Ethical Challenges

Does the planned research respect the autonomy of human participants? Respect for persons assumes that people are able to make informed decisions about whether or not to participate in research. Researchers are to provide enough information so that an informed, voluntary decision can be made.

Whatever the decision of the potential research participant, that choice should be respected. Moreover, if a person decides to withdraw from research participation, that decision is to be respected. The principle, respect for persons, is implemented as voluntary informed consent to participate in research. If people with diminished or limited autonomy, such as children, some cognitively impaired people, those in a coercive environment, those with compromised consciousness or other vulnerabilities are to be involved in research, additional protections are required. How much protection is needed is a function of the risk of harm and the likelihood of benefit.

Beneficence, in the context of research with humans, means to do no harm, minimize risk of harm and maximize the benefits of research to protect human welfare. Investigators have the responsibility of analyzing the risks and benefits. If the probability and/or magnitude of harm is not outweighed by the benefits, the risks must be justified in terms of the importance of the research for the participants and/or society. Assessment of risks and benefits often is difficult. Both occur along a spectrum. They may be direct or indirect, immediate or for future persons in similar circumstances. They may be physical, psychological, social or economic and may be perceived differently by persons with differing interests. An assessment of risks and benefits is also done by the ethics review committee members who consider scientific merit and importance, competency and experience of the research team, and appropriateness of the subject population for risks (including threats to privacy and confidentiality) and benefits.

Justice relates to fair and equitable distribution of benefits and burdens of research. Practically, it means that research participants are selected fairly, with all segments of the population having an opportunity to be included in a study, provided that inclusion is scientifically and ethically justifiable.