Human Research Subject Protections Act of 2000
Section Summary
Section 1 Short title
This act may be cited as the Human Research Subjects Protections Act of 2000
Section 2 Findings and purposes
The purposes of this act are:
1. To apply common rule and vulnerable-population protections to all human research subjects independent of setting and funding source.
2. Require classified research to be approved by an Institutional Review Board (IRB) and compliant with other human research subject protections.
3. Establish an Office for Protection of Research Subjects in the HHS Office of the Secretary.
Section 101: Protection of Human Subjects in Research; Uniform National Applicability of Common Rule and Provisions Protecting Vulnerable Populations.
Applies common rule and vulnerable-population protections to all human research subjects independent of setting and funding source.
Section 102: Scope of Authority of Secretary
Establishes the Secretary’s authority to modify the common rule and vulnerable-population protections. Permits federal agencies to establish protections above and in addition to the common rule and vulnerable-population protections. Authorizes the Secretary to suspend or revoke the registration, impose restrictions on, or withhold federal funding from an IRB.
Section 103: Enhanced Human Subject Protections
Instructs the Secretary to promulgate new standards to protect research subjects with diminished decision-making capacity within 180 days of the date of enactment.
Section 201: Right of Informed Consent
Establishes a research subject’s legal right of informed consent. Requires the provision of "full and complete information" to research subjects necessary to "make an informed decision, free of coercion, regarding their participation in research." Also specifies the minimum elements of an informed consent form.
Section 202: Written Attestation and Disclosure
Requires investigators to file a written attestation of familiarity and agreement to comply with human subject research protections. Requires investigators to disclose to research subjects their financial interests in the research and any other conflicts of interest deemed necessary by the IRB.
Section 301: Requirements for Board
Requires IRB approval before human subject research can proceed. Establishes IRB membership requirements consistent with current common rule regulations. Establishes procedural requirements, including adequate funding, quorums for decision making, orientation and continuing education programs, and registration with the Secretary.
Section 302: Notification of Institutional Review Board
Requires sponsors and investigators to notify IRBs of prior IRB review and findings on a research proposal, as well as the regulatory disqualification or restriction of the sponsor, investigator, or research institution by a federal agency.
Section 303: Activities
Requires IRBs to compile and report summary annual data on the number of proposals reviewed, number of human subjects involved, and other subjects. Requires the Secretary to promulgate regulations on improved clinical trial monitoring and the conduct of research at multiple research sites.
Section 304: Disclosure of Interests
Requires investigators to disclose to IRBs their financial interests and conflicts of interest in the research. Requires all IRB members to disclose their conflicts of interest in the research, including ownership of financial relationships with the sponsors. Prohibits participation of IRB members in decisions on research in which they have conflicts of interest.
Section 305: Accreditation
Effective two years after the date of enactment, IRBs shall be accredited by a nonprofit private entity approved by the Secretary. Specifies that accreditation shall be to standards established by the Secretary.
Section 306: Cost Recovery
Authorizes institutions to recover the costs of compliance with human subject protections from government research sponsors as direct costs.
Section 307: Applicability of Requirements
Requirements of the Act shall apply on the date of enactment.
Section 401: Establishment of Office for Protection of Research Subjects
Establishes an Office for Protection of Research Subjects in the Office of the Secretary of Health and Human Services. Calls for an Office Director to be appointed by the Secretary.
Section 402: Authorization of Appropriateness
Authorizes $20 million for the Office in fiscal year 2001 and such sums as may be necessary in subsequent years.
Section 403: Institutional Programs for Providing Education on Protection of Human Subjects in Research
Requires a "comprehensive and ongoing program" to educate investigators and IRB members on human subject protections as a condition of federal grants, cooperative agreements, or contracts with public or private entities for the conduct of research.
Section 404: Certain Classified Human Subject Research
Prohibits federal funding of secret, classified research if an IRB has waived the requirement of informed consent or the research is exempt under the common rule from IRB review. Fulfills the recommendations of the 1995 Report of the National Advisory Committee on Human Radiation Experiments.
Section 405: Rule of Construction Regarding Individual Agency Offices
Provides for transferring duties from any existing office, such as the HHS Office of Human Research Protections, to the newly authorized Office for Protection of Research Subjects.
Section 406: National Bioethics Advisory Commission
Authorizes the National Bioethics Advisory Commission as the successor body to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1979-1986).
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