary IRB has the authority to suspend or terminate approval of research that is not conducted in accordance with the IRB's requirements or that has been associated with unexpected, serious harm to participants.
4. The William & Mary IRB full board and/or the IRB Chair (or their designee(s)) may suspend or terminate approval of an investigator’s research and secure critical documents at any time during or following an inquiry or investigation to assure the protection of research participants.
   1. The William & Mary Office of Research Compliance will ensure that the necessary resources are available to conduct a thorough review of all issues of noncompliance.
5. The goals of the IRB in investigating and managing issues of potential noncompliance include:
   1. appropriately identifying any issues related to the allegation of noncompliance;
   2. assuring the safety and welfare of human participants by assessing the risk associated with the allegations of noncompliance, including risks to primary and third-party participants, the human subjects research program, and the university;
   3. taking necessary immediate steps to reduce risk;
   4. developing action plans for researchers to prevent reoccurrence and promote future compliance and ethical behavior;
   5. educating researchers to ensure the understanding of federal guidelines, regulations, and William & Mary IRB’s policies and procedures; and
   6. Where appropriate, reporting serious or continuing noncompliance to the Institutional Official (IO) in charge of the IRB, any appropriate research sponsor or federal department or agency head, the Office for Human Research Protections, and any other stakeholders identified by the IRB full board.
6. If, at any time during an investigation, concerns arise regarding research misconduct, such concerns will be referred to the University’s research integrity officer. Allegations of research misconduct are potentially related to IRB noncompliance but are a separate issue covered by the University policy on responding to allegations of research misconduct. The investigation for noncompliance will continue regardless of referral.
7. If, at any time during an investigation, concerns arise regarding questionable research practices, academic integrity, student conduct, or issues related to Human Resources, such concerns will be referred to the appropriate offices at William & Mary. These allegations are potentially related to IRB noncompliance but are a separate issue covered by other University policy. The investigation for noncompliance will continue regardless of referral.

B. Investigations of Noncompliance and Outcomes

Once an allegation of noncompliance is brought to the attention of the William & Mary IRB office or full board, the IRB chair (or their designee(s)) must investigate the allegation and collect information that informs decisions made regarding the alleged noncompliance. The expectations and steps regarding the investigation of noncompliance are:

1. Any individual with a conflict of interest, as determined by the Institutional Official, must not participate in the noncompliance investigation.
2. The study investigator(s) must be informed in writing of the allegation and investigation.
   1. Depending on the nature of the potential noncompliance, a written response from the study investigator(s) will be requested to facilitate the review and conclusion of the investigation.
   2. As necessary, the PI, research staff, or others may be interviewed, and/or an audit of the investigators’ research may be conducted during the investigation.
3. During the investigation, the IRB chair or their designee must engage in fact-finding and information collection.
4. If the investigators are contacted for a response during the investigation, a written response must be requested.
5. Investigations will be completed promptly; however, the timing is dependent on participant safety and welfare, the finding of noncompliance, and the nature of the potential noncompliance.
6. Exempt noncompliance and Minor noncompliance determinations must be made by the IRB Chair or their designee(s) during the investigation; however, if the IRB Chair or their designee(s) believe that the noncompliance could be considered serious and/or continuing noncompliance, allegations and investigative findings must be presented to a meeting of the full IRB for final determination.
7. Based on the information gathered during the investigation, the IRB chair or their designee(s) must:
   1. Determine no noncompliance and close the matter if the allegations are unfounded; 
   2. Determine the activity is exempt under the William & Mary IRB Exemption Determination procedure and resolve the matter accordingly; 
   3. Address minor non‑exempt noncompliance by coordinating with relevant parties to implement and document corrective actions; or
   4. Refer the matter to the convened IRB—including the investigation record and input from the principal investigator (PI)—for review and final determination.
8. Investigations of Noncompliance for research activities eligible for Exemption
   1. The IRB chair or their designees must manage the investigation for any allegations of noncompliance for studies determined to be exempt under the William & Mary procedure for Exemption Determinations.
   2. Sponsored research determined to be exempt from the regulations must be handled in accordance with 45.CFR.46, OHRP guidance, contractual obligations, and William & Mary Policy for Research with Human Subjects.
   3. Research that is not sponsored or associated with a contract or agreement, and has been determined exempt, must be handled in accordance with William & Mary Policy for Research with Human Subjects.
   4. Should the investigation of the allegation of noncompliance provide sufficient information that the noncompliance increased risks to participants or the noncompliant activities would otherwise require a different type of review, the allegation of noncompliance must be handled as non-exempt.
   5. Should the investigation of noncompliance reveal a pattern of noncompliance for exempt research, the IRB Chair or their designees may choose to address the possible noncompliance as they would non-exempt noncompliance.
9. Investigations of Noncompliance for Non-Exempt Studies
   1. The IRB Chair or their designee must consult with relevant parties and, as needed, engage University Counsel or the Institutional Official.
   2. Investigations of Noncompliance for Studies Requiring Expedited Approval
      1. Sponsored research determined to be eligible for Expedited review must be handled in accordance with 45.CFR.46, OHRP guidance, contractual obligations, and William & Mary Policy for Research with Human Subjects.
      2. Research that is not sponsored or associated with a contract or agreement, and is eligible for Expedited review, must be handled in accordance with William & Mary Policy for Research with Human Subjects.
      3. If the allegations of noncompliance reveal that minor noncompliance occurred, the IRB Chair or their designees must resolve the investigation and include educational and corrective actions as appropriate.
   3. Investigations of Noncompliance for Studies Requiring Full Board Review and Approval
      1. If the potential noncompliance is reviewed by the convened IRB, the PI and co-investigators may respond in person at the meeting during which the review will take place.
      2. At a convened IRB meeting, the IRB chair or designees responsible for reviewing the research must review allegations of noncompliance following the investigation.
         1. The William & Mary convened IRB must consider the information from the investigation, the study investigators’ response (if any), and any other relevant materials to assess the seriousness of the potential noncompliance and to consider possible corrective action(s).
         2. The IRB chair or their designees must lead the discussion; materials as described above will be distributed to all scheduled attendees.
         3. The convened IRB must make final determinations in closed session by a majority vote of a quorum.
      3. The investigators must be notified in writing of the final decision of the convened IRB. If not previously reported, any suspension or termination of IRB approval for sponsored research or noncompliance that is determined to be serious or continuing must be reported to the proper agency.
      4. Possible outcomes of the investigation as determined by the convened IRB include but are not limited to:
         1. immediate actions to address participant safety and welfare;
         2. corrective action required (such as changes to the protocol, communications with participants, destruction of data, monitoring, limitations, suspension, or termination of the research project);
         3. referral to other appropriate university stakeholders such as offices handling research misconduct, the honor council, or HR;
         4. education and training for all researchers; and/or
         5. other outcomes determined necessary by the convened IRB to ensure noncompliance is unlikely to occur again.

C. Investigator Appeals

1. For a noncompliance finding related to a study eligible for exemption or expedited review, an investigator may appeal the determination to the convened IRB.
2. As required by regulations, any decision of the convened IRB with respect to research involving human participants is final. However, the convened IRB may review a study investigator’s request for reconsideration or appeal to a determination regarding noncompliance and/or corrective actions as warranted by the presentation of new information or unusual circumstances.
3. All investigator petitions, including appeals, must be made in writing within 30 days of their notification of the convened IRB’s findings. The convened IRB must review an investigator’s request or appeal within 30 business days, and the investigator must be notified, in writing, of the decision of the convened IRB within 14 days of the review.

D. Reporting Obligations

1. Researcher Obligations
   1. Investigators must self-report any instances of noncompliance.
   2. Investigators must respond promptly to any inquiries, correspondence, or directives from the IRB with respect to any allegations of, investigations of, or findings of noncompliance.
   3. Should an investigator fail to report an instance of noncompliance to the IRB within the allotted timeframe, the IRB will include that failure as part of the noncompliance investigation.
2. IRB Obligations
   1. Serious or continuing noncompliance must be identified by the convened IRB and must be promptly reported to appropriate parties. The IRB Chair or their designee(s) is responsible for reporting noncompliance to appropriate parties.
   2. When the convened IRB identifies serious or continuing noncompliance in research, the noncompliance must be promptly reported to the Institutional Official (IO), and other appropriate entities such as research sponsors, collaborating institutions, or study investigators.
      1. When the research is federally funded, the appropriate federal department or agency heads, and the federal Office for Human Research Protections (OHRP) will also be notified.
   3. For cooperative research, the institution at which the noncompliance occurred must report the event to the reviewing IRB.
   4. When reporting serious or continuing noncompliance, the IRB must include the following information:
      1. appropriate identifying information for the research protocol, such as the title, investigator’s name, and the IRB project number;
      2. a detailed description of the noncompliance;
      3. an explanation of the basis for determining that the event, incident, experience, or outcome represents serious or continuing noncompliance; and
      4. a description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the noncompliance.

E. Records Retention

Records relating to review and investigation of noncompliance must be retained by the William & Mary IRB office for a minimum of five years after completion of the research or any corrective actions (whichever is longer), in accordance with federal regulation, applicable state and local law, and University policy.

IV. Authority & Amendment

This procedure was approved by the William & Mary IRB on April 23, 2026. This procedure will be reviewed every 2 years to ensure it remains relevant, usable, and in compliance with university policy and relevant law.

V. Related Policy & Procedures

• Federal Regulations Governing Research with Human Subjects 45.CFR.46 
• The Belmont Report  
• Nuremberg Code of 1947 
• Office for Human Research Protections (OHRP) 
• Code of Virginia, Research with Human Subjects 
• William & Mary Policy for Conflicts of Interest  
• William & Mary Policy for Financial Conflicts of Interest   
• William & Mary Data Classification and Protection Policy  
• FDA Regulations  
  • 21.CFR.50 Protection of Human Subjects  
  • 21.CFR.56 Institutional Review Boards 
  • 21.CFR.312 Investigational New Drug Application 
  • 21.CFR.812 Investigational Device Exemptions  
  • 21.CFR.600 Biologics 
• DoD Regulations Governing Research with Human Subjects 32.CFR.219 
• DoD Instructions 3216.02 
• NIH Website for Human Subjects’ Research 
• NSF Website for Human Subjects’ Research  
• William & Mary’s Policy for Research with Human Subjects 
• William & Mary’s Policy for Research Misconduct 

Appendix A: Examples 

Examples of minor noncompliance include: 

• Lapses in continuing review approval/annual approval renewal for non-exempt research where research procedures continued outside of the approval period.  
• Failure to obtain an exempt determination before exempt research with human participants is conducted 
• Implementation of minor editorial changes in an approved protocol without prior IRB approval for the change. 
  • A minor editorial change does not increase risk to participants and includes, but is not limited to: 
    • Editing sentence structure communicated to participants without IRB approval (not including typos) 
    • Adding or removing items from recruitment, consent, and instruments (where doing so does not change the identifiable nature of the study or increase risk to participants) 
    • The changes to content/sentences should not change the nature of the message communicated to participants 
  • Minor deviations from an approved protocol. A minor deviation to a protocol does not increase risk to participants. A minor deviation includes, but is not limited to: 
    • Removing a data collection method from a non-exempt approved protocol, provided that removing the method does not change the risk/benefit analysis negatively 
    • Implementing an instrument more than the approved number of times as identified in the approved protocol 
    • Adding an additional recruitment method (e.g., recruiting via social media when only approved to recruit via flyer or email) 
    • Collecting extra biological samples, even when following the approved method for collection. 

Examples of serious noncompliance include: 

• Non-exempt research involving human participants that is conducted without IRB approval
• Changes that are made to non-exempt human subject research without appropriate IRB approval where these changes increase the risk to participants
• Changes are made to an approved research protocol involving human participants where the convened IRB deems the changes to be significant in nature
• Any other instances of unethical or noncompliant activities that the IRB has deemed serious in nature due to the increased risk to participants or negative effect on the integrity of the data