Question - How is informed consent obtained?

Answered by: Sandra Ward  |  Category: General  |  Last Updated: 26-06-2022  |  Views: 1107  |  Total Questions: 14

When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial. The Informed Consent is described in ethical codes and regulations for human subjects research. The goal of the informed consent process is to provide sufficient information so that a participant can make an informed decision about whether or not to enroll in a study or to continue participation. Informed consent: The process by which a patient learns about and understands the purpose, benefits, and potential risks of a medical or surgical intervention, including clinical trials, and then agrees to receive the treatment or participate in the trial. There are some precise requirements to acquire proper informed consent. If they are not met, then your physician failed to meet his or her obligation to get informed consent and may be liable for medical malpractice.

https://en.wikipedia.org/wiki/Consent

Types of consent include implied consent, expressed consent, informed consent and unanimous consent.

https://www.bjmp.org/content/right-consent-it-absolute

The basic difference between consent and informed consent is the patients' knowledge behind the consent decision. The amount of information required to make consent informed may vary depending on complexity and risks of treatment as well as the patient's wishes.

https://www.cancer.org/treatment/finding-and-paying-for-treatment/understanding-financial-and-legal-

The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider.

https://research.uncc.edu/departments/office-research-compliance-orc/human-subjects/informed-consent

Informed consent is a proceSs, not a form As a researcher, it is your responsibility to educate the participants about the study purpose, the procedures, the risks and benefits, and obtain their consent before involving them in your research, and keep them informed.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005206/

Types of Informed Consent Implied consent: Implied consent refers to when a patient passively cooperates in a process without discussion or formal consent. Verbal consent: A verbal consent is where a patient states their consent to a procedure verbally but does not sign any written form.

https://www.ncbi.nlm.nih.gov/books/NBK430827/

Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent.

https://www.rit.edu/research/hsro/basic_elements_consent_form

A statement that the study involves research, an explanation of the purposes of the research, the expected duration of a subject's participation, a description of the procedures to be followed, and if applicable identification of any experimental procedures.

https://www.sciencedirect.com/science/article/pii/S1556793108000508

Ethical Issues in Informed Consent. Important aspects of informed consent include ethical obligations to promote autonomy, provide information, and avoid unethical forms of bias. Patients have the right to refuse medical therapies, whether on religious or other grounds, if they are competent to do so.

https://www.emedicinehealth.com/informed_consent/article_em.htm

What Is Informed Consent? Components of Informed Consent. Decision-Making Capacity. Disclosure. Documentation of Consent. Competency. Informed Consent, The Right to Refuse Treatment. Clinical Trials and Research.

https://www.verywellmind.com/what-is-informed-consent-2795276

Informed consent ensures that a patient, client, and research participants are aware of all the potential risks and costs involved in a treatment or procedure.

https://oprs.usc.edu/files/2017/05/Informed-Consent-Booklet-4.4.13.pdf

Informed Consent is a voluntary agreement to participate in research. It is not merely a form that is signed but is a process, in which the subject has an understanding of the research and its risks. Informed consent is essential before enrolling a participant and ongoing once enrolled.

https://www.healthline.com/health/informed-consent

In a healthcare setting, informed consent allows you to participate in your own medical care. It enables you to decide which treatments you do or do not want to receive. This collaborative decision-making process is an ethical and legal obligation of healthcare providers.

https://www.registerednursing.org/nclex/informed-consent/

The nurse is responsible and accountable for the verification of and witnessing that the patient or the legal representative has signed the consent document in their presence and that the patient, or the legal representative, is of legal age and competent to provide consent.

https://www.hg.org/informed-consent-law.html

Informed Consent Law covers the legal aspect regarding an individual's right to be informed of and consent to a procedure or treatment suggested by a physician or professional. The patient can then make an informed decision to accept or refuse the treatment or procedure.