Clinical and medical trials involve experimentation or trying out new medications, therapies, and other medical procedures. The importance of this is to seek significant findings toward their effectiveness before being mass-produced or given to the public. So, what’s the role of a lawyer in medical trials? Why do you need to seek legal advice before undergoing such a procedure?
In this post, you’ll learn the importance of hiring a good lawyer in clinical or medical trials to keep you guided accordingly.
Makes Sure You’re Working with Clinical Experts
Phase 3 is the most costly and complicated aspect of investigational medical trials, like drug development. The role of a clinical trial expert is to ensure that proper protocols and procedures of the clinical trial are carried out. In early development, clinical trials tend to have a very high failure rate, decreasing in later phases.
A lawyer will ensure you’re dealing with clinical experts by asking proof, certification, accreditation, and legal documents governing the clinical trial. As Wagstaff & Cartmell explains, it’s crucial to value the preparation and strategy of a case over legal distractions. With years of handling cases, a good lawyer has a full understanding of what would and wouldn’t work. That’s why it’s better to be prepared at all times by consulting a clinical research lawyer beforehand.
Ascertain Your Health and Safety
The future of clinical trials involves simulation or using robotics, like a simulation of the human heart. However, not until such new technology proves to be effective, human clinical trials are still ongoing. A major concern though, is the subject’s health and safety. But how can a lawyer help in ensuring your health and safety before undergoing clinical trial?
Here’s how a lawyer can help:
- Verify Health and Safety: Hiring a good lawyer can help ensure your health and safety before undergoing the clinical trial. So it’s a good idea to choose a lawyer with years of experience to cover all legal aspects of such a procedure. For instance, your lawyer can demand documents and third-party verification.
- Inform the Government: A lawyer can induce government awareness and interaction to provide you assistance when the need arises. For instance, the FDA has placed new policies over the pharmaceutical industry because of the current pandemic concerning the lengthy review process, clinical trials, and manufacturing plants’ inspection process to seek an immediate cure for coronavirus.
- Document Everything: All steps should be properly documented, from preparation or assessment phase to full-blown clinical trial.
Create an Interdisciplinary Team
For clinical trial providers or institutions, hiring a good lawyer can help them meet legal requirements beforehand through creating an interdisciplinary team. It will ensure that all people involved in the project are aware of their legal obligations and to safeguard subjects at all times, following standard health and safety protocols.
Here are the things that a legal counsel can do:
- Drafts and reviews of all clinical trial or research consent forms, recruitment materials, HIPAA authorizations, and other participant-facing forms to ensure all inclusions, conditions, and terms are specified for mutual protection.
- Provides legal guidance to ensure successful new product development (vaccine, medicine, or medical equipment), approval, product launch, and sales and marketing efforts.
- Conducts in-depth preparation for reporting to the Institutional Review Board or Ethics Committee, Biosafety Monitoring Committee, Stem Cell Research Oversight Committee, Institutional Animal Care, and other private or government committees involved in the review processes.
- A lawyer provides risk management advice according to internationally accepted standards.
Ensure Your Legal Protection
An experienced lawyer who has been working with clinical trial cases knows the importance of consent form details. Without your signature or consent, a medical trial won’t surface. Your lawyer will check all inclusions or the finest detail of the consent form to ensure that:
- You would get compensation if the medical trial caused you injuries or adverse effects that may lead to hospitalization or disability.
- Your family will get compensated if, in any event, that the medical trial fails and results in death. All possible events are anticipated by a good lawyer and ensure that you are legally protected at all causes.
Hiring a good lawyer is important to ensure you or your loved one’s health and safety when undergoing a clinical trial. While experiments or trials are not a hundred percent effective, side effects or adverse reactions should be kept at the minimum levels by complying with global-approved standards. Your attorney can demand proof of legitimate operations and safety guidelines, and ensure all legal aspects are checked, most especially consent forms.