Ethics in International Affairs IRL4527 L, Adibayeva Aigul

taking steps to prevent or deter the public communication of information or ideas. In science, censorship may involve prohibiting the publication of research or allowing publication only in redacted form (with some information removed).

failing to cite important work in the field in a paper, book, or presentation.

research that the government keeps secret to protect national security. Access to classified research is granted to individuals with the appropriate security clearance on a need-to-know basis.

a researcher involved in conducting a clinical trial

an experiment designed to test the safety or efficacy of a type of therapy (such as a drug).

a clinical trial in which the control group receives a treatment known to be effective. The goal of the trial is to compare different treatments.

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.

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.

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

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

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.

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

a body of law based on judicial decisions and rulings.

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 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 legal right to make decisions for one’s self. Adults are considered to be legally competent until they are adjudicated incompetent by a court. See Decision-making capacity.

in research, complying with laws, institutional policies and ethical guidelines related to research.

Action or behavior. For example, conducting research involves performing actions related to research, such as designing experiments, collecting data, analyzing data, and so on.

the obligation to keep some types of information confidential or secret. In science, confidential information typically includes: private data pertaining to human subjects, papers or research proposals submitted for peer review, personnel records, proceedings from misconduct inquiries or investigations, and proprietary data. See also Privacy.

a situation in which a person has a financial, personal, political or other interest which is likely to bias his or her judgment or decision-making concerning the performance of his or her ethical or legal obligations or duties.

a situation in which a person has a financial, personal, political or other interest that is not likely to bias his or her judgment or decision-making concerning the performance of his or her ethical or legal obligation or duties but which may appear to an outside observer to bias his or her judgement or decision-making.

a situation in which an institution (such as a university) has financial, political, or other interests which are likely to bias institutional decision-making concerning the performance of institutional ethical or legal duties.

strategies for minimizing the adverse impacts of a conflict of interest, such as disclosure, oversight, or recusal/prohibition.

See Informed consent.

an approach to ethics, such as utilitarianism, which emphasizes maximizing good over bad consequences resulting from actions or policies.

in human subjects research, subsequent review of a study after it has been approved by an IRB. Continuing review usually happens on an annual basis.

a right, granted by a government, which prohibits unauthorized copying, performance, or alteration of creative works. Copyright laws include a fair use exemption which allows limited, unauthorized uses for non-commercial purposes.

fixing a minor problem with a published paper. A minor problem is one that does not impact the reliability or integrity of the data or results. Journals publish correction notices and identify corrected papers in electronic databases to alert the scientific community to problems with the paper. See also Retraction.

the idea that the institutional culture plays a key role in preventing research misconduct and promoting research integrity. Strategies to promote a culture of integrity include education and mentoring in the responsible conduct of research; research policy development; institutional support for research ethics oversight, consultation, and curriculum development; and ethical leadership.