Key PHS/NIH Policy Changes Relating to COI in Research (Effective August 24, 2012)
Note: This is not an all inclusive list; it captures some of the major new NIH requirements.
|Covered Person's Institutional Role||NIIH requires that when reviewing a Covered Person’s individual financial interests, our Committee must take into consideration the individual’s institutional responsibilities.|
|Reporting Conflicts to the PHS/NIH||1. NIH has reduced its reporting threshold from $10,000 to $5,000. As a result, MSSM must now report all conflicts ≥$5K on NIH funded projects.
2. MSSM must provide the NIH with details of every conflict ≥$5K, including:
|Travel Reimbursement and Sponsored Travel||Covered Persons on Federally funded projects must keep a record of business meals and travel paid to them/for them by an outside entity unless that entity is the government or another academic medical center. This means that if you are currently named on an NIH grant or expect to participate, you should keep travel records, even if the travel is unrelated to a specific NIH grant. Keep a record of the activity, the date, the entity that paid and – to the extent possible – the value of the payment. We are awaiting guidance from the NIH regarding how MSSM will collect, review and report this information.|
|Violations of MSSM Policy||Non-compliance on NIH studies will trigger an NIH-mandated retrospective review by MSSM of the project to ensure that the conflict did not influence the research; this is likely be a time-consuming and difficult process for everyone involved in the project. Make sure you and your team all know your COI reporting responsibilities and the policy requirements. The greatest area of vulnerability is likely to be failure to disclose relevant financial interests, so when in doubt, DISCLOSE, and let the Committee determine whether a conflict exists. Policy violations will require education sessions with COI staff, and may result in disciplinary action; a standard stepwise remediation plan is currently under development.|
|Public Access to Individual Financial Information||Although MSSM has posted individual financial interests of our faculty since November 2010, an additional reporting requirement has been imposed by the NIH, i.e., MSSM must now respond to written requests for information concerning the financial interests of Senior/Key Personnel relating to NIH-funded projects.|