It is the responsibility of the clinical investigator to ensure that the consent of each research participant is obtained prior to participating in the research study. The FDA does not require the investigator to conduct the consent interview in person. The researcher remains ultimately responsible, even if he or she delegates the task of obtaining informed consent to another person familiar with the research. For studies subject to FDA regulatory requirements, informed consent documents must meet the requirements of 21 CFR 50.20 and include the information required for each of the eight core elements of 21 CFR 50.25(a) and each of the six elements of 21 CFR 50.25(b) suitable for the study. IRBs have the final authority to ensure that the information contained in the consent form is adequate. The IRB should know who will conduct the consent interview. The IRB should also be informed of issues such as when informed consent is obtained and the waiting periods (between informing the subject and obtaining consent) that will be respected. The consent process begins with subject recruitment and includes advertising used to recruit subjects for the clinical trial. 3 Once a potential subject has been identified, an individual who is aware of the clinical trial and is able to answer the potential subject`s questions should be interviewed with consent. Fourth, consents are legal documents. The courts have characterized informed consent as establishing contractual relationships between investigators and subjects that involve legal obligations.
[8] The content of informed consent has been an important issue in many prosecutions of investigators and institutions by aggrieved researchers. [9] The consideration of informed consent as a legal document has undoubtedly encouraged the inclusion of language in forms to protect the institution, sponsor or investigator from legal liability, making the documents more difficult to read and understand. While I acknowledge and regret this trend, it would be irresponsible to ignore the legal implications of informed consent. It is important to pay close attention to these documents, as they can end up in court. According to the regulatory definition, children are “persons who have not reached the legal age to consent to research-related treatment or proceedings under the applicable law of the jurisdiction in which the research is conducted” (45 CFR 46.402(a)). In the United States, the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state. In the vast majority of states, age 18 is the legal adulthood, but this is not true for all states, cities or territories. State law may also address certain circumstances in which a person younger than adulthood is legally permitted to consent to medical procedures: For example, some states allow children younger than the legal age to consent to the provision of contraceptive services. Some states provide for a mechanism for the emancipation of minors, whereby a child younger than the legal age can acquire certain civil rights, which may include the legal possibility of consenting to participate in research. 26. It is the responsibility of sponsors and investigators to determine whether their clinical trial meets the definition of an “applicable clinical trial” and to ensure compliance with the most recent applicable legal and regulatory requirements.
For more information on “applicable clinical trials,” see ClinicalTrials.gov, FDAAA 801 Requirements, and the “Elaboration of Definitions of Responsible Party and Applicable Clinical Trial” (see pages 4-10). In cases where the documentation requirement is waived, the IRB may require the investigator to provide a written explanation of the research to the subjects or parents of the children who are subjects. Investigational New Drug (IND) applications submitted to the FDA do not need to include a copy of the consent document. If the sponsor submits a copy, or if the FDA requests a copy, the agency reviews the document and may comment on the suitability of the document. For other clinical trials, the FDA often considers the following factors when deciding whether to require the submission and review of informed consent: If a child is to be enrolled in a clinical trial, the parent or guardian must grant permission, if necessary with the child`s consent. (21 CFR 50.55). Parental or guardian consent must be obtained in accordance with informed consent requirements (21 CFR 50.55(e)) 58 and documented in accordance with 21 CFR 50.27. (21 CFR 50.55(f).) FDA regulations provide these safeguards for children participating in clinical trials, as described in 21 CFR Part 50, Subpart D. 59 As with informed consent, the exceptions in 21 CFR 50.23 or 21 CFR 50.24 also apply to the parental consent requirement.
60 (21 CFR 50.55(e).) FDA regulations also require the IRB to determine whether the participating child`s consent is appropriate, as described below. (21 CFR 50.55(a).) Informed consent documents for studies involving research articles should include a statement that one of the objectives of the study is to assess the safety of the investigational article. Statements that the test items are safe or statements that safety has been demonstrated in other studies are not appropriate if the purpose of the study is to determine safety. In studies that also assess the effectiveness of the test item, consent documents should include this purpose, but not efficacy claims. A person who can understand and understand spoken English, but cannot speak or write physically, may be included in a study if they are competent and able to signal their approval or disapproval by other means. If (1) the person retains the ability to understand the concepts of the study and assess the risks and benefits of participating in the study, if explained orally (still competent), and (2) is able to indicate approval or rejection of admission to the study, they may be included in the study. Informed consent should document the method of communication with the potential subject and the specific means by which the potential subject communicated consent to participate in the study. An impartial third party should witness the entire consent process and sign the certificate of consent. A video recording of the consent interview is recommended.
Yes, if it is more convenient for subjects or parents of children who are subjects to fax a signed copy of the consent or approval form to the investigator, researchers or parents may fax the signed form. Subjects or parents are not required to submit the original signed consent form or parental authorization documents to the examiner. (a) definitions. The following definitions apply for the purposes of this section: All informed consent forms and processes for “applicable clinical trials”26 initiated on or after March 7, 2012 must include the above statement. 27 Although additional explanations may be provided, the declaration cannot be amended. The concept of informed consent is based on state laws. It requires your doctors to provide information about your treatment, including: The definition of children also takes into account any particular interventions or interactions involved in the proposed research (e.g., surveys, blood tests). For example, in some places, people as young as 16 can legally consent to certain clinical interventions or interactions. If an individual`s participation in a proposed research activity consists of these interventions or interactions, those individuals may be considered adults for that purpose. However, if a proposed activity involves an intervention or interaction for which the subject has not yet reached the legal age of consent, that person must be considered a child. If you are asked to sign a consent document, follow these guidelines: (3) Consent for treatments and procedures that require signature consent shall be documented in the health record on a form required by VA for this purpose or as specified in this subsection (d).
The FDA`s guidelines on the inclusion of women in clinical trials [58 FR 39406] now give IRBs greater discretion to encourage the entry of a wide range of people into the early stages of clinical trials. The FDA calls on IRBs to question any study that appears to restrict enrollment based on gender and/or minority status. Statements such as “You cannot participate in this research study if you are a woman who could become pregnant” should not be routinely included in consent forms. For all FDA-regulated clinical trials (except as provided in 21 CFR 50.23 and 50.24-5), effective informed consent must be obtained from the subject or his or her legal representative. Informed consent must meet the requirements of 21 CFR 50.20 and contain the basic information required by 21 CFR 50.25(a). If appropriate for the clinical trial, one or more of the additional pieces of information must also be addressed in accordance with 21 CFR 50.25(b).
