(real conflict of interest) 42 C.F.R. Part 52h. 42 C.F.R. sections 52h.1, 52h.5. This regulation specifically contains the following definition of a “real conflict of interest”:
Real conflict of interest means a reviewer or close relative or professional associate of the reviewer has a financial or other interest in an application or proposal that is known to the reviewer and is likely to bias the reviewer’s evaluation of that application or proposal as determined by the government official managing the review (the Scientific Review Administrator, or equivalent), as acknowledged by the reviewer, or as prescribed by this part. A reviewer shall have a real conflict of interest if he/she or a close relative or professional associate of the reviewer:
(1) Has received or could receive a direct financial benefit of any amount deriving from an application or proposal under review;
(2) Apart from any direct financial benefit deriving from an application or proposal under review, has received or could receive a financial benefit from the applicant institution, offeror or principal investigator that in the aggregate exceeds $10,000 per year; . . .
(3) Has any other interest in the application or proposal that is likely to bias the reviewer’s evaluation of that application or proposal. Regardless of the level of financial involvement or other interest, if the reviewer feels unable to provide objective advice, he/she must recuse him/herself from the review of the application or proposal at issue. The peer review system relies on the professionalism of each reviewer to identify to the designated government official any real or apparent conflicts of interest that are likely to bias the reviewer’s evaluation of an application or proposal. 42 C.F.R. sect. 52h.2(q).
The regulations do not contemplate that a self‑certification by the evaluator is all that is ever needed to satisfy the requirement that he or she does not have a real conflict of interest, particularly where, as here, specific and colorable allegations of a real conflict of interest on the part of the evaluators were brought to the attention of cognizant agency officials. Under the circumstances present here, NIH was required to specifically determine whether these evaluators had real conflicts of interest under the applicable regulations. However, the record shows that NIH made no such determination. While we do not decide whether the evaluators here had real conflicts of interest, the record shows that the agency failed in its obligation to determine whether these individuals’ employment caused them a real conflict of interest that could bias their evaluation of Celadon’s proposal as contemplated under its applicable regulation.