720. Noncompliance

Research studies may result in the implementation of unapproved changes to IRB-approved research plans (including unintentional changes) or failure to comply with established regulations, policies, and procedures. The research plan is documented in the IRBNet application form. The RI and IRB address all instances of potential or known noncompliance carefully, consistently, and with consideration for the protection of human research participants according to regulations, laws, and University policy.

Unapproved changes to research plans, deviations from approved plans, or noncompliance with IRB policies may necessitate review and investigation by other University officials and may result in disciplinary actions or sanctions. Discrepancies in study documents should be resolved upon notification. The research activity described in the application should be consistent in other study documents, e.g. informed consent document, recruitment and advertisements, etc.

NOTE: If research participants are at immediate risk of harm or have the potential to be placed at further risk while awaiting the outcome of a convened IRB meeting, the IRB Chair may place some or all aspects of the study on suspension pending the decision of the convened IRB.

(See the policy for reporting problems to the IRB for information about who may report, what to report, and how to report. For information about the preliminary steps in the assessment of problem reports, including potential noncompliance, see the policy for administrative assessment of problems.)

Examples of Noncompliance

Conducting research with human participants without IRB or exempt approval:

"Conducting research" includes recruitment, consent, data collection and analysis, and writing up findings or research related reports. Engaging in these activities before IRB approval is obtained or after IRB approval expires constitutes noncompliance and may result in sanctions against the use of data obtained before or after IRB approval.

Changing or deviating from the IRB-approved research plan (for non-exempt research):

Failure to implement research activities according to the IRB-approved research plan constitutes noncompliance. The IRB must approve all changes to non-exempt human research before the changes are initiated unless changes are necessary to eliminate immediate harm to participants. In the latter case, the PI may implement the changes but must report them to the IRB within five days of implementation.

Common changes include the following:

  • Increasing or decreasing participant enrollment by greater than 10% of the anticipated number.
  • Editing materials to which participants will be exposed (e.g., recruitment, educational, and consent materials).
  • Adding, removing, or editing questions on surveys or interview guides.
  • Collecting information that could identify participants when the research plan stated that no personal identifiers would be collected.
  • Removing study activities. In the approval process, the IRB assesses research benefits. Removing components of a research study may affect the IRB's assessment of study benefits.

For examples of deviations, see reporting complaints, deviations, and problems in the online HRPP Policy Manual.

Implementing study procedures with a participant who did not agree to the specific activity:

Some research is designed to allow participants to agree to some aspects of the study and to decline to participant in other aspects (e.g., video-taping). Involving a participant in an activity to which she/he has not consented constitutes noncompliance and may constitute an unanticipated problem if the activity involves risks to the participant or others.

Failing to record, code, store, or destroy data as described in the IRB-approved research plan:

PIs provide specific information in the IRB application about their plans for data management and storage, and for removing or coding personally identifiable information. Failure to adhere to the stated plans constitutes noncompliance and may constitute an unanticipated problem if unauthorized disclosure may harm a participant or others.

Initiating research prior to receiving notification of IRB approval:

The IRB sometimes approves research with conditions. Before any research activities may commence under these conditions, researchers must provide the IRB with the requested revisions for review. Once the IRB determines the revisions are satisfactory, the PI will receive formal notification of IRB approval. Initiating any research activities prior to notification of IRB approval constitutes noncompliance and may result in restrictions in the use of any data collected before notification of IRB approval.

Using data from a minor who did not have parent permission to participate in the research study:

This may occur in classroom research activities when not all parents agree to their child's participation in research, or when minor undergraduate students engage in research that was not designed to include minors and consequently, did not include processes for obtaining parent permission.

Changing or adding study locations:

The IRB considers study locations in assessing equity in participant enrollment. Changing or adding study sites may alter the IRB's assessment. Failure to obtain acknowledgement or approval for changes or additions to study locations constitutes noncompliance.

Not using the IRB-approved, date-stamped consent document  when enrolling participants:

RI staff electronically "stamp" the IRB approval date in the footer of approved versions of consent documents/materials. Researchers must use the stamped, approved versions when enrolling research participants. Failure to do so constitutes noncompliance.

Pre-testing or piloting research materials or activities without IRB approval:

The definition of "research" in the Federal regulations includes "research development, testing and evaluation" among activities that may be considered research. Pre-testing or piloting materials or activities before obtaining IRB approval may constitute noncompliance.

Tips to Minimize Noncompliance

  • If materials are edited after IRB approval has been obtained, submit an amendment to have the changes approved.
  • Contact the IRB if an immediate change is necessary.
  • Ensure all members of the research team, including students, know what is expected of them and are familiar with the approved research plan.
  • When uncertain, contact the IRB or QI Officer with any questions, before taking action.

Determination of Minor Noncompliance

If an investigation results in a finding of minor noncompliance, the issue may be resolved by the RI Director or IRB Chair or designee.

The QI Officer will

  • prepare a summary report of the investigation,
  • make recommendations for resolution of the issues identified in the report (e.g., corrective actions, education and training, or a combination), and
  • send a copy of the report to the RI Director, IRB Chair, and the PI.

Within 10 business days of receipt of the report or on a date agreed upon in writing by the QI Officer, the PI must reply with an action or management plan for addressing the recommendations in the report.

Upon approval of the plan, the investigator must implement the action or management plan and notify the QI Officer (in writing) within 30 calendar days of successful implementation.

The QI Officer will send the PI an acknowledgement of successful implementation of the action or management plan, and confirmation that the minor noncompliance has been satisfactorily resolved.

Determination of Potential Serious or Continuing Noncompliance

If the investigation suggests the incident may constitute serious or continuing noncompliance, the QI Officer, with confirmation from the RI Director, IRB Chair, or an appointed IRB sub-committee, will refer the matter for review by a fully convened IRB at the next scheduled meeting. The QI Officer will notify the investigator and the Responsible Official of pending IRB review.

The RI Director or IRB Chair or designee may provide preliminary notice to the DHHS Office of Human Research Protections and the Food and Drug Administration, as appropriate.

IRB Review of Potential Serious or Continuing Noncompliance

As noted above, allegations of noncompliance that may constitute serious or continuing noncompliance are reviewed by the convened IRB.

Materials for IRB Review

The materials for IRB review are available via access to the project in IRBNet (granted to Primary Reviewer and IRB members planning to attend the meeting) and include:

  • Problem report or complaint form;
  • Report of findings prepared by the QI Officer or designee, or IRB sub-committee; and
  • Approved research plan and study documents.*

*Approved documents that are relevant to the review may be flagged as such.

To facilitate the review, the QI Officer sends the assigned reviewer the categories of noncompliance as defined by the University IRB, and relevant excerpts from the IRB policy manual.

IRB Determinations

Following review and discussion of these materials, the IRB will make one of the four following determinations:

  1. The incident does not meet the criteria for serious or continuing noncompliance but it constitutes minor noncompliance and should be addressed accordingly.
  2. Further investigation by the QI Officer is needed before the IRB can make a determination. The QI Officer will present a revised report at the next scheduled IRB meeting.
  3. Further investigation and consideration by an ad hoc panel is warranted. The panel will report its findings at the next scheduled IRB meeting for review and recommendations.
  4. The incident constitutes serious or continuing noncompliance. The IRB takes the actions necessary to protect the rights and welfare of research participants and ensure PI compliance.

NOTE: The convened IRB may determine the matter doesn't constitute noncompliance and should be dismissed.

Outcomes Following Review at a Convened Meeting

IRB Determination of Minor Noncompliance

NOTE: As noted above, minor noncompliance may be determined outside of a convened meeting by the RI Director or IRB Chair or qualified designee.

If the IRB determines that minor noncompliance has occurred, the QI Officer will send the PI written notification of the Board's decision and recommendations (i.e., IRB-approved action or management plan).

  • Within 30 calendar days of receipt of the notification, the PI must implement the action or management plan and notify the QI Officer (in writing) of successful implementation.
  • The QI Officer will send the PI an acknowledgement of successful implementation of the action or management plan, and confirmation that the minor noncompliance has been satisfactorily resolved.

IRB Determination that Further Investigation by Ad Hoc Panel Is Warranted

If an ad hoc panel is assembled, it will consist of a minimum of three IRB members whose areas of expertise are suited to the area of study and reviewing the possible noncompliance. The IRB Chair may not be a member of the panel but the QI Officer who conducted the initial inquiry may serve in lieu of a third IRB member.

  • The ad hoc panel may conduct further interviews or employ other methods to gather information.
  • The ad hoc panel will provide a written report to the fully convened IRB following their inquiry, including a summary of the information gathered, conclusions and recommendations.

IRB Determination of Serious or Continuing Noncompliance

If the IRB determines that the incident constitutes serious or continuing noncompliance or both, the IRB may

  • require remediation or educational measures for the research team;
  • require monitoring research activities by appropriate persons;
  • require monitoring the informed consent process by appropriate persons;
  • require the PI to notify or provide additional information to past or current research participants;
  • require the PI to re-consent participants;
  • require amendments to the research plan;
  • require the PI to report to the IRB more frequently for this or all of her/his studies;
  • reduce the approval period (i.e., require more frequent continuing reviews);
  • require periodic audits by the QI Officer;
  • restrict the PI's research practice (e.g., limiting her/his research privileges to minimal risk or supervised projects);
  • suspend IRB approval for one or more of the PI's studies; or
  • terminate IRB approval for one or more of the PI's studies.

NOTE: If the IRB determines that an allegation constitutes serious or continuing noncompliance and may violate other University policies, the appropriate authority will be notified of the IRB's findings for possible further review and resolution by those bodies.

PI Notification of IRB Determination and Confirmation of Completion of IRB Required Actions

The PI will be notified in writing of the IRB's determination and required actions.

Within 30 days of the IRB notification, the investigator must submit written confirmation that all actions required by the IRB have been implemented.

The QI Officer will review the notification of implementation from the PI to confirm the required actions have been implemented. If warranted, she/he may contact the Pi for additional information. The QI Officer will acknowledge receipt of the PI's confirmation of implementation.

Prohibition of Retaliation for Reporting Noncompliance to the RI or IRB

Care is taken to maintain the confidentiality of the person making the report and the details of the situation or incident. Upon the complainant's request, his or her anonymity will be preserved to the extent possible.

Retaliation against an individual for having made in good faith an allegation of noncompliance with human research regulations or policy is a violation of University policy and an offense subject to University disciplinary procedures.

Concerns about possible retaliation or harassment must be immediately reported to the RI, IRB Chair, or the VPRI.