|by Sharon J. Glazer, MPH, Editor, Academics@Baystate newsletter | August 01, 2012
Increased Responsibilities for Both Investigators and Institutions
For the first time since 1995, U.S. Department of Health and Human Services has substantially revised regulations governing research funded by a U.S. Public Health Service (PHS) agency, including NIH, AHRQ, SAMHSA, HRSA, CDC and FDA. (See Resources section for links to the regulations.)
These regulations apply to grants and collaborative agreements, as well as contracts.
Baystate's new policy, effective August 24 2012, will affect:
- all applications that are submitted to a Public Health Service agency after August 24
- all grants for which a Notice of Award is received after after August 24.
The new policy applies only to PHS funded research. Research funded through other sources will not be affected.
The new regulations include:
- redefining financial interests that must be disclosed to Baystate
- adding a training requirement
- requiring public access to the policy and information on managed financial conflicts of interest.
Significant Financial Interests Redefined and Threshold Lowered from $10,000 to $5,000
The most significant changes to the definition of Significant Financial Interest are:
- Significant Financial Interests are those related to any of an investigator’s institutional responsibilities at Baystate, including professional practice, teaching, and committee membership—not just those which may be affected by the research.
- Significant Financial Interests now include:
- payments and equity interests from a publicly traded entity in excess of $5,000
- payments from a privately-held entity in excess of $5,000
- equity interest in a privately held entity of any value, even if it cannot be ascertained
- travel reimbursement or the value of sponsored travel
- paid authorship.
- The threshold is based on amounts actually received in the previous 12 months.
Baystate Responsible for Identifying Financial Conflicts of Interest
The new regulations require the institution, not the investigator, to determine whether a reported Significant Financial Interest is a Financial Conflict of Interest—one that could directly and significantly affect the design, conduct, or reporting of the federally-funded research.
When a management plan for a Financial Conflict of Interest is necessary, the details that must be reported to the federal funding source have been expanded to include the name of the entity, the value of the interest, and how the conflict will be managed
New Training Requirement for Investigators
Training in financial conflicts of interest is now required before an investigator may engage in federally funded research, and must be repeated at least every four years.
Investigators currently participating in federally funded research are strongly encouraged to complete training as soon as possible. Those considering participation in a federal grant application should take advantage of the upcoming training.
There are several options for training:
- 1 hour training session offering CPD risk management credit (see Training box.)
- a new CITI module that will be available in the near future
- NIH FCOI online tutorial can be used by Investigators who must comply with this requirement before other options are available. To use this option, contact Anita Sarro, Research Integrity Officer, for Baystate-specific information.
Applications Not Complete Until All Investigators Have Disclosed Significant Financial Interests
Federal regulations require that all individuals on an application who meet the definition of Investigator—an individual who has responsibility for the design, conduct, or reporting of research—must submit a Disclosure Form to Baystate before the application can be submitted to the funding agency.
It is the responsibility of the Principal Investigator to ensure that all Investigators named in an application have completed the disclosure requirement. Baystate cannot waive this requirement under any circumstances—it is a matter of federal law that permits no discretion.
Public Access to Information
The new regulations stress transparency and institutions now must make some information readily available to the public. Baystate's financial conflict of interest policies will be posted on Baystate’s public website no later than August 24, 2012.
When a financial conflict of interest requires a management plan, institutions must allow public access to information about the federal project affected, nature of the financial conflict, and the plan for its management.
Of the two options for access— posting the information on the public website, or providing it within five business days of a written request—Baystate has chosen the latter. Instructions on how to make a request will be posted on baystatehealth.org.
FCOI Resources for Investigators
Baystate policy BH-AA-2.09, "Disclosure of Financial Interests and Management of Financial Conflicts of Interest for U.S. Public Health Service Funding" and links to sources such as NIH’s Frequently Asked Questions will be posted on the Academic Affairs eWorkplace site by August 15. In the coming weeks disclosure forms, guidelines and FAQs will also be available there.
Investigators on active grants will receive further information via email on how to comply with the new requirements.