for Protection of Human Subjects The Department of Health and Human Services (HHS) regulations [45 CFR part 46] apply to research involving human subjects conducted by the HHS or funded in whole or in part by the HHS. The Food and Drug Administration (FDA) regulations [21 CFR parts 50 and 56] apply to research involving products regulated by the FDA. Federal support is not necessary for the FDA regulations to be applicable. When research involving products regulated by the FDA is funded, supported or conducted by FDA and/or HHS, both the HHS and FDA regulations apply.

IRB Regulations Section Numbers Description

ß 56.102 (FDA) ß 46.102 (HHS) FDA definitions are included for terms specific to the type of research covered by the FDA regulations (test article, application for research or marketing permit, clinical investigation). A definition for emergency use is provided in the FDA regulations.

ß 56.104 (FDA)
ß 46.116 (HHS) FDA provides exemption from the prospective IRB review requirement for "emergency use" of test article in specific situations. HHS regulations state that they are not intended to limit the provision of emergency medical care.

ß 56.105 (FDA)
ß 46.101 (HHS) FDA provides for sponsors and sponsor-investigators to request a waiver of IRB review requirements (but not informed consent requirements). HHS exempts certain categories of research and provides for a Secretarial waiver.
ß 56.109 (FDA)
ß 46.109 (HHS)
ß 46.117(c)(HHS) Unlike HHS, FDA does not provide that an IRB may waive the requirement for signed consent when the principal risk is a breach of confidentiality because FDA does not regulate studies which would fall into that category of research. (Both regulations allow for IRB waiver of documentation of informed consent in instances of minimal risk.) ß 56.110 (FDA)
ß 46.110 (HHS) The FDA list of investigations eligible for expedited review (published in the Federal Register) does not include the studies described in category 9 of the HHS list because these types of studies are not regulated by FDA
ß 56.114 (FDA)
ß 46.114 (HHS) FDA does not discuss administrative matters dealing with grants and contracts because they are irrelevant to the scope of the Agency's regulation. (Both regulations make allowances for review of multi-institutional studies.)
ß 56.115 (FDA)
ß 46.115 (HHS) FDA has neither an assurance mechanism nor files of IRB membership. Therefore, FDA does not require the IRB or institution to report changes in membership whereas HHS does require such notification. ß 56.115(c) (FDA) FDA may refuse to consider a study in support of a research or marketing permit if the IRB or the institution refuses to allow FDA to inspect IRB records. HHS has no such provision because it does not issue research or marketing permits.
ß 56.120 ----
ß 56.124 (FDA) FDA regulations provide sanctions for non-compliance with regulations.

Informed Consent Regulations Section Numbers Description

ß 50.23 (FDA)
FDA, but not HHS, provides for an exception from the informed consent requirements in emergency situations. The provision is based on the Medical Device Amendments of 1976, but may be used in investigations involving drugs, devices, and other FDA regulated products in situations described in ß 50.23.
ß 46.116(c)&(d) (HHS) HHS provides for waiving or altering elements of informed consent under certain conditions. FDA has no such provision because the types of studies which would qualify for such waivers are either not regulated by FDA or are covered by the emergency treatment provisions (ß 50.23).
ß 50.25(a)(5) (FDA)
ß 46.116(a)(5) (HHS) FDA explicitly requires that subjects be informed that FDA may inspect the records of the study because FDA may occasionally examine a subject's medical records when they pertain to the study. While HHS has the right to inspect records of studies it funds, it does not impose that same informed consent requirement.
ß 50.27(a) FDA explicitly requires that consent forms be dated as well as signed by the subject or the subject's legally authorized representative. The HHS regulations do not explicitly require consent forms to be dated.

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