Who Manages Conflicts, and Your Part in It

Part of Conflict of Interest in Clinical Research: What a Conflict of Interest Is and Why It Matters.

About 5 minutes. Free, in your language, no account needed.

Expert review pending. CRLN wrote this lesson against the primary sources listed under References. A subject-matter expert has not yet reviewed it. Where your institution's policy or your sponsor's instructions are stricter, follow them.

Why this matters

Conflict of interest management is shared work. Each party sees part of the picture and has a defined job. When site staff know who does what, they know where a disclosure goes, and they stop assuming that someone else has already dealt with it.

You

Every person on the study team is responsible for noticing their own conflicts and saying so. That includes staff who are never asked to fill in a federal form. Your institution's policy, your employment terms and the sponsor's procedures may all ask you to disclose, and none of them can work if you stay silent.

You also have a part in other people's conflicts. If you see something that looks like an undisclosed interest, such as a colleague receiving gifts from a sponsor representative, you raise it through the route your site uses. Module 5 covers escalation.

The investigator

The investigator leads the site's conduct of the trial. Under ICH E6(R3), the investigator may delegate trial activities but keeps ultimate responsibility and must maintain oversight of the people doing them (Annex 1 §2.3.1). That oversight includes knowing when a team member's conflict affects a delegated task.

In the United States, investigators also have their own disclosure duty under FDA rules, covered in Module 2.

The institution

Many sites belong to a hospital, university or health system with a conflict of interest office or committee. In US federally funded research this is required: an institution receiving Public Health Service research grants must keep an up-to-date, written, enforced conflict of interest policy that is publicly accessible (42 CFR 50.604(a)), designate an official to solicit and review disclosures (50.604(d)), and decide whether a disclosed interest is a financial conflict of interest (50.604(f)).

Independent sites and site networks without a hospital behind them often set their own policies and may rely on the IRB and sponsor for parts of the review. Learn which arrangement applies where you work.

The IRB or ethics committee

The IRB or independent ethics committee reviews the study before it starts and during it. Its own independence is protected: in the United States, no IRB member may take part in the initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB (21 CFR 56.107(e); 45 CFR 46.107(d)). ICH E6(R3) says only members independent of the investigator and the sponsor should vote or provide an opinion (Annex 1 §1.3.1). The Declaration of Helsinki says the research ethics committee must have the independence and authority to resist undue influence from the researcher, the sponsor or others (paragraph 23).

Many IRBs also ask investigators about financial interests and may require changes to the consent form or the study team. Follow your IRB's submission forms and instructions.

The sponsor

The sponsor arranges the financial side of the trial. ICH E6(R3) says the financial aspects should be documented in an agreement between the sponsor and the investigator or institution (Annex 1 §3.5). In the United States, the sponsor must collect financial disclosure information from each clinical investigator before letting the investigator begin participating in a drug study (21 CFR 312.53(c)(4)), and the applicant reports it to FDA later in any marketing application (21 CFR 54.4).

Regulators and funders

FDA uses disclosed interests when it judges the reliability of data. Federal funding agencies, through the Public Health Service rule, receive reports of financial conflicts from institutions. Outside the United States, national regulators and ethics committees set their own requirements; Module 3 gives regional pointers.

In practice

A new coordinator asks her manager where conflict disclosures go. The answer at her site has three parts: she completes the institution's annual disclosure form; the investigators also complete each sponsor's financial disclosure form for every study; and any change during a study goes to both the conflict office and the investigator the same week. She writes the three routes on the inside cover of her study binder.

Key takeaways

References