Informed consent is an essential protection in research. The obligation to obtain informed consent stems from respect for individuals and the desire to respect the autonomy of the person who decides to voluntarily participate in biomedical or health research. For these reasons, no one may be used against his will as a subject of research. Informed consent is defined as the process by which subjects receive important information about the clinical trial, including the procedures they undergo and the potential risks and benefits. The information is designed to help participants make an informed decision about starting or continuing a clinical trial. When researchers were asked why they obtained a consent form, some said it was a legal and regulatory requirement: «We get it mainly because we have to do it» [P08] or because the institute is «trying to cover itself» [P19]. However, the main reason has been identified as ethical: «I think there are several layers, so it`s a legal requirement, and ethical, . but also from a personal point of view, I think it`s important that people who volunteer to participate in a study receive enough information» [P20]. When obtaining informed consent for applicable clinical trials as defined in 42 U.S..C. 282(j)(1)(A), each subject must receive the following statement in the consent documents and procedures. This informs the subject that clinical trial information has been or will be submitted for inclusion in the Clinical Trials Registry pursuant to section 402(j) of the Public Health Services Act. The statement reads: «A description of this clinical trial will be available on www.ClinicalTrials.gov as required by U.S.
law. This website does not contain any personally identifiable information. The website shall contain at most a summary of the results. You can browse this website at any time. Second, if the IRB approves an investigation under paragraph 50.53 or 50.54 of 21 CFR or 50.54 after it has been determined that paragraph 50.56(a) of the CFR is complied with, the IRB must require that a lawyer be appointed for each child who is a ward. (21 CFR 50.56(b).) The IRB must ensure that such counsel is in place, but the IRB itself does not have to appoint the lawyer. The lawyer, who may act as an advocate for more than one child, acts in addition to any other person acting on behalf of the child as guardian or in loco parentis (i.e., Has legal authority and responsibility to act in the place of a parent). (21 CFR 50.56(b)(1) and (2).) The lawyer must be a person who has the background and experience to act in the best interests of the child for the duration of his or her participation in the clinical trial and who agrees to act in the best interests of the child. Appropriate expertise for a lawyer may include, but is not limited to, education and/or experience in the following areas: pediatric medicine, law, child advocacy, foster parenting, behavioral sciences, or child psychology. The lawyer must be sufficiently informed about the potential risks and benefits of the proposed clinical trial and how the intervention is likely to affect the individual child.
Counsel may not be associated in any way (except in the role of counsel or member of the IRB) with the clinical trial, investigator or sponsoring organization. Guillemin M, Gillam L, Rosenthal D, Bolitho A. Resources used by health researchers to ensure ethical research practices. J empir res hum res ethik. 2010;5(2):21–34. Interviews were conducted in person, individually by AX and lasted from 21 minutes to 59 minutes (average = 38 minutes). Participants agreed in writing that their interviews will be audio-recorded and that the data will be used in this study. If a subject has given consent to participate in the research, the informed consent process does not stop there, and obtaining consent in clinical research rather than a one-time event is indeed a dynamic and ongoing process. Consent also does not require study participants to remain in research until they graduate.
Study participants have the right to withdraw their consent at any time during the study. Continuous consent refers to the repeated obtaining of consent by subjects whenever required or indicated during the conduct of the study, even if the initial consent was obtained at the time of the start of the study. Once informed consent has been obtained from a study participant, re-investigating the subject`s consent is an important ethical aspect in clinical research regarding «when the new consent should be obtained.» Even after obtaining informed consent from study participants, certain situations may arise in which it is necessary to relearn informed consent. Source documents must show that consent was obtained prior to the start of treatment and study procedure. Examiners must use a written consent form approved by the IRB when documenting informed consent in accordance with 21 CFR 50.27, except as set out in 21 CFR 56.109(c). Therefore, the IRB should consider the relevance and relevance of all language in consent documents, as well as the overall length and presentation of the information. Consent forms that are long, complex, legalistic and with a high reading level of 39 can overwhelm potential topics and hinder reading the full document and understanding the relevant information. The conditions under which informed consent is obtained and the relationship between the subject and the person receiving consent must be carefully weighed to minimize the possibility of coercion or undue influence (21 CFR 50.20). According to the Belmont Report, «coercion occurs when an open threat of harm is intentionally presented by one person to another to achieve compliance. On the other hand, undue influence is given by an excessive, unjustified, inappropriate or inappropriate reward offer or by another opening to achieve compliance.
«If a subject and/or a subject`s LAR are unable to read the written information, an impartial witness must be presented throughout the discussion of informed consent. If the subject has a general practitioner and wishes the general practitioner to be informed of his or her participation in the research, the investigator must inform the subject`s general practitioner before seeking his or her consent. Paasche-Orlow MK, Brancati FL, Taylor HA, Jain S, Pandit A, Wolf MS. Readability of declarations of consent: a second look. IRB. 2013;35(4):12–9. A semi-structured interview guide was developed by a clinician-principal investigator (DR), senior hospital scientists (JC, SS), a qualitative research expert (MB) and a research student (AX) and refined based on pilot interviews. Topics covered included researchers` views on informed consent, training and guidance, informed consent, and challenges in obtaining informed consent.
(Supplementary file 1). Disclosure of information refers to the provision of information necessary for a patient to make an informed decision and is one of the essential elements of valid informed consent. To obtain meaningful consent, the information provided to a research topic should include, among other things, the health status for which the research is proposed; the type and purpose/reason for the study; study of treatment or intervention and experimental procedures; the likely risks and benefits associated with participation in the research; the type of disease and possible outcome if the condition is not treated; the availability, risks and benefits of alternative treatments; Right of withdrawal at any time; and any other information seems necessary for the patient to make an informed decision. [1–4] Prior disclosure of information is intended to enable patients to make an informed, rational and logical decision in light of their cultural, psychological and social values and beliefs. Dawson L, Kass NE. Views of U.S. researchers on informed consent in international collaborative research. Soc Sci Med. 2005;61:1211-22.
Informed consent is an ethical and legal requirement for research involving human participants. It is the process by which a participant is informed of all aspects of the study that are important for them to make a decision, and after studying all aspects of the study, the participant voluntarily confirms their willingness to participate in a particular clinical trial and the importance of the research for the advancement of medical knowledge and social welfare. .