This is a brief overview of principles, regulations, and policies which affect research involving human subjects in research activities supported by the Department of Education.
II. What is the role of the Office of the Chief Financial Officer in the protection of human subjects?
The Office of the Chief Financial Officer is responsible for implementing the Department's Regulations for the Protection of Human Subjects and for providing guidance on the requirements for complying with the regulations. The Department of Education's Protection of Human Subjects Coordinator, the Department's primary contact for matters concerning the protection of human subjects in research, is in OCFO/FMO.
III. What are the applicable regulations?
The regulation is Title 34, Code of Federal Regulations, Part 97, Protection of Human Subjects, which includes Subpart A, Basic Policy, and Subpart D, Additional Protections for Children.
Title 34, Code of Federal Regulations, Part 350, Disability and Rehabilitation Research: Disability and Rehabilitation Research Projects and Centers Program, and Title 34, Code of Federal Regulations, Part 356, Disability and Rehabilitation Research: Research Fellowships, provide additional safeguards in certain research activities funded by the National Institute on Disability and Rehabilitation Research.
On June 18, 1991, seventeen Federal Departments and Agencies, including the Department of Education, adopted a common set of regulations known as the Federal Policy for the Protection of Human Subjects or "Common Rule." The design of these regulations is based on established, internationally recognized ethical principles. The "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," known as the Belmont Report, describe the ethical principles on which the regulations are based.
IV. What are the major provisions of the applicable regulations?(This section does not address all the requirements and is, therefore, not a substitute for the regulations. Interested persons should read the regulations as well.)
Definitions of research and human subjects:The regulations define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." It includes activities which meet this definition, whether or not conducted under a program considered "research" for other purposes. [34 CFR 97.102(d)] If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research. The regulations define human subject as "a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information." [34 CFR 97.102(f)(1) and (2)]
Exempt and nonexempt research:The regulations classify as exempt certain categories of research. Research that is nonexempt is covered by the regulations. The exemptions are found in 34 CFR 97.101(b).
Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt:
(1) 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.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the information identifies the subjects and disclosure could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Subpart D amends this exemption, in part: If the subjects are children, research involving interview or survey procedures and research involving observations of public behavior in which the researcher(s) participate in the activities being observed are not exempt. However, research involving the use of educational tests and research involving observations of public behavior in which the researcher(s) do not participate in the activities being observed are exempt. [34 CFR 97.401(b)]
(3) 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 section (2) above, if the human subjects are elected or appointed public officials or candidates for public office, or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(4) 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 a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(5) 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.
(6) 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 for a 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.
Institutional review boards:The regulations require that all covered research projects be reviewed and approved by an Institutional Review Board before the research takes place. Institutional Review Boards are authorized to approve, request modification in, or disapprove research activities [34 CFR 97.109(a)] and to conduct continuing reviews of the research activities at intervals appropriate to the degree of risk, but not less than once a year [34 CFR 97.109(e)].
Each Institutional Review Board must have at least 5 voting members. Each Institutional Review Board must have members whose expertise and experience together constitute an appropriate background for its decisions. No Board should consist exclusively of the members of one gender or of one profession. It must include at least one person whose primary concerns are in scientific areas, at least one person whose primary concerns are in a nonscientific areas, and at least one voting member not affiliated with the institution. The Institutional Review Board must possess the professional competence necessary to review specific research activities and be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. If the Board regularly reviews research that involves vulnerable categories of subjects, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. [34 CFR 97.107]
34 CFR Parts 350 and 356 impose additional Institutional Review Board membership requirements. For research sponsored by the National Institute on Disability and Rehabilitation Research, when children with disabilities or persons with mental disabilities are purposefully included as research subjects, the Institutional Review Board's membership must include at least one person who is primarily concerned with the welfare of these research subjects [34 CFR 350.4(c) and 356.3(c)].
Assurances and certifications:The regulations require that each institution, defined in the regulations as "any public or private entity or agency (including federal, state, and other agencies)," engaged in the conduct of covered research activities have an approved Assurance of Compliance on file and provide Certification that the Institutional Review Board designated in the Assurance has reviewed and approved the proposed activity in accordance with the regulations, or that is has provided approval on condition that all covered research activities will be reviewed and approved before they are initiated and that appropriate Certification will be submitted. The Assurance sets forth the commitment of the institution to employ the basic ethical principles of the Belmont Report and to comply with the regulations. [34 CFR 97.103] (An independent investigator proposing to conduct covered research must be affiliated through a written Agreement with an organization that has an Assurance of Compliance and has accepted responsibility for the research activities of the individual.)
Criteria for institutional review board approval of research:The regulations stipulate that in making its decision to approve, modify, or disapprove proposed research activities, the Institutional Review Board must ensure that the risks to subjects are minimized, that the risks to subjects are reasonable in relation to anticipated benefits, and that the selection of subjects is equitable. Where appropriate, the Institutional Review Board must ensure that informed consent will be sought from each prospective subject or the subject's legally authorized representative, that informed consent will be documented, that data collection will be monitored to ensure the safety of the subjects, that the subjects' privacy is protected and confidentiality of data is maintained, and that the rights and welfare of subjects from vulnerable populations are protected by additional safeguards. [34 CFR 97.111]
Subpart D provides additional protections to safeguard the welfare of children involved as subjects in research. It limits the risks to which children can be made vulnerable without the prospects for additional benefits, and modifies the informed consent provisions to include both assent by the child and the permission of the parent or guardian or, in certain circumstances, the permission of the parent or guardian without the assent of the child.