August 2024 SOCRA Source Journal - Journal - Page 15
34 For additional discussion of exculpatory language, see the joint draft guidance from OHRP and
FDA, “Guidance on Exculpatory Language in Informed Consent,” which, when 昀椀nal, will represent
FDA’s current thinking on this topic, available at https://www.fda.gov/regulatory-information/searchfda-guidance-documents/exculpatory-language-informed-consent.
35 See pages 7-8 of FDA’s “Guidance for Industry Investigator Responsibilities – Protecting the Rights,
Safety, and Welfare of Study Subjects,” available at https://www.fda.gov/regulatory-information/searchfda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects.
36 See, “Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects
Withdraw from FDA- Regulated Clinical Trials,” at https://www.fda.gov/regulatory-information/searchfda-guidance-documents/data-retention-when-subjects-withdraw-fda-regulated-clinical-trials.
37 FDA supports the principles of the “3Rs,” to reduce, re昀椀ne, and replace animal use in testing
when feasible. FDA encourages sponsors to consult with the relevant review division if it they wish to
use a non-animal testing method they believe is suitable, adequate, validated, and feasible. FDA will
consider if such an alternative method is adequate to meet the regulatory need.
38 The Patient Protection and Affordable Care Act added section 2709 to the Public Health Service
Act (42 U.S.C. 300gg-8). Among other things, this provision prohibits a group health plan or health
insurance issuer in the group and individual health insurance market from denying certain individuals’
participation in certain clinical trials and from denying or limiting coverage of routine patient costs for
items or services furnished in connection with participation in such trials.
39 See “Guidance for Institutional Review Boards and Clinical Investigators, Charging for
Investigational Products,” available at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/charging-investigational-products, and “Guidance for Industry, Charging for
Investigational Drugs Under an IND – Questions and Answers,” available at https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/charging-investigational-drugs-undER–indquestions-and-answers. Also, sponsors of expanded access INDs and treatment protocols that meet
certain requirements may recover other costs than these direct costs. See 21 CFR 312.8(d)(2).
40 For further information about the timing of payments to research participants, see the “Guidance for
Institutional Review Boards and Clinical Investigators, Information Sheet: Payment and Reimbursement
to Research Subjects,” available at Payment and Reimbursement to Research Subjects | FDA.
41 For further information, see FDA’s “Guidance for Sponsors, Investigators, and Institutional Review
Boards, Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answersinformed-consent-elements-21-cfr-ss-5025c?source=govdelivery.
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