FMRIFight Medicine Research Institute

Participant protection

How FMRI proposes to protect any fighter who takes part in its research. External ethics review is planned. No agreement has been signed and no approval is held.

Scope and status

This policy applies to any FMRI research that involves people or their identifiable private information. It is a proposal and takes effect when the owner confirms its adoption.

As of this draft:

  • FMRI has not started any study and is not recruiting participants.
  • FMRI has not signed an agreement with any Institutional Review Board (IRB).
  • FMRI holds no IRB approval, no exemption determination and no Federalwide Assurance.

FMRI will update this page when any of those facts changes. Until then, external ethics review is planned, not in place.

Independent external IRB review

FMRI will arrange independent external IRB review for its human-participant research. FMRI will not review its own studies.

Before any study is submitted, FMRI will sign a written reliance or service agreement with the reviewing IRB. The agreement must set out who is responsible for what, including review, reporting, record keeping and communication with participants.

FMRI is evaluating commercial independent IRBs. Providers under consideration include Advarra and WCG IRB. FMRI has no agreement with either. Neither is a partner of FMRI, and neither has reviewed or endorsed FMRI or its work.

Determinations before research begins

Before FMRI recruits anyone, or accesses identifiable private information for research, it must hold the written determination that applies to the project:

  • IRB approval; or
  • an exemption determination; or
  • a determination that the project is not human-subjects research.

The determination must come from a designated independent review process. Investigators must not authorize their own exemptions. An investigator’s belief that a project is exempt, or is not human-subjects research, is not a determination.

Project register

FMRI will keep a register of every project. For each project it records:

  • the reviewing body;
  • the determination;
  • the protocol version reviewed;
  • the dates of submission, determination and expiry, where one applies;
  • any conditions attached;
  • the reporting and continuing-review obligations that apply.

The register is the single record of what FMRI may and may not do under each determination.

Amendments

A change to an approved study must be approved before it is put into practice. The only exception is a change needed to remove an immediate hazard to participants. FMRI will document any such change and report it to the reviewing body promptly.

Federalwide Assurance

A Federalwide Assurance (FWA) is required for institutions engaged in nonexempt human-subjects research that is conducted or supported by the U.S. Department of Health and Human Services (HHS).

FMRI will assess whether an FWA is required for each funding and research arrangement, and will obtain one when it is. FMRI will not display an FWA number or claim registration until an assurance has been approved.

Official references: HHS on IRBs and assurances and HHS assurance process questions and answers.

Voluntary participation

Taking part in FMRI research is voluntary. A fighter who declines, or who withdraws, must lose nothing by it. Declining or withdrawing must not affect:

  • licensing;
  • bout selection;
  • purses;
  • rankings;
  • medical care;
  • access to ordinary services.

FMRI will not sign a recruitment agreement with a promotion, gym, manager or commission unless the agreement supports this protection in writing.

Power relationships

Fighters depend on people who control their careers. A request from one of those people is hard to refuse.

Recruitment and consent must be kept separate from decisions controlled by commissioners, promoters, managers, coaches and the personnel who clear fighters to compete. None of them may recruit for an FMRI study, be present when a fighter decides, or be told who agreed and who declined.

Where a dependent relationship or possible duress exists, consent must be obtained by qualified personnel who are independent of that relationship.

Each study that could enroll a fighter soon after a bout or a head impact must have a protocol-specific process for assessing whether the fighter has the capacity to consent.

FMRI will not rely on the signature of an acutely impaired fighter as valid consent. A fighter who has just been knocked out, stopped or visibly hurt is not asked to decide then.

Any pathway that relies on a representative’s consent, or on rules for emergency research, requires its own legal basis and ethics-review basis before it is used.

Clinical priority

Care comes before research. A study must never delay emergency assessment, treatment, transport or necessary clinical reporting.

Each protocol must name who is responsible for clinical oversight and how a fighter is referred for care when a research procedure finds something that needs attention.

Mental health and suicide risk

Before a study collects identifiable information about suicide risk, FMRI must have in place:

  • a qualified clinical response;
  • written criteria for escalation;
  • named monitoring responsibilities;
  • response timeframes;
  • a plain statement of the limits of confidentiality, given to participants before they answer;
  • referral arrangements.

Monitoring and independent safety oversight must match the risks of the study. A study that cannot meet these conditions does not collect the information.

This website does not collect suicide-risk information. If you are in the United States and need help now, call or text 988 to reach the 988 Suicide & Crisis Lifeline.

Injury and safety reporting

Each study must have:

  • a procedure for reporting adverse events;
  • safety review by people independent of the study team, scaled to the risk;
  • written criteria for pausing the research;
  • arrangements that address research-related harm, explained to participants before they consent.

Confidentiality

FMRI will:

  • collect only the information a study needs;
  • restrict access by role;
  • store identifiers separately from research data;
  • encrypt sensitive data;
  • define how long data is kept and how it is deleted;
  • control data sharing through written agreements.

Fighters are a small population with public records. A weight class, a date and a result can identify a person. Each study must address the risk of re-identification from small groups and identifiable bout histories before any data is shared or published.

Data disclosures

Before a fighter consents, FMRI must explain what information may be shared, with whom, for what reason, and under what authorization or legal duty. That includes any disclosure to clinicians, to commissions or to other parties.

Research findings about an individual fighter are not given to a commission, a promoter, a manager or a coach unless the fighter authorizes it or the law requires it. The consent materials must state any legal duty that could require disclosure.

Compensation and withdrawal

Consent materials must explain:

  • any payment and any reimbursement of costs;
  • that payment does not depend on the answers a fighter gives;
  • how to withdraw, and that no reason is needed;
  • what can happen to data already collected when a fighter withdraws.

Feedback and concerns

FMRI will offer participants the results of the research in language they can understand.

Participants must have a way to raise a concern that does not go through the study investigator. The route is described in the governance charter.

Foundations

This policy rests on three documents: