Human Subject Policy
The IRB follows the Code of Federal Regulations (CFR) to define human subject research.
Research means "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities."
A human subject is defined 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.”
To be considered human subject research, data obtained by the researcher from a living individual must be about the individual. Asking a school principal "What are the policies and procedures for dealing with faculty grievances?" does not solicit personal information about the principal, so it does not fit the definition of human subjects research. However, the question "As a school principal, how has dealing with faculty grievances affected you personally?" is about the principal, hence it fits the definition.
The basic ethical principles underlying the conduct of research involving human subjects are described in the Belmont Report. The report identifies three principles as particularly relevant to the ethics of human subject research:
- respect for persons,
- beneficence, and
- justice.
Definition of respect for persons
Respect for persons incorporates at least two ethical convictions: 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. In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information.
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. Some persons are in need of extensive protection. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.
Application of respect for persons in research: Informed consent
Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.
While the importance of informed consent is unquestioned, the nature and possibility of a subject’s informed consent is not universal across all studies. There is widespread agreement that the consent process can be understood as containing three elements: information, comprehension and voluntariness.
- Information. Most codes of research establish specific items for disclosure intended to ensure that subjects are given sufficient information. These items generally include: the research procedures, their purposes, risks and anticipated benefits, alternative procedures (if any), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.
A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that
- incomplete disclosure is truly necessary to accomplish the goals of the research,
- there are no undisclosed risks to subjects that are more than minimal, and
- there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.
Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research.
- Comprehension. The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questions, all may adversely affect a subject's ability to make an informed choice.
Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
- Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.
Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially where possible sanctions are involved -- urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins.
IRB review criteria
The research plan must contain a clear and detailed description of the process by which participants’ informed consent will be obtained. The informed consent process must be free of coercion and undue influence.
Consent and/or assent forms, as well as written or oral scripts used in the consent process must be provided. When communicating research procedures and potential risks and benefits to prospective participants, information must be conveyed in a comprehensible manner.
Definition of beneficence
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:
- do not harm, and
- maximize possible benefits and minimize possible harms.
The different claims covered by the principle of beneficence may come into conflict and force difficult choices.
Application of beneficence in research: Risk/benefit assessment
The assessment of risks and benefits requires a careful analysis of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity for gathering systematic and comprehensive information about proposed research and a responsibility to do so. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate in the research.
IRB review criteria
Risks to subjects must be minimized by using procedures consistent with sound research design and which do not needlessly expose subjects to risk.
Risks to subjects must be reasonable in relation to anticipated benefits (if any) to the subjects, and the importance of the knowledge that may reasonably be expected to result.
The research plan must protect the privacy of subjects and the confidentiality of data. When appropriate, the research plan must make adequate provisions for monitoring the data collected to ensure safety of subjects.