There are several important concepts within the clinical trial process meant to protect trial participants, and the use of informed consent is a great example. However, while some are under the mistaken impression that informed consent only involves getting a quick signature for participation in the study, the reality is that this is actually a much more in-depth area that covers participants and researchers in several ways.
At Advanced Research Institute, we're proud to serve as a top clinical research company in Reno, Nevada and several other nearby areas, providing studies ranging from IBS and diarrhea to cancer, migraines, Crohn's Disease and numerous other conditions the medical world needs more information on. We detail and explain every part of informed consent to our participants before any research begins, ensuring they fully understand their rights and have made their decision to participate with all the proper information. Here's a primer on what informed consent is, what information must be given to each trial participant, and some other basic details on this important part of the research study world.
Informed Consent Basics
Informed consent is a theme the FDA and other regulatory bodies take very seriously within clinical trials. It involves providing any potential participant in a clinical trial with several areas of information:
- Proper information that allows the patient to make an informed decision about their participation.
- Any facilitation that's needed to help the participant understand the information.
- The appropriate amount of time to make a decision, including asking important questions, discussing options with family and going over research protocols in detail.
- Information on what to do if the individual decides not to participate or has questions later.
- Any potential risks or benefits that may come from their involvement in the study.
- Obtaining the participant's voluntary agreement to participate, typically in writing.
In many cases, especially with more complex trials that require a long period of participation, participants will be provided with this information several times during the course of their involvement.
As part of this process, potential participants will typically exchange information with the investigator or other study staff, allowing them to ask questions and voice any concerns they have about the research. In addition, participants will typically be asked to read and sign a consent form that details all of their rights as a trial participant, including how their personal information is going to be stored and used going forward.
Specific Elements of Informed Consent
Let's get a bit more specific here to ensure you fully grasp this realm. Here are some of the direct details informed consent is meant to inform potential trial participants of:
- They may not benefit from participating in the research.
- The study may not have any effect on their condition or prognosis.
- They are being asked to provide a sample that will be used for research purposes, including potential direct benefit to others.
- They may experience unpleasant side effects from the treatments being studied.
- The circumstances of this study might be very different from standard medical practice.
- They will be required to return to the study center at specific points during the course of their involvement, and may need to travel long distances for these appointments.
- Their decision not to continue participation should not affect their current medical care or any other aspect of their life.
- The information they provide during this process is confidential unless there are legal or regulatory reasons to disclose it.
- Participants will be provided with contact information for the study team, and will not lose any rights if they decide not to participate or want to withdraw at any point in time.
On top of this, a major function of informed consent is informing the potential trial participants of what kinds of research might be done on them, how protocols will be used to protect their privacy and confidentiality, as well as helping them understand how their information might be used.
What Happens If a Trial Participant Doesn't Have Informed Consent?
The short answer here is that there are several potential issues that can occur if those participating in a clinical trial do not have what's called proper informed consent. This can include:
- A clinical trial not being able to continue.
- Patients having legal recourse if they have suffered harm because of their participation in the study.
- Participants being unwilling or unable to provide samples for research or other purposes without appropriate compensation.
- Researchers not being able to get data on the participants, which can prevent them from understanding whether their findings apply to a wider population.
In some cases, there can also be potential regulatory consequences for not obtaining informed consent from patients, including the loss of an investigational drug or device's approval from the FDA when testing begins in human subjects. For all these reasons, plus to ensure patients are protected and comfortable, researchers will take informed consent very seriously.
Language That Cannot Be Included
There are also a couple important restrictions on the language that can be used within the realm of informed consent. Here are these general restrictions:
- Language cannot be included that causes the research subject to ignore, or appear to ignore, any of their own legal rights within the study.
- Language cannot release, or appear to release, the investigator, the sponsor, the institution, agents or any other representatives of the research organization from liability for negligence. If such language is present on signed contracts, it will be considered null and void by courts -- as might the entire agreement in many cases.
For more on informed consent and why it's so important within the clinical trials world, or to learn about any of our clinical research studies, speak to the staff at Advanced Research Institute today.