What is informed consent?
This was writen based on guidlines from the British General Medical Council:
Informed consent – GMC 2008
To caricature, obtaining consent often involves a junior member of the clinical team being charged with obtaining a signed piece of paper declaring that the patient has understood the nature of the procedure and its consequences. Consent is often completed a few hours before the intended procedure, and patients seldom have time to read, never mind reflect on, information about possible harms and benefits—rare or otherwise.
Although the consent discourse has hardly been studied in depth, many clinicians report the process of obtaining consent from patients as a perfunctory chore—to be accomplished in a superficial albeit efficient way—to ensure a smooth transition from preoperative assessment to preparation for the operating theatre. In the real world of rapid throughputs and turnaround times, consent is—and often has to be—assumed. Evidence shows that patients want to be given more relevant information about risks and consequences. This emphasises the fundamental aim of informed consent—that patients should be neither coerced nor deceived.
The new GMC guidance urges doctors to re-think their approach. It advocates the communication of risks; it advises what should be done when patients refuse treatment; and it notes changes in the law, including the new legal safeguards for patients who lack capacity to make their own decisions. It encourages doctors and patients to be actively engaged in discussions about investigations and treatment, to enable patients to make informed decisions that are tailored to their individual circumstances and beliefs. The guidance stresses that obtaining and giving consent should not be a "tick the box" exercise but should be based around nine fundamental points (box).
Fundamental points of the consent process : General Medical Council. Consent: patients and doctors making decisions together. London: GMC, 2008.
1. Consent should be obtained at a time and in a place that enables patients to best retain information
2. Allow time for reflection before and after decisions
3. Tailor the approach to individual wishes, making no assumptions about information needs, levels of understanding, or about the importance patients attach to different outcomes
4. Use clear, simple, and consistent language
5. Give information about risk in a balanced way, avoiding bias
6. Provide the likelihood and uncertainties of benefits, risks, and the side effects of each option
7. Tell patients about serious adverse outcomes, even if the likelihood is very small
8. Use written material and visual aids—accurate and up to date—and refer to other sources
9. Check that patients understand the information they are given
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Informed consent is the document that can assure that a fully informed patient can participate in choices about his/her health care.
Although a physician/clinical personnel is required to inform a patient about benefits, risks, and alternative treatments it is in patient interest to take an active part in it by asking questions in order to get more detailed information.
The International Conference on Harmonization has published a list of the 20 required elements for consent forms used in studies of investigational pharmaceutical agents. Pharmaceutical sponsors write consent forms to meet the GCP standard.
Note: The GCP document of required elements for consent is not a regulatory requirement in the United States. FDA regulations on consent do not require all consent elements recommended by GCP guidance.These required elements under GCP are:
(a) That the trial involves research.
(b) The purpose of the trial.
(c) The trial treatment(s) and the probability for random assignment to each treatment.
(d) The trial procedures to be followed, including all invasive procedures.
(e) The participant's responsibilities.
(f) Those aspects of the trial that are experimental.
(g) The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant.
(h) The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this fact.
(i) The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks.
Note: FDA regulations do not require a list of benefits and risks associated with alternatives to participation.
(j) The compensation and/or treatment available to the participant in the event of trial related injury
(k) The anticipated prorated payment, if any, to the participant for participating in the trial.
(l) The anticipated expenses, if any, to the participant for participating in the trial.
(m) That the participant's participation in the trial is voluntary and the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled.
(n) That the monitor(s), the auditor(s), the IRB/IEC [Institutional Ethics Committee], and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant's legally acceptable representative is authorizing such access.
(o) That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant's identity will remain confidential.
(p) That the participant or the participant's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the trial.
(q) The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury.
(r) The foreseeable circumstances and/or reasons under which the participant's participation in the trial may be terminated.
(s) The expected duration of the participant's participation.
(t) The approximate number of participants involved in the trial.
Note: This is an optional element in FDA regulations, guided by whether including this information could influence enrollment.
The GCP standards for consent forms may be found at the following web site:http://www.fda.gov/cder/guidance/959fnl.pdf