Protect People
Evaluate consent, privacy, vulnerability, fairness, confidentiality, recruitment, burden, and potential harm.
Research Governance
Research Review and Oversight
A developing institutional framework for determining which research activities require ethical, scientific, safety, security, conflict, data, animal-care, or specialized review before they begin.
Responsible Authorization
Review research before risk is created, participants are enrolled, data is accessed, or specialized work begins.
The Institute intends to use proportionate review processes that protect people, animals, communities, researchers, facilities, data, public trust, and the integrity of scholarly work.
This page describes a future oversight structure. It does not
establish that the Institute currently operates an
Institutional Review Board, Institutional Animal Care and Use
Committee, Institutional Biosafety Committee, or other
formally constituted review body.
Purpose of Research Oversight
Oversight should match the nature, scale, complexity, and risk of the proposed activity.
Protect Animals
Confirm scientific necessity, alternatives, humane care, veterinary support, approved procedures, and monitoring.
Protect Research Integrity
Support sound methods, accurate records, qualified supervision, conflict disclosure, and responsible reporting.
Manage Safety
Identify biological, chemical, radiation, electrical, mechanical, environmental, field, transportation, and facility risks.
Protect Information
Review data access, cybersecurity, confidentiality, retention, sharing, repository use, and preservation.
Maintain Public Trust
Ensure research decisions are documented, accountable, transparent where appropriate, and independent of improper influence.
Proposed Review Pathways
Different research activities may require one or several coordinated review pathways.
Human Research
Future Review Pathway
Human Research Review
Review of research involving living individuals, identifiable private information, biospecimens, interventions, interactions, surveys, interviews, observation, or potentially sensitive records.
- Participant risk and expected benefit
- Recruitment and informed consent
- Privacy and confidentiality
- Vulnerable or dependent populations
- Data use, retention, and sharing
Animal Research
Future Review Pathway
Animal Research Review
Review of proposed animal use, care, housing, procedures, alternatives, veterinary support, personnel qualifications, endpoints, and humane treatment.
- Scientific justification and necessity
- Replacement, reduction, and refinement
- Veterinary care and monitoring
- Training and facility requirements
- Humane endpoints and incident response
Laboratory Safety
Future Review Pathway
Biosafety and Laboratory Review
Review of biological agents, recombinant or synthetic materials, hazardous chemicals, radiation, specialized equipment, containment, waste, exposure, and emergency response.
- Hazard and risk classification
- Containment and engineering controls
- Training and protective equipment
- Storage, transport, and disposal
- Spill, exposure, and emergency procedures
Research Integrity
Institutional Review
Scientific and Integrity Review
Assessment of study design, qualifications, methods, feasibility, documentation, conflicts, authorship, reproducibility, and the responsible communication of results.
- Research question and methodology
- Investigator qualifications and supervision
- Data quality and reproducibility
- Authorship and publication expectations
- Conflicts and independent judgment
Data and Privacy
Institutional Review
Data Governance and Cybersecurity Review
Review of sensitive information, system access, encryption, third-party services, cloud environments, data sharing, retention, repository access, and incident response.
- Data classification and sensitivity
- Access, authentication, and authorization
- Storage, transmission, and backups
- Vendor and collaborator controls
- Retention, destruction, and preservation
Research Security
Institutional Review
Export Control and International Collaboration Review
Review of controlled technology, foreign participation, international travel, visitors, restricted-party concerns, publication restrictions, and research-security obligations.
- Technology and information classification
- International partners and personnel
- Travel, shipping, and equipment access
- Disclosure and conflict requirements
- Publication and access restrictions
Financial Interests
Institutional Review
Conflict of Interest Review
Review of financial, professional, personal, supervisory, intellectual-property, or organizational interests that could affect research judgment or public confidence.
- Disclosure of relevant interests
- Independent evaluation
- Recusal or management measures
- Participant and publication disclosure
- Ongoing monitoring
Operational Risk
Institutional Review
Facilities, Fieldwork and Transportation Review
Review of facility access, field sites, remote operations, aviation, marine activity, vehicles, environmental hazards, emergency planning, and insurance requirements.
- Site and facility conditions
- Operator qualifications and training
- Equipment and maintenance
- Emergency and communications plans
- Insurance and incident reporting
Determining the Required Review
Researchers should not decide independently that a project is exempt from oversight when there is uncertainty.
No Specialized Review
Activities involving only public information, routine internal operations, or nonresearch work may not require specialized review, but a determination may still be documented.
Administrative Screening
Low-risk or clearly defined activities may receive an administrative assessment to confirm the applicable pathway.
Limited or Expedited Review
Certain lower-risk activities may qualify for a focused review by authorized reviewers when formal criteria are met.
Full Committee Review
Greater-than-minimal risk, complex, novel, controversial, or sensitive activities may require review by a formally constituted committee.
External Review
The Institute may rely on or seek review from a qualified external institution, specialist, committee, regulator, or adviser.
Multiple Coordinated Reviews
A single project may require human, safety, data, conflict, security, financial, and operational review before activation.
Do not begin regulated or higher-risk work without authorization.
Recruitment, consent, data access, specimen collection,
animal use, laboratory work, field deployment, participant
interaction, or use of restricted systems should not begin
before the required reviews and written approvals are complete.
Proposed Review Process
A consistent sequence for moving research from initial screening through approval, monitoring, and closure.
Submit
Provide the protocol, methods, participants, data, personnel, locations, risks, resources, and supporting materials.
Screen
Confirm completeness, identify applicable review pathways, and determine whether specialized expertise is required.
Review
Evaluate scientific value, risk, protections, qualifications, conflicts, methods, safety, data, and operational readiness.
Decide
Approve, approve with conditions, request changes, defer, refer externally, suspend, or decline the proposed activity.
Monitor
Track amendments, incidents, continuing review, reports, deviations, complaints, corrective action, and project closure.
Core Review Standards
Review decisions should be based on documented criteria applied consistently and proportionately.
Scientific and Social Value
The question, methods, and expected contribution should justify the burdens, resources, and risks involved.
Risk Minimization
Risks should be reduced through sound design, safeguards, qualified personnel, monitoring, and appropriate alternatives.
Fair Selection
Participants, communities, sites, and research subjects should be selected fairly and without inappropriate exploitation.
Informed Participation
Consent or authorization should be understandable, voluntary, documented, and appropriate to the activity.
Privacy and Confidentiality
Information should be collected, accessed, used, retained, and shared only as justified and authorized.
Qualified Responsibility
Investigators and personnel should have appropriate expertise, training, supervision, authority, and resources.
Independent Judgment
Reviewers should disclose conflicts and avoid decisions improperly influenced by funding, status, relationships, or pressure.
Ongoing Accountability
Approval should be followed by monitoring, reporting, correction, incident response, and closure documentation.
Respect for Communities
Research should consider local knowledge, community impact, cultural context, public trust, and responsibilities after the study ends.
Changes, Incidents and Continuing Review
Approval applies to the reviewed activity and should not be treated as permission to make material changes without review.
Amendments
Review Required
Changes to Approved Research
Material changes to methods, personnel, locations, recruitment, consent, data, equipment, funding, or risk should be submitted before implementation.
- Protocol and design changes
- New personnel or collaborators
- New data sources or sharing plans
- Changes in participant risk
- New facilities, equipment, or field sites
Safety Reporting
Prompt Reporting
Incidents and Unanticipated Problems
Injuries, exposures, breaches, complaints, protocol deviations, equipment failures, participant concerns, or unexpected risks should be reported promptly.
- Immediate protective action
- Evidence and record preservation
- Notification of responsible officials
- Corrective and preventive measures
- External reporting when required
Monitoring
As Required
Continuing Review and Monitoring
Higher-risk or long-duration projects may require periodic review, progress reports, audits, site visits, data review, or renewal before approval expires.
- Enrollment and activity status
- New findings or changed risks
- Incidents and complaints
- Data and safety monitoring
- Continued resource and staffing adequacy
Closure
Final Documentation
Project Completion and Closure
Closure should document the completion or termination of activities, participant follow-up, data disposition, publication plans, preservation, and remaining obligations.
- Final activity and enrollment status
- Outstanding safety or participant issues
- Data retention and repository plans
- Publications and corrections
- Equipment, specimen, and record disposition
Review Independence and Committee Standards
Formal review bodies should be structured to provide competent, diverse, impartial, and documented judgment.
Appropriate Expertise
Membership and consultation should reflect the scientific, ethical, legal, community, safety, and technical issues involved.
Conflict Management
Members should disclose conflicts and refrain from participating in decisions when impartiality is compromised.
Diverse Perspective
Review should include perspectives capable of identifying burdens, community concerns, accessibility issues, and practical risks.
Documented Decisions
Minutes, findings, conditions, votes, determinations, and reasons should be recorded according to applicable requirements.
Confidentiality
Protocols, participant information, proprietary material, allegations, and committee deliberations should be appropriately protected.
Authority to Act
Review bodies should have clearly delegated authority to approve, condition, suspend, terminate, or refer activities.
Review Records and Transparency
Oversight records should support accountability while protecting confidential, personal, proprietary, and security-sensitive information.
Institutional Records
Controlled Access
Records to Preserve
- Submissions and supporting materials
- Review comments and determinations
- Approval letters and conditions
- Amendments and continuing reviews
- Incident and corrective-action records
- Closure and final-status documentation
Public Accountability
Aggregate Reporting
Information That May Be Reported Publicly
- Oversight structure and committee charters
- General review procedures and standards
- Aggregate review volumes and outcomes
- Material policy revisions
- Public corrective notices when appropriate
- Institutional metrics without protected details
Ask which reviews may apply before beginning a project.
Provide a brief description of the research question, participants or subjects, methods, data, locations, equipment, collaborators, funding, and known risks. Until formal review bodies are active, the Institute may refer projects to qualified external review resources.