31. The FDA Review Division for the product area under investigation may be contacted to discuss alternative methods of obtaining informed consent. For an individual to give valid informed consent, there must be three components: disclosure, capacity, and voluntariness. [4] [5] The consent process should describe what the subject`s participation entails in order to comply with the protocol, at para. B examples the number of clinic visits, journaling, and medical or dietary restrictions (including the need to avoid certain medications or activities, such as . B participation in other clinical trials (see section c., participant participation in more than one clinical trial)). If the description of each procedure makes the consent form too long or detailed, the FDA recommends that the general procedures of the consent form be accompanied by an addendum describing all study procedures. It may be helpful to provide a diagram that describes what happens at each visit to simplify the consent form and help the subject understand what participation in the clinical trial will entail. The FDA believes that removing details from the consent form process shortens length, improves readability, and allows for a focus on more important content such as expected risks and benefits. Informed consent is legally effective if it is obtained from both the subject or the subject`s legally authorized representative and documented in a manner consistent with HHS human subject protection regulations and the applicable laws of the jurisdiction in which the research is conducted. In general, the regulation states that an investigator must obtain consent only in circumstances that give the potential subject or legally authorized representative sufficient opportunities to consider whether to participate and that minimize the possibility of coercion or undue influence. The information provided must be in a language understandable to the subject or representative. No informed consent, whether oral or written, may contain exculpatory language.
Note that coercion and undue influence can be situational. For example, in a clinical trial involving the surgical insertion of an investigational product, waiting for informed consent until the potential subject is in the preoperative area cannot minimize the possibility of undue influence. Historians cite a number of medical guidelines to trace the history of informed consent in medical practice. The information provided to the IRB should indicate and justify the proposed amount and the compensation targets, which should also be clearly indicated in the attached consent forms. Researchers who carry out data collection subject to the General Data Protection Regulation (GDPR) must use this template with a general consent template/document. The consent process must describe 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. B by changing the subject`s stable drug regimen or switching to placebo at random) should also be addressed. An explanation of the potential risks of the test item and control, if any, and 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. The description of the potential benefits should be clear, balanced and based on reliable information where such information is available. This element requires a description of the potential benefit not only for the subject (e.B.
« This product is intended to reduce XXX; However, we cannot guarantee that you will benefit from it »), but also to « others » (for example.B. « Your participation in this research may not benefit you, but may benefit future patients with your disease or condition »). Overly optimistic accounts of the clinical trial can be misleading and violate FDA regulations prohibiting the advertising of investigational drugs and devices (see 21 CFR 312.7 and 21 CFR 812.7). Since the purpose of the study is to determine the safety and/or efficacy of the test article compared to the control, it is not yet known whether the trial article can provide a benefit or not. Where appropriate, the consent procedure must include a statement that the object or procedure in question may involve risks to the subjects (or to the embryo or fetus if the subject is or could become pregnant) that are currently unforeseeable. (21 CFR 50.25(b)(1).) If long-term safety studies (e.g.B. laboratory and animal studies) are not completed, the informed consent procedure should explain that researchers have not completed studies in which the potential risks, by . B carcinogenicity or teratogenicity can be identified.
The FDA`s requirements for informed consent are set out in the FDA Regulations for the Protection of Humans (21 CFR Part 50). These regulations apply to FDA-regulated clinical trials. 2 The informed consent requirements set out in Part 50 of 21 CFR are not intended to provide for applicable federal, state or local laws requiring the disclosure of additional information for informed consent to be legally effective. (21 CFR 50.25(c).) If the clinical trial is conducted or supported by the Department of Health and Human Services (HHS) and involves an FDA-regulated product, the study is subject to both Part 46 of the CFR and Part 50 of CFR 21, which means that both sets of rules must be followed. Where rules differ, rules that offer greater protection to human subjects should be followed. The FDA recognizes that subjects are often interested in the aggregate results of the clinical trial in which they have been enrolled. Aggregated research results should be returned to subjects in a clear and understandable manner. Title VIII of the FDAAA requires the « responsible party » (typically the sponsor or principal investigator) of certain clinical trials of drugs, products, and biologics (referred to as « applicable clinical trials » in the FDAAA) to register the studies and submit the summary results to the government-run clinical trial database www.ClinicalTrials.gov within a specified time frame. 65 The summary results of those clinical trials are made available to the public in the database.
66 As explained above in point III.D, (Informed Consent Element for `Applicable Clinical Trials`), the FDA adopted Final Rule 67 amending the Informed Consent Rules (21 CFR 50.25) to require that informed consent documents for applicable clinical trials involving drugs, biologics and devices contain the specific statement: which contains in the Regulation that information on clinical trials for these clinical trials will be available on www.ClinicalTrials.gov. . . .