Statutory Notes and Related Subsidiaries

Protection of Human Research Subjects

Pub. L. 114–255, div. A, title III, § 3023, Dec. 13, 2016, 130 Stat. 1098, provided that:

“(a)

In General.—

In order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research, the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall, to the extent practicable and consistent with other statutory provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b).

“(b)

Avoiding Regulatory Duplication and Unnecessary Delays.—

The Secretary shall, as appropriate—

“(1)

make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules as may be necessary—

“(A)

to reduce regulatory duplication and unnecessary delays;

“(B)

to modernize such provisions in the context of multisite and cooperative research projects; and

“(C)

to protect vulnerable populations, incorporate local considerations, and support community engagement through mechanisms such as consultation with local researchers and human research protection programs, in a manner consistent with subparagraph (B); and

“(2)

ensure that human subject research that is subject to the HHS Human Subject Regulations and to the FDA Human Subject Regulations may—

“(A)

use joint or shared review;

“(B)

rely upon the review of—

“(i)

an independent institutional review board; or

“(ii)

an institutional review board of an entity other than the sponsor of the research; or

“(C)

use similar arrangements to avoid duplication of effort.

“(c)

Consultation.—

In harmonizing or modifying regulations or guidance under this section, the Secretary shall consult with stakeholders (including researchers, academic organizations, hospitals, institutional research boards, pharmaceutical, biotechnology, and medical device developers, clinical research organizations, patient groups, and others).

“(d)

Timing.—

The Secretary shall complete the harmonization described in subsection (a) not later than 3 years after the date of enactment of this Act [Dec. 13, 2016].

“(e)

Progress Report.—

Not later than 2 years after the date of enactment of this Act, the Secretary shall submit to Congress a report on the progress made toward completing such harmonization.

“(f)

Definitions.—

“(1)

Human subject regulations.—

In this section:

“(A)

FDA human subject regulations.—

The term ‘FDA Human Subject Regulations’ means the provisions of parts 50, 56, 312, and 812 of title 21, Code of Federal Regulations (or any successor regulations).

“(B)

HHS human subject regulations.—

The term ‘HHS Human Subject Regulations’ means the provisions of subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations).

“(C)

Vulnerable population rules.—

The term ‘vulnerable population rules’ means—

“(i)

except in the case of research described in clause (ii), the provisions of subparts B through D of part 46, Code of Federal Regulations (or any successor regulations); and

“(ii)

in the case of research that is subject to FDA Human Subject Regulations, the provisions applicable to vulnerable populations under part 56 of title 21, Code of Federal Regulations (or any successor regulations) and subpart D of part 50 of such title 21 (or any successor regulations).

“(2)

Institutional review board defined.—

In this section, the term ‘institutional review board’ has the meaning that applies to the term ‘institutional review board’ under the HHS Human Subject Regulations.”

Informed Consent for Newborn Screening Research

Pub. L. 113–240, § 12, Dec. 18, 2014, 128 Stat. 2857, provided that:

“(a)

In General.—

Research on newborn dried blood spots shall be considered research carried out on human subjects meeting the definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursuant to the Public Health Service Act [42 U.S.C. 201 et seq.] until such time as updates to the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c). For purposes of this subsection, sections 46.116(c) and 46.116(d) of title 45, Code of Federal Regulations, shall not apply.

“(b)

Effective Date.—

Subsection (a) shall apply only to newborn dried blood spots used for purposes of Federally funded research that were collected not earlier than 90 days after the date of enactment of this Act [Dec. 18, 2014].

“(c)

Regulations.—

Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed regulations related to the updating of the Federal Policy for the Protection of Human Subjects (the Common Rule), particularly with respect to informed consent. Not later than 2 years after such date of enactment, the Secretary shall promulgate final regulations based on such proposed regulations.”

Study Concerning Research Involving Children

Pub. L. 107–109, § 12, Jan. 4, 2002, 115 Stat. 1416, provided that:

“(a)

Contract With Institute of Medicine.—

The Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine for—

“(1)

the conduct, in accordance with subsection (b), of a review of—

“(A)

Federal regulations in effect on the date of the enactment of this Act [Jan. 4, 2002] relating to research involving children;

“(B)

federally prepared or supported reports relating to research involving children; and

“(C)

federally supported evidence-based research involving children; and

“(2)

the submission to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, not later than two years after the date of enactment of this Act, of a report concerning the review conducted under paragraph (1) that includes recommendations on best practices relating to research involving children.

“(b)

Areas of Review.—

In conducting the review under subsection (a)(1), the Institute of Medicine shall consider the following:

“(1)

The written and oral process of obtaining and defining ‘assent’, ‘permission’ and ‘informed consent’ with respect to child clinical research participants and the parents, guardians, and the individuals who may serve as the legally authorized representatives of such children (as defined in subpart A of part 46 of title 45, Code of Federal Regulations).

“(2)

The expectations and comprehension of child research participants and the parents, guardians, or legally authorized representatives of such children, for the direct benefits and risks of the child’s research involvement, particularly in terms of research versus therapeutic treatment.

“(3)

The definition of ‘minimal risk’ with respect to a healthy child or a child with an illness.

“(4)

The appropriateness of the regulations applicable to children of differing ages and maturity levels, including regulations relating to legal status.

“(5)

Whether payment (financial or otherwise) may be provided to a child or his or her parent, guardian, or legally authorized representative for the participation of the child in research, and if so, the amount and type of payment that may be made.

“(6)

Compliance with the regulations referred to in subsection (a)(1)(A), the monitoring of such compliance (including the role of institutional review boards), and the enforcement actions taken for violations of such regulations.

“(7)

The unique roles and responsibilities of institutional review boards in reviewing research involving children, including composition of membership on institutional review boards.

“(c)

Requirements of Expertise.—

The Institute of Medicine shall conduct the review under subsection (a)(1) and make recommendations under subsection (a)(2) in conjunction with experts in pediatric medicine, pediatric research, and the ethical conduct of research involving children.”

Requirement for Additional Protections for Children Involved in Research

Pub. L. 106–310, div. A, title XXVII, § 2701, Oct. 17, 2000, 114 Stat. 1167, as amended by Pub. L. 106–505, title X, § 1001(a), Nov. 13, 2000, 114 Stat. 2350, provided that: “Notwithstanding any other provision of law, not later than 6 months after the date of the enactment of this Act [Oct. 17, 2000], the Secretary of Health and Human Services shall require that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services be in compliance with subpart D of part 46 of title 45, Code of Federal Regulations.”

[Pub. L. 106–505, title X, § 1001(b), Nov. 13, 2000, 114 Stat. 2350, provided that: “The amendment made by subsection (a) [amending section 2701 of Pub. L. 106–310, set out above] takes effect on the date of the enactment of the Children’s Health Act of 2000 [Oct. 17, 2000].”]