REVIEW AND DECISION OF THE INSTITUTIONAL OFFICIAL:
If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or designee for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institutional Official will take action to manage the financial conflict of interest including the reduction or elimination of the conflict, as appropriate.
- A Financial Conflict of Interest will exist when the Institutional Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of sponsored research. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must develop and implement a written management plan. The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related sponsored research goes forward.
- The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of students and other University personnel), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.
Review of Significant Financial Interests related to Clinical Trials:
- Clinical trials involve particularly sensitive issues if the Investigator has a Financial Interest related to the clinical trial.
- K&A Wireless, LLC is extremely sensitive to any Financial Conflict of Interest involving clinical trials whose purpose is to evaluate the safety or effectiveness of a medical device, the impact of the medical device on treatment or a recommended treatment.
- In the event of non-compliance with reporting and/or management of a financial conflict of interest involving a clinical trial, as required by this Policy, the investigator must disclose the financial conflicts of interest in each public presentation of the results of the affected sponsored research and request an addendum to previously published presentations.
REPORTING TO PHS:
The institutional official will report financial conflicts of interest or non-compliance to PHS in accordance with PHS regulations. If the funding for the Research is made available from a prime PHS-awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within 60 days of any subsequently identified financial conflict of interest such that the prime awardee may fulfill their reporting obligations to the PHS.
When a Financial Conflict of Interest is not identified or managed in a timely manner, including, for example, because the underlying SFI is not disclosed timely by an Investigator, or, because a FCOI was not timely reviewed or reported by K&A Wireless, LLC; or because an Investigator failed to comply with a management plan; then K&A Wireless, LLC will within 90 days:
- Complete a retrospective review of the Investigator’s activities and the research project to determine any bias in the design, conduct or reporting of research; Document the retrospective review consistent with the regulation; Document K&A Wireless, LLC’s determination as to whether any research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with this Policy or a FCOI management plan, was biased in the design, conduct, or reporting of such research; and Notify the PHS Grantee in writing.
- If bias is found, K&A Wireless, LLC shall notify the PHS Grantee promptly and submit a mitigation report to the PHS Grantee that shall address the following:
- Impact of the bias on the research project and K&A Wireless, LLC’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
- Thereafter, K&A Wireless, LLC shall submit FCOI reports annually to the PHS Grantee, in accordance with the regulation and terms and conditions of the agreement.
- Depending on the nature of the FCOI, K&A Wireless, LLC may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the FCOI is identified and the completion of K&A Wireless, LLC’s independent retrospective review.
- In addition, K&A Wireless, LLC will document the disciplinary action, if required, taken against the individuals, or investigators for non-compliance to this policy.
Each Investigator must complete training on this Policy, the investigator’s responsibilities regarding disclosure and the PHS regulations prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the Investigator is new to the institution, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.
The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardee, unless any litigation, claim, financial management review, or audit is started before the expiration of the three year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the Institution may be required to make such information available to the PHS Awarding Component and/or Health and Human Services (HHS), to a requestor of information concerning financial conflict of interest related to PHS funding or to the primary entity who made the funding available to the Institution, if requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.
Prior to the expenditure of funds, the Institution will publish on a publicly-accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:
- The Significant Financial Interest was disclosed and is still held by the senior and key personnel;
- A determination has been made that the Significant Financial Interest is related to the PHS-funded research; and
- A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest. The information to be made available shall be consistent with the requirements of the PHS regulation.
10) REGULATORY AUTHORITY
This policy implements the requirements of 42 CFR 50 Subpart F and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.
LAST UPDATED: August 22, 2017
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