New JHSPH FCOI Policies (Part One)

As a follow-up to last month’s general rundown of the changes to the Financial Conflict of Interest (FCOI) regulations for research funded by the Public Health Service (PHS), what follows are the official JHSPH guidelines with respect to PHS proposals and awards.  (Note that these are directed to JHSPH personnel; procedures for subrecipients will be addressed in a later post.)

These requirements relate to research under the following PHS agencies:

Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Substance Abuse and Mental Health Services Administration (SAMHSA)

Keep in mind that these policies affect any grant, contract, cooperative agreement, subgrant, and subcontract at every competitive funding increment (i.e. new, renewal, competing supplement).

FORMS

(All forms mentioned in this section are available via our portal, as well as from your department administrator.)

1.            For each proposal, the JHSPH PI must fill out the Principal Investigator Certification Form (FORM 1).

2.            If the PI lists other JHSPH Investigators in question 4 of FORM 1, each Investigator is required to fill out an Investigator Certification Form (FORM 2).

3.            If there is a subrecipient, follow procedure in “JHSPH COI Procedure for Subrecipients”.

4.            When a Notice of Award (NOA) is issued on or after August 24, 2012, ORA will require the COI form(s) as stated above prior to award setup.

5.            If there is a conflict indicated on FORM 1 or FORM 2, the form will be forwarded to Marla Hallacy in the Research Compliance Office, and Investigators are required to enter any conflicts into eDisclose within 30 days of the existence of the conflict.

TRAINING

1.            All faculty MUST complete COI training by October 31, 2012, regardless of whether they have, or plan to have, PHS funding, including proposal submissions or awards.

2.            The PI and JHSPH Investigators listed in FORM 1 are required to complete COI training before a proposal can be submitted or a NOA can be processed.

For more information, visit JHU’s website, or, for more general questions, be sure to read NIH’s online repository of all things COI.