This is our discussion with Lydia Ainsworth which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and not a transcript. This was done to improve readability.
Olga: Welcome to the next episode of our podcast. In today’s episode, we will discuss a paper we published in July 2025, titled “Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations.”
Today, we’ll provide an overview of our work, and I have invited one of our team members and main contributors, Lydia Ainsworth.
It’s very important to mention that the information in this article is based on our practical experience of designing and reviewing informed consent documents for different manufacturers, and it’s also my personal experience as a member of the ethics committee in the UK responsible for reviewing informed consents. So, it’s not literature research.
It’s really a hands-on practical experience from our team for something we’ve been working on, and I hope that will be interesting for everyone who works in the industry and also everyone in academia who is developing new medical devices.
I’d like to begin with a brief introduction on why we wrote this article. Those of you working in the industry know that regulations and guidance have long been standardised, largely developed with drug clinical trials in mind. For medicines, regardless of formulation, the concept is fairly straightforward: a treatment is given to patients at specific intervals, and the framework is more or less uniform.
In contrast, medical devices are far more diverse, ranging from robotic surgery systems to implants and diagnostic tests. Because of this variety, the requirements and information needed in informed consent forms for medical devices can differ significantly. Unlike drug trials, there is no single standard structure that applies across all cases.
This is why we decided to develop this guidance. Our focus is specifically on medical devices, aiming to provide practical advice and examples that can support manufacturers in creating or adapting their own informed consent templates.
In our article, we also looked at regulations across multiple regions, including the European Union, the United Kingdom, the United States, as well as parts of Asia such as Taiwan and Malaysia. We chose these regions because, in many ways, European and American regulators set the global standard for how medical devices and clinical trials are developed. Most other regions either follow their recommendations or work towards aligning with them.
That’s why we felt it was important to provide not only practical guidance but also an overview of the specific requirements in different regions. The idea was that companies could create a master informed consent template incorporating all regional requirements. Then, depending on where a clinical trial is conducted, they could simply remove the parts that are not applicable and adapt the template accordingly.
Another important aspect is understanding how this guidance can support companies and identifying our target audience. As mentioned earlier, our primary audience is medical device manufacturers. However, this guidance is equally relevant for universities, hospitals, and research institutions developing their own medical devices. We hope it will not only assist them in creating informed consent templates but also serve as a useful resource when developing standard operating procedures (SOPs). In this way, our article and recommendations can help organisations strengthen and streamline their internal processes.
Lydia, is there anything you want to add to what I’ve just shared?
Lydia: Yes! First of all, thanks for having me on the podcast. I’m not sure if you’d like to go to the table we’ve set up for this topic.
Olga: Yes, we will do it in a second, but I’d like to add something first.
It’s about the people who contributed to our research and review. I’ve already introduced you, and of course, we had Galina and Wai Theng, who did an outstanding job in preparing this review.
I’d also like to acknowledge others who supported us. From the Ethics Committees, Alison and Elizabeth from the Welsh Ethics Committees provided valuable feedback. I also want to thank Deborah from the HRA, who assisted with coordinating reviews to support our peer review process.
Additionally, Lisa from Southampton University Hospital shared important insights from a site perspective, and of course, our peer reviewers from Dove Press, who gave us very constructive feedback on the final article.
I’ll now hand over to Lydia to discuss the different requirements outlined in the table we developed as part of our paper.
Lydia: Thank you, Olga. Having all those perspectives is so important. We often only see things from one angle, but when developing any trial document, it’s essential to incorporate input from people across all stages of the process. This collaboration has been extremely valuable, and it has clearly paid off in the final outcome.
As part of the article, we included a comparative table summarising the core regulatory requirements across the regions that we discussed: the USA, EU, UK, Taiwan, and Malaysia. This table highlights both the differences and the commonalities among these regions.
One of the few consistent requirements across all regions is the inclusion of information on risks, benefits, and potential discomforts, along with prohibitions and restrictions. These elements are central to informed consent, as they are crucial for ensuring patients can make an informed decision about participation and for verifying eligibility.
On the other hand, certain requirements are region-specific. For example, in Taiwan, informed consent forms must include personal patient information, reflecting local regulations on anonymisation. In contrast, the UK and EU rely on pseudo-anonymisation, typically limiting identifiers to patient initials and anonymised trial numbers. Malaysia has a unique requirement that consent forms must address any factors that could render a device culturally unacceptable, an important consideration given the country’s large Muslim population.
In the US, EU, and UK, regulations extend beyond the content of informed consent to cover aspects such as layout and format. This demonstrates how some regulators place emphasis not only on the information provided but also on how it is presented to patients.
The table also shows the close alignment between UK and EU regulations, which is largely a legacy of the UK’s prior EU membership. Post-Brexit, the UK has developed its own regulations, but these are still based on EU frameworks, resulting in continued similarities. The EU, in particular, is recognised for its strict regulatory standards, which the UK continues to follow closely. In contrast, we see that some developing countries maintain fewer regulatory requirements.
Olga: Yeah, I think that’s a very great point that you made. Thank you for that.
I’d like to expand a little on some of the specific differences between regulations in the US, Europe, and Asia. As Lydia already mentioned, data protection is one of the major distinctions. The European Union has very comprehensive and detailed requirements, whereas in many other countries, the scope is not as extensive.
Another thing that I wanted to mention is the diversity requirements. Our review covers regulations up to December 2024. I’m aware that in the US, the guidance on diversity in global trials has recently been withdrawn, but we decided to retain that information in our paper, and I’d like to explain why.
I think the term diversity has been politicised and has become a little bit toxic if we have to agree on this. We’ve always wanted to have diversity in clinical trials. This is not a new concept invented by politicians.
This has been ongoing for many years, and the rationale behind this is that if you have a country where you have different people in different communities. You want all of these people to have equal access to clinical trials and to participate in clinical trials, which is why clinical trial diversity exists. So, it has nothing to do with politics.
That is why I believe it is critical to maintain that one and ensure that everyone in the country has access to clinical trials, as many of these therapies are very unique for patients with special needs, and they may not have any other treatment options.
Participating in a clinical study provides them with an excellent opportunity to access treatments that they would not otherwise have. That is why I believe it is vital to consider diversity from that perspective.
Another important part I wanted to mention is about patients’ involvement. In the UK, it is now a requirement to involve patients in drafting informed consent documents and related materials. Similar trends are emerging in the US and the EU. While this is not yet mandated in Asia, we anticipate the region may move in that direction, as international alignment continues to strengthen.
As Lydia already discussed, we included Taiwan and Malaysia to illustrate the differences within Asia. In particular, we chose to highlight Malaysia as a developing country, since it is important to recognise how regulations are evolving not only in established markets but also in emerging ones. We also recently released a Chinese translation of our article, with the hope that it will make our findings more accessible to stakeholders in Asia and support them in developing their own documentation.
Now I’ll leave Lydia to share more about the ethical considerations because this was a big section that she developed as part of the paper. So, Lydia, you can say a few words on the ethical part.
Lydia: Thank you, Olga. When it comes to medical device studies, there are several unique ethical considerations that differ from those in investigational drug trials.
One of the key principles we highlight in the article is the interest principle, which states that the interests of participants must always come first. Informed consent alone is not sufficient if the risks involved are not aligned with the participant’s best interests. This becomes particularly important with new medical devices, where safety data may be limited or risks may be higher in early trials. For this reason, informed consent documents must clearly explain the risks, potential benefits, and purpose of the study, so participants can make decisions that truly reflect their own interests. Without this clarity, consent cannot be considered ethical.
One significant advancement in this area is the introduction of e-consent. This allows us to incorporate various multimedia formats, such as diagrams and videos, which can enhance participants’ understanding of medical devices. Often, it can be challenging to convey complex information using only written words or standard images. E-consent also facilitates the consent process for participants who do not speak English as their first language, which is crucial.
Additionally, we need to consider the capacity to consent, especially in patients with conditions or comorbidities that may affect their ability to understand or express consent. This consideration is particularly important in life-saving situations where a device is used in an emergency context. Promoting the capacity to consent in these cases is essential.
Clinicians must ensure they conduct proper capacity assessments in accordance with the country’s regulations. In the UK, for instance, we have the Mental Capacity Act.
And in situations where patients lack capacity, it’s important to make arrangements for legal representatives who can consent on the patient’s behalf. However, this process brings its own challenges because how exactly do you identify someone who is genuinely acting in the patient’s best interests? We are all subject to our own internal biases, so we can’t expect representatives to make decisions that fully align with the patient’s wishes every time.
But overall, having the option for proxy consent, such as a legal representative, is very important for obtaining a representative sample of patients.
I believe this relates to what you mentioned earlier, Olga, because some participants might face discrimination, especially those with reduced capacity, who are already underrepresented in clinical research and experience health disparities because of it.
There has been a lot of research and guidance published to assist researchers in promoting capacity and determining what to implement to support it. You can read more about it in the article.
Olga: Yeah, brilliant. Thank you so much, Lydia, for this overview of the ethical aspects that we considered for the research.
So, another point I wanted to discuss briefly is why it’s important for medical device manufacturers to recognise the flexibility available in how clinical trials are conducted. I think this mainly stems from the fact that, even today, a few years after we began conducting more regular clinical investigations with medical devices, we still have relatively few specialists with experience in working with such devices. As a result, most people who seek advice from medical device companies tend to come from drug or pharma companies, and they possess that experience.
The way of thinking about drug clinical trials often adds unnecessary complexity because they try to mimic what is done with medical devices in drug studies, which is not always needed.
That’s one thing. The other is that it could actually add a lot of additional costs to the manufacturer and could also generate a lot of extra work for everyone trying to meet some requirements which are not necessarily real requirements. Many of the stereotypes about how we conduct clinical trials originate from drug clinical trials.
So, if you have a medical device, you really need to try and shift away from this way of thinking and focus on what is best for your clinical trial.
Can you use electronic informed consent? Yes, you should use electronic informed consent regardless of what people tell you—that we don’t do that in drug clinical trials and you can’t do it.
So, I think we need to move past this constant refrain of ‘no, you can’t do that’ because no one else has done it or because I don’t know anyone doing it.
I believe that the main mentality preventing people from being innovative and adopting different approaches in clinical research is not due to regulatory restrictions. Quite the opposite, even if you examine the guidance issued by regulatory agencies such as the UK and FDA, they all advocate using different designs, methods, and keeping things simple, making it effective for both the researchers and the patients.
There’s no pressure that you have to do things in a very particular way. You can think about what is best for your medical device and try to design the study in a way that works best for you and for the patients.
I think this is the main point we try to emphasise to companies in our discussion section.
It’s essential to consider the specific device and how to perform tasks in the most effective way. If it’s transparent, has an audit trail, and is safe, you can definitely proceed. You can also explore different options, so you’re not required to follow what drug companies are doing.
And as part of our research, we developed a checklist to provide companies with the main components they can consider when developing their informed consent documents. It’s very high-level; of course, you must always consider your local regulations in the country where you will conduct the clinical trial. However, this can offer very useful checklist information if you want to review and improve your SOPS. I will now hand over to Lydia to say a few more words about the checklist we have developed.
Lydia: Thanks, Olga. As you mentioned, the purpose of the checklist is to provide a high-level summary of the considerations companies can take into account when producing clinical trials or developing their SOPs for such documents.
It’s a good summary of the topics we discussed throughout the article. It includes information about which specific trial details should be explained or emphasised so that patients can make a fully informed decision, which, as we discussed earlier, is very important.
As you mentioned, it is an overview, and any company developing those documents should conduct thorough research on this, including specific regional requirements within the countries where they are recruiting, before creating their informed consent documents to ensure compliance with local regulations.
But overall, it does provide a summary of the considerations that need to be made, and the suggestions we discussed throughout the article.
You can find more information within the article, and I would suggest reading it first, so you understand the rationale behind the items included in the checklist, as it does require that to make more sense.
Olga: Yeah, I agree with you. It’s because the checklist we developed is based on all our discussion points.
Based on our discussion in the article, we have created this checklist to cover all these points, and another point I wanted to mention at the very end. For those interested in reviewing what we’ve written, I would like to conclude by emphasising that we should always remember the purpose of the informed consent document is to help patients understand the clinical research.
It’s not a tick box exercise. It’s not a nuisance. It’s not just a regulatory requirement. It’s not to cover your back in case something goes wrong.
It’s really about providing sufficient information to the patients, and this is what you need to consider when developing informed consent. That’s the main point.
