Informed Consent in Clinical Trials: What You Need to Know
How much do you really know about clinical trials? For most people, the answer is not a lot. Although clinical trials are used in almost all of the different drugs and vaccines we have today, there isn’t much general information on how they work, why they’re needed, and who participates in them.
The simple answer is that clinical trials test new and current drugs and treatments using human participants. Clinical trials and research also rely on an idea called research transparency.
Research transparency states that data collected should be shared between clinical research teams, sponsors and stakeholders, government agencies, clinical trial participants, and future patients. Clinical trial monitoring processes, review boards, ethical guidelines, and research transparency created an informed consent rule to protect human volunteers and participants.
What Is Informed Consent?
Informed consent, also known as human subject protection, is a federal regulation requiring doctors, clinical research teams, etc., to disclose all relevant information and data about any stage of a drug, clinical research process or a consent discussion.
The discussion should cover previous drug data and research on animals, potential risks and side effects, participant rights, and more. Once informed, participants must sign a legal form confirming they know all relevant information about the new drug and the clinical trial.
According to the Department of Health and Human Services (HHS), informed consent requirements include:
- Consent documentation detailing the extent of the clinical trial research and participant expectations during the trial, including all drugs, tests, procedures, and protocols, even if they’re new or experimental
- Lists of known risks, side effects, and adverse events found in the favorable benefit-risk ratio or previous research data
- List of possible benefits for participants
- If applicable, a list of any other possible treatment options or medical alternatives
- Who the data collected will be shared with, i.e., research team, sponsors, and government agencies, and how will the data be stored and protected
- If applicable, potential compensation for severe risk or injury sustained by participants during the trial
- Contact list for participants and safety rights
- Consent documentation stating that participants are volunteers and can end clinical trials at any time with no penalties
Participant Understanding and Participant Protection
Informed consent allows for research transparency while also strengthening participant understanding. With participants, clinical trials are possible.
Under informed consent is participant protection. Review boards guide participant protection as a layer of safety; they’re known as institutional review boards (IRBs) and independent ethics committees (IECs).
The role of these boards is to ensure that participants are:
- Informed of their patient autonomy and how to institute it
- Chosen unbiasedly
- Aware of the favorable benefit-risk ratios, and the ratio is acceptable
- Granted patient privacy throughout the trial
- Knowledgeable of their patient data, what it is, how it’s shared, and the results generated from it
Clinical research ethics also state that clinical trials must enact other parameters in each trial, including social and clinical value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects.
- Scientific validity: Clinical trials generate data to answer a specific goal or objective and provide protocols and processes within scientific means.
- Fair subject selection: Distinct criteria for who can participate in clinical trials must be available and followed but not discriminatory.
- Respect for potential and enrolled participants: This agreement assures participants are treated with constant respect throughout the clinical trial
Clinical Trial Information
Clinical trials are how researchers’ study and test new drugs and vaccines before Food and Drug Administration (FDA) approval. The goals of clinical trials and research teams are to learn if the drug has proven efficacy and safety and what side effects exist.
The clinical trial begins with clinical research, animal testing, and human subject’s trials. Clinical trials can go through up to four phases, each testing safety, dosage, efficacy, side effects, or a combination. The clinical trials process and monitoring teams call for informed consent to link the data between the clinical research team and volunteers.
The key to successful clinical trials is many participants with the targeted condition or disease and a healthy number of volunteers with no health conditions. This is where informed consent plays a crucial role in clinical trials.
Patient recruitment and enrollment rely on participant decision-making. Informed consent guarantees that potential volunteers are provided with all relevant information for the clinical trial, what it aims to achieve, how it can benefit them, and how it can harm them.
Through informed consent and patient rights, participants can be assured that:
- They are in control of their privacy rights
- They control their participant autonomy; participants have the right to end or change their minds at any step of the clinical trial process
- They will receive quality standards of care throughout the clinical trial
- The drug being tested has undergone extensive clinical research and preliminary laboratory testing through animal testing and, in some cases, other human subject testing depending on the phase of the clinical trial
When a clinical trial completes and passes a Phase 3 clinical trial, the data is collected and analyzed by the clinical research team and sponsors of the drug and clinical trial. Once properly analyzed, the drug is sent to governmental agencies like the FDA for approval if there is sufficient evidence that the data answers the initial question and proves the drug is safe and effective with a low favorable benefit-risk ratio.
Clinical trials depend on participants; with a better understanding of informed consent and participant protection, you can find the clinical trial information that’s right for you.
Wake Research also provides clinical trial frequently asked questions and information on what to expect before and after you become a volunteer.
Interested in joining a study or want to learn more? View a list of our currently enrolling studies.