Research Ethics & Governance
NeuroBehavior Clinic conducts clinical, behavioral, forensic, and neurobiological research under a framework of independent review, scientific validity, informed participation, proportionate risk, and accountable data governance.
Independent Review
Participant-facing research does not begin before the required ethics and institutional review has been completed.
Informed Participation
Consent is an ongoing process supported by clear information, voluntary choice, and an accessible route for questions or withdrawal.
Participant Safety
Screening, trained staff, escalation routes, and protocol-specific safeguards are required wherever procedures may create risk or burden.
Scientific Integrity
Methods, limitations, funding relationships, protocol deviations, and findings are documented and reported without avoidable overstatement.
1. Scope and Governing Standards
This framework applies to research involving patients, volunteers, forensic populations, biological material, neuroimaging, electrophysiology, psychometrics, biometrics, neuromodulation, and coded or identifiable data. Work is governed, as applicable, by the 2024 Declaration of Helsinki, Spanish Law 14/2007 on Biomedical Research, data protection law, professional duties, competent ethics committees, and the requirements stated in each approved protocol. Study-specific information and consent documentation remain authoritative for the individual project.
2. Independent Review and Protocol Authorization
Ethics review: research is submitted to the competent research ethics committee and, where required, institutional, sponsor, regulatory, or data-access review.
Protocol accountability: each study identifies responsible investigators, eligibility criteria, methods, data flows, safety procedures, analysis plans, and reporting responsibilities.
Change control: material amendments, new data uses, additional procedures, or revised recruitment plans follow the required review route before implementation.
3. Scientific Validity and Proportionate Design
Research questions must be methodologically defensible and the expected scientific or clinical value must justify participant burden and foreseeable risk. Sample selection, measurement strategy, statistical planning, equipment use, and data quality controls are documented in proportion to the study. Procedures are not added solely because a technology is available.
4. Consent, Withdrawal, and Continuing Information
Before participation, individuals receive information about purpose, procedures, duration, foreseeable risks and discomforts, expected benefits, alternatives, confidentiality, data and sample use, funding, relevant conflicts, withdrawal, and contact routes.
Consent is revisited when material circumstances change. A decision not to participate, or to withdraw, does not affect ordinary clinical rights. Data or samples already used may remain where deletion is impossible or where retention is required by law, safety, research integrity, or the approved protocol; these limits are explained in the study documentation.
5. Fair Selection, Capacity, and Vulnerability
Recruitment must be scientifically justified and free from inappropriate pressure. Additional safeguards are required where decision-making capacity, acute distress, institutional dependency, legal status, age, language, health literacy, or socioeconomic circumstances may affect voluntary participation. Depending on the protocol, safeguards may include capacity assessment, interpreters, accessible materials, legally authorized representatives, assent, additional time for decision-making, independent support, or exclusion where participation would be disproportionate.
6. Separation of Clinical, Research, and Forensic Roles
Clinical work is directed by patient welfare, professional scope, assessment needs, and documented care decisions.
Research addresses protocol-defined questions and does not create a therapeutic relationship unless a separate clinical pathway is established.
Forensic work is limited by the referral question, legal authority, evidentiary context, and the duty to report impartially rather than act as a treating advocate.
7. Safety, Incidental Findings, and Research-Related Harm
Neuroimaging, EEG, fNIRS, eye-tracking, biometrics, biological sampling, TMS, tES, and other procedures require trained personnel, screening, contraindication checks, calibrated equipment, and documented escalation routes. Protocols define how adverse events and unexpected or clinically relevant findings are reviewed, communicated, referred, and recorded. Participants are informed of the applicable arrangements for treatment, compensation, or insurance in the event of research-related harm.
8. Data, Biological Material, and Secondary Use
Minimization: collect only data and material justified by the protocol.
Coding: separate direct identifiers from research records wherever feasible.
Access: restrict access by role, project, location, and documented need.
Reuse: secondary analysis or sharing requires a compatible legal basis, consent scope, ethics decision, and data-access controls.
Genetic information, biological samples, neurodata, and linked longitudinal records receive protocol-specific governance because their sensitivity and re-identification risks may exceed those of ordinary study data.
9. Computational Models and Human Oversight
Statistical models, machine learning, automated pattern detection, and risk models may support analysis or structured review. Outputs require documented provenance, validation, bias assessment, uncertainty, and professional oversight. A probabilistic research result is not presented as a stand-alone diagnosis, prediction, or definitive conclusion about an individual.
10. Registration, Reporting, Funding, and Conflicts
Studies are registered where required, and results are reported in a manner consistent with the protocol, ethics approval, participant confidentiality, and scientific integrity. Negative, inconclusive, and adverse findings are not suppressed solely because they are inconvenient. Relevant funding, institutional support, and conflicts of interest are disclosed through the appropriate study and reporting documents.
11. Community and Stakeholder Engagement
Where the subject matter or participant population warrants it, protocol development and dissemination may include consultation with patient representatives, professional stakeholders, affected communities, or participating institutions. Engagement does not replace independent ethics review, but it can improve relevance, accessibility, risk assessment, and responsible communication.
12. Raising a Concern
Research conduct and participant welfare: contact ethics@neurobehaviorclinic.com regarding consent, safety, scientific integrity, conflicts, or conduct of a study.
Privacy and data protection: contact the Data Protection Officer at privacy@neurobehaviorclinic.com regarding confidentiality, data use, or data protection rights.
Concerns are handled as confidentially as circumstances allow and are directed to the responsible investigator, clinical lead, ethics route, or competent authority. Raising a concern in good faith must not result in retaliation or loss of ordinary care rights.