Ethics in International Affairs IRL4527 L, Adibayeva Aigul

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.

legally recognized property pertaining to the products of intellectual activity, such as creative works or inventions. Forms of intellectual property include copyrights on creative works and patents on inventions.

1. treating people fairly. 2. An ethical principle that obligates one to treat people fairly. Distributive justice refers to allocating benefits and harms fairly; procedural justice refers to using fair processes to make decisions that affect people; formal justice refers to treating similar cases in the same way. In human subjects research, the principle of justice implies that subjects should be selected equitably. See also Belmont Report .

An ethical theory developed by German philosopher Immanuel Kant (1724-1804), which holds that the right thing to do is to perform one’s duty for duty’s sake. One’s duty is defined by an ethical principle known as the categorical imperative (CI). According to one version of the CI, one should act according to a maxim that could become a rule for all people. According to another version, one should always treat people as having inherent moral value (or dignity) and never only as objects or things to be used to achieve some end.