With respect to description of risks and benefits [4], the FDA notes that if applicable, the consent document should include a description of the reasonably foreseeable risks not only to the subject but also to “others” (for example, radiation therapy, where close proximity to subjects post procedure may pose some risk to others). The Guidance also discusses additional elements of informed consent that are included, as appropriate, pursuant to 21 C.F.R. 50.25 (b) – i.e., (i) that the study involves unforeseeable risks to the subject; (ii) anticipated circumstances under which the subject’s participation in the study may be involuntarily terminated by the investigator; (iii) additional costs to the subject resulting from participation in the study; (iv) consequences to the subject of withdrawing from participation; (v) that significant new findings in the study potentially affecting the subject’s willingness to continue participating will be communicated to the subject; and (vi) the approximate number of subjects involved in the study. The Guidance notes that to satisfy element (ii) above, a broad statement indicating that a subject’s participation may be terminated at any time will not suffice; rather, a description of specific situations that would trigger termination of the subject’s participation is required.

The clinical studies' IRB must review and approve the informed consent form, and the IRB is the final authority on the consent form content. In addition, informed consent forms are required to contain the basic elements found in 21 CFR § 50.25(a), and any element(s) of 21 CFR § 50.25 (b) that are appropriate to the specific clinical study.

ted clinical research, including the addition of a new exception for the documentation of informed consent; elimination of the requirement for continuing review of clinical studies under certain conditions; and changes to the way subjects vulnerable to coercion or undue influence are considered.Sponsors of FDA-regulated clinical investigations should carefully review the proposed rule and consider submitting comments no later than December 28, 2022.231See FDA, Proposed Rule, “Protection of Human Subjects and Institutional Review Boards,” 87 Fed. Reg. 58,733 (Sept. 28, 2022), https://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards.2See The 21st Century Cures Act, Pub. L. 114-115, § 3023 (enacted Dec. 12, 2016) (codified at 42 U.S.C. § 289 note), https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf.3See 21 C.F.R. § 50.20.4Proposed Rule, 87 Fed. Reg. at 58,736.5Id. at 58,738-39.6Id. at 58,737.7Id.8Id.9Id.10See 21 CFR § 50.25(a).11Proposed Rule, 87 Fed. Reg. at 58,738.12See id.13See 21 C.F.R. § 50.25(b).14See Proposed Rule, 87 Fed. Reg. at 58,738.15Id. at 58,736.16Id. at 58,736-37.17Id. at 58,740.18See 21 C.F.R. § 56.109(f).19Proposed Rule, 87 Fed. Reg. at 58,746.20See 21 C.F.R. § 56.111(a)(3).21Proposed Rule, 87 Fed. Reg. at 58,742.22Id.23FDA, Proposed Rule, “Protection of Human Subjects and Institutional Review Boards, and Institutional Review Boards; Cooperative Research; Extension of Comment Period,” 87 Fed. Reg. 68,118 (Nov. 14, 2022), https://www.federalregister.gov/documents/2022/11/14/2022-24689/protection-of-human-subjects-and-institutional-review-boards-and-institutional-review-boards.

ng for adverse events, response to treatment, and changes in clinical status, as well as proposed modifications to the treatment plan to mitigate risks to patients if appropriate;key details of the patient’s history, including diagnosis and summary of prior therapy (including response to such therapy), and information regarding a patient’s relevant clinical characteristics (such as comorbid conditions and concomitant medications); and,summary of the known risks of the drug.The guidance also provides that the IRB’s review of an expanded access request for an individual patient should include:an assessment of the qualifications of the requesting physician submitting the individual patient expanded access request;if the request is for a pediatric patient, confirmation that adequate provisions are included for soliciting age-appropriate assent from children and permission from a parent or guardian; and,confirmation that the informed consent document contains the information required under 21 C.F.R 50.25. Given that the drug used under expanded access is investigational, FDA considers a statement in the informed consent document indicating that although the primary use of the drug is for treatment, the drug is investigational and FDA has not determined that the drug is safe or effective for use in treating COVID-19, to satisfy the requirement under 21 C.F.R §50.25(a)(1) that the informed consent provide a statement that the use of the product “involves research.”

See also Mark Barnes et al., What to Know About New FDA Informed Consent Guidance (August 14, 2017), https://www.ropesgray.com/en/newsroom/alerts/2017/08/What-To-Know-About-New-FDA-Informed-Consent-Guidance.8 These informed consent elements are found at 21 C.F.R. § 50.25(a) and (b).9See 45 C.F.R. § 46.116(d). 10See 82 Fed. Reg. 7,149 (Jan. 19, 2017).

By Nisha P. Shah –On February 9, 2012, FDA released a new guidance document called, “Guidance For Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” The guidance is intended to help small businesses understand the new informed consent requirements described in 21 C.F.R. § 50.25(c), which requires that informed consent documents and processes for “applicable clinical trials,” initiated on or after March 7, 2012, include a specific statement that clinical trial information will be entered into the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine.

By Susan J. Matthees –Last week, FDA announced thatthe Agencyhas adopted final amended informed consent regulations. As we noted last year, the Food and Drug Administration Amendments Act ("FDAAA") § 801(b)(3)(A) required that FDA amend the informed consent regulations set forth at 21 C.F.R. § 50.25 to include a statement to inform potential clinical trial participants that data from the trial has been or will be entered into a databank accessible to the public via www.clinicaltrials.gov. FDA published the proposed rule implementing the FDAAA requirement in December 2009, and after considering comments, adopted the final rule, which will become effective on March 7, 2011.

o provided a sample key information section for a hypothetical clinical trial in the draft guidance’s appendix. Flexible ApproachesFDA and OHRP recognized that there are multiple strategies for providing key information to prospective research subjects in a way that would be consistent with the provisions of the revised Common Rule and FDA’s proposed regulations in the HS NPRM. The agencies encouraged the exploration and development of innovative ways to provide key information that will help prospective subjects better understand the reasons why one might or might not want to participate in the research, including utilization of available technologies and alternative media (e.g., illustrations, video, and electric tablets).Addressing Basic and Additional Elements of Informed Consent in the Key Information SectionFDA and OHRP were clear in their recommendation that the key information section need not include each element of informed consent contained in 45 CFR 46.116(b) and (c) or in 21 CFR 50.25(a) and (b), including the proposed revisions to that section, clarifying that which of the basic and additional consent elements should be included will vary based on factors such as (i) the study attributes and its design; (ii) the condition(s), behavior(s), or outcome(s) being examined; and (iii) the prospective subject population. Elements not addressed in the key information section would still need to be included elsewhere in the document, as required. If appropriate, the draft guidance notes that the elements of informed consent that are addressed in the key information section can also be repeated more comprehensively in other parts of the consent form to further help clarify concepts and ensure that the entire consent form remains understandable to prospective subjects. In the draft guidance, FDA and OHRP identified the following list of topics that are likely to be considered key information:Voluntary Participation and Right to Discontinue ParticipationPurpose of the Research, E

The FDA also highlighted other important components of the IRB’s review:Assessing the qualifications of the physician submitting the request.If the request is for a pediatric patient, confirming that age-appropriate assent is solicited from the patient and permission from a parent or guardian is obtained, as required under 21 C.F.R. § 50.55.Confirming that the informed consent form for the treatment includes a statement that explains the investigational nature of the drug and the fact that the FDA has not determined that the drug is safe or effective for use in treating COVID-19. This type of statement will satisfy the requirements of 21 C.F.R. § 50.25(a)(1).This guidance represents an important effort by the FDA to respond to continuing uncertainty by IRBs as to how to review expanded access requests for treatment of individual patients through the lens of the research approval and informed consent criteria that they are required to apply even though expanded access uses are not research. Although the FDA’s recommendations are intended to remain in effect only for the duration of the COVID-19 public health emergency declared by the U.S. Secretary of Health and Human Services, the FDA indicated that this guidance is expected to assist the FDA more broadly in its continued effort to facilitate patient access to drugs through expanded access beyond the public health emergency, and noted that it reflects the FDA’s general thinking on this issue.

42 C.F.R. § 110.20(d). 42 U.S.C. § 247d-6d(a)(2)(B).Kehler v. Hood, 2012 WL 1945952 (E.D. Mo. 2012). 21 C.F.R. § 50.25(a)(2). 45 C.F.R. pt. 11.