CHA has established policies, including reporting requirements, which must be abided by when research is conducted, regardless of funding source.
The COI in Research, A-COM-0009 (StaffNet access required) policy establishes the definition of COI involving research conducted at CHA or by CHA workforce. It is intended to serve as a guide for research staff in structuring their relationships with industry and other outside ventures in view of their responsibilities for research and patient care. The policy applies to any CHA workforce who is responsible for the design, conduct, or reporting of research activities.
The Pharmaceutical/Medical Device Industry Relations, A-PHA-0001 (StaffNet access required) policy specifies requirements regarding COIs that may arise from relationships with pharmaceutical and medical device companies.
Furthermore, investigators conducting research funded by the Public Health Service (for example, National Institutes of Health (NIH) and Department of Health and Human Services) and National Science Foundation, as well as those conducting studies regulated by the US Food and Drug Administration, are subject to agency specific regulations. Those regulations set forth the obligations of investigators, sponsors, and institutions for research involving significant financial interests (SFI) or other COIs. Affected parties are advised to review the relevant regulations prior to submissions of a research proposal or application.
In August 2012 new regulations went into effect regarding research funded by the US Public Health Service (PHS).
The regulations require specific information to be reported at specific time points; summaries are below, but all affected parties are strongly advised to read the CHA policy on COI in PHS-Funded Research, A-COM-0015.
The regulations require disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or via sub-award P.C.O.R.I. The American Cancer Society, American Heart Association, Alliance for Lupus Research, Arthritis Foundation, and Susan G. Komen for the Cure have also adopted the PHS requirements.
All CHA employees, collaborators, or contractors, regardless of title or position, who are responsible for the design, conduct, or reporting of research activities that are funded by the PHS, and any of its components, including NIH, Agency for Healthcare Research and Quality (AHRQ), and Centers for Disease Control (CDC), funding by means of a grant or cooperative agreement are subject to these regulations.
The CHA Summary Guidance on PHS COI regulations may assist researchers.
Please also reference the CHA COI Reporting Requirement Reminders for PHS-Funded Grants for a quick summary about the "who, what, and when" of PHS COI reporting.
The CHA Office of Sponsored Research will determine if a financial conflict of interest exists and develop a proposed resolution. The CHA COI Committee will make final determinations on the resolution of financial COIs. The CHA IRB retains authority to make final determinations to disapprove research involving human subjects based on the existence of financial COIs.
This is a summary of Investigator significant financial interest (SFI) disclosure and Institutional FCOI reporting requirements for PHS-funded research:
|When Investigators, including sub-recipients, are to disclose a known SFI to CHA
||When CHA designated official reviews SFI disclosure and reports identified FCOIs to the PHS Awarding Component
|At the time of application
||Prior to fund expenditure
|Within 30 days of acquiring or discovering SFI
||Within 60 days of identification
|Annually at the time period prescribed by the Institution during the award period
||Annually: At the same time as when the grantee is required to submit the annual progress report, including multi-year progress report, or at the time of extension. Annual FCOI reports are submitted through the eRA Commons FCOI module.
This is a summary of types of reports, information to be included in each report and the reporting time points:
|Type of Report
||Information in Report
|Initial FCOI report
||Grant number, PD/PI name or contact PD/PI if a multiple PD/PI model is used, name of the Investigator with the FCOI, name of the entity with which the Investigator has a FCOI, nature of the FCOI, value of the financial interests, description how the financial interest related to the PHS-funded research and the basis of CHA’s determination that the financial interest conflicts with the research, and key elements of the Institution’s management plan.
- Prior to fund expenditure.
- Within 60 days of any subsequently identified FCOI.
|Annual FCOI report
||Status of the FCOI and any change(s) to the management plan.
||Due at the same time as when the grantee is required to submit the annual progress report, a multi-year progress report, or at the time of award extension.
|Revised FCOI report
||If applicable, update a previously submitted FCOI report to describe actions that will be taken to manage a FCOI going forward.
||After completion of a retrospective review, if needed.
||Project number, project title, PD/PI or contact PD/PI if a multiple PD/PI model is used, name of Investigator with the FCOI, name of the entity with which the Investigator has a FCOI, reason(s) for the retrospective review, detailed methodology used for the retrospective review, findings of the review, conclusions of the review, description of the impact of the bias on the research project, and the plan of action(s) to eliminate or mitigate the effect of the bias.
||When bias is found after a retrospective review.
In August 2012, US Public Health Service regulations went into effect requiring investigators to meet new requirements for disclosing financial interests. Included in the new Federal regulations is the requirement that COI training must be completed before engaging in any PHS-funded research at CHA and every 4 years thereafter.
CHA has developed training materials and a mandatory quiz, which are online. Researchers must complete the training and submit the quiz before the PHS-funded grant is awarded, including renewals.
Industry or Foundation Sponsored and Unfunded Research
As of May 18th, 2015, CHA has added an online Conflict of Interest reporting system, called “CLICK”. The system includes reporting for PHS funded research. Harvard faculty, frequent researchers and co-investigators will be entered into the system in order to maintain their financial conflict of interest record in the CLICK system. Other less frequent researchers will be notified to fill out the paper forms.
- At the time of initial grant application:
- CLICK Users will receive an email to submit a research specific disclosure in the CLICK COI Reporting System.
- Other Researchers will be contacted by the PI or designee with the PHS disclosure form.
- The online system can be used to report updates to a previously reported SFI or to report a new SFI and to report travel.
- The link to the site is: https://esupport.hms.harvard.edu/OAR
- Consultants will still be asked to use the PHS-Funded Grant Financial Disclosure Form at the time of initial grant application, for their annual report, or to report a new SFI.
- Those using a paper form can update an existing, previously reported SFI and report travel using the PHS-Funded Grant Financial Disclosure Form – Updated Info
- PHS-Funded Grant Travel Tracker
This document was developed to help researchers keep track of travel, which must be reported per federal regulation.
With respect to PHS-funded research, there are numerous resources about the regulations that went into effect regarding COI, including the Final Rule on the FCOI regulations - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors. In addition, Frequently Asked Questions may help answer questions researchers have on the topic.
CHA Office of Sponsored Research personnel are also available to assist researchers with COI-related questions.