Protection of Human Subjects

Issues in Ethics Statements: Definition

From time to time, the Board of Ethics determines that members and certificate holders can benefit from additional analysis and instruction concerning a specific issue of ethical conduct. Issues in Ethics statements are intended to heighten sensitivity and increase awareness. They are illustrative of the Code of Ethics and intended to promote thoughtful consideration of ethical issues. They may assist members and certificate holders in engaging in self-guided ethical decision-making. These statements do not absolutely prohibit or require specified activity. The facts and circumstances surrounding a matter of concern will determine whether the activity is ethical.

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Introduction

The conduct of research and scholarly activities is critical to the development of the professions, clinical practice, and basic scientific knowledge in speech, language, and hearing processes. Principle of Ethics I, Rule N, states: “Individuals shall use persons in research or as subjects of teaching demonstrations only with their informed consent.” A basis for this rule is embodied by ethical principles that guide the participation of human subjects in biomedical research. The key components of informed consent revolve around three principles: respect for persons, beneficence, and justice.

From an historical perspective, ethical issues underlying informed consent are addressed in three internationally recognized documents. In 1947, the Nazi War Crimes Tribunal issued the first internationally recognized code of research ethics, the Nuremberg Code (1947; JAMA, 276, 30, Nov. 27, 1996, p.1691). It became a prototype for later codes of ethics. In 1964, members of The 18^th World Medical Assembly, which was held in Helsinki, Finland, established formal recommendations to guide physicians in biomedical research involving human participants, the Declaration of Helsinki (World Medical Organization, 1964; British Medical Journal 313, 7070, Dec. 7, 1996, pp.1448–1449). Ten years later, in 1974, the U.S. Congress passed the National Research Act (Pub. L. 93-348) and established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In the course of its deliberations over a four-year period, the Commission developed the foundation of ethical principles for human research participants, the Belmont Report (1978: DHEW Publication No. [OS] 78-0013 and No. [OS] 78-0014). This prompted the establishment of Institutional Review Boards (IRB) at the local level to review and approve all federally funded research and is now required by the Department of Health and Human Services (DHHS). Although members and certificate holders engage in research activities as a part of their professional responsibility, they may not be in settings that require approval of an IRB for the conduct of such activities. Nevertheless, they must resolve ethical issues to protect the involvement of human participants in research activities. Individuals in this situation who are unfamiliar with protection of human participants during research activities may choose to contact ASHA's research office for assistance.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides additional guidance to researchers who provide treatment to research participants. (Federal Register: August 14, 2002, Volume 67, Number 157, Page 53181–53273) [45 CFR 164.501, 164.508, 164.512(i)] [See also 45 CFR 164.514(e), 164.528, 164.532] With a compliance date of April 14, 2003, the rule requires that prior to the use or disclosure of protected health information, researchers who are covered entities under HIPAA must receive authorization from research participants. Although there are exceptions to these provisions, the intent of the rule is to assure the privacy of information collected as part of most human research activities. Waiver of these provisions can be obtained by an IRB or Privacy Board that conforms to the general structure outlined in the Common Rule (National Institutes of Health, Office for Protection from Research Risks, Part 46, Protection of Human Subjects, Subpart A) which supercedes the research provisions of HIPAA.

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Discussion

The key components of informed consent, tenets defined by the 1979 Belmont Report, are:

• Respect for Persons. Persons participating in research should be fully informed about the research activity and given the respect, time, and opportunity needed to make a personal decision to participate. Those persons with diminished capacity to make an informed decision should be protected.

• Beneficence. The gains or benefit from the research must be greater than any potential harm to human participants. According to the 1979 Belmont Report, the goal is to “maximize benefits and minimize possible harms.”

• Justice. The selection of research participants must be fair. The persons who are given the opportunity to participate and bear the risk of possible harm should also receive the benefits of the research.

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Guidance

Involvement of human participants in research activities may take many forms. In addition to large-scale clinical efficacy or medical studies, research activities may include pilot projects, case studies, and student or course projects. Approval for the research activity should be sought from the local IRB if one is in place. In any case, informed consent should be obtained and documented. Members and certificate holders should evaluate the research activity with respect to the basic tenets of the 1979 Belmont report, and should document the procedures employed to adhere to these principles.

• Respect for Persons

  Participants should be treated as autonomous agents and no pressure should be used or implied to encourage participation. Furthermore, participants should be given the opportunity to decide to withdraw from participation at any time, without prejudice or penalty. Participants should be given the opportunity to ask questions about the research. Special consideration must be taken when interacting with participants who may be incapable of understanding information to make a fully informed decision about research. Experimental protocols should be scrutinized for consistency with current ASHA policies and guidelines.

• Beneficence

  To secure the well-being of all research participants, every action must be taken to protect them from harm and ensure that they experience the possible benefit from participating in the research. The concept of potential harm goes beyond physical injury. It may include feeling stress or embarrassment. Frequent breaks or rest periods should be planned to avoid against possible boredom or fatigue. In addition, stimuli for use in research should be scrutinized for possible vocabulary or concepts that may offend participants.

• Justice

  Every effort should be made to distribute the risks and benefits fairly and without bias, therefore the decision about whom to include or exclude in a research activity is sensitive. Equal opportunity for participation should be provided, independent of race, socioeconomic status, or education, unless it is justified by the objectives of the research activity. Additionally the decision to exclude a group, for example, children or women, from participation must be driven by scientifically sound arguments. Precautions should be taken to guard against the perception of possible manipulation or coercion that may be part of teacher-student, clinician-client, or doctor-patient relationship. Informed consent involves the knowledge of the potential risks inherent in participating in research and what personal or general benefits, if any, may be gained by participating. Every effort should be made to ensure that those asked to bear the potential risks also receive the benefits.