(657)-214-3679
info@AscadaResearch.org
What is Informed Consent in Clinical Research?
What is informed consent in clinical research?
Informed consent in research is the process by which information about a clinical trial is shared with potential participants to allow them the ability to make a fully informed decision. Each potential participant in a clinical trial decides for themselves whether or not to enroll in a given study. This process is typically more in-depth than other consent processes for standard treatments, as a clinical trial may include an investigational drug, treatment, or procedure.
What's in an informed consent form?
The informed consent form details all the information required for a individual to make an informed and voluntary choice about whether to participate. It is a central part of the informed consent process as it documents a subject's willingness to participate, and is obtained before any research procedures may start.
Some necessary information to be included in the informed consent form include:
- An explanation of the purposes of the research.
- The expected benefits/risks/discomforts that could occur as a result of the research.
- Information about the experimental medication/procedures that will be involved in the trial.
- A description of all procedures that will be completed while enrolled in the trial.
- Information about alternative treatments or procedures that may benefit the participant for their consideration.
- The research subject's rights.
- Any added cost to the subject that may arise from participating in the trial.
- Any monetary compensation or reimbursements the participant may expect.
- An outline of the length of the study and how many visits would be involved in the trial.
- A notice that informs the potential participant that participation in the trial is entirely voluntary.
The informed consent form must be written in language that the potential participant is able to understand. Besides containing information about the study the informed consent form also includes an area for potential participants to sign, thus indicating their willingness to participate in the clinical trial. Only individuals of sound decision-making capacity and of legal age are allowed to sign consent on behalf of themselves. In special cases, the presence of a legal guardian or witness to the informed consent process is required for participation.
The informed consent process.
The informed consent process is designed to allow a potential participant the opportunity to read the informed consent form fully and to freely ask questions about anything they may not understand.
At Ascada, this process usually occurs in a quiet, private room free of distractions. Potential participants are given ample time to read the informed consent form on their own and at their own pace, and are later introduced to the study doctor and study coordinator who are there to provide clarification. From there, a conversation takes place where the study doctor and/or qualified study staff explains the purpose of the research, what they should expect from participating, and provides answers to any questions the potential participant might have. It is at this point after the potential participants has been educated about all aspects of the study and have had all concerns addressed, that they are able to make their voluntary decision to participate or not. In some cases, the potential participant is able to take the consent form home to discuss with their family or doctor if they are unsure. If they decide to participate, a copy of the signed consent form will be provided to them and can be requested at any point during the study.
The informed consent process is also continuous. If at any point during the study new findings are discovered that might impact the subject or influence the subject's decision to participate, it is shared with the subject immediately. The subject is then allowed to determine if they wish to continue enrollment or not.
Can I opt out of signing a informed consent form?
One of the core principals of clinical research is that participation is always voluntary. Interested individuals are never forced or coerced into signing the informed consent form and are not obligated to sign after inquiring about study information. However, refusal to sign this form indicates that the individual is declining participation in the clinical trial, and thus is not able to participate in any capacity. Informed consent forms exist to protect the subject and the site. No research procedures may be initiated prior to obtaining the informed consent of the participant. As such, enrollment and research procedures are only allowed for individuals who give their full, voluntary consent.
What happens if I want to stop participating after signing a consent form?
Participation in a clinical trial is always voluntary. Subjects who consent into the study may withdraw their consent at any point during their participation for any reason and with no penalties.
