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Committees · Now appointing

The Scientific & Ethics Committee

Herbal Trials is now appointing the 7 inaugural members of its Scientific and Ethics Committee. Each seat is recruited separately, with its own qualifications, responsibilities, and application pathway.

The Committee holds independent authority over the research Herbal Trials conducts, sponsors, or funds: scientific pre-review, botanical standards, participant-protection analysis, statistical review, safety review, research-quality oversight, publication consistency, and evidence grading.

The inaugural Committee is being seated now. No human-subject or animal-subject research commences until the Board confirms that all mechanisms required by the Framework are operational. Before any such research begins, the Board must either seat this Committee or retain an external IRB, IACUC, or other independent ethics body qualified under applicable law to perform the Committee's functions. Herbal Trials is seating the Committee. (Framework §3.1 and §13.2)
This is not a one-time posting. Interest is collected continuously, not only while the inaugural seats are being filled. Expressions of interest are retained for future terms as seats turn over, for the two expansion seats, and for the nonvoting ad hoc reviewer panel appointed per protocol. A strong candidate who is not appointed to an inaugural seat remains in consideration.
Independent authority

The Committee can stop a study. Nobody here can overrule it.

The Committee has independent authority to approve, require modifications in, disapprove, suspend, or terminate any research activity within its jurisdiction. No officer, director, funder, or other person shall override a determination of the Committee except through a documented appeal to a second independent ethics committee.

Framework §3.4 (Authority), Scientific and Ethics Oversight Framework, Rev. 1.0, adopted by the Board of Directors 30 April 2026.

Approve
Issue a favorable determination on a protocol within its jurisdiction.
Require modifications
Condition any determination on changes the Committee specifies.
Disapprove
Decline to endorse a protocol.
Suspend
Halt a study already underway, in whole or in part.
Terminate
End a research activity within its jurisdiction.
Composition

Why the inaugural Committee has 7 voting seats

The governing framework permits a minimum of five members. Herbal Trials has chosen an inaugural structure of seven voting seats, because a five-member roster could be compromised by a single recusal, absence, vacancy, or need for specialized review. Seven gives meaningful interdisciplinary coverage while remaining manageable.

Scope

This Committee is not an IRB

It is an institutional scientific-governance and pre-review body, and Herbal Trials does not represent it as replacing a properly constituted Institutional Review Board. Four distinct functions, deliberately kept separate.

Scientific and Ethics Committee

A standing committee of Herbal Trials constituted to exercise independent scientific and ethical judgment under the Board-adopted Scientific and Ethics Oversight Framework. Its determinations are protected from officer, director, funder, and other interference except through a documented appeal to a second independent ethics committee.

This Committee

External IRB

Independent human-subject review, required under the Framework and applicable law for every applicable human-subject protocol. Herbal Trials applies the Common Rule whether or not research is federally funded.

DSMB or independent safety monitor

Study-specific review of accumulating safety and conduct data, added when a protocol requires it.

IACUC

Required separately for covered animal research, under the Animal Welfare Act, the PHS Policy, and the principles of Replacement, Reduction, and Refinement.

No human-subject study may open solely on the Committee's review. Applicable studies must also receive approval from an appropriately constituted independent Institutional Review Board. Study-specific safety monitoring and specialist review are added when the protocol requires them.
Who belongs here

Who these seats are for

Clinical-trial methodologists, pharmacognosists and botanical authentication scientists, biostatisticians, bioethicists and human-subjects protection specialists, toxicologists and pharmacovigilance specialists, regulatory and research-quality specialists, and unaffiliated community and participant representatives. One seat requires no scientific credential at all and must be independent of Herbal Trials entirely.

The Committee sits above every other department in the sequence: nothing Clinical, Botanical, or Study Design & Data proposes can proceed without its determination. It is distinct from the external IRB, which separately reviews human-subject protocols, and from any study-specific safety-monitoring board. Legal, Regulatory & Ethics supports it; it does not report to them.

Seats

The seven inaugural seats

Each links to its own listing: required and preferred qualifications, the specific review work it performs, expected workload, term, and the questions asked of candidates for that discipline.

Seat 1 · Open

Clinical-Trial Methodologist

Evaluates study rationale, endpoints, controls, randomization, masking, feasibility, and risk-benefit coherence.

ScientificRequirements & apply
Seat 2 · Open

Botanical and Pharmacognosy Scientist

Reviews identity, sourcing, voucher specimens, extraction, standardization, certificates of analysis, contaminants, adulteration, and batch consistency.

ScientificRequirements & apply
Seat 3 · Open

Biostatistician

Reviews sample size, estimands, statistical analysis plans, missing-data treatment, interim analysis, multiplicity, and interpretability.

ScientificRequirements & apply
Seat 4 · Open

Bioethicist or Human-Subjects Protection Specialist

Reviews consent, voluntariness, vulnerable populations, recruitment fairness, participant burden, privacy, and publication ethics.

Non-scientific depends on appointeeRequirements & apply
Seat 5 · Open

Toxicology and Safety Specialist

Reviews known and plausible toxicity, drug-herb interactions, dose justification, exclusion criteria, safety monitoring, adverse-event attribution, and escalation rules.

ScientificRequirements & apply
Seat 6 · Open

Regulatory and Research Quality Specialist

Reviews regulatory classification, GCP compliance, documentation, protocol deviations, monitoring plans, data integrity, and quality systems.

ScientificRequirements & apply
Seat 7 · Open

Unaffiliated Community and Participant Representative

Represents participant comprehension, community acceptability, accessibility, recruitment burden, practical fairness, and public trust.

Non-scientific · Must be unaffiliatedRequirements & apply
Roster requirements

Required composition

These are satisfied across the roster, not by any single appointment, which is why candidates are assessed against the resulting Committee rather than in isolation.

Board-adopted §3.2

Not fewer than five members

The Framework sets the floor at five. Herbal Trials is seating seven, because a five-member roster can be compromised by a single recusal, absence, vacancy, or need for specialized review.

Board-adopted §3.2(a)

At least one primarily scientific member

Seats 1, 2, 3, 5, and 6 would ordinarily qualify.

Board-adopted §3.2(b)

At least one primarily non-scientific member

Seat 7 is expected to satisfy this. Seat 4 may also, where the appointee's own primary professional background is non-scientific. Classification is determined from the person, not the seat, and is documented at appointment.

Board-adopted §3.2(c)

At least one wholly unaffiliated member

Not otherwise affiliated with Herbal Trials, and not a member of the immediate family of anyone affiliated with it. Seat 7 must be wholly unaffiliated. Herbal Trials will also seek at least one additional unaffiliated appointee among Seats 1 through 6, where the candidate otherwise meets that seat's qualifications.

Board-adopted §3.2(d)

Additional expertise as the research requires

Including, where applicable, a veterinarian for animal research and a representative with relevant cultural or community expertise.

Recruitment design

Botanical expertise

Seat 2. A generic clinical-research committee without botanical expertise cannot credibly evaluate the intervention itself.

Recruitment design

Quantitative competence

Seat 3, as a voting member rather than an occasional consultation.

Already binding

What the Framework already requires

Not aspirations. Every item below is adopted governance under the Scientific and Ethics Oversight Framework, Rev. 1.0, in force since 30 April 2026.

Annual conflict disclosure
Framework §3.3
Committee members sign annual conflict-of-interest disclosures consistent with the Conflict of Interest Policy. A member may not participate in initial or continuing review of a project in which they have a conflicting interest, except to provide factual information.
Written determinations
Framework §4.2
Every Committee determination is in writing and specifies the review category, approval period, required modifications, and conditions of approval.
Continuing review
Framework §4.4
Approved research is reviewed again at intervals set by the Committee based on degree of risk, and not less than once per year for open studies.
Modifications reviewed before implementation
Framework §4.3
Material modifications to an approved protocol are submitted and approved in writing before implementation. Changes needed to eliminate an immediate hazard may be made at once and reported as soon as practicable.
Adverse-event reporting
Framework §8.1
Investigators report serious adverse events, unanticipated problems involving risk, protocol breaches, confidentiality breaches, and other events relevant to subject safety or research integrity.
Halting authority
Framework §8.2
A study may be suspended immediately, pending review, by the reviewing ethics committee, the Committee, the Principal Investigator, the President, or any two directors acting jointly on a written statement of specific safety, participant-welfare, or research-integrity concern. A suspension by two directors convenes the Committee within 72 hours and lapses if the Committee does not ratify it within ten business days.
Audits
Framework §10.4
The Committee may conduct, or cause to be conducted, routine or for-cause audits of research activities.
Training
Framework §10.1
All research personnel complete human-subjects protections training, such as CITI or equivalent, before involvement, with refresher training at intervals the Committee determines.
Full publication
Framework §9.2
Herbal Trials publishes the methodology, data summaries, and findings of every study it conducts or sponsors, including negative, null, inconclusive, unfavorable, and unflattering findings. Suppression, selective reporting, and cherry-picking are prohibited.

Every determination is written

A Committee determination is issued in writing and specifies:

  • The category of review: exempt, expedited, or full
  • The approval period
  • Any required modifications
  • Any required conditions of approval
Depth

Beyond the seven

Two further seats will be added as resources and candidate quality permit:

  • Seat 8. Clinician in the Proposed Therapeutic Area. Brings therapeutic-area clinical judgment to protocol review, without becoming a permanent substitute for protocol-specific expertise.
  • Seat 9. Natural-Products Manufacturing and Analytical Chemistry Specialist. Adds depth in extraction, formulation, stability, contaminant testing, method validation, dosage-form manufacturing, GMP-related quality, and lot-release specifications.

A therapeutic-area clinician should not become a permanent substitute for protocol-specific expertise. Additional disease-specific reviewers are appointed for individual protocols.

Nonvoting ad hoc reviewers

The Committee does not pretend that seven people can cover every future study. The Framework contemplates additional expertise as the research requires, including a veterinarian for animal research and a representative with relevant cultural or community expertise. Ad hoc reviewers may include:

  • Disease-area specialist
  • Veterinarian, for animal research
  • Microbiologist, for fermented products
  • Mycologist, for medicinal mushroom studies
  • Analytical chemist
  • Pediatric specialist
  • Reproductive-health specialist
  • Cultural or traditional-knowledge advisor
  • Accessibility or language specialist
  • Cybersecurity or data-privacy specialist
Process

How members are appointed

Published as a defined sequence, so candidates know what they are entering and so the process can be held to.

Step 1

Application or nomination

Candidates may apply directly or be nominated.

  • CV or professional résumé
  • Statement of interest
  • Relevant publications, committee service, or oversight experience
  • Preferred Committee seat
  • Current professional affiliations
  • Anticipated availability
Step 2

Completeness and qualification review

Verification is proportionate to the seat, conducted with appropriate notice and consent, and limited to information relevant to Committee service. Herbal Trials verifies:

  • Education and credentials
  • Licenses, when relevant
  • Employment and institutional affiliations
  • Publications and claimed experience
  • Prior disciplinary or research-integrity findings, where lawfully available
  • Ability to perform the actual responsibilities of the designated seat
Step 3

Conflict and independence review

Industry experience does not automatically disqualify anyone. Undisclosed or unmanageable conflicts do. Candidates disclose:

  • Supplement, botanical, pharmaceutical, testing-laboratory, contract-research, and healthcare-industry relationships
  • Consulting and speaking arrangements
  • Research funding
  • Ownership interests
  • Intellectual property interests
  • Leadership positions
  • Close family relationships creating relevant conflicts
  • Prior relationships with Herbal Trials, its directors, officers, investigators, or major funders
Step 4

Structured interview

At least two disinterested reviewers interview the candidate concerning:

  • Scientific or ethical judgment
  • Willingness to reject an inadequate study
  • Approach to uncertainty
  • Understanding of participant protection
  • Ability to distinguish evidence generation from advocacy
  • Ability to work across disciplines
  • Potential conflicts and recusals
Step 5

Composition review

Candidates are not appointed in isolation. Before appointment, Herbal Trials assesses whether the resulting Committee collectively satisfies the Framework composition requirements and has:

  • Scientific and non-scientific representation
  • Genuine unaffiliated representation
  • Botanical expertise
  • Statistical expertise
  • Ethical expertise
  • Safety expertise
  • Regulatory or quality expertise
  • Sufficient diversity of institution, profession, geography, and perspective
  • No dominance by a single discipline or commercial sector
Step 6

Board appointment

The Board appoints members to specifically identified seats after reviewing the qualification and conflict record. The Board does not select members merely because they support herbal medicine or the organization's mission.

Step 7

Public disclosure

For each appointed member, Herbal Trials publishes:

  • Name
  • Committee seat
  • Professional affiliation
  • Relevant qualifications
  • Term
  • Whether the member is scientific or non-scientific
  • Whether the member is affiliated or unaffiliated
  • A summarized conflict and independence disclosure
  • A public summary of recusals from specific matters, where applicable and consistent with participant confidentiality, proprietary-information protection, and the integrity of ongoing review
Step 8

Orientation before voting

Before participating, members complete orientation concerning:

  • The Scientific and Ethics Oversight Framework
  • Committee charter
  • Conflict and recusal rules
  • Belmont principles and applicable human-subject standards
  • Good Clinical Practice fundamentals
  • Botanical intervention issues
  • Publication and preregistration commitments
  • Confidentiality
  • Document retention
  • Appeals and non-override provisions
Industry experience does not disqualify anyone. Undisclosed or unmanageable conflicts do. Disclosure is the requirement, not a spotless record.

What service involves

Members should ordinarily expect quarterly organizational meetings, protocol-review meetings as needed, asynchronous document review, annual conflict disclosure and training, and timely participation when safety or research-integrity concerns require urgent consideration. Workload varies with the number and complexity of proposed studies, and Herbal Trials does not promise a fixed light commitment it could not honor.

Governance status

Terms and operating structure

Two different kinds of statement appear below, and they are labelled so nobody has to guess which is which.

Board-adopted
Already binding under the Scientific and Ethics Oversight Framework adopted by the Board on 30 April 2026.
Proposed charter term
Proposed operating detail. Not yet adopted, and subject to formal Board adoption in the Committee charter before members begin voting.
Recusal
Board-adopted §3.3
No member may participate in the initial or continuing review of a project in which the member has a conflicting interest, except to provide factual information.
Annual disclosure
Board-adopted §3.3
Members sign annual conflict-of-interest disclosures consistent with the Conflict of Interest Policy.
Term
Proposed charter term
Three years.
Initial staggering
Proposed charter term
Two members serve one-year initial terms, two serve two-year initial terms, and three serve three-year initial terms.
Renewal
Proposed charter term
Maximum of two consecutive full terms, followed by a one-year break unless the Board documents exceptional need.
Chair and Vice Chair
Proposed charter term
Elected by the Committee from among its voting members. Neither office is assigned through recruitment, and no seat carries the chair by right.
Quorum
Proposed charter term
Majority of filled voting seats, but never fewer than four for a seven-member Committee.
Quorum composition
Proposed charter term
Must include at least one scientific member, one non-scientific member, and one unaffiliated member.
Approval threshold
Proposed charter term
Majority of eligible members present, with recusals excluded from the denominator.
Protocol approval
Proposed charter term
No protocol receives a favorable determination without affirmative participation from the statistical, botanical, and ethics functions, whether through standing members or qualified ad hoc reviewers.
Vacancies
Proposed charter term
The Committee may continue operating with a vacant seat only if all mandatory composition and quorum requirements remain satisfied.
Compensation
Proposed charter term
Initially volunteer or advisory, with disclosed and reasonable compensation permitted later.
Removal
Proposed charter term
For failure to participate, breach of confidentiality, undisclosed conflict, research misconduct, loss of required credentials, or conduct materially inconsistent with Committee duties.
Annual review
Proposed charter term
Membership, attendance, conflicts, recusals, composition, and training reviewed annually.
The 7-seat recruitment structure and the appointment process have been established for the inaugural Committee. Operating provisions marked as proposed charter terms remain subject to formal Board adoption in the Committee charter before members begin voting.

Take a seat at the table

If one of the seven seats is clearly yours, apply to it directly. If your expertise spans several, fits none of them cleanly, or you are nominating someone else, use the general Committee entry.

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