Governance & Ethics

Purpose and status

This charter sets out how Fight Medicine Research Institute (FMRI) proposes to govern itself and its research. It is a proposal. The rules below take effect only when the owner confirms their adoption, and this page will say so when that happens.

FMRI has not appointed a governing body, a scientific review committee, a fighter advisory council or any officer named in this charter. FMRI has not started a study. Nothing on this page should be read as a statement that a body exists, that a person has been appointed, or that an approval has been granted.

Research governance applies to FMRI whatever its tax status. FMRI is privately operated and is not a nonprofit. That does not lower any standard in this charter.

Organizational accountability

The operator of FMRI is responsible for:

• finances, including accurate records of income, spending and funders;
• contracts, including research, data and service agreements;
• staffing, and the training each person needs for the duties assigned to them;
• data stewardship, including security, retention and lawful use;
• insurance arrangements appropriate to the work being done;
• compliance with the laws and regulations that apply to FMRI and its research.

The operator answers to the governing body for each of these. The operator cannot waive a rule in this charter for a study, a funder or a deadline.

Governing body

FMRI will be overseen by a governing body. Its job is to hold the operator and the research program to this charter.

Independence. A majority of voting members must be independent of FMRI’s executive management and of any material study sponsor. A member is independent if they are not an employee, contractor, owner or immediate family member of the operator or of executive management, and have had no material financial relationship with a study sponsor in the previous 24 months.

Size and composition. The governing body has five to nine voting members. It must include at least one current or former fighter, at least one person with experience in research ethics or the protection of research participants, and at least one person with experience in research methods or biostatistics.

Appointments. The first members are appointed by the operator through a written process with stated criteria, and the record of that process is kept. After the first seating, the governing body fills its own seats by majority vote. The operator may nominate candidates and does not vote on the appointment of independent members.

Terms. A term lasts three years. First terms are staggered so that the whole body never turns over at once. A member may serve two consecutive terms.

Chair. Members elect a chair from among the independent members. A member of executive management cannot chair.

Quorum. A meeting has a quorum when a majority of voting members is present and independent members are a majority of those present. A member who is recused on an item does not count toward the quorum for that item.

Voting. Each member has one vote. Decisions pass by a majority of members present. A tied vote fails. There are no proxy votes.

Recorded decisions. Minutes record who attended, the conflicts declared, each recusal, each motion, the vote and the reasons. Minutes are approved at the next meeting and kept as a permanent record. FMRI publishes a summary of each decision that affects its research program.

Removal. A member may be removed for breaching the conflict rules, failing to disclose an interest, sustained absence or misconduct. Removal requires written notice, a chance to respond, and a two-thirds vote of the other members. The operator cannot remove an independent member alone.

Annual review. At least once a year the governing body reviews, and records its findings on:

1. finances;
2. research risks;
3. conflicts of interest and how they were managed;
4. compliance with FMRI’s policies;
5. the research program, including what was started, paused, completed and published.

The governing body meets at least twice a year. It may pause any FMRI research at any time.

Scientific review

No FMRI project starts until it has passed scientific review. Scientific review asks whether the study is worth doing and can answer its question. It covers:

• the rationale for the study;
• the relevant literature, including evidence against the study’s premise;
• the methods;
• feasibility, including whether enough fighters can take part without undue burden;
• the analysis plan;
• the competence of the investigators for the work proposed.

Each review includes biostatistical review suited to the study design. Reviewers must be independent of the study team. The outcome is written down as one of: approved, approved with conditions, returned for revision, or declined, with reasons.

Scientific review comes before ethics review and does not replace it. Human-participant research also requires the determinations set out in the participant protection policy.

FMRI will publish the names and qualifications of its scientific advisers only after their appointments are confirmed.

Fighter representation

FMRI will establish a fighter advisory council. Fighters must hold a majority of its seats, and it must include both active and retired fighters.

The council has a defined role in four areas:

1. Research priorities. The council is consulted before FMRI sets or changes its priorities.
2. Participant burden. The council reviews what each study asks of fighters: time, travel, tests, questions and risk.
3. Recruitment language. The council reviews recruitment and consent materials for plain meaning and for pressure, stated or implied.
4. Return of findings. The council advises on how results are reported back to the fighters who took part and to fighters in general.

Council members disclose their relevant financial relationships, including ties to promoters, managers, sponsors and commissions. FMRI may pay council members for their time. Any payment is disclosed.

FMRI records each council recommendation and what was done with it: adopted, adopted in part, or not adopted, with reasons. That record is published.

Conflicts and recusals

Every governing member, adviser, investigator and staff member with a role in research discloses their relevant interests once a year, and again for each study they take part in. Disclosures cover financial, professional, regulatory, promotional, publishing and other relevant interests.

FMRI keeps a register of conflicts. It records, at a minimum, interests involving:

• promoters and promotions;
• managers and management companies;
• athletic commissions and other regulators;
• sponsors and funders;
• equipment companies;
• publishers;
• investigators;
• members of the governing body.

Each recorded conflict has a written management plan. Each recusal is recorded in the minutes or the study file.

A conflicted person must not decide the matter that creates the conflict. Three applications of that rule are fixed:

• A person who holds a regulatory role over fighters, such as a commission member or official, must disclose it. That person must not recruit, obtain consent from, or make research decisions about fighters they regulate.
• A person with a financial or ownership interest in a publisher must disclose it. That person must not decide whether FMRI lists, features or describes that publisher’s works.
• A person with a financial interest in a promotion, a management company or an equipment maker must not decide the design, analysis or reporting of a study that could affect that interest.

Funding independence

For each study, FMRI identifies who funded it and what role the funder had in design, data collection, analysis, writing and the decision to publish.

Every research agreement must preserve:

• the investigators’ access to the study data;
• the investigators’ ability to publish the findings, including negative and inconclusive results;
• FMRI’s control of the analysis and the conclusions.

No funder may veto, delay without limit, or edit a publication. FMRI will decline funding offered on those terms.

Sponsorship disclosures are published beside the research they relate to. Editorial decisions on this website, including which research is listed and how it is described, are made independently of advertising and sponsorship.

This website does not solicit donations.

Research integrity and accountability

Each project has one named person who is responsible for it. One named role is responsible for research integrity across FMRI. FMRI will publish who holds each role once appointments are confirmed.

FMRI requires:

• secure, traceable research records, so that any reported result can be followed back to its data;
• training suited to each person’s assigned duties, completed before they begin those duties;
• written records of every protocol change, with the date, the reason and the approval obtained;
• a fair process for complaints about research conduct.

A complaint may be made by a participant, a staff member, a collaborator or a member of the public. The process must include an escalation route that does not pass through the person complained about or through executive management. A complaint can go directly to the chair of the governing body or to another independent member.

FMRI prohibits retaliation against anyone who raises a concern in good faith. Retaliation is itself a breach of this charter.

Publication and correction

FMRI follows the authorship and disclosure standards of the International Committee of Medical Journal Editors (ICMJE): authorship and disclosure of interests.

FMRI will:

• label every research record with an accurate study type and peer-review status;
• keep a version history for its own publications;
• publish correction notices that say what changed and when;
• follow a written retraction procedure;
• link original research to its journal or repository;
• credit outside authors, and describe FMRI’s actual contribution to any work it lists.

The full rules are in the Publication & Corrections Policy.