Question

What ethical measures and requirements are in place to guide human subject research nowadays?

Answer 1

All research involving human subjects should be conducted in accordance with four basic ethical principles, namely respect for persons, beneficence, non-maleficence, and justice.One of the most important parts of any human subjects protocol is the informed consent process.

The most salient ethical values implicated by the use of human participants in research are beneficence (doing good), non‐maleficence (preventing or mitigating harm), fidelity and trust within the fiduciary investigator/participant relationship, personal dignity, and autonomy pertaining to both informed, voluntary, competent decision making and the privacy of personal information.

Respect for persons involves two ethical considerations: (1) individuals are and should be treated as autonomous agents and (2) individuals with diminished autonomy, due to youth, illness, mental disability, or restricted liberty (e.g., prisoners) should receive additional protections. The principle of respect for persons means recognizing the authority of an individual's preferences and choices about his or her life. In the context of research, the principle of respect for persons is expressed primarily in the use of informed consent, which requires that, as a general rule, individuals be afforded the opportunity to choose whether or not to be involved in research. It is incumbent upon investigators to disclose information about a study in language that is comprehensible to potential subjects so that they can provide meaningful and voluntary informed consent.

Beneficence involves two considerations: (1) the maximization of possible benefits for society and subjects; and (2) the minimization of possible harm to subjects.The purpose of health research is to discover new information that would be helpful to society. The purpose of research should never be to hurt anyone or find out information at the expense of other people.

Justice: This principle deals with the concept of fairness. Question of justice and equal treatment in the research context are critical in the selection of subjects. The application of justice means that investigators must not offer potentially beneficial research only to some groups, nor select only some accessible, vulnerable, or disadvantaged groups for research that involves high risk or little prospect of direct benefit.