SOP-104

Conflict of Interest and Financial Disclosure

Number: SOP-104
Category: Governance and Quality System
Edition: Reference Edition 1.3
Approx. pages: 7

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On this page

1. Purpose
2. Scope
3. Responsibilities
4. Definitions
5. Procedure
6. Related Forms and SOPs
7. References

1. Purpose

This SOP describes how investigators at [SITE NAME] provide accurate financial disclosure information to sponsors under 21 CFR 54 and keep it current, and how the site identifies, reviews, manages and discloses financial and other conflicts of interest of investigators, staff and the site itself.

2. Scope

This SOP applies to:

each PI and Sub-I listed on a Form FDA 1572 or in device investigator records, for sponsor financial disclosure under 21 CFR 54
all research staff and the site's owners and directors, for the site conflict of interest (COI) policy in 5.4 to 5.8
disclosure of interests to the reviewing IRB

Follow the protocol, sponsor or IRB requirement where it is stricter than this SOP. When a study is funded by the Public Health Service (for example, NIH), 42 CFR 50 Subpart F also applies (5.8).

3. Responsibilities

Role	Responsibilities
Principal Investigator (PI)	Provides accurate financial disclosure for themself, their spouse and dependent children to each sponsor before participating, and updates it during the study and for 1 year after completion. Makes sure each Sub-I does the same. Completes the site COI disclosure. Follows any management plan.
Sub-Investigator (Sub-I)	Same duties as the PI for their own financial disclosure and site COI disclosure.
Regulatory Coordinator	Collects, checks for completeness and sends sponsor financial disclosure forms. Tracks the update period for each study. Files copies in the ISF. Answers IRB COI questions in submissions using current disclosures.
Quality Lead	Runs the site COI disclosure cycle on F-104-01. Reviews disclosures with the Site Director and keeps COI determinations and management plans.
Site Director	Makes COI determinations with the Quality Lead. Approves management plans. Discloses site-level (institutional) interests. Where the Site Director has a conflict, the PI not involved or an external reviewer takes their place.
Finance / Contracts Lead	Tells the Regulatory Coordinator about sponsor payments to the site that may be reportable as significant payments of other sorts (5.1.5). Flags contract terms that tie payment to study outcome.
All Research Staff	Complete F-104-01 at hire, annually and when an interest changes. Do not accept payments, gifts or roles from sponsors that conflict with this SOP.

4. Definitions

Term	Definition
Clinical Investigator (21 CFR 54)	Only a listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects. Includes the spouse and each dependent child of the investigator (21 CFR 54.2(d)).
Covered Clinical Study	A study of a drug, biologic or device that the applicant or FDA relies on to establish effectiveness, or in which a single investigator makes a significant contribution to the demonstration of safety (21 CFR 54.2(e)). The sponsor decides whether a study is covered; most sponsors collect disclosure for every investigator in every study.
Compensation Affected by the Outcome	Compensation that could be higher for a favorable outcome than an unfavorable one, for example payment explicitly greater for a favorable result, equity in the sponsor, or royalties tied to product sales (21 CFR 54.2(a)).
Significant Equity Interest	Any ownership interest, stock options or other financial interest in the sponsor whose value cannot be readily determined from public prices, or any equity interest in a publicly traded sponsor that exceeds $50,000, during the study and for 1 year after completion (21 CFR 54.2(b)).
Proprietary Interest in the Tested Product	Property or other financial interest in the product, including a patent, trademark, copyright or licensing agreement (21 CFR 54.2(c)).
Significant Payments of Other Sorts	Payments from the sponsor to the investigator or the institution to support the investigator's activities, worth more than $25,000 in total, not counting the costs of conducting the study or other clinical studies, during the study and for 1 year after completion (21 CFR 54.2(f)). Examples: research grants, equipment, retainers for ongoing consultation, honoraria.
Form FDA 3454 / Form FDA 3455	Certification (3454) and Disclosure (3455) forms that the applicant (the sponsor) submits to FDA with a marketing application. Investigators do not file these forms; they give the sponsor the information the sponsor needs to complete them.
Conflict of Interest (COI)	A financial or other interest, or a relationship, that could affect, or appear to affect, a person's judgment in conducting or reporting research.
Institutional Conflict of Interest	A financial interest of [SITE NAME] itself, or of its owners or directors acting for it, that could affect, or appear to affect, the site's research.
Management Plan	A written plan approved under 5.5 that sets the actions taken to reduce, manage or eliminate a conflict.

5. Procedure

5.1.1

At study start-up, the Regulatory Coordinator sends the sponsor's financial disclosure form to the PI and each Sub-I listed on the 1572 or device investigator records. If the sponsor has no form, the Regulatory Coordinator uses the content of 5.1.2 in a site letter or F-104-01.

5.1.2

Each investigator discloses, for themself, their spouse and each dependent child, any of the following related to the sponsor of the study or the tested product:

compensation affected by the outcome of the study
significant equity interest in the sponsor
proprietary interest in the tested product
significant payments of other sorts from the sponsor

5.1.3

The investigator answers from current information, reviews their own records (brokerage statements, consulting agreements, Open Payments data) where needed, and signs and dates the form. Stating "none" requires the same review.

5.1.4

The Regulatory Coordinator checks each returned form for completeness (every question answered, signed, dated, correct study and sponsor) before sending it, sends it to the sponsor, and files a copy in the ISF. An investigator does not begin study activities until the sponsor has received a complete disclosure, unless the sponsor confirms otherwise in writing.

5.1.5

The Finance / Contracts Lead gives the Regulatory Coordinator a list of payments from the study's sponsor to [SITE NAME] that are not study costs (for example, advisory fees paid to the site, equipment grants, sponsored training). The Regulatory Coordinator shares the list with each investigator before they complete the disclosure.

5.2.1

Each investigator tells the Regulatory Coordinator promptly, and no later than [DEFAULT: 30 calendar days], after any relevant change in the interests in 5.1.2. This duty continues during the study and for 1 year after completion of the study (21 CFR 54.4(b); 21 CFR 312.64(d); 21 CFR 812.110(d)). Examples of relevant changes: buying sponsor stock that takes holdings over $50,000, signing a consulting agreement with the sponsor, a spouse taking a job with equity at the sponsor, licensing a patent to the sponsor.

5.2.2

The Regulatory Coordinator sends updated information to the sponsor promptly, on the sponsor's form if it has one, and files a copy in the ISF.

5.2.3

The Regulatory Coordinator records for each study the date the investigator's participation ends and the end date of the 1-year update period. Where the sponsor defines study completion differently (for example, completion at all sites), the Regulatory Coordinator records the sponsor's date. Closeout includes a reminder to investigators of the continuing duty (SOP-601 Study Closeout).

5.2.4

At the end of the 1-year period, the Regulatory Coordinator asks each investigator to confirm there were no unreported changes, sends any update to the sponsor if the sponsor asks for one, and records the confirmation in the study file.

5.2.5

When a new Sub-I is added during the study, 5.1 applies to that person before they begin study activities.

5.3 Investigators who are IRB members

5.3.1

An investigator who is a member of the reviewing IRB does not take part in the IRB's initial or continuing review of a study in which they have a conflicting interest, except to provide information the IRB requests (21 CFR 56.107(e)). The investigator asks the IRB to record the recusal.

5.4 Site COI disclosure

5.4.1

All research staff, the site's owners and its directors complete F-104-01 Conflict of Interest and Financial Interest Disclosure:

at hire or before first research activity
at least [DEFAULT: annually]
within [DEFAULT: 30 calendar days] of acquiring a new interest or relationship that F-104-01 asks about
before starting a study whose sponsor or product they have an interest in

5.4.2

F-104-01 asks about, for the person, their spouse or partner and dependent children:

equity, stock options or ownership in any company that sponsors or manufactures products studied at [SITE NAME]
consulting, advisory board, speaker or other paid roles with such companies, with approximate annual amounts
patents, royalties or licensing income related to products studied at the site
gifts, travel or meals from such companies beyond those permitted by site policy
employment of a family member by a sponsor or CRO
non-financial interests, such as a leadership role in a patient advocacy organization or a close personal relationship with a sponsor employee who manages the site's studies

5.4.3

The Quality Lead reviews each F-104-01 within [DEFAULT: 15 business days] of receipt and refers any reported interest to 5.5.

5.4.4

Staff do not accept compensation from a sponsor or CRO that is tied to enrollment numbers or study outcome for their personal benefit, outside the site's study contract and budget.

Network note: In Model N, F-104-01 also asks about, for the person and their family members in 5.4.2: any ownership, equity, profit share or board role in the Network Office, its parent or investors, or another member site; and any compensation tied to the number of studies or participants allocated to a member site. A PI or Site Director who owns part of a member site or of the network discloses it. In Model N, finder's fees and per-referral bonuses are prohibited across the network (SOP-902, 5.7.2), and the site decision in 5.4.4 cannot permit them. N-Affiliated: payments between member sites, or from the Network Office to a member site, for referring participants or studies are referral payments between separate entities. Where any related item or service is billed to Medicare, Medicaid or another federal health care program, such payments can create risk under the Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)). The Site Director sends any such payment term to [LEGAL COUNSEL] before it is agreed (SOP-201).

5.5 COI review and management

5.5.1

The Quality Lead and Site Director review each reported interest against the studies the person works on or may work on. Where either reviewer has the interest under review, the PI not involved in the interest takes their place; where no such PI exists, or the owner, PI and Site Director are the same person, the independent reviewer named at adoption under SOP-102 5.3 takes their place. A person with the interest under review does not select, replace or direct the reviewer.

5.5.2

The reviewers record one determination on F-104-01:

no conflict: the interest is unrelated to any study the person works on
conflict, managed: the person may continue under a management plan
conflict, not manageable: the person does not take part in the affected study, or the site declines the study

5.5.3

A management plan names the study, the interest and the controls, chosen from or in addition to:

disclosure of the interest to the IRB and, if the IRB requires, to participants in the consent form
the conflicted person does not obtain consent, determine eligibility, assess AE causality or assess efficacy endpoints for the study
an investigator without the interest reviews the conflicted person's eligibility and safety decisions
the conflicted person reduces or divests the interest
the conflicted person does not serve as PI for the study

5.5.4

The Site Director approves the management plan. The person and the PI sign it. The Quality Lead files it with F-104-01 and checks compliance with the plan during internal QC (SOP-700 Internal Quality Control and Quality Assurance Audits).

Network note: In Model N, conflicts of people who work at more than one member site or for the Network Office, and conflicts involving network ownership, are reviewed by the Network Quality Lead and a network executive without the interest (Appendix B, SOP-104 rows). A person with an ownership, equity or compensation interest in a member site does not recommend or decide an allocation that affects that site, and the decision maker records any such interest on F-902-01 Study Allocation Decision Record (SOP-902 Network Study Feasibility, Allocation and Central Contracting, 5.4.3.1). N-Affiliated: each member site makes the COI determination and management plan for its own staff and keeps the record. The Network Office can set network conditions, such as not allocating a study to a conflicted PI, but cannot impose a management plan on another entity's employee except as the network or affiliation agreement allows.

5.5.5

A conflict that is not disclosed, or a management plan that is not followed, is handled as noncompliance under SOP-308 Protocol Deviations and Noncompliance and, where it may affect data integrity, under SOP-704 Research Misconduct and Fraud Reporting.

5.6 Disclosure to the IRB

5.6.1

The Regulatory Coordinator answers the reviewing IRB's COI questions in the initial submission using the current sponsor disclosures and F-104-01 records. IRB disclosure thresholds and the people covered may differ from 21 CFR 54; the Regulatory Coordinator follows the IRB's definitions (SOP-203 IRB Submissions, Approval and Continuing Oversight).

5.6.2

The Regulatory Coordinator reports new or changed interests to the IRB in the timeframe the IRB's policy sets, and submits any consent form change the IRB requires to disclose the interest.

5.6.3

The Regulatory Coordinator files IRB COI correspondence and determinations in the ISF.

5.7 Institutional conflicts of interest

5.7.1

The Site Director discloses on F-104-01 any financial interest of [SITE NAME], its parent company or its owners in a sponsor, CRO or product studied at the site (for example, equity held by an investor in the site, a revenue-sharing agreement with a sponsor, or a royalty).

5.7.2

The Quality Lead and an investigator without the interest review institutional interests under 5.5 (where the Site Director or an owner holds the interest, or the available investigator reports to that person, the independent reviewer named under SOP-102 5.3 takes the investigator's place) and decide what to disclose to the IRB and to sponsors. The Site Director discloses institutional interests to the IRB when the IRB's submission asks for them.

5.8 PHS-funded research

5.8.1

When a study is funded by a Public Health Service agency (for example, NIH), [SITE NAME] follows 42 CFR 50 Subpart F, including a written, publicly accessible financial conflict of interest policy, investigator disclosure of significant financial interests, investigator training before engaging in the research and at least every 4 years, and reporting of financial conflicts to the funding agency. The Quality Lead adds the PHS-specific requirements to the study's file before the award is accepted.

5.9 Open Payments

5.9.1

Manufacturers report research payments and other transfers of value to physicians, certain non-physician practitioners and teaching hospitals in the CMS Open Payments database. Each investigator should review their own Open Payments record [DEFAULT: annually, during the CMS review and dispute period] and use it to check the accuracy of their disclosures under 5.1 and 5.4.

5.10 Records

5.10.1

The Regulatory Coordinator files sponsor financial disclosure forms and updates in the ISF for each study. The Quality Lead keeps F-104-01 disclosures, determinations and management plans in a confidential COI file.

5.10.2

COI records are kept for at least the retention period of every study they relate to (SOP-402 Record Retention, Archiving and Destruction).

F-104-01 Conflict of Interest and Financial Interest Disclosure
F-204-01 Investigator Site File Index
Appendix B Central and Site Responsibility Matrix (Model N only)
SOP-101 Roles and Responsibilities of the Principal Investigator
SOP-203 IRB Submissions, Approval and Continuing Oversight
SOP-300 Participant Recruitment, Pre-Screening and Advertising
SOP-308 Protocol Deviations and Noncompliance
SOP-402 Record Retention, Archiving and Destruction
SOP-601 Study Closeout
SOP-700 Internal Quality Control and Quality Assurance Audits
SOP-704 Research Misconduct and Fraud Reporting
SOP-902 Network Study Feasibility, Allocation and Central Contracting (Model N only)

7. References

Reference	Title
21 CFR 54	Financial Disclosure by Clinical Investigators
21 CFR 312.64(d)	Investigator reports: financial disclosure reports
21 CFR 812.43(c)(5)	Investigator agreements: financial disclosure
21 CFR 812.110(d)	Specific responsibilities of investigators: financial disclosure
21 CFR 56.107(e)	IRB membership: members with a conflicting interest
42 CFR 50 Subpart F	Promoting Objectivity in Research (PHS-funded research)
42 CFR 403 Subpart I	Transparency Reports and Reporting of Physician Ownership or Investment Interests (Open Payments)
42 U.S.C. 1320a-7b(b)	Anti-Kickback Statute (Model N payments between entities)
ICH E6(R3) Principle 1	Ethical conduct of clinical trials
FDA Guidance (2013)	Financial Disclosure by Clinical Investigators

Independent Site SOP Library. Licensed CC BY-NC 4.0 by the American Institute for Medical Research (AIMR), with added permission for any site's internal use (license terms). Not legal advice: each adopting site confirms state law, IRB and sponsor requirements with its own counsel and owns every step it approves.