Contention over medical research, especially research that involves human participants, is nothing new. Companies and other entities that conduct medical research are quick to cover their abases when it comes to the possibility of expenses. Even so, putting a ‘test’ or ‘trial’ label on care is not all encompassing.
Even the most extensive and air-tight of test and research waivers leaves room for claims of medical malpractice. Gross negligence and failure of duty continue even if there are potential pitfalls spelled out.
It becomes harder to prove that injuries are related to a mistake or neglect and not potential results of experimental procedures/medicines. In this article we’ll go over a few of the outcomes and parameters involved in medical research and malpractice cases.
Entering a drug or treatment trial comes with a lot of paperwork. The majority of this paperwork relates to the duties of the patient and of the research staff. Within these documents you’ll find details on the responsibilities a patient has to the trial.
Most of this is what kind of reporting you do and how often. It provides stipulations for when you can be removed and reminds participants that they might be in a control group.
Waivers for medical care and making legal claims of injury can be included. These must be phrased in certain ways to be binding. Ideally, medical costs related to injury are explained and costs for extended care are often put on the patient.
While the agreements try to cover everything, the less specific the statement, the more room there is to question validity. Hand-waving over ‘other unexplored options’ opens arguments about what can and cannot be reasonably known.
Liability Not Covered
Clinical trials create a problem for multiple fields and disciplines. Legally they are a challenge, medically they are a challenge, and ethically they require sophisticated questions.
For example: a trial includes known or potential side-effects of an experimental drug. If you experience injury related to these side-effects, the trial would not be liable. If a trial involves a surgery or invasive procedure, you can still sue if the surgeon makes an error.
In either case, the resulting injury would have to be carefully compared to the expectations and restrictions given within the trials’ wavers.
Pay to Participate Trials
Most trials are paid for by whatever governing body that conducts them. In some cases, a trial may be so expensive that to even be conducted payment from participants is required.
These types of trials create even more insidious ethical quandaries. The largest of which relates to patient expectations. It’s one thing to offer a treatment and provide waivers against damages, it’s quite another to require someone to pay for a treatment that causes injury.
While these types of trials are closely scrutinized, they are legal.
In some instances, a compensation fund is created to deal with injuries resulting from trials. These funds pay out to those injured by a trial while not exposing the entities running the trials to liability claims.
Gaining access to a fund still requires proof that an injury was caused by a trail.
Start a Dialog
Medical research and clinical trials are important for expanding our knowledge and creating new treatments. That said, they are not given a blank check to harm participants. The research is important but must be conducted ethically and with an eye towards ‘do no harm’.
When these basic tenants are violated, you need to seek compensation. Contact us to learn more about your options and the rules governing clinical trials. We’re here to help.