Scope

This policy establishes the framework for the operation of the Ethiclear Ethics Review Committee (committee) for non-Clinical Trial of Investigational Medicinal Product (non-CTIMP) human research studies. The committee provides opinions, based on independent ethical review, of research proposals to ensure the protection of research participants whilst supporting legitimate scientific advancement.

Scope limitations:

• This committee will NOT review or provide an opinion over medical research or Clinical Trials of Investigational Medicinal Products (CTIMP).
• This committee will NOT review or provide an opinion over work that does not constitute research.

Committee composition & roles

Required committee member roles

The committee shall comprise members with a range of roles and expertise, which may include:

• Chair: Experienced in research ethics with leadership capabilities
• Deputy Chair: Deputy with equivalent qualifications to Chair
• Lay Member / Participant Advocate: Non-academic and non-scientific members representing public interest (such as participant advocate)
• Nutrition Expert: Specialist in nutrition and nutritional research
• Data & Legal Lead / Expert: Specialist in data protection and privacy law and relevant regulation
• Scientific / Research Expert / Advocate: Qualified in science, research design and statistical methods
• Real World Evidence (RWE) Expert: Specialists relevant to research involving RWE

The committee may appoint a rotating Deputy Chair to assist in management and process, depending on project expertise and member availability.

Individual members may fulfil multiple roles simultaneously if their expertise and experience is appropriate, and roles may overlap. Each project review may involve different subsets of the entire Ethiclear committee, depending on availability and appropriateness. Committee members are not limited or bound by their role, and may offer opinions and discuss factors related to other areas as they see fit or relevant.

Member qualifications

All committee members must possess expertise and professional experience directly relevant to their designated role during their time on the committee. Members must also demonstrate their understanding of research ethics principles and/or have demonstrable experience in working on similar committees in the past.

Members undergo mandatory training, as set out in the Committee Member Handbook (and any other company policy, as relevant). At a minimum, all members must be qualified against up-to-date GCP (Good Clinical Practice) and data protection, including GDPR (UK and EU General Data Protection Regulation), training. Such training must be renewed at regular intervals, and, at least every two years (or when substantial changes are made to applicable regulation or framework guidelines).

In addition to training and the Handbook, members must adhere to applicable company security requirements and policies at all times. This includes the company Information Security Policy, Secure Working Policy (incorporating clear desk, use of passwords and multi-factor authentication, encryption, and secure workflows and work patterns), and Confidential Waste Policy. Member agreements stipulate that contracts may be terminated in the event of non-adherence to such policies.

It is also recommended and expected that committee members undergo CPD (continuing professional development) in their professional area and in ethics review.

Quorum requirements

In order for the Ethiclear committee to be quorate in the review of any research project application, four committee members must be present for the individual review and when convening the committee for the subsequent review meeting. Ethiclear administration will attempt to ensure that as many of the enrolled committee members as possible can attend for each research project application.

Essentially, at least one lay member, a scientific/medical member, and a chair (or vice-chair) must be present. Depending on project scope and methodology, other role-specific members may also be required for expert quorum to be met.

In some cases, customers may request specific roles. In these cases, the customer accepts that delays may occur in ensuring such members are available.

Ethical review process

Service standards

The Ethiclear committee is targeted on a two-week turnaround of ethical review and opinion (delivered via a report back to the customer) after receipt of complete application and payment (or invoice raised on a maximum payment term of 30 days).

This target is not a guarantee, and some reviews may take longer and, in particular, in the review of more complex research projects.

Ethiclear administration aim to acknowledge receipt of project applications within two working days of submission.

Review scope and limitations

The committee will review submitted proposals having been assessed as appropriate for the committee to review; assess ethical acceptability of proposed research methodologies; review "project materials" (see below); consider risk-benefit ratios and participant welfare; ensure compliance with relevant ethical frameworks, guidelines and any applicable laws; and ensure lay review accessibility in consideration of public and participant involvement.

Project materials would likely include the study protocol, data-handling processes, any participant-facing documentation or information, data capture forms, participant information sheets, and consent forms and procedures. Some materials may also include data protection impact assessments (DPIAs), privacy notices, contracts, and information sharing agreements.

The committee will NOT review research feasibility or scientific merit beyond ethical considerations; provide regulatory approval or replace statutory requirements; review CTIMP studies; or replace the NHS HRA ethical review requirements for NHS patients.

Right to refuse review

The committee reserves the right to outright refuse to review any project for any reason, as determined by either:

• The Committee Chair
• Committee vote (or inability to form quorum as a result of refusal of engagement)
• Administrative assessment
• Consultation with any applicable regulatory or supervisory authority and applicable governing laws

Reasons may include but are not limited to: insufficient information, inappropriate scope, resource constraints, ethical concerns that cannot be adequately addressed, or legal or regulatory issues surrounding the review. The customer will be reimbursed any already-paid but unspent monies.

Process overview

The diagram below shows the overall review process. Note that this process may update from time-to-time and/or in response to customer need or regulatory/framework requirements. The process diagram is for information only and is not a guarantee.

Prices & payments

The initial ("small") review fee is charged at £100.00, and includes a check over the material submitted to ensure that Ethiclear is able and allowed to review the project proposal. At this stage, Ethiclear administration and quality assurance members will also work to ensure that all required information has been provided, and may request additional information or documentation from the customer before the project can progress to full review.

If and when the project can progress to full review, an additional fee of £1,000.00 is charged in order to provide the following:

• Full review by the committee
• Meeting and discussion time
• Report generation
• One round of minor amendment review

All prices quoted are exclusive of VAT. All payments are non-refundable and must be made (or invoice raised with 30-day terms) before the review can begin. Payments can be made via bank transfer or via credit/debit card.

Discretionary discounts may be provided to non-profit organisations and charities. Customers may wish to contact hello@ethiclear.com to discuss their needs in such cases. Upon research project submission, where such a discount is requested, Ethiclear administration will reach out to the customer to understand needs.

Sponsor responsibilities

For the purposes of this policy, sponsor refers to the study sponsor of the research proposal or, if different, the entity submitting the project to Ethiclear.

Regulatory compliance

The responsibility to determine whether Health Research Authority (HRA) NHS Research Ethics Committee approval is required lies entirely with the study sponsor. Sponsors (and project submitters) must use relevant HRA decision tools and seek appropriate statutory approvals where required.

The responsibility to seek appropriate ethics review lies purely with the sponsor.

Information accuracy

Sponsors must provide complete and accurate information for review. Any material changes to study protocols must be reported immediately, and all parties understand that the committee's opinion is based solely on information provided at the time of review, and is based on information limited only to that submitted. Good version control is encouraged between revisions to enable the committee to clearly identify most recent documentation versions.

If the subsequently-run study differs in any way from the information submitted to Ethiclear, the outcome from the ethical review is no longer valid.

Independence & conflicts of interest

Declaration requirements

All committee members must internally declare any potential conflicts of interest upon receipt of project proposal information.

Furthermore, any financial, personal, or professional interests that may affect impartiality, in addition to any relationships (personal, professional or otherwise) with study sponsors, investigators or competitors, must also be declared.

Such declarations, at the Chair and/or Ethiclear administration's discretion, may result in the member being excluded from the review of that research project.

Members may also recuse themselves from the review of any project for any reason they may have; whether personal or professional. In such cases, whilst a justification for such a recusal is useful to know, there is no obligation for the member to reveal this.

Conflict management

Members with declared conflicts may be required to withdraw from relevant discussions and decisions related to the relevant research project. However, this will not in itself affect their involvement in other projects.

The committee chair and/or Ethiclear administration will determine appropriate conflict management measures in-line with the type and severity of the declaration. Where the member is still permitted to conduct the review, the declaration and resultant decisions must be logged with justifications provided.

If a member declares or is found to be in severe or repeated conflict, the member may be excluded from specific future projects automatically.

The committee Chair or Ethiclear administration may decide to exclude committee members from a review/project if it is felt that there is potential risk or conflict of interest or other involved risk.

Any declarations of conflicts will be recorded on a declarations log.

Independence requirement

Committee members must act independently of personal, professional, or commercial interests. Members are reimbursed for their time irrespective of the ultimate ethical opinion determined.

Members must maintain objectivity when also working for competitors or related organisations. All members sign and agree to non-disclosure agreements (NDAs) when joining the Ethiclear committee, and thus have legal obligations to maintain full confidentiality with regard to all and any work conducted as part of the Ethiclear committee.

Participant welfare and ethical considerations are paramount, and must be considered above all other concerns.

Data protection & confidentiality

Information security

All review materials are confidential and must be handled according to company data protection and security policies. All committee members (including administrative staff) must sign appropriate contracts (including Non-Disclosure Agreement (NDAs) clauses or schedules) when starting work with or on the Ethiclear committee, which forms part of the primary agreement.

Electronic documents are stored securely and accessed only by authorised personnel. Company policy dictates that sensible security practices are adhered to, including the use of disk encryption, secure storage solutions, use of antivirus/anti-malware solutions, and secure workflows.

The customer or sponsor submitting a project for review remains Data Controller over such data, and authorise Ethiclear and its committee (together, as Data Processors) to process data on the Data Controller's behalf.

Data retention and deletion

All sponsor-provided materials (information submitted to Ethiclear) must be securely deleted from committee member devices within seven days of final report issuance.

Some or all materials and documentation may be retained indefinitely by Ethiclear administration (excluding non-relevant personal data, where there is no legal basis to do so). For example, this may enable Ethiclear to conduct follow-up reviews of related or similar studies, or to receive updates on the progress or completion of previously-reviewed projects. Any such record retention shall be performed in adherence with legal requirements for retention and destruction of personal data. The sponsor may request that such materials are removed from Ethiclear systems after the review completes.

Please refer to the Ethiclear Privacy Policy for more information.

Ethiclear committee members are not employees of Seastorm Limited. Whilst training processes, contracts and NDAs, and security controls are in-place, committee members work and operate and conduct their reviews independently.

Reporting & documentation

Final report requirements

Each review will produce a final report containing:

• Overall ethical opinion (Favourable/Non-Favourable/Major Non-Favourable)
• Rationale for the decision and any related comments
• Specific recommendations or required modifications
• Committee member information from those participating in the decision
• Review date and a unique reference number

Report distribution

Final reports will be provided to study sponsors within one business day of the committee meeting in which the relevant research project is discussed. Internal copies of such reports are retained by Ethiclear administration for audit and quality assurance purposes.

In cases of non-favourable opinion, amendments made based on Ethiclear committee comments and/or recommendations can be re-submitted via email. A new report will be issued in relation to the amended submission.

Committee decisions are final and binding.

Committee member obligations

Handbook and training compliance

All committee members must adhere to all provisions in the Committee Member Handbook, complete and refresh mandatory training programmes, maintain any required professional or continuing education requirements, and follow all relevant company policies and procedures.

Non-disclosure obligations

All committee members must sign and comply with Non-Disclosure Agreements, maintain strict confidentiality of all review materials, not discuss review details outside official committee business (including with friends and family), and secure all confidential documents securely and in-line with Handbook and policy guidance and requirements.

The Ethiclear customer or sponsor may wish to put in place a Data Processing Agreement or non-disclosure agreements with Ethiclear.

Disciplinary measures

Breach of committee member obligations may result in any or all of formal warning, mandatory retraining, temporary suspension from committee duties, permanent removal from the committee, or legal action (or regulatory or supervisory authority actions imposed) for serious breaches of confidentiality.

Public accountability

Committee member disclosure

Names, short biographies, and relevant qualifications and expertise areas of current committee members will, at the member's consent, be published on the company website and made available on other relevant material.

Contact information for the committee administration is publicly available.

Transparency measures

Annual reports summarising committee activities (anonymised and aggregated) may be published. Committee meeting schedules (if set) will be made available to potential applicants.

This Ethics Policy is made publicly available on the Ethiclear website.

Balancing innovation & ethics

Proportionate review

The committee commits to applying proportionate ethical oversight appropriate to study risk and benefit levels and supporting legitimate scientific innovation while maintaining ethical standards.

Members will individually and collectively provide constructive feedback to improve study design, method, and legal adherence, where possible, and facilitate timely review processes to support research advancement. The committee will also facilitate accessibility by way of lay review and involvement.

Continuous improvement

Ethiclear welcomes feedback from sponsors, researchers, and committee members. It is Ethiclear's collective mission to make ethical review accessible, safe and fair to all organisations conducting good research.

Ethiclear will continually benchmark itself against best practices in research ethics review, following NHS/HRA guidelines, in addition to relevant guidelines published by other regulatory bodies, and adjust its processes and practices accordingly.

Policy review

This policy will be reviewed annually (or on-demand or in response to business need or external factors, compliance with applicable and up-to-date legal, regulatory and associated supervisory authority requirements, and internal or external feedback), with updates made as/when relevant.

Annual reviews and audits will also be made against committee processes and decisions and customer feedback to ensure maintained quality assurance.

Annual training reviews will be made for all committee members, highlighting and remediating any gaps in professional, operational, legal, or security knowledge and skills.