(a) An "Associated Entity" of a Faculty Member means any trust, organization or enterprise other than the University or any affiliated Hospital over which the Faculty Member, alone or together with his/her Family, exercises a controlling interest.

(b) "Business" means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes, but excluding the University, any affiliated Hospital, any Private Medical Practice, or any other entity controlled by, controlling, or under common control with the University or an affiliated Hospital.

(c) "Clinical Research" means any research or procedure involving human subjects in vivo or the use of human samples for the development and evaluation of patient therapies such as diagnostic tests, drug therapies, or medical devices. It includes early clinical studies, evaluative research, epidemiological studies and clinical trials. It does not include a Faculty Member's participation in the design of a clinical study for which he/she is subsequently neither a participant nor an author.

(d) "Executive Position" refers to any position which includes responsibilities for a material segment of the operation or management of a Business.

(e) "Faculty Member" means any person possessing either a full- or part-time academic or fellowship appointment in the Faculty of Medicine.

(f) The "Family" of a Faculty Member includes his/her spouse, minor children, and other persons living in the same household.

(g) A "Financial Interest" is an interest in a Business consisting of: (1) any stock, stock option or similar ownership interest in such Business, but excluding any interest arising solely by reason of investment in such Business by a mutual, pension, or other institutional investment fund over which the Faculty Member does not exercise control; or (2) receipt of, or the right or expectation to receive, any income from such Business (or from an agent or other representative of such Business), whether in the form of a fee (e.g., consulting), salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of Technology, rent, capital gain, real or personal property, or any other form of compensation, or any combination thereof.

(h)"Hospital" means a Harvard Medical School affiliated institution, including hospitals and health and research institutions.

(i) "Participate" means to be part of the described activity in any capacity, including but not limited to serving as the principal investigator, co-investigator, research collaborator or provider of direct patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis) or, in the case of clinical research, to the trial participants, unless they are in a position to influence the study's results or have privileged information as to the outcome.

(j) "Private Medical Practice" means the professional services rendered by a physician, including departmental practice plans, and the procedures integral to those services.

(k) "Sponsored Research"⁽¹⁾ means research, training and instructional projects involving funds, materials, or other compensation from outside sources under agreements which contain any of the following:

1. The agreement binds the University or Hospital to a line of scholarly or scientific inquiry specified to a substantial level of detail. Such specificity may be indicated by a plan, by the stipulation of requirements for orderly testing or validation of particular approaches, or by the designation of performance targets.

2. A line-item budget is involved. A line-item budget details expenses by activity, function or project period. The designation of overhead (or indirect costs) qualifies a budget as "line item".

3. Financial reports are required.

4. The award is subject to external audit.

5. Unexpended funds must be returned to the sponsor at the conclusion of the project.

6. The agreement provides for the disposition of either tangible or intangible properties which may result from the activity. Tangible properties include equipment, records, technical reports, theses or dissertations. Intangible properties include rights in data, copyrights or inventions.

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Policy on Conflicts of Interest and Commitment

Guidelines for Conflicts of Interest (previous section)

Appendix A - Operating Definitions

Appendix B - Implementation (next section)