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In order to successfully navigate the human subject approval process in clinical or behavioural research, one needs a good understanding of the ethical principles guiding the conduct of research involving human subjects. Federal and international codes and guidelines frame the context of ethical research. These codes and guidelines include The Nuremberg Code (1949),1 the Declaration of Helsinki (1964-2000),2 The Belmont Report (1979),3 Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) International Guidelines (1993, 2002),4 and the International Conference on Harmonization: Good Clinical Practice Guidance (ICH/ G CP, EU, 1996).
There are 3 ethical principles that guide all research involving human subjects: beneficence, justice, and respect for persons.3,4
* Beneficence refers to the ethical obligation to maximize benefits and minimize harm. In effect "do no harm." Assessment of risk falls under this principle. Risk in this context is defined as the probability that certain harm will occur to subjects from participation in research. It is the obligation of investigators to minimize this potential by selecting optimal study designs and interventions for their research.
* Justice is the ethical obligation to treat each person (population) equitably and equally. In this principle, the benefits and burdens or risks of research to participants and populations should be distributed fairly among diverse populations. Justice protects vulnerable populations from exploitation and protects of the rights and welfare of vulnerable persons.
* Respect for Persons incorporates 2 ethical considerations: respect for autonomy and protection for persons with reduced autonomy. Autonomy refers to a person's ability to make sound decisions. In research, an autonomous person must be able to consider the potential harms and benefits, analyse the risks associated with the proposed research, and make a decision in his or her own best interest. This autonomy includes the ability to read and understand the informed consent document.
In 2000, Emanuel, Wendler, and Grady proposed a framework of 7 ethical principles for clinical research studies, believing that informed consent is not sufficient to ensure ethical research.5 Expanding on the 3 basic principles described above, this framework adds the principles of social or scientific value, meaning that some enhancement of health or knowledge must be derived from the research, and scientific validity, meaning that the proposed research has a...