One of the most important phases of clinical research is consenting because there won’t be any participation without an agreement. Furthermore, it is generally believed that a participant in a trial who has more knowledge will have a decreased likelihood of quitting later on. The goal of a clinical research organization like Veristat holding trial informed consent procedures is to provide participants with ongoing information so they can make an informed choice regarding whether to enroll in or continue participating in a clinical study. Although obtaining informed permission is a crucial step in clinical research, problems with clinical trial participants’ understanding, competence, and voluntariness may hurt the process.
In response to these issues, new solutions are being proposed to enhance the consent process. These include;
Make the informed consent procedure more participant-friendly
First, while keeping the target group in mind throughout the clinical trial research process, modify the consent procedure to reflect the preferences, interests, and needs of the possible participant. The target audience should be represented at every stage, from developing and co-creating the documentation to carrying out the informed consent procedure and obtaining post-implementation input that can enhance the initial procedure. To adapt the material to the audience, the Design Thinking approach is recommended. Participants can choose the amount of information they get about a research study thanks to the method of giving information in layers.
Present information in various formats.
Reading and learning habits have shifted in today’s society, and written texts increasingly include additional features such as multimedia, hyperlinks, photos, and infographics. The informed consent must therefore be customized to social reforms that make it easier for people to grasp and should be provided in a variety of ways that may or may not incorporate new technology. Depending on their unique qualities, the participants can pick the style that best meets their requirements and interests.
Adopt modern techniques to enhance communication
The recommendations offer helpful checklists and tools that assist users in meeting compliance and stakeholder requirements as well as in locating and examining all essential elements of the informed consent process. This strategy will enhance comprehension and meet the requirements and preferences of prospective participants. The tools cover topics like effective communication, how to write a letter of thanks, and strategies for taking participants’ perspectives into account, which are not specifically linked to the informed consent technique but are nonetheless helpful for enhancing it.
Reduce data breaches by centralizing patient identifiers.
In comparison to paper document files, secure and highly limited electronic systems can provide enhanced secure storage for personal data as well as transparency and better control over who can access the data. Additionally, several records of participants’ personal identifiers may be kept by different stakeholders (such as couriers, home nurses, etc.) in hybrid and decentralized clinical trials, raising the potential of data privacy breaches. By utilizing eConsent, we can do away with these extra filings and create a “one” secure database that is heavily guarded over participants’ personal information. To enable remote document verification, the same secure environment can also be used to collect participants’ extra personal identifiers (like their home addresses or phone number) or to upload their medical data.
Informed consent is a vital part of the clinical research process and is essential to the ethical carrying out of clinical trials. To address these challenges, numerous cutting-edge communication approaches are currently being advised to better communication and the consent process.