Ethics in International Affairs IRL4527 L, Adibayeva Aigul

taking personal responsibility for one’s conduct

a process in which an accrediting body determines whether an institution or organization meets certain standards developed by the body. For example, the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) accredits animal research programs, and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredits human subjects research programs.

a medically undesirable event occurring in a research subject, such as an abnormal sign, symptom, worsening of a disease, injury, etc. A serious adverse event (SAE) results in death, hospitalization (or increased hospital stay), persistent disability, birth defect, or any other outcome that seriously jeopardizes the subject’s health. AEs which are also unanticipated problems should be reported promptly to institutional review boards and other appropriate officials.

a change to a human subjects research protocol approved by an institutional review board or the board’s chair (if the change is minor).

see Institutional animal care and use committee.

the view that (non-human) animals have moral or legal rights. Proponents of animal rights tend to regard animal experimentation as unethical because animals cannot consent to research.

1. The health and well-being of animals. 2. The ethical obligation to protect and promote animal welfare in research. Factors affecting animal welfare include: food, water, housing, climate, mental stimulation, and freedom from pain, suffering, disease, and disability. See also Three Rs.

a meeting of scientists, held in Asilomar, CA in 1975, who were involved in development recombinant DNA techniques concerning the oversight of responsible use of this technology. The scientists recommended the development of safety protocols as a means of protecting laboratory workers and the public from harm.

a subject’s affirmative agreement to participate in research. Assent may take place when the subject does not have the capacity to provide informed consent (e.g. the subject is a child or mentally disabled) but has the capacity to meaningfully assent. See Informed Consent.

a formal review of research records, policies, activities, personnel, or facilities to ensure compliance with ethical or legal standards or institutional policies. Audits may be conducted regularly, at random, or for-cause (i.e. in response to a problem).