ETHICLEAR

Guidance through a grey area

Sponsors feel increasing pressure to demonstrate objectivity, ethical rigour and scientific credibility in their in human participant studies. This becomes highly impractical when:


(1) NHS review (NHS REC) is not supported or is not an appropriate route
(2) Independent Ethics Committee (IEC) approval is gatekept by academic institutions
(3) Approval becomes impossible, but journals, consumers and stakeholders still demand it

CEO @ Biotics Startup

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"Our research is outside the scope of NHS REC, but we still want to demonstrate that our work is ethically robust..."

Project Manager @ Nutritional Company

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"We felt anxious about promoting our results... we didn't need ethical approval and, while the study was ethically sound, we had little proof for journal publication and marketing..."

We can help

Get approval - and fast

Our review process is designed to be thorough, efficient and transparent. Once a submission is received, it is screened to ensure all required materials are complete. A review panel is then convened from our committee members based on the relevant expertise and availability for your project. Each protocol is reviewed independently against ethical standards, participant protections, data privacy compliance and scientific merit. Our decision cycle is typically one month.

• The Process

• Our Ethics

True transparency

Trust is earned

Our ethics review process is transparent, independent and grounded in real-world expertise. Submissions are reviewed by a multidisciplinary panel with no ties to sponsors or platforms, ensuring impartial, proportionate oversight.We focus on non-CTIMP human research - including nutrition, nutraceuticals, digital health and real-world evidence - with decisions guided by participant protection, data responsibility and clearly documented governance.

• Clarity

Meet the Team

Your experts in non-CTIMP research

Our committee comprise a diverse group of experts in clinical research, ethics and participant advocacy. Together, we provide a balanced, independent review grounded in practical experience and a commitment to participant protection.

Coming soon

Chair, Appointment Pending

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We are actively recruiting new members to our IEC - stay tuned!

IEC Member, Appointment Pending

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We are actively recruiting new members to our IEC - stay tuned!

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Your questions answered

Full transparency

CONFLICT OF INTEREST (COI) STATEMENTThe Independent Ethics Committee (IEC), Ethiclear, receives operational and administrative support from Seastorm Limited, a UK-based technology company that develops digital platforms and technology infrastructure for research. This includes the use of Seastorm's infrastructure for submission management and payment processing. While Seastorm facilitates certain administrative functions, it has no role in the ethical review, decision-making, or governance of study submissions. In addition, Seastorm is not involved in electing or removing committee members. This responsibility lies solely with the Chair.Seastorm also owns Trialflare, a data collection platform for human participant research. To safeguard independence, no committee member involved in ethical decision-making holds a position with, or uses, Seastorm products. Should a committee member become associated with Seastorm products outside of their Ethiclear commitments, through employment or other contract and professional work, they must declare this. In such situations, the committee member is contractually unable to review applications any longer. Any study that involves a Seastorm-developed product is reviewed by an independent panel with strict recusal procedures in place for any potential conflicts of interest.We are committed to maintaining a transparent and impartial review process. All committee members are required to declare any conflicts of interest and are recused from any review where impartiality could reasonably be questioned by anyone.

FREQUENTLY ASKED QUESTIONS (FAQ)What types of studies do you review?
We cover ethical approvals for non-CTIMP research - specifically nutraceuticals, supplements, foods, non-medical device wearables and real-world studies. Before you commit to Ethiclear for review, please ensure that you do not need NHS research ethics committee (REC) review by using the Health Research Authority (HRA) decision-making tool here.

Are you recognised by regulatory bodies in the UK?
At present, there are no regulatory bodies in the UK that formally recognise or accredit independent ethics committees (IECs) for non-CTIMP research conducted outside the NHS REC pathway. However, our committee operates in alignment with established ethical and governance standards, including:- The UK Policy Framework for Health and Social Care Research
- Governance Arrangements for Research Ethics Committees (GAfREC)
- International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) principles

Are you affiliated with any sponsors or any other organisations?
No, the IEC operates independently of any trial sponsor. While the committee receives partial financial support from Seastorm Limited - a UK-based technology company that develops digital tools and infrastructure for STEM research - all ethical reviews are conducted without influence.Seastorm also owns Trialflare, a platform used in clinical and nutritional trials; however, none of the IEC panel members are affiliated with or currently use this system, and all reviews involving related technologies are subject to strict conflict of interest safeguards.

Who sits on the committee and how are they selected?
We are currently recruiting members of the IEC.

How are the committee incentivised?
We believe in fairly compensating committee members for their time, expertise, and careful attention to each submission. Members are paid £25 per hour for review work (roughly twice the UK living wage) reflecting the value of their professional input while avoiding undue financial influence. This rate is intended to acknowledge the work involved without creating an incentive to accept projects or issue favourable opinions. It supports fairness, accountability, and the integrity of the review process, ensuring decisions are made solely on ethical merit.

How much time do members typically spend on an application?
To ensure that each application is reviewed thoroughly and fairly, we allocate a reasonable amount of time for committee members to carry out their responsibilities based on their role. This helps maintain consistency across reviews, ensures members are compensated appropriately for their time, and protects the integrity of the process by allowing thoughtful, independent consideration of every submission. Below is a typical breakdown of review time by role, based on an average non-CTIMP study.

Primary Review activities

Amendments and add-on activities

How do you manage conflicts of interest (COI) among committee members?
We have a clear and proactive conflict of interest policy in place. All committee members complete annual declarations and are required to disclose any potential conflicts before reviewing a study. If a member has any professional, financial, or personal connection to a sponsor, study team, or product under review, they are recused from all discussion and decision-making related to that submission. This process ensures that every opinion issued by the committee is impartial, independent and in the best interests of research participants.

What documents do I need to submit for review?
To ensure a thorough and efficient review, we ask applicants to provide a complete submission package in five key areas including:- Study protocol (including eligibility, assessment tools, biological sampling, statistical analysis plan, data governance)
- Participant Information Sheet (PIS)
- Informed Consent Form (ICF)
- Recruitment material (e.g. adverts, emails, social posts and compensation plan/s)
- Participant safety and risk assessments

How do I submit my study for ethical review?
To make things more accessible we have three ways that you can submit an application:(1) Create an account and use our online portal for your submission and for tracking your approval.
(2) Email us at [email protected] with your pre-filled forms (download here) from our website.
(3) Use the website uploader with your pre-filled forms (download here) from our website.

Do I need ethics approval if my study doesn’t involve the NHS?
Every study is different and some studies need no ethical approval at all. In general, if your work is not considered research, you do not need ethical approval. You can check if this is the case with the Medicines and Healthcare products Regulatory Agency (MHRA) decision-making tool here on what constitutes "research" by definition in the UK.From a regulatory perspective, if you need ethical approval it will be with an NHS REC. In other cases where you NHS REC is not required, it is still best practice to ensure that you are adhering to ethical principles. In such cases, an IEC such as Ethiclear can support you in progressing your idea in industry best practices.

Do you accept submissions from outside the UK?
Not currently, but we are always looking closely at regulatory best practices both in the UK and abroad.

How long does the review process take?
From submission to approval, the process can be as quick as 4 weeks. However, complex protocols and numerous amendments can draw out timelines and make the process longer.

What are the possible outcomes of a review?
There are 4 possible outcomes of the primary review:
(1) Approval - no changes are needed and you will be provided with a letter of approval from the Panel.
(2) Pre-approval (with minor amendments)
(3) Pre-approval (with major amendments)
(4) Resubmission - the application was lacking in a significant number of areas and requires a new submission.It's important to note that, whatever the outcome, feedback will be provided by the panel.

What happens if my study isn't approved?
If your study isn't approved, it doesn't mean that it won't be. Most studies will need amendments (minor or major). Though this can add to your study timelines with some back and forth, our panel will help guide you in producing a protocol which is ethically robust.

What is the committee composition? Is it always the same for all review steps?
The committee consists of seven members in total, however, they are not always all required for meetings.The committee consists of nine members:
One Chair
One deputy Chair
Three scientific advisors
One data protection advisor
One legal and ethics advisor
Two participant advocatesCommittee composition is at the Chair's discretion, however, our Ethiclear policy stipulates that a panel must comprise a minimum of five members in order to proceed.

Do minor amendments require full committee review?
No. If the Chairman has deemed the amendments as minor, a small sub-committee of three people can convene to cover these small items. Ideally, members will be selected based on their participation in the primary review of that same application.

Do major amendments require full committee review?
No. Similarly as with minor amendments as described above, a full panel is not required for major review. Ideally, members will be selected based on their participation in the primary review of that same application.

How do you handle urgent submissions or time-sensitive studies?
In exceptional cases where a delay in review could compromise participant safety or wellbeing, we offer an expedited review pathway. This is reserved for time-sensitive studies involving more urgent public health needs or safety-monitoring amendments. An additional fee applies to cover the additional coordination and fast-tracked review scheduling. Expedited requests are assessed individually, and approval depends on both ethical complexity and reviewer availability. We remain committed to maintaining review quality while responding proportionately to urgent situations.

How much does it cost to submit a study?
Costs for the ethical review are covered here and begin from £900 for primary review. Costs carry depending on (i) your organisation type, (ii) the stage in the process (primary review or amendment), (iii) whether multiple amendments are needed back and forth, and (iv) if you need your study or amendments expedited in light of urgent timelines or due to participant safety concerns.

Why do you charge a fee - is that ethical? and what does it cover?
The fee for ethical review helps cover the time, expertise and administrative work required to deliver a thorough and independent assessment. This includes reviewer time, committee coordination, data protection oversight and issuing formal documentation. It is an amount which is both fair and not too much to promote undue financial influence.For larger organisations or commercially sponsored studies, a higher fee applies to reflect the increased complexity, scale, and risk profile these studies often carry. This tiered structure ensures that smaller research teams and academic investigators still have access to high-quality ethical review, while allowing us to sustain fair and independent operations across all study types.

How are reviewer payments handled and who processes them?
Reviewer payments are processed through Stripe using a split payment system, ensuring each committee member receives their portion directly and transparently. No single individual handles or redistributes funds preventing risks of bias and influence over committee members. Seastorm receives an administrative fee for facilitating the payment process and supporting the operational infrastructure that enables the committee to function smoothly and independently.

How do you ensure data protection and GDPR compliance during review?
We take data protection seriously and operate in full alignment with UK GDPR requirements. All study materials submitted for review are stored securely, with access restricted to authorised committee members only. We do not collect or process participant-level identifiable data as part of the ethics review process. Any documentation containing personal or sensitive information is handled in accordance with strict confidentiality protocols. Additionally, our Data Protection Officer oversees compliance and supports applicants in meeting data protection expectations within their study design.

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Privacy policy

EthiclearEthiclear (the “service”, etc.) is provided by Seastorm Limited. Seastorm Limited ("Seastorm", "we", "us", etc.) considers your privacy to be very important. We will therefore process and use your data in a secure manner in accordance with the General Data Protection Regulations (GDPR) and other applicable laws and regulation. In this document we set out how and why we use your information.

SeastormSeastorm is a limited company registered in England and Wales, with company number 11867862. Our address is 141 Albany Road, Cardiff, CF24 3NT. You can contact us on [email protected] with any questions or concerns.

Scope of this PolicyThis policy applies to all users and participants of the Ethiclear service. This includes usage of our web app and any other approved clients.This policy also applies to visitors to our website (https://ethiclear.com or its subdomains), even if the visitor is not an Ethiclear user.This policy does not apply if you contact us (e.g. via email or otherwise), engage with us in any project or consultancy agreement, engage with us for billing or payment, for any marketing or sales activity, or for anything else not directly related to Ethiclear. In these cases, our general Seastorm Limited privacy policy applies, which can be found at https://www.seastorm.co/privacy.This policy also does not apply if you follow links to any resources outside of our control or services.For the purposes of relevant data protection regulation, we act as data processor for all Ethiclear web app user data.

CookiesOur website does not use cookies to track visitors to the site.Our web platform, accessible by Ethiclear applicants, stores small pieces of data in your browser’s local storage. This is done to allow you to login and maintain a login “session” and we cannot provide our services to you without this.

What data do we collect?In this section we identify the key points at which we collect data, and the purpose for the collection.

When you visit our website(s)When you visit our website(s) or web application(s) using a web browser, we collect some data about your computer and the way our services are used by you, even if you don't have an account. We do not collect your name or other personal details about you at this stage, but we may process information such as your computing device’s country and details about your browser and where you arrived from. We do this for observing aggregated usage of our services, so that we can better understand how to improve our services for their audiences. The legal basis for processing this data is a legitimate interest in recording aggregated analytics data for improvement purposes and to see how often people visit our website.

When you join us as a userThe service allows you to register for an account for (i) the submission of applications, and (ii) review of applications as independent ethics committee (IEC) member. This is the primary way by which we collect personal data from you, since such data is needed in order to identify you when you want to login and use these services. We may also use your email address to update you on platform updates and notifications, which you can control. When signing-up we collect your email address, name, and password. For wider communication and notification options (e.g. by SMS and WhatsApp), we also ask you to provide your phone number, though this is not needed to use the platform should you wish not to share this with us.We ask you for consent to this policy when you create or enrol an account, and the legal basis for processing this data is a legitimate interest in being able to provide services to you and to also to enable us to deliver contracted services as a supplier to your (or the host) organisation.

When you use our services as an applicantAs you continue to use Ethiclear for the submission and management of applications, key actions you take are logged for audit and compliance purposes with your host organisation. This audit log data may include your IP address and browser information and is collected for the purposes of compliance and legal record-keeping duties.We do not ask for or collect any additional personal data (further to the items above) as you use our services as a logged-in user. We do collect data relating to your study protocol, the associated documentation and any other information you wish to provide which is essential for your application review.You can modify your account details (including personal data) using your account settings.

When you join us as a panel memberThe service allows you to login as an IEC member. When you login, we collect your name and email address and phone number in order to contact you. These data are also used between panel members to perform panel-related roles, including document review, dissemination, feedback and teleconferencing scheduling.All participant personal information that is collected as described above is processed securely by us on behalf of the host organisation, who remain the data controller of such data.

SubprocessorsWe work with selected subprocessors to help run our services, as described below.Amazon Web Services (AWS): We use AWS to host and run our services.Mailgun: We use Maligun for the purposes of sending emails to registered users (e.g. password reset emails or notifications). To send the mail, we provide this subprocessor with your email address.Twilio: We use Twilio for the purposes of sending SMS (text messages) and WhatsApp messages. To send the SMS or WhatsApp messages, we provide this subprocessor with your phone number (if you have provided this).

Who can access your Data?As an Ethiclear user, Seastorm staff responsible for managing or maintaining your account can view your account and its data, with the exception of passwords, which are fully encrypted.We may be required to provide data to legal authorities if we receive such a request or warrant. If Seastorm is purchased or otherwise has its control transferred to another organisation or body, then data we hold will also be transferred to the new business controller. However your data will still only be used for the same purpose for which it was originally supplied to us. In any case, we act and will take steps with the aim of ensuring your privacy is protected.

How long do we keep data for?As an Ethiclear user, we keep your account data (e.g. name and email address and phone number if you provide it) for as long as your account is active. You can fully and irreversibly delete your account at any time from within your account settings.When data is deleted from Ethiclear systems, the deletion is done securely such that the data is non-recoverable (we do not use “deletion flags”).Please note that data held in backup systems may be held for up to an additional 30 days after it is deleted from our services.

Where is your data stored and processed?We store and process all user and application study data within our UK data centres, and this includes backups.When sending communications (e.g. emails, SMS and WhatsApp messages) we use Mailgun’s EU servers for transmitting email. Twilio’s services are based in the EU and the US.

How do we protect your data?Your data is well-protected. We use industry grade practices to help prevent against unauthorised access. This includes fully encrypting data in-transit (e.g. between your device and our servers, and between our servers) and at-rest (e.g. when it is saved onto the hard disks of our database servers).We use data centres that practice advanced protection mechanisms to prevent unauthorised access.

Child safetyChildren under the age of 16 are not allowed to use our services or to directly provide us with personal data. As such, we do not knowingly store or process personal data relating to children under the age of 16.

Your rightsAs an individual, you have rights with regard to personal data processed by us. Should you wish to exercise any of these rights then please get in touch with the email address shown on this policy. We will endeavour to action any rights within one business week.

Right to accessAt any time you have the right to know about any personal data we hold about you.

Right to correctYou have the right to have your personal data corrected or updated or deleted.

Right to objectYou have the right to object to us processing your data.

Right to data transferYou have the right to request your data in a sensible format such that it can be transferred to a different provider or system.

Rights relating to automated processingIf you feel you are being affected by us carrying out actions as a result of an automated process, to which you object to, you can object. We do not use automated decision making in a way that will affect an individual.

Withdrawal of consentIf you have provided consent for us to process your personal data, you can withdraw this consent at any time. This can be achieved by deleting your account, or by reaching out to us.

ComplaintsIf you would like to complain about the way in which we have handled your personal data, or about this policy, then please get in touch with us using the details in this policy.You may also get in touch with the Information Commissioner's Office (https://ico.org.uk) to raise a complaint.

Contact us: [email protected]

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