Ethics in International Affairs IRL4527 L, Adibayeva Aigul

a process for involving a community in the review of research conducted on members of the community. Some research studies include community advisory boards as a way of involving the community.

The U.S. Department of Health and Human Services regulations (45 CFR 46) for protecting human subjects, which has been adopted by 17 federal agencies. The Common Rule includes subparts with additional protections for children, neonates, pregnant women and fetuses, and prisoners.

a body of law based on judicial decisions and rulings.

the process of developing and marketing commercial products (e.g. drugs, medical devices, or other technologies) from research. See also Copyrights, Intellectual Property, Patents.

an agreement between two or more collaborating research groups concerning the conduct of research. The agreement may address the roles and responsibilities of the scientists, access to data, authorship, and intellectual property.

using force, threats, or intimidation to make a person comply with a demand. 

the clinical usefulness of information, e.g. for making decisions concerning diagnosis, prevention, or treatment.

providing information about a clinical trial in a public registry. Most journals and funding agencies require that clinical trials be registered. Registration information includes the name of the trial, the sponsor, study design and methods, population, inclusion/exclusion criteria, and outcome measures.

sequential stages of clinical testing, required by regulatory agencies, used in the development of medical treatments. Pre-clinical testing involves experiments on animals or cells to estimate safety and potential efficacy. Phase I trials are small studies (50-100 subjects) conducted in human beings for the first time to assess safety, pharmacology, or dosing. Phase I studies are usually conducted on healthy volunteers though some are conducted on patients with terminal diseases, such as cancer patients. Phase II trials are larger studies (500 or more subjects) conducted on patients with a disease to assess safety and efficacy and establish a therapeutic dose. Phase III trials are large studies (up to several thousand subjects) conducted on patients to obtain more information on safety and efficacy. Phase IV (or post-marketing) studies are conducted after a treatment has been approved for marketing to gather more information on safety and efficacy and to expand the range of the population being treated.

a clinical trial in which the control group receives a placebo. The goal of the trial is to compare a treatment to a placebo.