12. Explain the Legal and Ethical Considerations Relating to the Use of Informed Consent

Capacity to consent is an individual`s ability to understand information relevant to the decision to be included in a study, i.e., to weigh the risks and benefits of participation, to evaluate available alternatives (including non-participation), to make an informed and voluntary decision about participation, and to communicate that decision. The ability to consent also depends in part on the complexity of the decision the person faces, taking into account factors such as study design, risks and expected benefits. HHS regulations do not require documentation of consent. It is at the discretion of the IRB to determine, if necessary, the appropriate way to document the child`s consent. Based on considerations such as the child`s age, maturity and literacy level, the IRB should decide which form of documentation, if any, is most appropriate. If adolescents are involved in research that would have used consent if the subjects were adults, it would generally be appropriate to use a similar form to document a young person`s consent. The subject or the legally authorized representative of the subject only signs and dates the short form. (21 CFR 50.27(a) and (b)(2).) The witness must sign both the short form and the summary, and the person receiving the consent must sign the summary. (21 CFR 50.27(b)(2).) Autonomy, as is the case for the 4 principles, must be weighed against competing moral principles and may be overridden in some cases; An obvious example would be when the autonomous action of a patient causes harm to one or more other people. The principle of autonomy does not extend to persons who do not have the capacity (competence) to act autonomously; Examples include infants and children and incompetence due to developmental disorders, mental or physical disorders.

Health care institutions and state governments in the United States have policies and procedures in place to assess incompetence. However, a rigid distinction between incapacity to make decisions in the health care system (assessed by health professionals) and incompetence (established by a court) is not practically useful, since a physician`s determination of a patient`s inability to make decisions due to a physical or mental disorder has the same practical consequences as a legal finding of incompetence [11]. The informed consent procedure describes the reasonably foreseeable risks or inconveniences to the subject. This includes risks or complaints related to tests, procedures and procedures required by the protocol (including standard medical procedures, examinations and tests), especially those that pose a significant risk of morbidity or mortality. Possible risks or complaints due to changes in a subject`s medical care (for example, by changing the subject`s stable drug regimen or switching to placebo at random) should also be addressed. The explanation of the potential risks of the test item and the control, if any, as well as an assessment of the likelihood of occurrence of these risks, should be based on the information contained in the protocol, the investigator`s brochure, the labelling of the packaging and previous research reports. There is also a legal aspect to this concept. No one has the right to touch, let alone treat, another person. Any such act committed without authorization is classified as “assault and battery”[3] – physical assault and is punishable. Therefore, obtaining consent is a must for everything but a routine physical exam. In the event that a IRB waives the requirement for written documentation of informed consent (pursuant to 21 CFR 56.109(c)(1)), the FDA recommends that elements of informed consent be reviewed orally with the subject or his or her legally authorized representative.

In addition, the IRB may require the investigator to provide subjects with a written statement of a clinical trial. (21 CFR 56.109(e).) The FDA recommends that if a IRB waives the documentation requirement for informed consent in cases where there is minimal risk of harm, as permitted by 21 CFR 56.109(c)(1), the consent process and discussion are described and noted in clinical trial records. 30 The informed consent procedure should clearly describe the likely duration of the subject`s participation in the clinical trial [see 21 CFR 50.25(a)(1)], which may include the subject`s active participation and long-term follow-up. The subject should be informed of the procedures that will occur during such follow-up, which may be indicated in a table as described above.