Verbal communication is the only form of communication that can be used to indicate informed consent because it is specific and not ambiguous in meaning. The vocabulary for this type of communication does not include any other forms, including writing or even gestures, which are also forms of communication but aren’t specific or clear enough to indicate informed consent. Informed consent is a process where the patient needs to be able to ask questions and verify that they are not being deceived or coerced into doing something against their will. Verbal communication provides this opportunity for clarification and understanding, which other forms do not.
For example, imagine that you are in need of some medical treatment. The doctor tells you they’re going to give you something to make you feel better, but they aren’t clear about what it is or what side effects it may have. Imagine further that written consent forms weren’t included as a part of this process, and instead, the doctor just told you everything without giving any documentation or examples. This lack of clarification would mean that your ability to give informed consent was not possible because there wasn’t a chance for clarification if needed. Some researchers have taboos against using certain forms of language because they may be perceived as having negative connotations or associations. For example, sayings such as “the operation was a success” are avoided in some medical contexts due to their being associated with death.
1. What Is Informed Consent?
Informed consent is a process of communication between a research subject and another person (most often a researcher or physician) wherein the subject is given sufficient information to make an informed and voluntary decision about whether to participate in a research study. Informed consent is a process in which a patient or research participant is made aware of the risks and benefits of medical treatment or study and gives her voluntary agreement to participate in it. This process typically involves the disclosure of information by a health care provider to the patient, followed by the patient’s decision whether or not to proceed with the treatment or study. Informed consent must be obtained before participation in any human subject research activity. When a person gives informed consent, he or she may sign a document. This is known as informed written consent. This type of written consent provides clear proof of consent and is more effective than oral consent. The written document can be given to anyone who needs it, even if it is a stranger. A person can also give informed verbal permission, but a written document will be more reliable and recognizable. Informed consent is part of shared decision making, in which patients and physicians work together to make an informed decision about a medical procedure. While a patient must be adequately informed to make an informed decision, the physician plays an important role as an educator. While there are many ways to document informed consent, a written document is the most effective. When in doubt, a written version should be used.
2. What Are the Types of Informed Consent?
There are two types of informed consent: express and implied.
Express Consent
It happens when a researcher says directly to the participant that they agree to participate. This is usually done with language like “I agree.” Express consent implies that verbal communication was used to indicate informed consent. Expressing your agreement verbally makes it clear what you agree to and your association with whatever activity is being discussed because there are no other factors involved. Explicit consent is defined as a written statement signed by the participant indicating his or her agreement to participate in a given study. This written documentation must meet specific requirements, such as being dated and identified with the full name of the individual signing it. For example, if a person agrees to take part in an experiment where they’re asked to give truthful answers about crime rates after watching videos that dramatize those statistics, the researcher might ask for their written consent for that specific project.
The requirements that ensure this informed consent is explicit include:
The document should contain (a) an explanation of all procedures that will be followed; (b) any risks and/or discomforts to which participants will be exposed; (c) anticipated benefits to the participants or society; (d) a statement that participation is voluntary; and (e) the approximate length of time required for each participant
- The document should be signed and dated by both the researcher and participant in order to indicate that all parties have agreed.
- Neither the subject nor any third party can induce consent under this model, which stands apart from other consent models that allow either
Explicit consent is used when an experimenter wants to ensure that they are getting written permission from every single individual who may take part in their study. It must contain certain specific information, such as risks associated with creating a personal identification number for a research study. This data must be presented in writing so there’s no confusion over what will happen.
Implied Consent
Implied consent occurs when it can be inferred by the participant’s behavior that he or she wishes to participate in the research, such as showing up for an appointment or signing a form.
Implied informed consent must necessarily follow from either explicit (written or oral) informed consent OR observation of the subject’s actions which are consistent with an individual’s right to control his participation in research activities until he has been debriefed. Implied consent can also lack documentation because it is difficult to put into writing the use of certain forms of communication, such as gestures or nonverbal cues that are used to indicate consent. For example, if a doctor tells you “this may hurt” before giving you an injection but doesn’t explicitly ask for your consent first, implied consent would be assumed since it is clear through the doctor’s statement what they intend to do with your participation. The reason why this type of consent must follow either explicit informed consent or observation of the subject’s actions which are consistent with an individual’s right to control his participation in research activities until he has been debriefed, is that there needs to be some evidence that shows the participant knowingly and voluntarily.
3. How Is Written Informed Consent Better?
Written informed consent is a written document that describes the study to the participant. The three essential elements of this type of consent are: who to contact with questions, what procedure will be done, and any potential risks the participant may face.
The purpose of writing down your informed consent is to ensure that you have provided an explicit verbal agreement to participate in the study. Written informed consent documents are helpful for both parties because it provides clear evidence that someone has given their consent for something instead of just saying so verbally. It also helps researchers because experiments are designed based on specific experimental parameters intended to obtain results that are applicable if not generalizable for larger categories of people/participants who would otherwise remain unrepresented or excluded from such opportunities had they not been given the opportunity to participate.
Written informed consent is not meant to replace an in-person explanation of research by a researcher but rather is intended only as documentation that informed consent has been provided. Most studies involving human participants are considered “research” and therefore require written consent before participation. Researchers are expected to explain the study thoroughly, answer any questions, provide information about risks/benefits, and ensure voluntariness prior to permission from each participant.
Writing down your informed consent allows for greater documentation demonstrating that you were properly informed about experimental aspects of what you would be doing as a subject in such research. Participants who do not know how they will be used once data has been collected can more easily claim, later on, they were misled or forced into participating than if there is written evidence that they were properly informed.
The fundamental premise of the ethic of respect for persons also requires that subjects are able to withdraw from participation in research activities at any time without penalty or reprisal, and this must be documented as well. According to the Belmont Report, “the process by which potential research participants are asked to assume risk should involve a procedure through which they can initially give or refuse their consent.” Documentation that describes what kind of information was given to potential study participants about how they could withdraw their consent. It should include details like when it would be appropriate for them to withdraw (e.g., during data collection), who would actually perform this step (e.g., an undergraduate researcher under supervision), etc.
4. How Is Informed Consent Given?
Informed consent is obtained after a participant has understood the research and assessed his or her understanding. The person signing the document indicates that the patient understands and has freely consented to the research. Informed consent is an important part of conducting ethical research. For this, a physician should ensure that he or she is aware of the risks of the procedure before he or she begins. When the patient refuses to sign the document, they violate their legal rights.
Often, a witness signature is required for informed consent, but this is not always possible. In some instances, a person may not be able to read, write, or talk or maybe blind. Regardless of the language used, an individual can indicate approval by verbal or written communication. The consent form must note the method of communication. This can be written or verbal. Whether the participant is able to sign a form does not matter – as long as the individual gave their informed, freely-provided consent.
5. What Are the Benefits of Getting Informed Consent Beforehand?
There are several benefits when an individual gets written informed consent before they participate in research. The first is that written consent means there is always a record of the participant’s participation, which prevents any confusion about what was agreed to. This can be important if issues later arise about how public information was used or if the researcher starts using information for purposes other than originally listed. Lastly, written consent helps protect volunteers because it makes it clear what they consented to and gives them greater control over their participation.
Written consent requires the participant to sign on a written document explaining details of the study, the purpose of study, risks associated with the study, participants’ rights (inclusion in research results).
Another advantage of getting written informed consent beforehand has to do with protecting participants. If a participant writes out his or her consent before participating, the researcher has to follow that person’s wishes. The participant is protected because he or she can revoke consent at any time if the risks involved become dangerous, putting them at risk for serious illness, injury, disability, or death.
6. What Was the Recent Use of Informed Consent?
The covid-19 pandemic, which was a new thing in the medical world, required the active participation of people and patients for researchers to understand the disease. The COVID-19 consent forms were over eight thousand words on average and ranged from 7821 to 9340 words.
Conclusion
Informed consent is a collaborative process between the physician and the subject. Both parties need to understand the risks and benefits of a specific procedure, as well as the implications for his or her health. The physician’s role in the process of informed consent involves ensuring that the patient is well-informed and makes an informed decision based on his or her values. The patient’s understanding of the risks and benefits of a particular treatment should be carefully communicated in advance.
Informed consent is part of the shared decision-making process between a patient and a physician. Informed consent involves both parties. The patient must be fully informed about the risks and benefits of the procedure, and he or she must be able to make an informed decision based on his or her values. He or she should be consulted as a member of the decision-making team.
