What Is Included in Informed Consent Form
The IRB notes that reasonable steps are taken to obtain the consent of children if the IRB is satisfied that the children are able to give their consent. If the IRB determines that the abilities of some or all of the children are so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research offers a direct benefit perspective that is important to the health or well-being of the children and is available only in the context of the research, Children`s consent is not a necessary condition for further research. Even if the IRB determines that subjects are capable of consenting, it may waive the consent requirement in cases where consent can be waived under Subpart A§46.116. The IRB must review and approve all English and non-English versions of all consent documents (long or short form with written summary) to be used by investigators to document informed consent of subjects (21 CFR 50.27(a) and 21 CFR 56,111(a)(4) and (5)). When reviewing proposed informed consent procedures that involve the translation of written and oral information to be presented to subjects, the FDA recommends that the IRB review and, if necessary, approve procedures to ensure that translations are prepared by a qualified person or company. In addition to signing the consent form, the subject or the subject`s legally authorized representative must record the date of signature on the form (21 CFR 50.27(a)) to confirm that the subject or the subject`s legally authorized representative has given consent prior to participating in the clinical trial, as required by 21 CFR 50.20. In cases where the subject gives consent on the same day 32 that he or she begins participating in the clinical trial, the subject`s medical history must document that the subject gave consent prior to participating in the research (see 21 CFR 312.62(b) and 21 CFR 812,140(a)(3)). The person signing the consent form must receive a copy of the consent form (21 CFR 50.27(a)), and the subject`s case history must include the signed and dated consent form. Although FDA regulations do not require that the subject copy be a signed copy, the FDA recommends that a copy of the signed consent form be submitted. Informed consent is a collaborative process that allows patients and health care providers to make decisions together when there is more than one reasonable alternative, taking into account the patient`s unique preferences and priorities, as well as the best available scientific evidence. The FDA`s review of informed consent does not replace the IRB`s responsibility or authority to review and approve the declaration of consent and consent process as a condition of the initiation of the clinical trial. (21 CFR 56,103(a).) THE IRB is responsible for ensuring the relevance of the information contained in the consent form and may request changes if necessary. (21 CFR 56.109.) HHS recommends that CISRs consider whether subjects should be informed of the financial relationships or interests associated with the clinical trial, such as.
B payments for services, interest or intellectual property rights. 37 As stated in the HHS guidelines referred to in the footnote, certain financial interests in the clinical trial may affect the rights and well-being of subjects and CIRs should consider approaches to ensure that subjects are adequately protected, including the provision of information about the subjects` financial relationships and interests. THE IRB should consider whether to make available to participants information on the source of funding, the funding arrangements, the financial interests of the parties participating in the clinical trial and any techniques used to manage the financial interests. The IRB should consider the nature, scope and level of detail of the information to be provided to subjects. During the clinical trial, the investigator may need to revise the informed consent to reflect changes to the protocol or new information, such as . B important new results. The auditor must obtain a review from the IRB and approval of the revised form. (21 CFR 56.109.) Since informed consent is amended to reflect changes to the protocol or new information, each of which may affect the willingness of previously registered and actively participating subjects to participate in the clinical trial, the IRB should consider whether it is necessary to renew the consent of registered subjects. To avoid confusion about the change, the examiner may use a prepared summary of the change to support an informative presentation of the registered topic. However, this summary does not constitute the revised informed consent document. Informed consent as a whole must present research information in sufficient detail and be organized and presented in such a way as to provide not only lists of isolated facts, but also to make it easier for the potential participant or legally authorised representative to understand why they wish to participate or not.
4. The regulation allows for the use of an abbreviated form of consent when the elements of informed consent are presented orally to the subject. For a discussion of written consent in abridged form, see section III.E.4.b, abbreviated form. (8) A statement as to whether clinically relevant research results, including individual research results, are disclosed to subjects and, if so, under what conditions; and if the patient`s record does not contain the basic information necessary to determine eligibility for the clinical trial, additional information may be required from the potential subject. Before obtaining the additional information, informed consent may be required. Please refer to the FDA`s fact sheet “Pre-Registration Screening Tests,”52 for a discussion of when informed consent would be required under the regulations. 7. See “Guidelines for Institutional Review Panels, Clinical Investigators and Sponsors; Exemption from informed consent requirements for emergency research. (ii) a statement that the subject`s information or biological samples collected in the course of the research, even if the identifiers are removed, will not be used or distributed for future research studies.
Consent forms must describe any compensation or medical treatment provided in the event of an injury. If no specific declaration can be made (e.g. B, it is likely that each case will require a different response), subjects should be informed when additional information can be obtained. Consent should also indicate whether subjects will be charged for the cost of such medical treatments. When costs are charged, statements such as: The description of the benefits for the subject should be clear and not exaggerated. If no direct benefit is expected, this should also be indicated. The IRB should be aware that this element contains a description not only of the benefits to the subject, but also to “others.” This can be a problem if the benefits to the investigator, sponsor or others are different from those normally expected. Therefore, where these benefits may be essential to the participant`s decision to participate, they should be disclosed in the informed consent form.
As noted earlier, there is a deficit in providing the necessary information to patients when they receive informed consent. Providers should be trained by experts on routine procedures and procedures and should be able to share this information with patients as well as other members of the healthcare team. Members of the healthcare team, such as nurses and patient caregivers, should also be informed of any possible side effects so that they can identify them and notify a provider so that any immediate intervention required can be performed in a timely manner. .