New Regulatory Guidance Referencing Consent

FDA: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
FDA – Final rule.
Summary
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
…Summary of the Major Provisions of the Final Rule
The final rule amends FDA’s regulations to allow IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations. For an IRB to approve a waiver or alteration of informed consent requirements for minimal risk clinical investigations, the rule requires an IRB to find and document five criteria that are consistent with the revised rule entitled “Federal Policy for the Protection of Human Subjects” (the revised Common Rule (January 19, 2017)). FDA believes the amendment provides appropriate safeguards to protect the rights, safety, and welfare of the human subjects participating in such clinical investigations. We are also making conforming amendments to FDA’s regulations.

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; Availability
Food and Drug Administration, HHS.
Final guidance. Scheduled Pub. Date: 12/22/2023  FR Document: 2023-28262
PDF: https://downloads.regulations.gov/FDA-2021-D-1128-0066/attachment_1.pdf     8 Pages (112 KB)
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient. This guidance finalizes the draft guidance of the same title issued on December 23, 2021.
Consent
Risk Considerations When Using Digital Health Technologies
p.19 …3. Informed Consent
   FDA regulations at 21 CFR part 50 set forth the requirements for obtaining the informed consent of participants⁵⁹ in clinical investigations. DHTs can be used to obtain electronic informed consent in a clinical investigation.⁶⁰
   Some considerations for what information to include in the informed consent process regarding the DHT being used in a clinical investigation include but are not limited to the following:

• The informed consent process must describe any reasonably foreseeable risks or discomforts to participants (see sections IV.F.1 and IV.F.2 of this guidance), including reasonably foreseeable risks or discomforts related to the use of the DHT in the clinical investigation.⁶¹ Information regarding what may be done to mitigate serious risks, and risks and discomforts more likely to occur, should also be considered for inclusion.
• When appropriate, a statement must be included indicating that use of the DHT during the clinical investigation may involve risks to the participant (or to the embryo or fetus if the participant is or may become pregnant) which are currently unforeseeable.⁶²
• The informed consent process should explain the type of information that will be collected by the DHT and how that information will be used and monitored. When relevant, participants should be informed of what action to take in case of any concerning sign, symptom, or abnormal clinical event (e.g., hypoglycemia or abnormal cardiac rhythm) detected by a DHT, such as seeking emergency medical attention, if appropriate.
• The informed consent process should specify who may have access to data collected through the DHT during or after the clinical investigation (e.g., sponsors, investigators, participants, DHT manufacturers, other specified third parties) and during what time frame.⁶³
• An explanation of measures to protect participant privacy and data, and limitations to those measures, when DHTs are used should be included.
• If participants may incur additional expense because they are taking part in the clinical investigation, the consent process must explain the added costs,⁶⁴ which could include costs for the participants that may result from using the DHT during the clinical investigation (e.g., data use charges).
• DHTs or other technologies may be covered by end-user license agreements or terms of service as a condition of use, which may, among other things, allow DHT or other technology manufacturers and other parties to gain access to personal information and data collected by the DHT or other technology. When applicable, sponsors and investigators should ensure that the informed consent process explains to participants that their data may be shared outside of the clinical investigation, according to the end-user license agreement or terms of service. End-user license agreements and terms of service typically are lengthy and use complex terminology. Sponsors and investigators proposing use of DHTs for data collection should understand how such agreements or terms of service may affect trial participants and address this information when developing informed consent documents.⁶⁵

61 See 21 CFR 50.25(a)(2).
62 See 21 CFR 50.25(b)(1).
63 In addition, the informed consent process must note the possibility that FDA will inspect records identifying the participants (21 CFR 50.25(a)(5)).
64 21 CFR 50.25(b)(3).
65 For further information, see the Secretary’s Advisory Committee on Human Research Protections webpage “Attachment B-Clarifying Requirements in Digital Health Technologies Research,” available athttps://www.hhs.gov/ohrp/sachrp-committee/recommendations/april-7-2020-attachment-b/index.html.
66 See 21 CFR 312.57,312.58,312.62, and 312.68.
67 See 21 CFR 812.2(b)(1)(v)and(vi), 812.140, 812.145, and 812.150.
68 See FDA Study Data Standards Resources, available athttps://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources,and the Data Standards Catalog, available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog.