Summary of Major Changes to Federal Regulations for PHS-Funded Research (42 CFR Part 50 Subpart F; 45 CFR Part 94) and our Institutional Response (effective August 24, 2012)

Topic 1995 Regulations 2011 Final Rule Policy Changes for all BMC Research and PHS-Funded BU Research Only
(effective as of August 24, 2012)
Significant Financial Interests (SFI) threshold De minimis threshold of $10,000 for disclosure generally applies to payments or equity interests De minimis threshold of $5,000 for disclosure generally applies to payments for services and equity interests. Includes any equity interest in non-publicly traded entities. BU/BMC will apply federal de minimis threshold of $5,000 for disclosure generally applies to payments for services and equity interests. Includes any equity interest in non-publicly traded entities.
Which SFIs need to be disclosed (once the threshold is met) Only those SFI the investigator deems related to the PHS-funded research All SFI related to the investigator’s institutional responsibilities. BU/BMC, in line with federal change, will request all SFIs related to the investigator’s institutional responsibilities (i.e., using the same skill set for which the investigator was hired by BU/BMC).
Excluded from disclosure requirement Income from seminars, lectures, or teaching, and service on advisory committees or review panels, for public or nonprofit entities Income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. BU/BMC’s disclosure forms will ask for this information.
Types of SFI excluded All forms of remuneration are included—specific questions such as mutual funds and blind trusts are addressed in FAQs on the NIH website Excludes income from investment vehicles such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles. Consistent with the federal policy, BU/BMC excludes income from investment vehicles such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles.
Travel reimbursements and sponsored travel Travel reimbursement is not mentioned explicitly in the regulations but is not excluded from the SFI definition. Disclose the occurrence of any reimbursed travel or sponsored travel related to institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration). NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The institution will determine if any travel requires further investigation, including determination or disclosure of the monetary value. BU/BMC disclosure forms now request the travel information required by federal law, with the applicable exceptions.
Information on an identified Financial Conflict of Interest (FCOI) reported by the institution to the PHS Awarding Component
  • Grant/contract number
  • Project director/principal investigator (PD/PI) or contact PD/PI
  • Name of investigator with FCOI
  • Whether FCOI was managed, reduced, or eliminated
INITIAL REPORT Requirements in 1995 reg, plus: 

  • Name of the entity with which the investigator has an FCOI
  • Nature of FCOI, e.g., equity, consulting fees, travel reimbursement, honoraria
  • Value of the financial interest: $0–4,999; $5K–9,999; $10K–19,999; amts between $20K–100K by increments of $20K; amts above $100K by increments of $50K or statement that a value cannot be readily determined
  • A description how the financial interest relates to PHS-funded research and the basis for the institution’s determination that the financial interest conflicts with such research
  • Key elements of the institution’s management plan

ANNUAL REPORT

  • Status of the FCOI
  • Changes to the management plan
BU/BMC reports the expanded, required information to NIH where research is PHS-funded. Reporting is standard practice.
Subrecipient institutions/investigators and reporting of identified FCOIs Subrecipient institutions must take reasonable steps to ensure that investigators working for subs comply with the regs by requiring those investigators to comply with the institution’s policy or by requiring the entities to provide assurances to the institution that will enable the institution to comply with the regs.
  • Incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee institution or that of the subrecipient will apply to subrecipient investigators and include time periods to meet disclosure and/or FCOI reporting requirements.
  • Subrecipient institutions who rely on their FCOI policy must report identified FCOIs to the  awardee institution in sufficient time to allow the  awardee institution to report the FCOI to the PHS Awarding Component (e.g., NIH through the eRA Commons FCOI Module) to meet reporting obligations.
BU/BMC contract with subrecipients incorporate the changes required under federal law. 

 

 

Check box in contract is still there, with different wording to set forth which institution’s COI policy applies, as required. If able, subrecipient institution will use its own COI policy; otherwise, it will adopt a model COI policy, which can be provided; or as a third choice option, be swept into BU/BMC’s COI policy and process.

Public accessibility No requirement Make certain information available concerning identified FCOIs held by senior/key personnel via a publicly accessible website or by a written response to any requestor within five business days of a request, and update such information as specified in the rule. Public accessibility available via written request only and using a form that will be available on the COI website on or after August 24, 2012. Only FCOIs related to PHS-sponsored research are subject to request.
FCOI training No requirement Each investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the designated circumstances: 

  • Institutional FCOI policies change in a manner that affects investigator requirements
  • An investigator is new to an institution
  • An institution finds an investigator noncompliant with the institution’s FCOI policy or management plan
BU/BMC training requirements mirror federal regulatory requirements, plus training “any other time as reasonably determined by BU or BMC.”
Retrospective review (“Mitigation plan,” discussed in NPRM) Not mentioned Institution is required to conduct a retrospective review in those cases of noncompliance with the regulation but is not required to report the review to the PHS Awarding Component. The institution will be required to notify the PHS Awarding Component promptly and submit a report to the PHS Awarding Component only in cases where bias is found.  The report will address the impact of the bias on the research project and the actions the institution has taken, or will take, to eliminate or mitigate the effect of the bias. BU/BMC policies will mirror federal requirements and only apply to PHS-sponsored research.

Adapted from the “Summary of Major Changes” chart found here: http://grants.nih.gov/grants/policy/coi.

See http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf for full text of Final Rule.