Research Ethics & Human Subjects Policy

Purpose

CELLMEX is committed to the ethical conduct of research involving human participants, patients, identifiable human information, human cells, tissues, biological specimens and other human-derived materials.

This policy establishes institutional principles for protecting the dignity, autonomy, safety, privacy, welfare and rights of individuals whose participation, medical information or biological materials contribute to CELLMEX research and translational activities.

Scope

This policy applies, where relevant, to CELLMEX activities involving human research participants; patients participating in prospective research; clinical investigations; observational studies; prospective registries and research databases; patient- and donor-derived cells and tissues; blood, umbilical-cord and perinatal tissues; adipose tissue, biopsies, bone marrow and immune-cell specimens; genomic or genetic information; identifiable clinical information; stored research specimens; and investigational cellular or cell-free biological technologies.

The policy applies to CELLMEX personnel, investigators, physicians, scientists, contractors, collaborators and research partners when conducting activities under CELLMEX responsibility.

Fundamental Ethical Principles

Applicable Ethical and Regulatory Framework

Human research undertaken or supported by CELLMEX should comply with applicable laws, regulations and ethical requirements in the jurisdiction where the research occurs.

Depending upon the nature and location of a project, relevant frameworks may include Mexican health and research regulations; applicable COFEPRIS requirements; applicable Mexican ethics and research committee requirements; institutional research policies; the principles of the Declaration of Helsinki; internationally recognised Good Clinical Practice principles; applicable privacy and data-protection legislation; and requirements in collaborating or sponsoring jurisdictions.

International guidance may provide important ethical standards but does not replace applicable national law or regulatory authorisation. Where multiple jurisdictions participate, responsibilities should be identified before research begins.

Independent Ethics Review

Research involving human participants should undergo appropriate independent ethical review when required by the nature of the activity and applicable law.

Depending upon jurisdiction, this review may be performed by an Institutional Review Board (IRB), Research Ethics Committee, Comité de Ética en Investigación, institutional ethics committee or other appropriately constituted independent body.

The reviewing body should have sufficient independence to evaluate the proposed research without inappropriate influence from investigators or commercial interests.

Ethics Approval Before Research Begins

Where prior ethics approval is required, participant recruitment, research interventions and collection of research-specific specimens should not begin until the necessary approval has been obtained.

The protocol should appropriately describe the scientific rationale, objectives, design, participant population, inclusion and exclusion criteria, investigational procedures, potential risks and benefits, consent process, privacy protections, data management, specimen handling, safety monitoring, adverse-event procedures, investigator responsibilities, funding, material conflicts of interest and publication plan.

Material amendments should be submitted for further review where required before implementation, except where immediate action is necessary to protect participant safety.

Continuing Ethical Oversight

Ethical responsibility does not end when initial approval is obtained. Where required, ongoing research may remain subject to continuing ethics review, protocol amendment review, safety reporting, serious adverse-event reporting, protocol-deviation reporting, investigator updates, data and safety monitoring, study suspension, study termination and final research reporting.

CELLMEX investigators should cooperate with appropriately authorised ethics committees and regulatory authorities responsible for oversight.

Informed Consent

Voluntary informed consent is a central requirement of ethical human research unless an appropriately authorised waiver or exception applies.

Elements of Informed Consent

Where applicable, informed-consent information should explain in understandable language:

• That participation involves research and the purpose of the research.
• Why the individual is being invited and which procedures are investigational.
• Expected duration of participation.
• Reasonably foreseeable risks, discomforts and potential benefits.
• Available alternatives.
• Confidentiality and privacy considerations.
• Research-related injury arrangements where applicable.
• Relevant costs, compensation or reimbursement.
• Whether specimens will be stored or used in future research.
• Whether genetic or genomic analysis may occur.
• Whether findings may be published and who may access research information.
• Contact information for research questions and participant rights.
• The voluntary nature of participation and the right to withdraw.

Voluntary Participation

Participation should be voluntary. CELLMEX does not support obtaining research participation through coercion, intimidation, material deception, inappropriate pressure, exploitation of medical dependency or undue financial influence.

A patient's relationship with a physician should not be used improperly to obtain participation. Refusal to participate should not, by itself, prejudice access to otherwise available appropriate medical care.

Withdrawal from Research

Participants should generally be permitted to withdraw from research without penalty, subject to applicable protocol and legal requirements.

Withdrawal may not always permit removal of information already incorporated into completed analyses or records that must legally or scientifically be retained. These limitations should be explained where relevant.

Decision-Making Capacity

Investigators should consider whether prospective participants possess sufficient capacity to understand relevant information and make an informed decision.

Where capacity is impaired, additional protections may be required, including a legally authorised representative, independent assessment, additional consent safeguards, participant assent where possible and restrictions on the type of research permitted.

Vulnerable Participants

Certain individuals or groups may have an increased risk of coercion, exploitation or inability to protect their own interests.

• Children and adolescents.
• Individuals with impaired decision-making capacity.
• Critically ill patients or persons in emergency situations.
• Economically disadvantaged or institutionalised individuals.
• Prisoners or persons deprived of liberty.
• Individuals dependent upon investigators for medical care.
• Persons with limited literacy or significant language barriers.

Inclusion of a potentially vulnerable population should have appropriate scientific justification and additional safeguards proportionate to the risks involved. Vulnerability does not automatically require exclusion; it requires appropriate protection.

Children and Minors

Research involving children requires particular ethical consideration. Where applicable, participation should require permission from a parent or legally authorised guardian, age-appropriate information, assent where developmentally appropriate, risk appropriate to the scientific question, and additional ethics review requirements.

A child's objection should receive appropriate consideration even where parental permission has been provided.

Human Biological Specimens

Human biological materials should be handled with respect for the individual from whom they originated.

Examples include blood, bone marrow, adipose tissue, placental tissue, umbilical-cord tissue, umbilical-cord blood, biopsy material, skin, fibroblasts, immune cells, mesenchymal stromal cells, other primary cell populations, DNA, RNA and other human-derived biological materials.

Collection, processing, storage, transfer and research use should occur under appropriate ethical, scientific, biosafety and regulatory controls.

Patient-Derived Specimens

A specimen obtained during clinical care does not automatically become unrestricted research material.

Where clinical specimens are proposed for research, investigators should determine whether additional consent is required, existing consent permits research use, the specimen has been appropriately de-identified, ethics review is required, secondary research use is permitted, genetic analysis requires additional disclosure, and transfer to another institution is permitted.

Clinical care and research use should be distinguished appropriately.

Donor-Derived Materials

Donor-derived cellular and tissue materials may involve ethical considerations extending beyond ordinary laboratory procurement.

Where applicable, donor programmes should address donor eligibility, informed consent, medical history, infectious-disease screening, donor identification and traceability, collection procedures, privacy, permitted uses, storage, transfer, future research and commercial development where relevant.

Donor consent should accurately describe the intended use of the donated material to the extent reasonably foreseeable.

Commercial Development from Donated Materials

Research involving human specimens may contribute to commercially valuable technologies, intellectual property, biological products or therapeutic platforms.

Where reasonably foreseeable and legally required, consent documentation should appropriately address whether donated materials may contribute to commercial research or product development. Donors should not be led to assume ownership rights, royalties or financial participation unless such rights have been expressly established.

Genetic and Genomic Information

Genetic and genomic research can generate information extending beyond the immediate research question and may have implications for biological relatives.

Research involving genomic information should consider consent for genetic analysis, data security, identifiability, future research use, data sharing, incidental or clinically actionable findings, re-identification risk and familial implications. The handling of individual findings should be established before testing whenever reasonably practicable.

Privacy and Confidentiality

CELLMEX seeks to protect the privacy of research participants and confidentiality of research information.

Appropriate safeguards may include coded participant identifiers, restricted database access, role-based access, secure electronic storage, controlled physical records, encryption where appropriate, separation of identifiers from research datasets, confidentiality agreements, controlled data transfer, defined retention periods and secure destruction procedures.

Access should generally be limited to individuals requiring the information for authorised scientific, medical, quality, ethical or regulatory purposes.

De-Identification and Coding

Where scientifically appropriate, research information and specimens should be coded or de-identified to reduce unnecessary disclosure of participant identity.

De-identification is not necessarily absolute, particularly with genomic information, rare diseases, small patient populations and detailed longitudinal datasets. Data-management decisions should therefore consider realistic re-identification risks.

Biological Specimen Traceability

For research where specimen identity is scientifically or clinically significant, CELLMEX should maintain appropriate traceability.

Traceability should be sufficient to support scientific integrity and safety without unnecessarily exposing personal identity.

Storage and Biobanking

Long-term storage of human specimens should occur under defined procedures. Where applicable, records should identify specimen type, collection date, processing history, storage conditions, unique identifier, consent status, permitted research uses, restrictions, transfers and final disposition.

Future research use should remain consistent with applicable consent, ethics approval and legal requirements.

Clinical Investigations

Clinical investigations involving investigational biological technologies require safeguards beyond ordinary laboratory research.

Before beginning a clinical investigation, appropriate consideration should be given to preclinical justification, product characterisation, manufacturing controls, biological safety, dose rationale, administration route, patient-selection criteria, risk assessment, stopping criteria, clinical monitoring, emergency procedures, adverse-event management, follow-up, ethics approval and regulatory authorisation where required.

Distinction Between Research and Clinical Care

Clinical Care

Medical treatment directed primarily toward the welfare of an individual patient.

Human-Subject Research

Systematic investigation designed to develop or contribute to generalisable scientific knowledge.

Clinical Investigation

Prospective investigation of a medical product, biological technology, procedure or intervention according to a defined protocol.

Observational Research

Systematic collection and analysis of clinical information without necessarily assigning an investigational intervention.

These categories may overlap, but they are not interchangeable. Describing ordinary treatment as a clinical trial does not make it one; calling an intervention treatment does not remove research obligations when the activity is actually human-subject research.

Therapeutic Misconception

Investigators should seek to minimise therapeutic misconception. Research participants should understand that the primary purpose of research is to generate knowledge and that participation does not guarantee individual therapeutic benefit.

Laboratory evidence, biological plausibility or promising preliminary findings should not be represented as assurance that an investigational intervention will benefit the participant.

Risk–Benefit Assessment

Human research should proceed only where anticipated scientific and potential clinical benefits reasonably justify foreseeable risks and burdens.

Risk assessment should consider, where applicable, procedural and biological risks, infection, immune reactions, thrombosis, toxicity, unintended tissue effects, tumourigenic potential where scientifically relevant, long-term uncertainty, psychological burden, privacy risk and financial burden.

Risk assessment should be revisited when significant new information becomes available.

Safety Monitoring

Clinical research should include safety-monitoring procedures proportionate to the nature and risk of the investigation.

Depending upon the study, monitoring may include clinical observation, vital signs, laboratory testing, imaging, functional assessments, scheduled follow-up, physician review, independent medical review and data and safety monitoring. Higher-risk investigations may require independent safety oversight.

Adverse Events

An adverse event is a medical occurrence temporally associated with research participation or administration of an investigational intervention, whether or not a causal relationship has initially been established.

Investigators should document and evaluate adverse events according to the applicable protocol and regulatory requirements, considering seriousness, severity, expectedness, relationship to intervention, required treatment, outcome and need for follow-up.

Serious Adverse Events and Safety Signals

Serious or unexpected safety events should receive prompt medical assessment and, where required, be reported to the research sponsor, ethics committee or IRB, appropriate regulatory authority, safety-monitoring body or other responsible institution.

Emerging safety information may require protocol modification, revised informed consent, temporary enrolment suspension, additional participant monitoring or study termination.

Protocol Deviations

Material deviations from an approved protocol should be documented and evaluated. Where required, deviations should be reported to the responsible ethics body or regulatory authority.

Emergency deviation may be justified where necessary to protect the immediate safety of a participant, but the circumstances should subsequently be documented and reported as required.

Compassionate, Expanded-Access and Named-Patient Situations

CELLMEX recognises that circumstances may arise in which a physician considers access to an investigational or otherwise unavailable intervention for an individual patient with a serious medical condition.

Such access should not be confused with routine commercial treatment or a clinical trial. Depending upon jurisdiction, these circumstances may be described as compassionate use, expanded access, named-patient access, special access or individual-patient investigational use.

The precise legal meaning and availability of these mechanisms differ between jurisdictions.

Ethical Requirements for Individual-Patient Investigational Access

Where legally permitted, consideration should include a serious or appropriately compelling medical need, review of approved treatment alternatives, scientific rationale, available safety information, reasonable assessment of potential benefit and risk, qualified physician oversight, informed consent, manufacturer or product access where required, ethics review where required, regulatory authorisation where required, appropriate documentation and safety follow-up.

Individual-patient access should not be used to circumvent clinical research requirements or applicable regulatory controls.

Research Costs and Financial Transparency

Where research participants may incur costs, these should be disclosed appropriately. Participants should understand which procedures are research-related, which constitute ordinary clinical care, which costs are sponsor-covered, which remain the participant's responsibility, and whether compensation, travel or expense reimbursement is provided.

Financial arrangements should not create inappropriate pressure to participate.

Research-Related Injury

Where applicable, research protocols and consent documents should describe arrangements concerning medical treatment or compensation for research-related injury.

Participants should be informed whom to contact if they believe they have experienced an injury associated with participation.

International and Cross-Border Research

CELLMEX may participate in international scientific collaborations. Cross-border research may involve different ethics systems, privacy laws, specimen-transfer requirements, regulatory classifications and consent requirements.

Approval in one country does not automatically authorise research in another. Responsibilities of sponsors, investigators, laboratories and collaborating institutions should be established before cross-border research begins.

Transfer of Human Biological Materials

Transfer of human biological specimens between CELLMEX and another institution should, where appropriate, be governed by documented arrangements addressing permitted use, ownership or custodianship, confidentiality, biosafety, intellectual property, publication rights, further transfer, storage, destruction or return, and compliance with donor consent.

Material Transfer Agreements may be used where appropriate.

Publication of Human-Subject Research

CELLMEX supports responsible publication of scientifically meaningful human-subject research.

Publications should accurately report research methodology, participant population, relevant endpoints, material results, adverse findings, study limitations, funding and relevant conflicts of interest.

Positive findings should not be selectively published while material negative or inconclusive findings are intentionally concealed.

Protection of Participant Identity in Publications

Scientific publication should not unnecessarily disclose participant identity. Case reports, photographs, imaging, genomic information and unusual clinical characteristics may permit identification even where a participant's name has been removed.

Where identifiable information is proposed for publication, appropriate consent should be obtained where required. Images should be de-identified where reasonably possible.

Clinical Trial Registration

Where applicable under ethical, regulatory, journal or sponsor requirements, prospective clinical research should be registered in an appropriate publicly accessible clinical-trial registry.

Registration improves transparency and helps distinguish formally structured clinical research from ordinary clinical treatment. Study registration does not constitute regulatory approval or proof of efficacy.

Research Results and Participants

Where scientifically appropriate and ethically justified, participants may be informed about significant information arising from research.

Policies concerning return of individual research results, genetic findings, incidental findings and aggregate study results should be considered during protocol development. Results requiring medical interpretation should be communicated through appropriately qualified professionals.

Conflicts of Interest

Investigators and research personnel should disclose material financial or professional interests that could reasonably influence research judgement.

Relevant interests may include ownership in the technology, patent rights, consulting payments, investigator compensation, sponsor relationships and commercialisation rights. Conflicts should be managed rather than concealed.

Research Misconduct Affecting Participants

Suspected fabrication, falsification, deliberate concealment of safety information or material protocol violation affecting participant welfare should be investigated appropriately.

Protective action may include suspension of research activity, restriction of investigator activity, notification of the ethics committee or regulatory authorities, participant notification, and corrective and preventive action.

Research Records

Research records should be maintained for the period required by applicable law, protocol, sponsor requirements and institutional policy.

Records may include approved protocols, ethics approvals, consent documents, participant records, laboratory and specimen records, safety and adverse-event reports, monitoring records, data analyses, protocol deviations and publications.

Records should be sufficiently complete to permit appropriate scientific, ethical and regulatory review.

Research Independence

CELLMEX scientific and clinical personnel should be able to identify ethical or safety concerns without inappropriate commercial pressure.

No commercial objective should justify bypassing required ethics review, misrepresenting informed consent, concealing safety information, improperly recruiting vulnerable participants or mischaracterising experimental treatment as established therapy.

Responsibility of Investigators

The principal investigator or responsible physician carries substantial responsibility for participant protection. Delegation of individual activities does not eliminate investigator responsibility for appropriate oversight.

Investigators should ensure that research personnel are appropriately qualified and understand the protocol, participant protections, consent requirements, safety procedures, data responsibilities and reporting obligations.

Suspension or Termination of Research

CELLMEX may suspend or terminate research activity when justified by participant safety concerns, unexpected toxicity, ethical concerns, serious protocol non-compliance, loss of ethics approval, regulatory action, inadequate scientific justification, unacceptable data integrity or investigator misconduct.

Ethical Review of Emerging Regenerative Technologies

Emerging technologies may present risks or uncertainties not fully characterised by conventional clinical experience.

Particular scrutiny may therefore be appropriate for research involving genetically modified cells, induced pluripotent stem cells, extensively manipulated cells, lineage-directed cellular populations, immune-cell engineering, extracellular vesicle technologies, novel cell-free biologics, gene-modified biological products and patient-specific experimental cellular preparations.

Novelty should increase scientific and ethical scrutiny rather than reduce it.

Relationship to the CELLMEX Scientific Integrity Policy

This policy should be read together with the CELLMEX Scientific Integrity Policy.

The Scientific Integrity Policy governs the credibility, accuracy and responsible communication of CELLMEX science. The Research Ethics & Human Subjects Policy governs protection of individuals, specimens and identifiable human information involved in research.

Together, these policies establish the foundation of CELLMEX scientific and clinical research governance.

Our Commitment to Research Participants

CELLMEX recognises that medical research ultimately depends upon the trust of patients, donors and research participants. That trust creates obligations extending beyond technical or regulatory compliance.

Research Ethics Contact

Questions regarding human-subject research, research participation, biological specimens, ethics review or research collaboration may be directed to:

CELLMEX
Scientific & Clinical Research Division
Marina Vallarta
Puerto Vallarta, Jalisco, Mexico

Email: info@cellmex.com
Telephone: +52 322 308 0021

Human Research Notice

Information concerning CELLMEX research programmes may describe investigational, emerging, translational or experimental technologies. The existence of a research programme does not establish that a technology has been proven safe or effective, approved for general clinical use, or appropriate for a particular patient.

Research participation and individual medical treatment are distinct activities and should be evaluated accordingly.