August 2024 SOCRA Source Journal - Journal - Page 14
References
24 For purposes of this guidance, when “approved or cleared” is used in discussing devices, the
terms refer to FDA permitting the marketing of a device via the premarket approval, premarket
noti昀椀cation (510(k)), De Novo classi昀椀cation, or Humanitarian Device Exemption (HDE) pathways.
25 For the purposes of this guidance only, FDA generally would consider a medically recognized
standard of care to be one evidenced by publication in a peer reviewed journal as a generally
recognized standard of care or recognition by a professional medical society (e.g., in a clinical
guideline).
26 For additional information, see Frequently Asked Question #11, “Can a subject participate in more
than one clinical investigation simultaneously?”
27 Note, 21 CFR 56.111(a)(7) requires IRBs to determine, where appropriate, that there are adequate
provisions to protect the privacy of subjects and to maintain the con昀椀dentiality of data.
28 See the FDA Information Sheet “Payment and Reimbursement to Research Subjects,” available
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-andreimbursement-research-subjects.
29 As FDA has recognized in prior guidance, unapproved new uses or treatment regimens for
approved or cleared drugs or devices may be important and may even constitute medically recognized
standard of care. See FDA “Guidance for Industry; Good Reprint Practices for the Distribution of
Medical Journal Articles and Medical or Scienti昀椀c Reference Publications on Unapproved New Uses
of Approved Drugs and Approved or Cleared Medical Devices,” available at https://downloads.
regulations.gov/FDA-2008-D-0053-0127/content.pdf.
30 Federal Register, “Protection of Human Subjects; Informed Consent” (46 FR 8942, January 27,
1981), available at https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/
protection-human-subjects-informed-consent; see response to comment 23.
31 For additional advice regarding the need to avoid coercion and undue in昀氀uence during the
informed consent process, see Section III.A.2.
32 When appropriate, a sponsor may request a discretionary Certi昀椀cate of Con昀椀dentiality (CoC).
A CoC generally prohibits a researcher from disclosing identi昀椀able, sensitive information about the
research participant, created or compiled for purposes of the research, in any Federal, State, or local
civil, criminal, administrative, legislative, or other proceeding. There are some exceptions to the
prohibition on disclosure of such information. See FDA guidance “Certi昀椀cates of Con昀椀dentiality,”
available at https://www.fda.gov/media/132966/download.
33 Investigators should ensure that subjects have access to reasonable medical care for medical
problems arising during their participation in the clinical investigation that are, or could be, related
to the study intervention. 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/search-fda-guidance-documents/investigator-responsibilities-protecting-rightssafety-and-welfare-study-subjects.
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