Ethics in International Affairs IRL4527 L, Adibayeva Aigul

information inadvertently discovered during medical treatment or research which was not intentionally sought. For example, if a research subject receives an MRI as part of brain imaging study and the researcher notices an area in the fontal cortex that appears to be a tumor this information would be an incidental finding.

in human subjects research, results pertaining to a specific individual in a study, such as the subject’s pulse, blood pressure, or the results of laboratory tests (e.g. blood sugar levels, blood cell counts, genetic or genomic variants). Individualized results may include intended findings or incidental findings. There is an ongoing ethical controversy concerning whether, when, and how individualized research results should be shared with human subjects research. Some argue that individualized results should be returned if they are based on accurate and reliable tests and have clinical utility, because inaccurate, unreliable, or uncertain results may be harmful. Others claim that the principle of autonomy implies that subjects should be able to decide whether to receive their results.

the process of making a free and informed decision (such as to participate in research). Individuals who provide informed consent must be legally competent and have enough decision-making capacity to consent to research. Research regulations specify the types of information that must be disclosed to the subject. See also Assent.

a provision in an informed consent document that gives general permission to researchers to use the subject’s data or samples for various purposes and share them with other researchers.

a record (such as a form) used to document the process of consent. Research regulations require that consent be documented; however, an institutional review board may decide to waive documentation of consent if the research is minimal risk and 1) the principle risk of the study is breach of confidentiality and the only record linking the subject to the study is the consent form or 2) the research involves procedures that normally do not require written consent outside of the research context.

a provision in an informed consent document that requires researchers to obtain specific permission from the subject prior to using samples or data for purposes other than those that are part of the study or sharing them with other researchers.

provisions in an informed consent document that give the subject various options concerning the use and sharing of samples or data. Options may include blanket consent, specific consent, and other choices.

in human subjects research, the decision by an institutional review board to waive (or set aside) some or all of the informed consent requirements. Waivers are not usually granted unless they are necessary to conduct the research and pose minimal risks to the subjects.

a committee responsible for reviewing and overseeing animal research conducted at an institution. IACUCs usually include members from different backgrounds and disciplines, with institutional and outside members, scientists and non-scientists.

a committee responsible for reviewing and overseeing human subjects research. An IRB may also be called a research ethics committee (REC) or research ethics board (REB). IRBs usually include members from different backgrounds and disciplines, with institutional and outside members, scientists and non-scientists.