42 U.S.C. § 241 — Research and investigations generally

(a) Authority of the Secretary: The Secretary must run research within the Service, and encourage, cooperate with, and help other public authorities, institutions, and scientists doing research, investigations, experiments, demonstrations, and studies on the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments — including water purification, sewage treatment, and pollution of lakes and streams. To do this, the Secretary may (1) publish and share information about this research; (2) let public officials and scientists use the Service's research facilities; (3) give grants to universities, hospitals, labs, and other institutions, and to individuals, for research projects recommended by the relevant advisory council, and give grants for general research support to public or nonprofit institutions; (4) get advice from experts, scholars, and consultants from the U.S. or abroad; (5) admit and treat people at Service institutions for study, even if they wouldn't otherwise qualify for treatment; (6) give technical advice on statistical methods to health officials, scientists, and public and nonprofit organizations; (7) enter research contracts under the same rules that apply to military department contracts under sections 3861 and 4141 of title 10, except that HHS's Secretary handles the approvals; and (8) adopt other means the advisory councils recommend, or that the Secretary finds necessary, including through the National Advisory Mental Health Council for mental health matters. (b) Testing for cancer-causing and other harmful effects. (1) The Secretary must study and test substances for whether they cause cancer, birth defects, genetic mutations, or other harm, and may fund this work through grants and contracts — consulting with other federal agencies doing similar work, and, on request and with paid expenses, running such tests for them. (2)(A) The Secretary must run a full research program on the health effects of low-level ionizing radiation, doing some of this research directly and supporting more through grants and contracts. (B) The Secretary must review federal radiation-research programs comprehensively. (3) The Secretary must research human nutrition — especially its role in preventing and treating disease and promoting health — and share nutrition information with health professionals and the public, coordinating this work across HHS divisions and consulting other agencies doing similar work; the Secretary may also do or support this work for outside agencies on request, with paid expenses. (4) The Secretary must publish a report every two years listing (A) substances known or reasonably expected to cause cancer, to which a significant number of people in the U.S. are exposed; (B) how people are exposed and roughly how many; (C) for each such substance, whether any federal agency has set an effluent, ambient, or exposure standard, and if so, how much that standard (and its enforcement) lowers the health risk; and (D) a description of requests received that year — from outside agencies to the Secretary, or between HHS divisions — for cancer research, testing, or the information in (C), and how the Secretary or the receiving division responded. (5) The Secretary's authority to contract for any study, test, program, research, or review under this subsection only applies to the extent that Congress has appropriated money for it in advance. (c) Diseases not significantly occurring in the U.S.: The Secretary may conduct biomedical research — directly or through grants or contracts — to identify, control, treat, and prevent diseases, including tropical diseases, that don't occur much in the United States. (d) Protecting the privacy of research subjects. (1)(A) If someone does biomedical, behavioral, clinical, or other research that collects identifiable, sensitive information (including on mental health, alcohol, or drug use), the Secretary must issue that person a certificate of confidentiality if the research is federally funded, and may issue one on request if it isn't. (B) Except as allowed by (C), anyone holding such a certificate can't disclose the name of, or identifiable sensitive information about, a research subject to anyone outside the research. (C) That disclosure ban doesn't apply to disclosures that are (i) required by federal, state, or local law (except as covered in (D)), (ii) needed for the subject's medical treatment, with the subject's consent, (iii) made with the subject's consent, or (iv) made for other scientific research that follows the federal rules protecting human research subjects. (D) Even so, the certificate holder can't disclose the subject's name or identifiable sensitive information in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding — except where (C)(iii) applies (the subject consented). (E) Protected identifiable, sensitive information, and all copies, are immune from legal process and can't be used as evidence or for any purpose in any judicial, legislative, or administrative proceeding without the subject's consent. (F) That protection lasts forever — it doesn't expire. (G) The Secretary must work to reduce the burden on researchers and speed up compliance with these rules. (2) The Secretary must coordinate with other federal agencies to make sure they have policies for issuing these confidentiality certificates and meeting the other requirements of this subsection. (3) Nothing here limits a research subject's own access to information about themselves collected during the research. (4) "Identifiable, sensitive information" means information about a person, gathered or used in this kind of research, through which (A) the person is identified, or (B) there's at least a small risk — based on current science or statistics — that the information, combined with a request for it and other available data, could reveal the person's identity. (e) Preterm labor and infant mortality: Acting through the CDC Director, the Secretary must expand, strengthen, and coordinate CDC's work on preterm labor and delivery, preventable maternal death and severe illness, and infant mortality. (f) Exempting certain biomedical information from disclosure. (1) The Secretary may exempt biomedical information about a person from disclosure under the Freedom of Information Act (5 U.S.C. § 552(b)(3)) if (A) the person is identified, or (B) there's at least a small risk that the information, the request, and other data could reveal the person's identity. (2)(A) Each exemption decision must be written and explained. (B) That decision and explanation must be made public on request, through HHS's Chief FOIA Officer. (3) This doesn't limit a research participant's own access to information collected about them. (g) Inapplicability of federal information policy: Subchapter I of chapter 35 of title 44 (the Paperwork Reduction Act's rules) doesn't apply to the National Institutes of Health voluntarily collecting research information. (h) Availability of substances and living organisms for research. (1) The Secretary may provide substances and living organisms to individuals and entities for biomedical and behavioral research, on terms (including payment) the Secretary sets. (2) When contractors provide these under (1), the Secretary may have them collect payment on the Secretary's behalf and forward it, on the schedule the Secretary sets. (3) Money collected under (2) goes back to the accounts that paid to provide the substances and organisms, and stays available until spent on those accounts' activities.