The DHHS regulations for the protection of human subjects provide a systematic means, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the DHHS. The regulations stipulate that an applicant organization, whether domestic or foreign, bears responsibility for safeguarding the rights and welfare of human subjects in DHHS-supported research activities. The regulations require that applicant organizations proposing to involve human subjects in nonexempt research, file a written Assurance of Compliance with the Office for Protection from Research Risks (OPRR), establishing appropriate policies and procedures for the protection of human subjects. These regulations, 45 CFR 46, Protection of Human Subjects, are available from the OPRR, National Institutes of Health, Bethesda, MD 20892, Telephone: (301) 496-7041.
The regulations define "human subject" as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." The regulations extend to the use of human organs, tissues, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable state and local law and is not directly regulated by 45 CFR 46
Research activities in which the only involvement of human subjects will be in one or more of the following six categories are exempt from coverage by the regulations:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2)(b) of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs: (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection service of the U.S. Department of Agriculture.
Investigators who conduct research involving fetuses, pregnant women, children, human in vitro fertilization, or prisoners must follow the provisions of the regulations in Subparts B, C, and D of 45 CFR 46, which describe the additional protections required for these subjects.
No DHHS award for nonexempt research involving human subjects will be made to an applicant organization unless that organization is operating in accord with an approved Assurance of Compliance and provides certification that an appropriate Institutional Review Board (IRB) has reviewed and approved the proposed activity in accordance with the DHHS regulations. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the DHHS regulations. Foreign applicant organizations must also comply with the provisions of the regulations.
The Center of Biologics Evaluation and Research (CBER), FDA, regulates the use of biological products in humans, at the investigational and marketing phases, including somatic cell therapies and gene therapies. If your work involves these areas or preclinical research which will support later work in these areas, please see the NIF Guide to Grants and Contracts.
Research on Transplantation of Fetal Tissue
In signing the application face page, the duly authorized representative of the applicant organization certifies that if research on the transplantation of human fetal tissue is conducted, the applicant organization will make available for audit by the Secretary, DHHS, the physician statements and informed consents required by section 498A(b)(2) and (c) of the Public Health Service Act, 43 U.S.C. 289g(b)(2) and (c), or ensure HHS access to those records, if maintained by an entity other than the applicant organization.
Gender and Minority Inclusion Policy
Research involving human subjects must comply with the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research." The following excerpts provide the key policy statements. Investigators should obtain full copies of the Guidelines from NIH staff, the NIH Guide for Grants and Contracts (March 18, 1994, Volume 23, Number 11) or the Federal Register (59 FR 11146-11151).
Research Involving Human Subjects: The policy of NIH is that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. This policy applies to research subjects of all ages.
The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. Describe the composition of the proposed study population in terms of gender and racial/ethnic group, and provide a rationale for selection of such subjects. Include a description of the proposed outreach programs for recruiting women and minorities as participants.