From Chpt:19
The conduct of any research project requires consideration of ethical issues. The most important of these concerns includes obtaining informed consent of the participants, protecting participants from harm, and protection of participant privacy. Ethical principles are derived from various national and international statements of principles for the conduct of healthcare–related research, legal requirements primarily at the federal level, as well as regulations at the institutional, governmental, and professional levels. The foundations of the regulatory structure are processes for reviewing, approving, and monitoring research at the institutional level, with accountability to governmental, funding, and professional authorities. The primary responsibility for compliance rests with the individuals conducting the research, specifically the principal investigator and the institutions at which the research is conducted. If conducting international research the regulatory processes are different.
The process of obtaining approval to conduct a research study varies among clinical settings. Many organizations have a nursing research committee (Pintz et al., 2018) that promotes the integration and acculturation of evidence-based practice (EBP) generating nursing research. The research proposals are then submitted to the institutional review board (IRB) or the hospital nursing research committee to examine issues related to the protection of participants from the risks of participating in research. At institutions without a nursing research committee, research proposals may go to the director of nursing research or the institution’s nurse scientist, if there is one, but generally go directly to the IRB for review with all of the other research protocols.
Discuss the need for institutional review boards (IRBs). How can they potentially affect or impact a study? Give a couple of examples [minimum 2].
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Discipline: Nursing Research
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