PHS Financial Disclosure
The Public Health Service (PHS) requires disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or by subaward. Other agencies have adopted the PHS requirements. For more information, see PHS Financial Disclosure Guidance.
Policies:
Indivior Policy:
Financial Conflict of Interest Policy
PHS Policy
National Institutes of Health Financial Conflict of Interest https://grants.nih.gov/grants/policy/coi/index.htm
U.S. Department of Health and Human Services (HHS) “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought “ (42 C.F.R., Part 50, Subpart F)
https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#subpart-F
PHS Disclosure Stages
Proposal Stage
At the proposal stage the Principal Investigator (PI) must fill out the Conflict of Interest screening questions on behalf of all investigators that will be involved in the project. For this purpose, an “investigator” is defined as: the Principal Investigator (PI) and any other person/s (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research.
If disclosure is required but the PI cannot access the screening questions, the PI will need to complete and submit the PHS Financial Interest Screening Questions Form on behalf of all investigators involved in the project to coi_team@indivior.com
Note: If any investigator prompts the PI to respond “yes” to any of the screening questions, the investigator will be required to complete and submit the PHS Financial Disclosure Form to the COI Office at coi_team@Indivior.com for review prior to the award being released.
Subrecipients: If subrecipients are included in the proposal, the authorized official of each FDP subrecipient will need to complete the most current Subrecipient Commitment Form and answer financial interest questions on behalf of all subrecipient investigators named in the Indivior proposal. Note: A subaward cannot be issued to a subrecipient that does not have a PHS compliant COI policy in place.
Award Stage
If any investigator prompted the PI to answer “yes” to any of the screening questions at the proposal stage, the investigator will be required to complete and submit the PHS Financial Disclosure Form to the COI Office at coi_team@Indivior.com prior to the award being released.
If the PI responded, “no,” to all the screening questions at the proposal stage then nothing more is required unless the PI’s responses to the screening questions were obtained more than 12 months prior to award receipt. If the questions were answered more than 12 months earlier, the PI will need to submit an updated PHS Financial Interest Screening Questions Form on behalf of all investigators currently involved in the project.
Training: All Investigators are required to take on-line training provided by NIH prior to engaging in PHS-funded research. The certificate of training completion must be emailed to coi_team@Indivior.com
During Life of Award
The PI is required to complete the PHS Financial Interest Screening Questions Form at least annually on behalf of all investigators involved in the project when the PI:
- Submits the progress report/non-competing continuation (RPPR),
- Requests a no-cost time extension,
- Adds new investigators to the project, and/or
- Becomes aware that an investigator that is involved in the project has acquired or discovered a new significant financial interest. (This must be reported within 30 days.)
If the PHS Financial Interest Screening Questions Form provided by the PI at any point listed above includes a “yes” response, then the investigator that prompted the “yes” response will be required to complete the PHS Financial Disclosure Form and email it to the COI Office at coi_team@Indivior.com
Investigators must disclose new Significant Financial Interests within 30 days of acquiring the new interest by submitting a PHS Financial Disclosure Form by email it to the COI Office at coi_team@Indivior.com
All Investigators are required to take PHS-compliant training prior to engaging in PHS-funded research for new awards or no later than the due date of the next subsequent progress report/non-competing continuation proposal for ongoing projects, whether receiving remuneration or not, and at least every four years while engaging in PHS-funded research. Training is also required immediately if an Investigator is new to the institution, if the Indivior policies change in a way that affects Investigator requirements or if Indivior finds that an Investigator is noncompliant with any policy or management plan. This training requirement applies equally for those funding agencies that have adopted the PHS regulations. The institution must be able to verify that training has been completed as follows:
• All Investigators should complete the on-line training provided by NIH and send training completion form to coi_team@indivior.com
• For any questions or comments please contact coi_team@indivior.com
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