A. The Belmont Report: Ethical Principles and Guidelines for the Justice Encyclopedia of Bioethics. Secondary use refers to the use in research of information or human biological materials originally collected for a purpose other than the current research purpose. When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the opinion of the REB. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. In contrast, participant observational research is the study of human acts or behaviours in a natural environment in which people involved in their normal activities are observed with or without their knowledge by researchers who participate in some way in the activity. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures. Coercion occurs when a person is compelled to involuntarily behave in a certain way by use of overt or implicit threat of harm, intimidation, or other form of pressure or force. While it is not a formal part of its responsibilities, an REB may raise concerns about the safety of student researchers as part of its communication to the student researchers, and to their supervisors. Ethical issues are distinguished from political issues in research in that: An agreement to participate in research constitutes a valid consent only if voluntarily given. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. Participant observational research generally does not meet condition (a) of Article 2.3, as there is interaction with the individuals or group being studied. For the most part, the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. This applies to materials derived from living and deceased individuals. The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called "experimental" when the terms "experimental" and "research" are not carefully defined. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. Based on the level of risk, the REB may consider referring these concerns for review by an appropriate body within the institution. Their inclusion in research should not exacerbate their vulnerability (Article4.7). The REB makes the final decision on exemption from research ethics review. Human Subjects Learners(CITI) quiz - Subjecto.com human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. Investigators are responsible for ascertaining that the subject has comprehended the information. The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Such individuals are not considered participants for the purposes of this Policy. The primary test to be used by REBs in evaluating a research project should be ethical acceptability and, where appropriate, relevant disciplinary scholarly standards. But the role of the principle of beneficence is not always so unambiguous. The evaluation of foreseeable risks to participants can be complicated if the prospective participants are already exposed to risks in the course of their daily lives. Article 10.3 addresses participant and non-participant observational studies in qualitative research. Risks should be assessed from the perspective of the community in consideration of the social, health, economic and cultural context. Traditions for scholarly review vary among disciplines or fields of research, including the stage at which scholarly review occurs, and this needs to be taken into account by REBs. Research Final Exam - Chapter 3 Flashcards | Quizlet In most research, the primary benefits produced are for society and for the advancement of knowledge. This guidance may also be helpful for research with other communities. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct research in a way that protects participants from any unnecessary or avoidable risks. 1. Encyclopedia of Bioethics. In accordance with Articles 4.1 and 4.7 on vulnerability and inclusion/exclusion criteria, prospective participants who are in high risk circumstances should not be inappropriately included in, or excluded from, participating in research.

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