Submission to an ethics committee is an essential part of the complex approval process that happens before a new medical device can be marketed. The UK Research Ethics Committees (REC) review applications of clinical studies to demonstrate the safety and performance of a medical device, and they ensure that participants are giving informed consent. EConsent solutions can make consent forms and documents more accessible and easier to navigate, enhancing informed consent and facilitating approval by the REC.
In this article, you will learn the importance of informed consent when submitting to ethics committees, the benefits of using an electronic based consent solution and some tips on how to prepare your REC submission. We will also introduce the impact of large language models in the future of digital consent solutions.
What is Informed Consent and Why it Matters?
Participants in a clinical trial are volunteers and should give their formal consent before the study can start. To protect their rights, privacy and welfare, this consent should always be informed, which means they are fully aware of the study’s objectives, possible results and the risks they will be subject to. Ethics committees work alongside regulatory bodies to ensure that patient’s rights are being observed by researchers and manufacturers submitting a product for approval.
In the UK, researchers should submit an MHRA (Medicines and Healthcare Regulatory Agency) application first and then, once it has been confirmed as valid, submit the Research Ethics Committee (REC) application. The organizations share information, and the reviewing processes happen in parallel. This process is different depending on region and country: in the US, for example, the FDA (Food and Drug Administration) oversees medical devices applications processes, and Independent Review Boards (IRBs) are the ethics committees responsible for protecting participants’ rights.
In all cases, however, informed consent will be required to classify clinical research as ethical and legal, and to comply with all regulatory requirements relevant to the medical product. According to the UK’s Medical Research Authority, informed consent should follow four general principles:
- It should be given by a person with capacity.
- It should be voluntary and not induced by undue influence.
- The participant should have been adequately informed.
- The informed consent should be a fair choice.
Therefore, informed consent is not just the act of signing a document after agreeing to participate in a study. The consent process involves careful preparation of consent forms and documentation, clear communication with prospective participants, transparency about data management and preparation of a submission to RECs that demonstrates that consent will be legally and ethically acquired. In the next section, we will discuss how electronic consent solutions can enhance this process.
The Benefits of Using EConsent Solutions
Traditionally, the informed consent process we just described was primarily paper based, with participants receiving physical copies of the study’s description and signing the consent forms by hand. However, with the development and popularization of electronic consent platforms, paper forms are gradually being replaced by digital tools and electronic signatures. They allow patients to read, review and sign consent documents from anywhere, using their own devices.
The MHRA, alongside with the UK Health Research Authority, recommends using eConsent because it can, according to the agency:
- Improve understanding.
- Test and reinforce participant comprehension.
- Provide feedback on how consent materials could be improved.
- Improve patient recruitment process and reduce dropout rates.
- Enable process efficiency.
To these benefits, we may also add:
- The possibility of offering participants alternative ways to read and review consent material remotely.
- It enhances communication, as it also provides patients with a safe and friendly environment to ask any questions about the study and have their concerns alleviated immediately.
- Patients can opt to stay updated on relevant information through the same platform, simplifying communication channels.
- Through these platforms, information about the study can be presented in a well-designed, straightforward way which allows for the inclusion of all relevant material required by RECs without tiring participants with extensive blocks of text.
- Digital consent platforms usually also offer additional functions such as patient recruitment and onboarding tools.
- These solutions integrate with other digital systems being used in the clinical trial, automating data entry processes.
How To Prepare Your REC Submission if You are Using EConsent
Details on how consent will be acquired from participants should be outlined in submissions to RECs. If you are using electronic based consent, it is recommended that you document the specific ways in which the consent solution will be helping participants to give informed consent. By submitting a well-developed consent acquisition plan, you avoid excessive requests for changes and may expedite the approval process.
Moreover, the ethics committee will need to review the documents and forms which you will provide to patients. It is recommended that they are presented in their final design, which should be clear, clean and with a user-friendly interface. In this section, we share some tips on how to build your REC submission and document your electronic consent process.
Give details on how the communication will happen
As one of the principles of informed consent states that participants should have been adequately informed, it is important to make clear how this will be done. This involves giving details about all the communication means that will be used. If you are using a digital solution, it could be that almost all communication will be remote, or that you choose to use a combination of face-to-face and remote communication.
You should also provide details on how patients will be asked for proof of identification, and which kind of documentation will be accepted. In your submission document, you may include a description of how you intend to approach patients to ask for consent: will you explain the study first? Will they be given the consent forms as soon as they are invited to participate? Finally, make sure to mention which platforms or communication tools will be used throughout the whole trial (videoconferencing platforms, video phone calls, etc.)
Explain how you will ensure that the process follows the informed consent principles
Aside from clear communication, what will be done to ensure that participants have fully understood the purposes, possible outcomes, and risks of the study they will be joining? The submission should include the documents with the study description that you will share with patients.
It is recommended that you also mention the means of comprehension assessment that you will be using. These could be simple questions to ensure that they have understood what they read, or more interactive strategies such as quizzes that appear throughout the electronic form. Another important point to consider is the questions format. Include in the submission document whether there will be open-ended questions, single choice or multiple-choice questions, as different levels of literacy are needed to answer each type of question.
Include a section about the eSignature process
If you choose to use eConsent, it is advised that you dedicate a section of your submission document to demonstrate that you are aware of the legislation regarding eSignatures. Electronic signatures are regulated by national laws, which means they may vary from country to country and not defined the same way everywhere.
In the UK, electronic signatures are defined as ‘data in electronic form which is attached to or logically associated with other electronic data, and which is used by the signatory to sign.’ They are classified as simple, advanced, and qualified electronic signatures, ranging from a simple check in a box to unique signatures linked to the signatory with a qualified certificate. Describe which one will be used and how its legitimacy will be proved.
Outline special circumstances that might need attention
You may need an extra section to address concerns such as asking consent for minors or for adults lacking capacity. The “Consent and Participant Information Guidance” offered by the UK Medical Research Council and the Health Research Authority also has details on emergency research and the situation of deceased participants. Check their examples page to see templates and access guidance on how to write consent documentation.
The “special circumstances” section might also include solutions to challenges like the need for translation or interpretation for participants who do not speak the language the study will be conducted in, and for support to patients who do not have access to the right technology to use the consent platform.
The Future of Digital Consent: Large Language Models
Large language models (LLMs) are a type of machine learning algorithm that is capable of recognizing, summarizing, translating, predicting, and generating content using very large datasets. They can be used to enhance AI (Artificial Intelligence) capacity of generating human-like content.
It can be used by medical researchers to enhance patient engagement with machine created video content and chatbots. LLMs can use huge amounts of previously recorded patient and research data to generate content that answers participants’ concerns instantaneously and remotely. For now, LLMs are not yet incorporated into eConsent platforms, but they represent a powerful potential development that could make electronic consent solutions even more interesting to improve the patients’ experience. Future REC submissions might include clarification on how LLMs are contributing to informed consent.
Partnering With a CRO to Get the Best of EConsent Solutions
In this article, we have explored how eConsent solutions can enhance the informed consent process in clinical trials and ultimately help to accelerate approval by research ethics committees. We have also covered specific strategies to write RECs submissions if you choose to use an electronic based consent solution.
ECLEVAR, as a leading CRO, supports the use of the latest technological developments to enhance clinical research. Our expertise in planning and implementing clinical trials includes advising our partners on the best digital solutions that can take their clinical studies to the next level. Contact our team if you have any questions or if you are ready to start discussing a new project.