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Q. What about sub-recipients?

If the University is passing on some of the funds to a sub-recipient, then as the awardee Institution, the University is responsible for ensuring any sub-recipient's compliance with the regulations and reporting identified financial conflicts of interests for sub-recipient investigators. The ROO will ensure that such requirement is addressed in the contract put in place with the sub-recipient.

Sub-recipients are entitled to follow the prime awardee's policy; however, where such party has its own compliant policy (as Cambridge does) they will be expected to follow their own.

Q. What will the PHS-funder do with the reports?

The funder will evaluate the information received to determine whether the University's actions are sufficient to manage the identified FCOI and will use the information to monitor the University's compliance with the regulation, requesting further information as necessary.

Q. What is the special requirement for clinical research?

In any case in which the HHS determines that an NIH-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not managed or reported by the Institution as required by the regulation, the Institution must require the Investigator(s) involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

Q. Where can I find out more information?

See the helpful NIH FAQ's