The first time anyone handed me a conflict of interest form, I was an advisor on my first clinical trial. I did not know enough to know whether I had one.

This issue is about a calendar nobody is in charge of. Two hundred health observances, most of them built by people with the condition and the organizations they belong to, renewed one statehouse at a time.

Those organizations have funders. So do the coalitions that ask for the proclamations, the groups that print the ribbons, and the people who sit on the advisory boards once the month is over and the research begins.

Every entry on that calendar has money somewhere behind it. There is no place to look it up.

Researchers are different. Every investigator on a federally funded study fills out a form about money. It asks what they have been paid, by whom, and whether any of it could bend the work. The form goes to their institution, the institution decides whether there is a problem, and if there is, the answer is on file where the public can ask for it.

Most people with lived experience never see that form.

Not because we are trusted more. Because the rule that requires it was written for a job title most of us are not given.

This piece is about that rule, the one public registry that also skips us, the one funder whose definition of a conflict reaches further than money, and what to say about yourself before anyone thinks to ask. It is also, once and for all, an explanation of why every article in this newsletter opens the way this one does.

What the rule says

The regulation dates from 1995 and was rewritten in 2011. It applies to anyone the rule calls an Investigator: the principal investigator, and any other person, regardless of title, who is responsible for the design, conduct, or reporting of the research. The regulation adds that this may include collaborators or consultants.

Read that definition again with yourself in mind. If you helped shape the research question, you had a hand in the design. If you co-wrote the plain-language summary, you had a hand in the reporting. On the plain words, a person with lived experience (PWLE) doing real partnership work fits.

What counts as a conflict is narrower than most people expect. The rule looks for a significant financial interest: more than $5,000 from one outside entity in the previous twelve months, counting honoraria, consulting fees, and paid authorship together, or any ownership stake in a private company, or income from a patent. Sponsored travel has to be reported too. Then the institution decides whether that interest could affect the research. If it could, the institution manages it, tells the funder, and has to make the basics available to anyone who asks, within five business days.

Here is the part that surprised me. The rule does not count money from service on advisory committees or review panels for a government agency, a university, or an academic medical center. Under the rule as written, most of what I listed at the top of this page would not be a significant financial interest at all.

The rule was written for a different kind of money than the kind most of us are paid.

Why it usually skips us

The institution decides who is an Investigator. It names them in the grant. Advisory board members, patient partners, and community co-investigators are often left off that list, sometimes deliberately, because naming someone triggers paperwork. Practice varies by university, and some do treat patient partners as Investigators. Most do not, and there is no rule requiring them to decide one way or the other in writing.

So the form never comes. That has two consequences, and only one of them is about us.

The first is that the study has no record of what its partners might be carrying into the room. A person with pain who also sits on a company’s patient council, or whose support group runs on a manufacturer’s grant, or who is hoping the study funds a second year of their own paid role, may be an excellent partner. The team should still know.

The second is that we have no record either. When the form is never offered, there is no file that says we were asked and answered. A researcher with a managed conflict has a paper trail proving it was handled. We have nothing.

The registry that also skips us

There is a second place the public can look, and it has the same gap. Open Payments, run by the Centers for Medicare & Medicaid Services (CMS), publishes every payment a drug or device company makes to a physician, a teaching hospital, and since 2021 to physician assistants, nurse practitioners, and several other clinical roles. You can search any doctor by name.

You cannot search a patient advocate. You cannot search an advocacy organization. Some companies publish their grants to patient groups voluntarily. There is no rule that they must, and no single place to look.

Go back to the calendar. “Who Gets a Month?” in this issue shows that most entries on it were built by people with the condition and the organizations they belong to. Those organizations have funders. I do not know who funds each entry on the list, and neither do you, because there is no place to look.

I am not saying the months are bought. I am saying nobody can show you that they are not, and that is a different kind of problem.

The funder whose definition reaches further

PCORI does something different, and it is worth knowing because it is the model I would hand any team.

PCORI’s authorizing law defines a conflict of interest as an association, including a financial or personal association, that has the potential to bias or has the appearance of biasing a person’s decisions. Not only money. Associations. Every advisory panel member fills out a disclosure form, updates it when something changes, and PCORI posts the disclosures publicly.

That definition is the one this newsletter borrowed. Every PWLE Voices article opens with a first-person note naming the relationships that could look like an interest: who pays me and how, and who I sit in rooms with. It goes at the top rather than the bottom because a reader should know it before they read, not after. And it names the form the money takes, because an honorarium, a stipend, a salary, and a stake in a grant that has not been funded yet are four different things, and a reader can tell the difference.

A disclosure is not a confession. Said first, it is the credential.

The sentence

Here is the one to have ready. Fill in what applies and drop what does not.

“Before I say anything: I [serve on / review for / advise] [organization], which pays me [an honorarium per meeting / a stipend / nothing]. I also [belong to / have a relationship with] [organization or person] that touches this work. If that changes how you weigh what I say, weigh it.”

Four things belong in it. Money, with its form and rough scale. Relationships, including the organization that sent you and the person who recommended you. Anything contingent, such as a role that gets paid only if this study is funded. And travel, if someone else is paying for the trip. If a fifth thing is nagging at you, it belongs in too.

Four things to ask

• Am I an Investigator on this study? The institution decides. Ask them to decide out loud, and to put it in your role description either way.
• Where is the form? If you are an Investigator, the training and the disclosure are required. If you are not, ask for the form anyway and ask that it be kept with the others.
• What do I do when something changes? Investigators have thirty days to report a new interest. Ask the team what they want from you, and write it down.
• Where do I say it in what we publish? If you are an author on the paper, the journal’s disclosure form is yours too. If you are quoted in a lay summary or a press release, ask that your relationship to the study be stated there.

For the research chair

If you run a study, here is what people with pain have asked me to pass along.

Decide whether each partner is an Investigator, say so in writing, and give every partner the disclosure form regardless. Keeping our answers in the same file as yours costs you one folder. Leaving us out of the file protects nobody, and it leaves us without the record you have.

Ask the question the way PCORI asks it. Associations, not only dollars. Who sent this partner, and what organization do they answer to on Tuesday nights.

Then return the favor. Tell your partners who funds the study, who funds you, and whether anyone on the team has an interest the institution is managing. We are asked to sit at your table and trust the work. We should know what you know about the money.

What this does not solve

A form is not integrity. It is a record. A partner can disclose everything and still argue for the outcome their funder wants, and a partner with no ties at all can still be wrong. Disclosure lets the room weigh what it hears. It does not do the weighing.

It also does not fix the fact that most of us are paid in amounts the rule was not written to notice. A person on Supplemental Security Income can be put at risk by an honorarium the regulation ignores entirely. That is a different problem, and this newsletter has written about it before.

Where this leaves us

Nobody hands out the months. Nobody hands us the form that says what we carried into the room.

Both gaps close the same way. Not by waiting for an office that does not exist. By saying it first, at the top, every time, and asking the team to keep our answers where they keep their own.

— Tom