Linked to the elements of the FDA Form 3410, the COI criteria guidance table merges the waiver criteria document and the interim section 502 guidance.

Working Definitions under Involvement Level:

NOTE: For convenience, the guidance table uses the categories of low, medium and high involvement to reflect the monetary levels involved. However, as the table demonstrates, the overall level of a conflict of interest is determined by more than one factor.

General Matters

Particular matter of general applicability means a particular matter that is focused on the interests of a discrete and identifiable class of persons, but does not involve specific parties. For example, a guidance document that affects an entire class of products and all similarly situated manufacturers is a matter of general applicability. In addition, the use of a potential product solely as a model or example for general discussion, the results of which will apply to a class of products may be a matter of general applicability.

Party Matters

Particular matter involving specific parties focuses on a specific product application or other matter affecting a specific manufacturer and its competing products/manufacturers (e.g., NDA, PMA, PLA/BLA, efficacy supplement for new indication). It focuses uniquely and distinctly on a given product/manufacturer.

Working Definitions under Expected Action:

Cover memo

The SGE's reported interests, including those that do not require a waiver, a written 502 or an exclusion, are explained to the Ethics Staff in a memorandum.

Decision (W)

This notation appears when it is most likely that a waiver will be granted. However, in all cases, each proposed waiver will be evaluated and judged on its own merits in light of all relevant factors during the review process, and it is understood that an approval is never automatic.

Decision (WC)

This notation appears when the extent of the interest must be examined and balanced against the need for the SGE's expertise. The decision to waive is not automatic and requires careful review. Before seeking a waiver in this involvement category, the Center may wish to consult with the Ethics Staff. When reviewing a waiver in this risk category, the Ethics Staff may consult with Center Officials, HHS General Counsel Ethics Division and the Office of the Senior Associate Commissioner to recommend the best course of action.

Decision (AC)

This notation appears for matters that may fall under the criteria for written 502s. In these cases, the Center will consult with the Ethics Staff to discuss the nature of the interest and determine whether it is necessary to prepare a written 502 (e.g., past financial interest is negligible, occurred over a year ago, but raises appearance concerns).

Decision (AE)

This notation appears when the SGE's interest will warrant a written 502 authorization or exclusion. The decision may require managerial prerogative. The Ethics Staff may consult with Center officials, HHS General Counsel Ethics Division and the Office of Senior Associate Commissioner to recommend the best course of action.

Exclusion

This notation appears when the SGE's reported financial interest and the conflict outweigh the need for the individual's services. However, the decision to exclude is always reviewed in context with the issues before the committee.

Definition of Institution Addressed in Section "I" of the Table

Institution means a nonprofit research center affiliated with academia. Research is defined as basic and applied research. The institution may also coordinate studies (clinical trials) at other research facilities. Institutional funding may be derived from government sources, private donations, industry donations, contracts and grants.

Net Worth

Net worth is defined as the value of an individual's total assets minus the value of the individual's debts (financial liabilities).

Related Issue

"Related" issue is defined as a matter surrounding a product(s) that competes or may potentially compete in the marketplace with the proposed product of interest.

Investigator

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. "Sub-investigator" includes any other individual member of that team.¹

Expected Action

Expected action is defined as the outcome that is anticipated in the majority of cases. It follows the course of action that weighs the Agency's need for expert advice against any appearance or actual conflict of interest.

Note on 502 Delegation of Authority

When an appearance or impartiality concern is present, the SGE should not participate in the matter unless he has informed the agency designee of the appearance problem and received authorization from the agency designee. The COI Criteria Guidance Table identifies appearance and impartiality concerns related to various topics, e.g., contracts and grants provided by a sponsor that are unrelated to the product at issue, and provides resolution direction.

If the appearance issue is of a certain magnitude, a written authorization signed by the agency designee is required for the SGE to participate. For issues that fall below the threshold for a written authorization, Robert J. Byrd, Deputy Ethics Counselor, delegated authority (memo dated April 6, 1996) to the Ethics Staff located in the Division of Management Programs, Office of Human Resources and Management Services.

If the reviewing officials in the Ethics Staff concur with the Center's request for the SGE to participate, an authorization is noted on the cover memorandum. If the reviewing official questions the participation or believes based on the facts of the case that a written determination signed by the agency designee is warranted, the Center will be contacted and a dialogue will take place seeking appropriate resolution.

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¹21 CFR Section 312.3(b)