What types of studies do you review?

We cover ethical review 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:

https://www.hra-decisiontools.org.uk/ethics
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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 aligns with principles established ethical and governance standards, including:
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>> 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 ERB 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.
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Who sits on the committee and how are they selected?

We hve 8 members of our committee. They are a multi-disciplinary group covering many aspects of research. You can view the members and their biographies in the Members tab.
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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 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.
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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 three key areas. We provide templates for all these documents as part of the submissions process and you should use these to submit to the committee:
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>> Study protocol (SP)
>> Participant Information Sheet (PIS)
>> Informed Consent Form (ICF)


How do I submit my study for ethical review?

The application process is very simple. Click on New Application in the header or footer of this website and you will be guided to a page with links to download the template documents listed above.
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Do I need ethics review if my study doesn’t involve the NHS?

Every study is different, however the general consensus in the ethics field is that any work involving human participants should be reveiwed.

You can check to see if you need HRA/NHS REC using the HRA decision-making tool here:

https://www.hra-decisiontools.org.uk/research
From a regulatory perspective, if you need mendatory legal ethical review 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.

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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 review, the process can be as quick as 4 weeks. However, complex protocols and numerous amendments can draw out timelines and make the process longer.
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What happens if my study isn't granted favourable review?

If your study design isn't favoured by the panel, 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. One minor amendment is free of charge and covered in the review cost.


What is the committee composition? Is it always the same for all review steps?

The committee consists of 8 members in total, however, they are not always all required for meetings. More details on this can be found in the Ethics Policy tab.
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Do minor amendments require full committee review?

No. If the Chair 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 favourable review depends on both ethical complexity and reviewer availability. We remain committed to maintaining review quality while responding proportionately to urgent situations.


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.
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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.