MMSx Authority› Research› Governance & Ethics
GCP ICH E6(R3) · Declaration of Helsinki · IREB Approved

Research Governance & Ethics

MMSx Authority Institute operates under a comprehensive multi-pathway ethics governance framework — applying the Declaration of Helsinki, GCP ICH E6(R3), and international reporting standards to all registered studies, framework development programmes, and systematic review outputs.

3ClinicalTrials.gov Registered
0Protocol Deviations Reported
IREBEthics Approval /2024/067
GCPICH E6(R3) Compliant
Institutional Commitment

Core Compliance Framework

All MMSx Authority research is governed by internationally recognised ethical standards. Compliance is not selective — every study type has a defined ethics pathway and governance protocol.

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Institutional Ethics Declaration

MMSx Authority Institute affirms that all human-subjects research is conducted in accordance with the Declaration of Helsinki (WMA, 2013), ICH-GCP E6(R3) guidelines, and applicable national regulations including 45 CFR 46 (Common Rule). All clinical investigations involving human participants are prospectively registered on ClinicalTrials.gov prior to enrolment. No data is collected, processed, or published without appropriate ethics approval and participant informed consent.

Declaration of Helsinki GCP ICH E6(R3) 45 CFR 46 · Common Rule IREB/2024/067 Pre-Registration Required Informed Consent Required Zero SAE Tolerance
Ethics Governance

Four Research Ethics Pathways

MMSx Authority applies differentiated ethics pathways based on the research design type — ensuring appropriate oversight without imposing clinical trial governance requirements on non-interventional work.

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Active
A
Pathway A
Controlled Human Participants Research — ClinicalTrials.gov Registered
  • Applies to: NCT07220200 · NCT07296640 · NCT07256717
  • Full IREB ethics review and approval (IREB/2024/067)
  • Declaration of Helsinki compliance required
  • GCP ICH E6(R3) — full Good Clinical Practice adherence
  • Prospective ClinicalTrials.gov registration before first enrolment
  • Written informed consent — all participants
  • Safety monitoring — SAE reporting within 24 hours
  • 45 CFR 46 (US Common Rule) applicable where required
  • Protocol deviation reporting and CAPA procedures
  • CONSORT reporting standards at publication
Active
B
Pathway B
Framework Development & Validation Research
  • Applies to: BPIT · FIKCC · MOLOCH · NEEBAL™ · MOVE (non-trial)
  • Methodological governance under MMSx Institutional Framework
  • No trial registration required (non-interventional)
  • Systematic documentation of methods and validation process
  • Peer-review required before publication claim of "validation"
  • IMSO standards registry submission for formal frameworks
  • Conflict of interest disclosure required from all authors
  • Version control — all framework iterations archived
Active
C
Pathway C
Systematic Reviews, Meta-Analyses & Literature Syntheses
  • Applies to: MMSx-STU-005 · STU-006 · STU-007 · STU-010 (BOST)
  • PROSPERO registration for systematic reviews (where applicable)
  • PRISMA 2020 reporting standards mandatory
  • STROBE compliance for observational study components
  • Study selection criteria pre-specified and documented
  • Quality appraisal using validated tools (RoB 2, GRADE)
  • Data extraction double-checked by independent reviewer
  • Conflict of interest disclosed for all included studies
Developing
D
Pathway D
AI Platform & Digital Tool Validation Research
  • Applies to: MMSx-STU-013 · STU-017 · TrainersEye Tools · BLMAL™
  • Pathway D governance framework under development (2026)
  • AI model transparency — XAI explainability required
  • Algorithmic bias assessment mandatory before clinical deployment
  • User data governance — no PII stored without explicit consent
  • Clinical decision support tools require clinical oversight designation
  • TRIPOD-AI reporting standards for predictive model studies
  • Open-source model availability where scientifically appropriate
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Note on Framework Studies (Pathway B): Framework development studies (e.g., BPIT, MOLOCH, FIKCC) that do not involve prospective data collection from human subjects do not require clinical trial registration. This distinction is consistent with international guidelines including WHO and ICMJE requirements. Observational sub-studies within Pathway B are assessed individually for appropriate ethics review requirements.

Reporting Compliance

International Reporting Standards

MMSx Authority mandates adherence to internationally recognised reporting standards at publication for all study types. These ensure reproducibility, transparency, and scientific validity of all published outputs.

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CONSORT
Consolidated Standards of Reporting Trials
Required for all randomised and interventional trial designs. 25-item checklist for complete, transparent reporting of trial methods, results, and participant flow.
Pathway A
STROBE
Strengthening the Reporting of Observational Studies in Epidemiology
Applied to observational, cross-sectional, and case-series designs. Ensures complete reporting of exposure, outcome, and confounding variable information.
Pathway APathway C
PRISMA
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Mandatory for all systematic reviews and meta-analyses. 27-item checklist and flow diagram. PRISMA 2020 edition applies.
Pathway C
GCP
Good Clinical Practice — ICH E6(R3)
International standard for design, conduct, monitoring, auditing, recording, analysis, and reporting of clinical trials. Applied to all Pathway A studies.
Pathway A
Helsinki
Declaration of Helsinki — WMA 2013
Fundamental ethical principles for medical research involving human subjects. All participant-facing research at MMSx Authority must comply. Non-negotiable baseline.
Pathway APathway B
TRIPOD
Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis
Applied to AI/ML prediction model studies including XAI injury prediction and BLMAL™ adaptive learning framework validation.
Pathway D
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BOST — Biomechanical Outcomes Systematic Tool (under development): MMSx Authority is developing the BOST framework as a domain-specific reporting standard for musculoskeletal biomechanics intervention research. BOST will complement CONSORT by specifying biomechanics-relevant outcome domains, validated instruments, and minimum reporting requirements. Submission to IMSO Standards Registry is planned for 2026.

Participant Protection

Participant Rights & Protections

All participants in MMSx Authority clinical research hold the following rights, which are communicated at enrolment and maintained throughout the study.

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Informed Consent
Written informed consent required before any data collection. Participants receive full study information in plain language prior to enrolment. Right to withdraw without consequence.
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Data Privacy
All identifiable data is anonymised before analysis. No participant-level personal data is publicly released. Data retained only for the period specified in the ethics protocol.
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Right to Withdraw
Participants may withdraw at any time without providing a reason and without penalty or disadvantage. Withdrawal may include request for data deletion.
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Safety Monitoring
All Pathway A studies include active adverse event monitoring. Serious adverse events (SAEs) are reported within 24 hours per GCP requirements. Participant welfare is the primary priority.
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Results Access
Participants are entitled to summary results upon study completion. All MMSx Authority results are published open-access via JMMBS and Zenodo — freely available to all.
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Ethics Oversight
Independent ethics review via IREB (IREB/2024/067). Participant concerns or complaints can be directed to the ethics committee independently of the research team.
Integrity Policies

Conflict of Interest & Data Handling

Conflict of Interest Policy

  • All authors and contributors must disclose financial, professional, and personal conflicts of interest prior to submission of any research output.
  • The Principal Investigator (Dr. Neeraj Mehta, PhD) is identified in all registered studies and publications with ORCID 0000-0001-6200-8495.
  • No MMSx Authority framework, protocol, or tool may be promoted as "validated" without documented peer-review or clinical trial evidence.
  • Institutional funding disclosures — MMSx Authority Institute is a 501(c)(3) nonprofit. No industry funding has been received for any registered clinical study.
  • Journal (JMMBS) editorial independence is maintained — the editor-in-chief does not make final decisions on manuscripts where a conflict is declared.
  • Review panel conflicts are managed through recusal — reviewers with declared COI are excluded from the review process for affected manuscripts.
Collection

Data is collected using validated instruments only. All collection methods are pre-specified in the study protocol prior to enrolment. No ad-hoc outcome changes are permitted after enrolment begins (outcome-switching).

Storage & Security

All participant data is stored on password-protected, encrypted systems with access restricted to named study personnel. Raw data retention period is defined in each ethics protocol, minimum 5 years post-publication.

Publication & Access

Aggregate anonymised results are published open-access via JMMBS (DOI 10.66078) and archived on Zenodo and OSF with permanent DOIs. Participant-level data is never released publicly without separate ethics approval.

Standards Registry

IMSO — Institutional Standards Integration

MMSx Authority frameworks and protocols that meet the threshold of a formal scientific standard are submitted to the IMSO International Movement Standards Organization registry.

International Movement Standards Organization

IMSO provides the formal standards registry infrastructure for MMSx Authority framework publications. Registered standards carry an IMSO-REG identifier, version history, and public access URL — functioning as the movement science equivalent of an ISO standard registration. MOVE Protocol is registered: IMSO-REG-20251021-PM-6994-A.

Visit IMSO ↗ Ethics Pathways ↑
Research Governance

Questions on Ethics & Governance?

All ethics-related enquiries, participant concerns, and governance questions should be directed to the MMSx Authority Research Office. We are committed to full transparency in our research operations.

Contact Research Office → Study Registry → ClinicalTrials.gov ↗