Research with Human Subjects

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At BAU there are principles and procedures that govern all the experimentation that deal with human subjects or animals for assurance of protection of humans and animals involved in research or related activities.

To guarantee such protection for both human and animal subjects, an Institutional Review Board (IRB) has been established at BAU with the responsibility to review, approve, and monitor biomedical and behavioral research involving humans and animals conducted by academic staff and students. The IRB has the right to approve, require modifications in planned research prior to approval, or disapprove research.

The IRB has the right to regularly monitor the compliance to the ethical guidelines of the approved protocols, at intervals of at least once per year, and until the research work is completed.

Experimentation on human subjects should take into consideration and abide by all the points and guidelines that were addressed in the different codes such as the Nuremberg Code that was published in 1947 as a consequence of the trial of physicians (the Doctors’ Trial) who conducted atrocious experiments on un-consenting prisoners and detainees during the Second World War.

The Nuremberg Code is further supported by the Universal Declaration of Human Rights (1948) and the Declaration of Helsinki (1964). The Nuremberg Code was designed to protect the integrity of the research subject and it sets out conditions for the ethical conduct of research involving human subjects, emphasizing their voluntary consent to research. The code also includes ten points that each research project dealing with human subjects should consider.

The three basic ethical principles, namely respect for persons, beneficence, and justice should guide all research involving human subjects:

  • Respect  of the capacity for self-determination in treating those who are capable of deliberation about their personal choices. Persons with impaired or diminished autonomy should be afforded security against harm or abuse.
  • Beneficence  refers to the ethical obligation to maximize benefit and to minimize harm.
  • Justice  refers to the ethical obligation to treat each person in accordance with what is morally right and proper, to give each person what is due to him or her. Accordingly, special provision must be made for the protection of the rights and welfare of vulnerable persons.