The legally acceptable representative of the subject/subject should not be forced to sign consent or participate in the trial/continue to participate Prisoners, defined as anyone who is involuntarily detained or detained in a detention center, are considered „vulnerable“ because they may be forced to participate in the study, and also because of cognitive and psychiatric impairment, you may have a reduced ability to volunteer Proof of informed consent.[28] To protect this population, the Office for Human Research Protections has established federal regulations according to which the only studies in which inmates can participate are those that have independent and valid reasons for participating (Table 4) [25]. All research conducted on humans must be accepted preventively by the subjects themselves through the procedure known as informed consent. Informed consent documents must be written in plain language at a level appropriate to the population concerned, usually at a grade 8 reading level. A best practice is for a colleague or friend to read the consent document before submitting it with the IRB application. Always: In studies that use the „consent to transferred information“ model, the consent process is conducted after the study is completed [16]. Ensure that subjects sign the currently approved consent form by printing the stamped copy of the iRIS (not mandatory, but highly recommended). Important Note: No changes can be made to the declaration of consent (including redaction or deletion of the text of the declaration of consent or changes to the wording) without the prior approval of the IRB. All these types of RCTs aim to avoid unnecessary stress in patients who will not receive the promising new investigational treatment. Moreover, these clinical trial designs do not affect the standard therapeutic approach or violate the rights of patients in the control group; Therefore, the clinical trial can be continued without obtaining informed consent [8].
Due to compromised free will and the inability to make conscious decisions, several ethical dilemmas (related to communication, privacy, and treatment) often arise when research involves these populations. Ensuring the protection of the rights, security, data protection and confidentiality of vulnerable subjects are prerogatives of good clinical practice and legal provisions are regulated and strictly controlled by the competent authorities [21]. in the case of research involving a more than minimal risk, an explanation and description of any available compensation and medical treatment for injuries sustained by research participants; when more information can be obtained and who to contact in the event of a research-related injury; Where appropriate, subjects shall receive additional relevant information after their participation. When a new principal investigator is appointed for a study, it can affect existing study documents. Updates to consent documents may be required and participants may need to be contacted. The following guidelines describe the scenarios in which study documents must be updated and new approval must be obtained from active study participants: After obtaining approval by the Institutional Review Committee (IRB) or the Independent Ethics Committee, it is mandatory to obtain the informed consent of each person before participating in clinical trials [5]. However, if certain circumstances occur, informed consent can be waived and „research without consent“ is possible, allowing patients to be admitted without their consent under strict regulations [7]. For research to be considered acceptable without consent, the following three conditions must be met: 1) consent cannot be obtained, 2) the research does not violate the principle of self-determination, and 3) the research is of significant clinical relevance [8]. Following this oral statement, the potential subject may receive a study fact sheet (written summary if required by the IRB) and sufficient time must be allowed to determine whether or not to participate in the research. „Sufficient time“ can range from minutes to hours, depending on how long it reasonably takes to assess procedures, risks, potential benefits and potential alternatives. Informed Consent of Human Subjects: FDA: 21 CFR 50 Subpart B In most cases, federal regulations require that informed consent be documented, but they also provide for some important exceptions. For more information, see Oral, electronic, or implied consent.
Informed consent must be obtained before non-routine screening procedures are performed and/or before a change is made to the subject`s current medical treatment for the purposes of the clinical trial Due to their young age and limited emotional and intellectual capacities, children are considered legally incapable of providing valid informed consent; Therefore, to include a child in a research study, permission from at least one parent or legal guardian is required (Table 3). For persons aged < 18, biological or adoptive parents or guardians (persons with both legal capacity and responsibility) may give consent on behalf of their child and freely exercise their decision-making power without any form of coercion. While both married mothers and fathers have parental responsibility, unmarried parents can only exercise parental responsibility if they are named individually on the child`s birth certificate. Divorced parents also retain parental responsibility, but it is necessary to know who received custody of the child [32]. However, European laws and regulations are not harmonised in this area, and there are several divergences in each country [33]. The examiner (or a representative approved by the IRB) must explain the study orally to the potential subject, provide all relevant information (purpose, procedures, risks, benefits, alternatives to participation, etc.) and give the potential subject ample opportunity to ask questions. An IRB may waive the requirements for obtaining informed consent provided that it determines and documents that the person signing the consent form is deemed to do so with a full understanding of what is stated on the consent form. However, it is very difficult to assess their views on the study because there is no established method to measure a participant`s understanding of the given information.
Thus, it can be assumed that there is some degree of misunderstanding. Misunderstandings may arise due to incorrect or inadequate translations. Many people sign the consent form without being fully aware of what they are signing, resulting in the subject being removed at later stages of ongoing clinical trials. As a result, the responsibility of the researcher expands when a study is conducted in multilingual subjects [Table 4]. [16] Research information should be provided by a physician or other persons (i.e., researchers) with appropriate scientific training and qualifications [6]. In addition, the place where informed consent is discussed and the physical, emotional and psychological abilities of the subject must be taken into account when obtaining consent from a human subject. Due to the context of the war in which they work, as well as the intensive care in which they are treated, military subjects often receive medical care and/or participate in biomedical research under a „condition of implied consent“. In addition, the higher sub-relationship contributes to fostering coercion or undue influence, making this population vulnerable [29]. To curb this phenomenon and ensure that participation is truly voluntary, the U.S. Department of Defense has issued similar requirements for medical research for civilians.
Therefore, the medical research recruitment session takes place in the absence of superiors and informed consent is obtained before participating in a medical research study. The presence of a mediator ensures and verifies that participation is voluntary and that the information provided at the time of recruitment is complete, accurate and clear. Payment as an incentive is acceptable, but should not be used to legitimize coercive intervention. Students enjoy additional protection in service academies, especially at the age of < 18. However, if emergency research is conducted or the research study advances the development of a medical device required by the armed forces, no informed consent is required [29]. The first condition of "impracticability" arises when obtaining informed consent is burdened by significant impacts on time and economic resources or could affect the validity of the study [8]. .