Inform consent is the process of informing potential participants on the key elements of a study so they can make an informed decision on their participation. The informed consent process is central to the ethical conduct of any study, and stakeholders should pay special importance to creating a robust form that complies with relevant rules and regulations.
The consent process involves providing a written document containing comprehensive information regarding the study. However, writing an informed consent form isn’t an easy task. Here are a few things to remember when writing an informed consent form.
Considerations When Writing an Informed Consent Form
One of the first things to keep in mind is that the informed consent document should be simple, easy, and straightforward. It shouldn’t have complicated terms, acronyms, or abbreviations that are hard to comprehend for someone not well-versed in the clinical trial landscape. A comprehensive informed consent form will have the following characteristics:
- Information regarding the study and element of consent
- Comprehensive and complete explanations in lay language
- Protection of confidentiality
- No unproven claims of effectiveness
- Consistent with the study protocol, research brochure, and the main contract
- Contact information
The Informed Consent Process
The informed consent process should be free from errors, unbiased, and should inform the participants of all considerations of the trial. The entire consent process should be comprehensive and interactive, allowing participants to engage in active discussions and ask questions from clinicians and others involved in the study.
It is important to remember that the entire process is unique to every study, and adopting a one-size-fits-all approach can impact the effectiveness of your study. The informed consent process will always be personalized for every subject and study.
Modern Tools and Technology
Modern tools and technology like eCRFs and EDC systems can help in patient selection, participation, and the informed consent process. Moreover, technology such as SDV in clinical trials and remote site monitoring has transformed the clinical trial landscape.
In addition, clinicians and data managers are always looking for an all-inclusive clinical data management system that helps them conduct result-oriented trials. If you’re looking for one, check out the products and services offered by ClinicalPURSUIT.
We are among the best in providing world-class EDC software and solutions for the clinical research community. We provide various solutions under one roof, and our pricing is flexible.
You can visit our website for more information or schedule a one-on-one free demo today!