Research ethics are based on three fundamental principles.
1. Respect for Persons
This principle incorporates two elements that deal with respecting people in regard to research:
People should be treated as autonomous The term autonomous means that a person can make his or her own decisions about what to do and what to agree to.
Researchers must respect that individuals should make their own informed decisions about whether to participate in research. In order to treat people as autonomous, individuals must be provided with complete information about a study and decide on their own whether to enroll.
People with diminished autonomy should be protected Some people in society may not have the capacity to make fully informed decisions about what they do or what happens to them. This could include young children, people who are very ill, or those with mental disabilities. In such cases, these people should be protected and only be included in research under specific circumstances, since they cannot make a true informed decision on their own.
The definition of beneficence is action that is done for the benefit of others. This principle states that research should:
Do no harm 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.
Maximize benefits for participants and minimize risks for participants The purpose of much research involving humans is to show whether a drug is safe and effective. This means participants may be exposed to some harms or risks. Researchers are obligated to do their best to minimize those possible risks and to maximize the benefits for participants.
This principle deals with the concept of fairness. Researchers designing trials should consider what is fair in terms of recruitment of participants and choice of location to conduct a trial. This encompasses issues related to who benefits from research and who bears the risks of research. It provides the framework for thinking about these decisions in ways that are fair and equitable.
People who are included in research should not be included merely because they are a population that is easy to access, available, or perhaps vulnerable and less able to decline participating.
An experimental strategy that is likely to be used by many types of people should be tested in the very populations of people who are likely to use it, to ensure that it is safe, effective, and acceptable for all of the potential users. For example, experimental treatments that are intended for use in the general population must be studied not only on men, but on enough women to ensure that they are also safe and effective for women.
The principle of justice also indicates that questions being asked in trials should be of relevance to the communities participating in the study.