Fundamental Principles for the Use of Human Subjects in Research
The use of human subjects in research is extremely important to the development of new knowledge in many areas. However, careful attention must be given to questions of ethics and human dignity whenever human subjects participate in research.
In 1978, the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research developed broad ethical principles to provide a basis on which specific rules could be developed. These principles, which are discussed in The Belmont Report, are set forth below:
The Belmont Principles
Three basic principles are particularly relevant to the ethics of research involving human subjects: respect for persons, beneficence, and justice.
Respect for Persons
Respect for persons incorporates at least two basic ethical tenets: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.
In most cases of research involving human subjects, respect for persons demands that subjects enter the research voluntarily and on the basis of adequate information about the research situation and possible consequences.
Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well- being. Such treatment falls under the principle of beneficence. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: first, do not harm and second, maximize possible benefits and minimize possible harms. Learning what will, in fact, benefit may require exposing persons to risk. The problem posed by these imperatives is how to decide when it is justifiable to seek certain benefits, despite the risks involved, and when the possible benefits should be foregone because of the risks.
The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risks that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.
Who ought to receive the benefits of research and bear its burdens? This is a question of justice--in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. The selection of research subjects needs to be scrutinized in order to determine whether some groups (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Especially when research supported by public funds leads to the development of therapeutic devices and procedures, justice demands that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
KCTCS Policy for Use of Human Subjects in Research
KCTCS Policy 126.96.36.199.2 applies to any research activity conducted at or sponsored by KCTCS that involves human subjects. It is relevant whenever an investigator conducts research in which he or she (1) obtains data through intervention or interaction with an individual or (2) obtains private information by which an individual could be identified. The policy is, therefore, applicable to research involving living human beings whose physical, emotional, or behavioral conditions, responses, tissues, or fluids are investigated for research purposes (that is, for any reason other than the sole purpose of benefiting the subject as an individual). It is applicable to the use of interviews, tests, observations, and inquiries designed to elicit or obtain nonpublic information about individuals or groups, as well as the study of existing public or privately held records where the identity of individuals is known. [See Part 1]
The policy is applicable whether the research is undertaken on a large or small scale and whether it is externally funded or not. Pilot projects, student dissertation and thesis projects, independent study projects, and course projects must follow this policy if they involve research with human subjects.
Basic Ethical Issues in Human Subjects Research
The KCTCS policies regarding research with human subjects use terms such as "subject" and "minimal risk," which may need further definition or explanation. This is especially so for borderline cases in which it may not be clear, for example, whether a project constitutes research or a person is a subject. The following sections attempt to explain these terms and to provide some guidance for the borderline cases.
Human Subject Research
As used in this document, the word research is defined as any systematic gathering and analysis of information, usually made under conditions determined by the investigator that aims to test a hypothesis, to discover some unknown principle, or effect, or to re-examine some known or suggested principle. The term research includes:
- studies in which any substance or stimulus is administered to a subject by any means,
- studies that involve changes in physical or psychological state or environment or major changes in diet,
- interviews, surveys, tests, observations, and inquiries designed to elicit or obtain nonpublic information about individuals or groups,
- studies of existing public or privately held records where the identity of individuals is known.
Activities that meet this definition constitute research even if they are supported or funded under a program that serves other purposes. For example, some demonstration and service programs may include research activities.
The term research is not intended to apply to:
- routine course, workshop, or curriculum development using accepted educational practices sponsored by KCTCS, including evaluation to determine student/participant satisfaction, attitude change, and/or knowledge gain during the educational experience.
- aid or services provided by professionals to their clients that are consistent with accepted and established practice, and intended only to meet the clients' own personal needs.
The term human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information.
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture)
and manipulations of the subject or the subjects' environment that are performed for
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subjects' environment that are performed for research purposes.
- Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place. It also refers
to information that has been provided for specific purposes by an individual with
the reasonable expectation that it will not be made public (for example, a medical
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also refers to information that has been provided for specific purposes by an individual with the reasonable expectation that it will not be made public (for example, a medical record).
- The definition of subject excludes all accepted and established service relationships, such as normal relationship
of patients to physicians, students to instructors, and other clients to professionals
in which the patient, student, or client is receiving aid or services consistent with
accepted and established practice, that is intended only to meet her or his own personal
needs. The professional-client relationship has the welfare of the client as the primary
objective, whereas the investigator- subject relationship has the discovery of new
knowledge as its primary objective. This difference may not be fully understood by
the subject who is also a client, and can result in the investigator's gaining consent
without free decision.
- The normal employer-employee relationship is also excluded from the definition of subject. Payment of research subjects for their time as participants does not alter their status as subjects and does NOT change the relationship to one of employer-employee.
- If doubt exists as to whether the procedures to be employed are within accepted and established practice or whether the purpose is only for the personal needs of the client, the activity should be considered to involve subjects whose rights and welfare are to be protected in accord with this policy statement. Similarly, if doubt exists as to whether the procedures are within the normal limits of the employee's scope of work, employees should be considered to be participating as human subjects; and their rights and welfare must be protected.
The rights of some subjects require special attention, as detailed elsewhere in this handbook. These include:
- Children, because of their vulnerability, diminished autonomy, and incomplete understanding. In Kentucky, anyone under the age of 18 is not legally able to give consent for research participation.
- Subjects with limited civil freedom, such as prisoners and persons subject to military discipline.
- People with limited capacities or mental disabilities, such as the mentally retarded or the mentally ill.
- Pregnant women and the viable fetus, both in utero and ex utero.
Responsible Project Investigator
Responsible project investigator means a qualified faculty member at or above the level of instructor or a qualified staff member who will monitor the conduct of research involving human subjects.
The ethical and professional codes governing the use of human subjects in research all require that the participation of the subject must be voluntary and that the subject gives her or his agreement to participate in the research based upon adequate knowledge and understanding of relevant information.
The principle of voluntary participation of subjects applies whether or not the research is governed by federal regulations and whether or not the research is exempt from full review.
The methods used to obtain consent may vary. They should be designed to fit the nature of the research, the nature and magnitude of the risks involved, the research setting, the nature of the subjects who will participate, and the requirements of applicable policies, laws, and regulations.
Fieldwork, or ethnographic research, typically involves observation of and interaction with groups of subjects in their own environment, often over long periods of time. It may not be possible to specify detailed contents of the experimental protocol and the research itself may involve continuing interaction between the researcher and hosts that are difficult to describe in an informed consent statement prior to initiation of the research. The general principle of consent is still applicable to fieldwork, but the HSRB will consider waiving formal informed consent under certain circumstances (see p. 21). The American Sociological Association and the American Anthropological Association have developed guidelines that address ethical issues, and investigators conducting research in these disciplines should be aware of them in the design of their protocol.
A research protocol is defined as having minimal risk if the risks of anticipated harm are not greater, considering probability and magnitude, than those ordinarily encountered in the subject's daily life or during the performance of routine physical or psychological examinations or tests.
Persons who have not attained the legal age for consent to treatment or procedures involved in research, as determined by the applicable law where the research will be conducted. (In Kentucky, this age is 18 years.)