Five Ethical Principles for Research With Human Participants

There are five general principles in the 2002 APA ethics code designed to "guide and inspire psychologists toward the very highest ethical ideals of the profession." These principles include beneficence and nonmaleficence (i.e., benefit people and do no harm); fidelity and responsibility; and integrity, justice, and respect for people's rights and dignity. The Belmont Report identified three basic ethical principles when conducting research: respect for persons, justice, and beneficence. The following are five basic ethical principles presented in the order of the general principles in the APA code that apply specifically to conducting biomedical and behavioral research with human participants.

Principle 1: Beneficence and NonmaleficenceRepresenting the utilitarian tradition, this principle requires that researchers, using considerations such as those described above, strive to maximize potential benefits while minimizing risks of their research. Although the cost-benefit mandate seems straightforward, it is rarely unambiguous in practice because costs to participants and benefits to the profession and to society are difficult to accurately estimate in advance and no universally agreed-upon method or criteria exist for optimally balancing the two. Where questions arise related to the degree of risk, researchers are responsible for seeking ethical advice and implementing safeguards to protect participants. Risks that are identified in advance must be communicated to prospective research participants or their legal equivalent, and informed consent must be obtained (except in special cases approved by the IRB, such as research involving a placebo control, in which fully informed consent compromises a scientifically required research design). Sometimes research presents risks to groups of people or social institutions. No consensus exists for whether a representative can provide consent on behalf of a collective entity, but full compliance to Principle 1 requires sensitivity to this issue.

Principle 2: Fidelity, Responsibility, and TrustThis principle requires researchers to establish and maintain a relationship of trust with research participants. For example, before individuals agree to participate in research, investigators must be clear and explicit in describing to prospective participants what they will experience and what consequences may result from participation. Researchers also are obligated to honor all promises and commitments that are made as part of the agreement to participate. When full disclosure is not made prior to obtaining informed consent (e.g., information germane to the purpose of the study would compromise its validity), safeguards must be implemented to protect the welfare and dignity of participants. In general, procedures that involve concealment or deception in a research design can be implemented only after rigorous criteria for the necessity of such procedures are met and the study is approved by the IRB. (Such instances also require a thorough debriefing of participants at the conclusion of their participation.) When children or adults with limited understanding serve as participants, researchers must implement special protective safeguards. When unintended negative consequences of research participation occur, researchers are obligated to detect, remove, and/or correct these consequences and ensure that they do not persist over time. Understandably, past ethical breaches have resulted in what some describe as widespread mistrust of biomedical and behavioral research in contemporary society. Principle 2 requires researchers to make every effort to foster trust and avoid causing further public mistrust.

Principle 3: IntegrityThis principle requires researchers to "do good science," to truthfully report their results, to take reasonable steps to correct errors that are discovered, to present work that is their own (or to otherwise make appropriate citations), to take responsibility and credit only for work that is their own, to avoid "piecemeal publication" (i.e., submitting redundant analyses of a single data set for multiple publications), to share data on which results are published with other qualified professionals provided they seek only to verify substantive claims and do not use the data for other any other purpose, and to respect the proprietary rights of others engaged in the scientific enterprise.

Principle 4: JusticeIn following this principle, researchers strive for two forms of justice. The first, distributive justice, requires psychologists to entitle all persons equal access to the benefits of research, as well as to ensure that the risks for harm from research are not disproportionately greater for a particular group or category of persons within society. The second, procedural justice, refers to the adequacy of research procedures to ensure fairness, such as when easily accessible mechanisms are made available to participants to address any concerns they may have related to their participation in research.

Researchers also are promoting Principle 3 when they attend to the special concerns of underrepresented groups in developing programs of research, so as to avoid continued underinclusion and lack of representation in the knowledge base.

Principle 5: Respect for the Dignity and Autonomy of PersonsRepresenting the deontological tradition, this principle asserts that researchers respect research participants as human beings with intrinsic worth, whose participation is a result of their autonomous choices. The implications of this principle are far-reaching and relate to matters of obtaining informed consent, avoiding coercive and deceptive practices, upholding confidentiality and privacy, and preserving the selfdetermination of participants. In abiding by this principle, psychologists are also aware of and respect individual differences, including those influenced by gender, age, culture, role, race, ethnicity, sexual orientation, religious identity, disability, linguistic background, economic status, or any other characteristic related to group membership.

Ethical Conflicts and Decision MakingThe potential for ethical conflict is ubiquitous in biomedical and behavioral research. When making ethical decisions about research, it may be prudent to develop a systematic approach to reviewing all relevant sources of ethical responsibility, including one's own moral principles and personal values; cultural factors; professional ethics codes, such as the APA code; agency or employer policies; federal and state rules and regulations; and even case law or legal precedent. A process-oriented approach to ethical decision making may involve some variation of the following: (1) writing a description of the ethically relevant parameters of the situation; (2) defining the apparent dilemma; (3) progressing through the relevant sources of ethical responsibility; (4) generating alternative courses of action; (5) enumerating potential benefits and consequences of each alternative; (6) consulting with the IRB, relevant colleagues, and/or legal professionals; (7) documenting the previous six steps in the process; and (8) evaluating and taking responsibility for the results of the course of action selected. As previously mentioned, all research studies must be approved by the relevant IRB. However, approval of a research proposal by an IRB does not remove the mandate of ethical responsibility from the researcher. In making ethical decisions, researchers should consider the likelihood of self-serving bias that can lead to overestimation of the scientific value of a proposed study and underestimation of its risks.

ConclusionScientific research with human participants is an inherently ethical enterprise, and ethical conflicts in research are virtually inevitable. Researchers who exercise the privilege to conduct research with human participants bear the responsibility of being familiar with and abiding by the ethical principles and relevant rules and regulations established by their professional organizations and by federal and state governments. However, rigid application of rules is not a substitute for well-reasoned, responsible ethical decision making.

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