Source: https://www.jdsupra.com/legalnews/another-step-toward-harmonization-fda-13351/
Timestamp: 2018-12-13 23:47:37
Document Index: 717730662

Matched Legal Cases: ['§ 360', '§ 355', '§ 50', '§ 50', '§ 50', '§ 46', '§ 46', '§ 50', '§ 56']

Another Step Toward Harmonization: FDA Issues Proposed Rule to Waive Informed Consent Requirements in Minimal-Risk Studies | Ropes & Gray LLP - JDSupra
On November 15, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule1 that would allow institutional review boards (“IRBs”) to waive or alter informed consent when a clinical investigation poses no more than minimal risk to, and includes appropriate safeguards for, human subjects (the “Proposed Rule”). If finalized in its current form, the Proposed Rule would harmonize FDA consent requirements with those of the “Federal Policy for the Protection of Human Subjects,” known as the “Common Rule.”2
Both FDA regulations and the Common Rule have provisions to protect human research subjects, including requirements pertaining to IRB review and informed consent. FDA regulations govern clinical investigations (1) that are subject to FDA’s investigational product application requirements (either an investigational device exemption under 21 U.S.C. § 360j(g) or an investigational new drug application under 21 U.S.C. § 355(i)) or (2) the results of which will be submitted to FDA in support of a product application or held for inspection by FDA.3 Currently, FDA’s regulations require investigators to obtain informed consent of clinical investigation participants, except (1) in certain life-threatening situations4 or (2) for emergency research.5
In an effort to promote scientific research and harmonize the Common Rule and FDA regulations, Congress passed the 21st Century Cures Act (the “Cures Act”) in December 2016. The Cures Act included a provision amending the Federal Food, Drug, and Cosmetic Act (“FDCA”) to permit waiver of informed consent for research involving no more than minimal risk to human subjects, if appropriate safeguards are in place to protect the rights, safety, and welfare of subjects.6 The Cures Act provision requires FDA, through regulation, to define and describe the conditions under which an IRB may waive informed consent for FDA-regulated minimal-risk research activities.
In advance of issuing such regulations, on July 25, 2017, FDA issued a guidance document (“Consent Waiver Guidance”)—described in this Ropes & Gray alert—announcing its intention not to object to an IRB’s waiving or altering of the informed consent requirements for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections.7 FDA stated that it planned to withdraw this guidance upon its promulgation of relevant regulations.
On January 19, 2017, the U.S. Department of Health and Human Services, together with 15 other federal departments and agencies, issued a final rule to revise and modernize the Common Rule (the “Revised Common Rule”).10 The Revised Common Rule retains the four criteria listed above, but also includes a fifth criterion for waiver of informed consent: “If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.”11 The Proposed Rule adopts the four criteria above from the Common Rule, but does not adopt this new fifth criterion from the Revised Common Rule—although FDA does not explain in the Proposed Rule its decision to omit this new criterion, it has invited comments on this point.
4 See 21 C.F.R. § 50.23.
5 See id. at § 50.24. FDA enforcement discretion policy announced in 2006 also allows for FDA-regulated clinical research on “leftover” de-identified specimens to be conducted without informed consent. See Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (April 25, 2006), available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071265.pdf.
8 These informed consent elements are found at 21 C.F.R. § 50.25(a) and (b).
9 See 45 C.F.R. § 46.116(d).
11 45 C.F.R. § 46.116(f)(3)(iii).
12 Informed consent for clinical trials requires the following statement to be provided to each study subject: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” 21 C.F.R. § 50.25(c).
13 See 21 C.F.R. § 56.109(c).