Policies, Procedures and Guidelines

Noncompliance Assessment Process and Potential Sanctions

1. Assessment

When a potential failure to comply with WU’s policies and processes governing research conflicts of interests is identified, the CIRC Chair will conduct an assessment of the situation and make a determination as to whether the individual failed to comply and the extent of the non-compliance. The Chair may involve/discuss the potential compliance failure with the covered individual and/or others as necessary to make a determination. If needed, the Chair may involve others with relevant expertise, such as CIRC members, in the assessment.

A covered individual is non-compliant when, for example, s/he fails to:

i. submit a Financial Disclosure Statement, as required;

ii. disclose his/her personal financial interests to the CIRC;

iii. cooperate or respond to the CIRC’s/RECO’s requests for additional information;

iv. agree to manage his or her financial conflict of interest; and/or

v. take the necessary steps to manage his or her conflict of interest as agreed to in the applicable management plan.

Each situation will be assessed on a case-by-case basis. Non-compliance deemed serious or continuing will be referred to the vice chancellor for research as prescribed in section 2.b. Serious non-compliance is defined as noncompliance that appears likely to have compromised the objectivity and integrity of the research or compromises the safeguards established for the protection of the research participants. Continuing non-compliance is defined as a pattern of repeated non-compliance including non-compliant acts, omissions or behavior that will likely materially and/or adversely affect (a)the integrity or validity of the pertinent study(s), or (b)the safeguards established for the protection of the research participants. Such non-compliance may be unintentional, for example, due to lack of understanding, knowledge, or commitment; or intentional, for example, due to deliberate disregard of applicable regulations, institutional policy, or the determination of the CIRC).

2. Determination

a. If the CIRC Chair determines non-compliance occurred that is not serious or continuing, such as a minor issue or unintentional error, the CIRC Chair will implement a corrective action plan. Examples of potential corrective actions are outlined in Section 4. A summary or copy of the findings and resulting corrective actions will be provided to the VCR and applicable Dean at least annually.

b. If the CIRC Chair determines serious or continuing non-compliance occurred or the CIRC fails to identify a financial conflict of interest related to a financial interest that was previously disclosed:

i. A written assessment of the CIRC’s findings, and relevant supporting documentation will be submitted to the vice chancellor for research;

ii. Corrective actions or other sanctions, as deemed appropriate, will be decided by the vice chancellor for research in consultation with the dean of the appropriate school. Examples of potential sanctions/corrective actions are outlined in Section 4.

c. If the compliance failure involves Public Health Services’ research funding (e.g National Institutes of Health funding), WU will also complete a retrospective review as prescribed in 42 C.F.R. Part 50 and 45 C.F.R. Part 94, which is outlined below in section 3.

i. When a retrospective review is initiated, depending on the nature of the financial conflict of interest, the vice chancellor for research may determine additional interim measures are necessary with regard to the covered individual’s participation in the PHS-funded research project between the date the financial conflict of interest or the individual’s noncompliance is determined and the completion of the retrospective review.

3. Retrospective Review for PHS funded research

If a compliance failure is identified involving PHS-funded research:

a. A retrospective review will be completed in the following instances:

i. whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the covered individual to disclose a significant financial interest that is determined by WU to constitute a financial conflict of interest;

ii. failure by WU to review or manage such a financial conflict of interest; or

iii. failure by the covered individual to comply with a financial conflict of interest management plan.

b. WU shall, within 120 days of its determination of noncompliance, complete the review of the covered individual’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

c. The vice chancellor for research will designate the individual(s) who will complete the retrospective review.

d. The retrospective review will be documented; such documentation shall include, but not necessarily be limited to, all of the following key elements:

i. Project number;

ii. Project title;

iii. PD/PI or contact PD/PI if a multiple PD/PIs are involved;

iv. Name of the covered individual with the FCOI;

v. Name of the entity with which the covered individual has a financial conflict of interest;

vi. Reason(s) for the retrospective review;

vii. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);

viii. Findings of the review; and

ix. Conclusions of the review.

e. The outcome of the retrospective review will be provided to the vice chancellor for research, who will determine whether additional corrective actions or other sanctions are appropriate in consultation with the dean of the appropriate school. Examples of potential sanctions/corrective actions are outlined in Section 4.

f. Based on the results of the retrospective review, WU shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward.

g. If bias is found, WU will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and WU’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, WU will submit FCOI reports annually, as required by the regulations.​

4. Corrective Actions or Sanctions for Non-Compliance

Corrective actions and/or sanctions will be communicated in writing to the covered individual, and others (e.g. department chair, dean) as appropriate, and will also include the details of the non-compliance. The covered individual will be required to agree to comply with the corrective actions/sanctions.

Examples of potential corrective actions/sanctions:

  • Education
  • Require the CIRC’s review of the covered individual’s personal financial relationships more frequently (e.g. every six months)
  • Restriction of access to all project funds until compliance is obtained
  • Removal of allocated salaries for the non-compliant individual from the research funds for the period of non-compliance
  • Suspension of protocol approvals
  • Removal of the individual from having further involvement in the applicable research
  • Require the individual to relinquish the personal financial interests
  • Require the individual to notify the editor of the journal(s) in which they s/he has published of the non-compliance
  • Require the individual to convey in writing to each study team member the extent of the non-compliance
  • Ongoing monitoring of the affected research and/or the individual’s other research activities
  • Independent oversight of the research
  • Independent monitoring of manuscript submissions
  • For human studies, WU’s IRB will assess the non-compliance to determine if additional corrective actions are needed related to the protocol and research participants. Typically, the PI will be required to notify the research participants of the compliance failure and may be required to re-consent the participants.
  • Referral to the Human Subjects Quality Assurance/Quality Improvement Committee to assess compliance with the human studies protocol. Compliance failures identified by the QA/QI committee will be addressed in accordance with its processes.
  • If the objectivity of the research was impacted, and if warranted, the situation may be referred to the Committee on Research Integrity.
  • Other potential employment sanctions as determined by the applicable dean