There are a number of international recognized codes and principles that guide the conduct of biomedical research and ensure the protection of research participants. Some of these include:
- The Nuremberg Code, 1947
- Declaration of Helsinki, 1964 (amended 2000)
- The Belmont Report, 1979
- The CIOMS Guidelines, 1982 (amended 2002)
- Ethical considerations in biomedical HIV prevention trials: UNAIDS Guidance Document, 2007
In addition, each research study goes through an extensive approval process, including reviews by national and/or local ethical review boards or committees. These boards and committees exist to ensure that the only trials undertaken are those that are both scientifically valid and ethically conducted.
A separate group, called a data safety monitoring board (DSMB), monitors a study’s progress and has the power to stop a study if they feel the study is causing harm, that it has already been shown that the study product is definitely effective or not effective, or if they feel the study can no longer resolve the study question it was designed to answer. This group is autonomous from the research institution conducting the research so they do not have a vested interest in whether or not the research goes forward. Instead, they exist to ensure the continued scientific validity of the research and the protection of the study participants.
All research studies are evaluated on the basis of three overarching ethical principles: autonomy, beneficence and justice.
Autonomy ensures ‘respect for persons’ or, in other words, that study participants have been given and understand all of the relevant information pertaining to a study and have given their voluntary informed consent to participate in the research. ‘Informed consent’ means that volunteers must understand exactly what is happening and make their own decisions about whether or not to participate in the trial. They undergo pre-screening (which will typically include preliminary questions and explanation of the trial) and screening before actually enrolling in the trial. Even once consent is given, participants are free to leave a study whenever they wish and for any reason.
The principle of beneficence states that the benefits of a person participating in research must outweigh the potential risks.
And finally, justice ensures that the selection of study participants is equitable and that certain groups are not favored or exploited.