[Code of Federal Regulations] [Title 42, Volume 1] [Revised as of October 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR52h.2] [Page 219-221] TITLE 42--PUBLIC HEALTH CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 52h_SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH AND DEVELOPMENT CONTRACT PROJECTS--Table of Contents Sec. 52h.2 Definitions. As used in this part: (a) Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.). (b) Appearance of a conflict of interest means that 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 or the government official managing the review and would cause a reasonable person to question the reviewer's impartiality if he or she were to participate in the review; the government official managing the review (the Scientific Review Administrator or equivalent) will evaluate the appearance of a conflict of interest and determine, in accordance with this subpart, whether or not the interest would likely bias the reviewer's evaluation of the application or proposal. (c) Awarding official means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated; except that, where the Act specifically authorizes another official to make awards in connection with a particular program, the awarding official shall mean that official and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated. (d) Budget period means the interval of time (usually 12 months) into which the project period is divided for budgetary and reporting purposes. (e) Close relative means a parent, spouse, domestic partner, or son or daughter. (f) Contract proposal means a written offer to enter into a contract that is submitted to the appropriate agency official by an individual or nonfederal [[Page 220]] organization which includes, at a minimum, a description of the nature, purpose, duration, and cost of the project, and the methods, personnel, and facilities to be utilized in carrying it out. A contract proposal may be unsolicited by the federal government or submitted in response to a request for proposals. (g) Development means the systematic use of knowledge gained from research to create useful materials, devices, systems, or methods. (h) DHHS means the Department of Health and Human Services. (i) Director means the Director of the National Institutes of Health and any other official or employee of the National Institutes of Health to whom the authority involved has been delegated. (j) Grant as used in this part, includes cooperative agreements. (k) Peer review group means a group of primarily nongovernment experts qualified by training and experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the scientific areas under review, to give expert advice on the scientific and technical merit of grant applications or contract proposals, or the concept of contract projects, in accordance with this part. (l) Principal investigator has the same meaning as in 42 CFR part 52. (m) Professional associate means any colleague, scientific mentor, or student with whom the peer reviewer is currently conducting research or other significant professional activities or with whom the member has conducted such activities within three years of the date of the review. (n) Project approach means the methodology to be followed and the resources needed in carrying out the project. (o) Project concept means the basic purpose, scope, and objectives of the project. (p) Project period has the same meaning as in 42 CFR part 52. (q) Real conflict of interest means a reviewer or a 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; this amount includes honoraria, fees, stock or other financial benefit, and additionally includes the current value of the reviewer's already existing stock holdings. The Director, NIH, may amend the dollar threshold periodically, as appropriate, after public notice and comment; or (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. (r) Request for proposals means a Government solicitation to prospective offerors, under procedures for negotiated contracts, to submit a proposal to fulfill specific agency requirements based on terms and conditions defined in the request for proposals. The request for proposals contains information sufficient to enable all offerors to prepare proposals, and is as complete as possible with respect to: nature of work to be performed; descriptions and specifications of items to be delivered; performance schedule; special requirements clauses, or other circumstances [[Page 221]] affecting the contract; format for cost proposals; and evaluation criteria by which the proposals will be evaluated. (s) Research has the same meaning as in 42 CFR part 52. (t) Research and development contract project means an identified, circumscribed activity, involving a single contract or two or more similar, related, or interdependent contracts, intended and designed to acquire new or fuller knowledge and understanding in the areas of biomedical or behavioral research and/or to use such knowledge and understanding to develop useful materials, devices, systems, or methods. (u) Scientific review group has the same meaning as peer review group, which is defined in paragraph (k) of this section. (v) Solicited contract proposal has the same meaning as the definition of offer in 48 CFR 2.101. (w) Unsolicited contract proposal has the same meaning as unsolicited proposal in 48 CFR 15.601.