Informed Consent: Your Rights Before You Participate in Research
- Have you ever considered participating in a clinical trial for a new medication or treatment?
- If so, you've likely encountered an "informed consent form." But what exactly is it, and why is it so important ?
Informed consent is the cornerstone of ethical research. It's a process that ensures you, the potential participant, fully understand the details of a study before you decide to take part. This blog post will break down the informed consent form and process, empowering you to make informed decisions about your health.
What is an Informed Consent Form?
Informed consent is a key founding principle of research ethics. It is based on the Belmont Report (1979), which dictates that a person has the right to decide for themselves what they do with their own body. Even research participants have autonomy and researchers need to have respect for people’s individual decisions.
Informed Consent, a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate.
Informed consent is documented by means of a written, signed and dated informed consent form.
Informed consent is a clear and standard process, not just a piece of paper. Think of an informed consent form as a detailed instruction manual for the research study.
It typically outlines the following key elements:
- Study Overview: This section explains the purpose of the study, duration, cost and additional expenses of the trials, alternative care options and the procedures involved.
- Risks and Benefits: No research is without risk. The form will detail potential side effects or complications associated with the study, alongside the anticipated benefits.
- Alternatives: You'll be informed of alternative treatment options available to you outside the study.
- Confidentiality: The form will explain how your personal information and medical records will be protected throughout the research.
Your Rights as a Participant: You have the right to ask questions, withdraw from the study at any time, and receive updates on the research progress.
The Informed Consent Process: More than Just a Form
The informed consent form is just one part of the process. Here's what you can expect:
- Explanation by a Qualified Researcher: A doctor, researcher, or qualified staff member will explain the study details in an easy-to-understand manner.
- Opportunity to Ask Questions: Don't hesitate to ask questions until you feel completely comfortable with the information provided.
- Time to Consider: Take your time to review the informed consent form at home and discuss it with loved ones before making a decision.
Empowering You through Informed Consent
The informed consent process empowers you to make informed choices about your health. By understanding the risks and benefits, you can participate in research that aligns with your values and health goals. Remember, your participation is voluntary, and you can withdraw from the study at any point.
Informed consent is the foundation of ethical research, ensuring, the potential participant, fully grasp the details of a study before deciding to take part. This blog post dives deeper into the role of a Legally Acceptable Representative (LAR) & IW within the informed consent process.
Who Can Be a Legally Acceptable Representative?
The specific criteria for an LAR can vary depending on your location and the research institution. However, some general guidelines apply:
- Legal Authority: The LAR must have legal authorization to make healthcare decisions on your behalf. This authorization could come from a court order, power of attorney document, or established guardianship.
- Understanding the Study: The LAR should be able to comprehend the research details and make informed choices regarding your participation.
The LAR's primary motivation should be to protect your well-being and make decisions that align with your best interests, as far as they are known or can be reasonably determined.
Impartial Witness
If the trial subject his or her legally acceptable representative is unable to read or write an impartial witness should be present during the entire informed consent process who must append his or her signature to the consent form.
IW,A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
An Impartial Witness is required to be present during the informed consent process in any of the following scenarios:
- The subject or the subject’s legal representative is unable to read the informed consent form.
- The subject or the subject’s legal representative is unable to sign or date the informed consent form.
- The role of an Impartial Witness is to attest that the information in the informed consent has been accurately explained to the subject or the subject’s legal representative, the informed consent has been apparently understood by the subject or the subject’s legal representative, and the subject or the subject’s legal representative has voluntarily agreed to participate in the clinical research study.
- An impartial witness is independent of the clinical trial and is not influenced by people involved in the clinical research study. Impartial witness should be present during the informed consent process.
The possible choices would be either a family member, friend, clinic staff (who is not part of the study team), or a layperson. The choice of an impartial witness should be made in the best interest of the research participant.
The Informed Consent Process with LAR/IW
Even when an LAR/IW is involved, the research team still has a responsibility to ensure you understand the study as much as possible, considering your situation. Here's what you can expect:
Accessible Information: The informed consent materials may be adapted to your level of understanding or presented in alternative formats if necessary. The LAR's/IW’s decisions should consider your known preferences and values, to the extent possible.
The Importance of Communication
Open communication is crucial throughout the informed consent process. If you have any questions or concerns, don't hesitate to voice them, even if you have a LAR/IW involved. Additionally, the research team should keep you and your LAR/IW updated throughout the study.
Informed Participation with Support
The involvement of a Legally Acceptable Representative/Impartial Witness doesn’t diminish your rights as a research participant. By understanding the informed consent process and the role of a LAR/IW, you can ensure informed decision-making, even when you require additional support.
Remember, your participation in research can significantly contribute to advancements in healthcare.
Keep Healthy & Stay Tuned!