Public Health Service Conflict of Interest Training and Disclosure Requirements
This policy details how QED identifies and addresses potential Financial and Non-Financial Conflicts of Interest relating to research funded by the U.S. Department of Health and Human Services Public Health Service (PHS) agencies to ensure QED’s research is free from bias or the appearance of bias. It applies to all QED employees who participate in research funded by PHS agencies and/or who hold certain management positions.
- Overview and Responsibilities
- Reporting and Training Requirements
- Identifying Significant Conflicts of Interests
- Review and Evaluation of Disclosed Interests
5. Review and Evaluation of Disclosed Interests
- Identifying SCOI
A disclosure of an Interest does not, by itself, create an impermissible conflict of interest. Each Interest disclosure will be reviewed by the COIC. The COIC is responsible for determining when an actual or potential conflict of interest exists in a given situation – that is, when a Interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research and for taking action as necessary to address and manage such conflicts of interest, including development and implementation of a management plan (see Section 5.2 below). This responsibility will be exercised in cooperation with the relevant PI and/or corporate manager and with full support by the Investigator. A variety of criteria may be considered in determining whether a particular Interest creates a conflict of interest with respect to a particular project funded by PHS or CMS.
- Managing SCOI
QED will take appropriate steps to address and manage SCOI to ensure that the design, conduct, and reporting of QED’s research is free from bias or the appearance of bias. As described in the PHS regulations, some examples of how conflicts of interest may be addressed and managed include:
- Public disclosure of an Investigator’s SCOI; disclosures will only occur after notice to and consultation with the Investigator
- Disclosure of SCOI directly to participants in Research projects involving human subjects
- Monitoring of Research projects by reviewers who do not have SCOI and who are capable of implementing measures to protect the design, conduct, or reporting of the Research against bias arising from identified SCOI
- Modification of the research plan, including, for example, change of personnel or personnel responsibilities with respect to particular tasks
- Disqualification of personnel from participation in all or a portion of a Research project funded by PHS
- Reduction or elimination of a SCOI (e.g., sale of stock)
- Severance of relationships (e.g., consulting activities) that create actual or potential conflicts.
The Chairperson of the COIC will report the occurrence and course of remediation for any SCOI to the Prime funding recipient (in the event of a QED subaward) or to the relevant PHS Awarding Component through the FOIC module of the ERA Commons web portal (in the event that QED is the Prime funding recipient) as well as by direct written notification when and as required by law.
In addition, with respect to FCOIs relating to PHS Compliant Research, QED will disclose such FCOIs to members of the public who request such disclosure as required by applicable law. The Chairperson of the COIC will notify the Investigator of any such request and the proposed response to such request and afford the Investigator an opportunity to comment on such request within a time period that will allow a timely response (i.e., within five (5) business days of the request) to be issued; however, QED will have the final authority regarding the content of such response.
If it is found that a Financial Conflict of Interest or a Non-Financial Conflict of Interest was not identified or managed in a timely manner, QED shall file such reports and take such actions as required by applicable law or as it otherwise deems necessary or appropriate in the circumstances.
The COIC Chairperson is responsible for the posting of this policy on a publicly accessible website and assurance of reporting under this section.