Your health care provider works with you to figure out the best way to give you the information you need. The provider may choose to use methods other than a verbal discussion or a written document, such as videos, interactive computer modules, audio files or other methods to help you understand the information better. Be sure you understand all the information given, even if it means going over it many times or asking your provider to explain it in different ways. Yes, you can change your mind at any time, even if you have already started treatment.
Let your health care provider know of your wishes. You have the right to refuse any and all treatment options. You may also choose other treatment options that have been presented to you by your health care provider, even if they are not as well proven as the one your health care provider recommends.
You may also refuse part of the treatment options, without refusing all care. For example, you may choose to refuse surgery, but still wish to be treated for pain. In this case, it may be up to you to find another health care provider or facility to treat you with such an approach if your health care provider is not comfortable with it. If you have decided to refuse treatment or diagnostic tests, your health care provider may tell you about the risks or likely outcomes of this choice, so you can make an informed refusal meaning, you understand what could happen to your health by refusing the recommended treatment but you still don't want the treatment.
Informed consent: Issues and challenges
In this case, you might be asked to sign a form to state that you received this information and that you still chose not to be treated. Shared decision-making is actually part of the informed consent process and allows patients to play an active role in making decisions that affect their health. In shared decision-making, the health care provider and patient work together to choose tests, procedures, and treatments, and then to develop a plan of care.
As described by the informed consent process, the provider gives the patient information about their condition and the pros and cons of all the treatment options. The patient then has a chance to ask questions and read more about the options. Simplifying the questions and content, adopting supportive technologies, using a more simple language, and spending more time for the information process have been suggested as useful and valid measures.
When all these strategies prove to be insufficient, the investigators are required to obtain consent from a legally authorised representative [ 30 ]. Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures. Obtaining informed consent in these groups is extremely complex. A friendly procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could represent an accessible location.
The reimbursement of travel expenses for applicants can be a valid solution to obtain a representative sample for the clinical research. Clear and simple language, emphasising confidentiality, with the help of professional interpreters, can tempt migrants to sign the consent form. Lastly, the possibility of receiving something back in return for their contribution may enable successful enrolment of migrants in research [ 31 ].
Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory table 3. However, on this matter, the European laws and regulations are not harmonised and several discrepancies are present in each country [ 33 ]. Despite potential benefits for the research subjects, the failure of parents to give consent or their refusal to give consent is not a rare circumstance [ 34 ].
It can be the case that researchers are dealing with underage parents, so that, although underage parents are responsible for representing their children, as minors themselves they are not considered to be sufficiently mature; therefore, they will be not able to give valid consent. Literacy and socioeconomic levels have been identified as the most common reasons for parental non-response [ 34 ].
Clarity and adequate explanation of research information materials should be part of effective planning to overcome language and social barriers. 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.
However, when it is impracticable to obtain consent, and the research does not infringe the principle of self-determination and also provides significant clinical relevance, the researcher is legally authorised to proceed without informed consent. Furthermore, in order to preserve the self-determination and decision-making rights, specific law dispositions are applied when vulnerable populations are enrolled in clinical trials. Which of the following pieces of information need not be included when obtaining informed consent? In which of the following cases is a minor not considered emancipated or self-sufficient?
All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent. Voluntary expression of consent and adequate information disclosure about the research are critical and essential elements of the informed consent process. When specific circumstances occur, informed consent can be waived: if it is impracticable to obtain consent, if the research does not infringe the principle of self-determination, and if the research provides significant clinical relevance.
Participation of vulnerable patients in clinical trials is regulated by specific law dispositions. Conflict of interest: None declared. National Center for Biotechnology Information , U. Journal List Breathe Sheff v. Breathe Sheff. Sara Manti 1 and Amelia Licari 2. Author information Copyright and License information Disclaimer. E-mail: ti. Breathe articles are open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4. This article has been cited by other articles in PMC.
Educational aims To provide a comprehensive overview of issues in obtaining informed consent in clinical research. To describe the process of obtaining informed consent in clinical trials.
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To highlight the circumstances under which informed consent can be waived. Informed consent: when is it not necessary?
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RCTs based on infeasibility of informed consent Emergency clinical studies, involving critically ill subjects, represent an exception to the requirement of informed consent. Open in a separate window. RCTs that omit informed consent entirely Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [ 17 ] or in prompted optional randomisation trials [ 18 , 19 ]. Social vulnerability Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures.
Special needs: children Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory table 3. Summary When conducting clinical research, the obtaining of informed consent is required.
Self-evaluation questions 1. In which of the following circumstances could informed consent be waived? Suggested answers 1. Key points All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent. Footnotes Conflict of interest: None declared.
World Health Organization Clinical Trials. Current Step 4 version. Available from: www. Date last accessed: March 22, Guidance for Applicants: Informed Consent. Nardini C. The ethics of clinical trials.
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How to obtain informed consent for research
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