SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part II: The Role of the Institutional Review Board in Food and Drug Administration–Regulated Radiopharmaceutical Research

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چکیده

CE credit: For CE credit, you can access the test for this article, as well additional JNMT tests, online at https://www.snmmilearningcenter.org. Complete no later than June 2025. Your will be scored immediately. You may make 3 attempts to pass and must answer 75% of questions correctly receive Continuing Education Hour (CEH) credit. Credit amounts found in SNMMI Learning Center Activity. members have their CEH credit added VOICE transcript automatically; nonmembers able print out a certificate upon successfully completing test. The is free members; pay $15.00 by card when logging onto website take goal clinical research advance medical knowledge hopes improving patient care. At core need perform on human volunteers. This absolutely required eventual approval drugs certain therapies. Unfortunately, history replete with stories involving exploitation abuse individuals research. Clinical using radiopharmaceuticals introduces apprehension. Although past few decades witnessed significant improvements safety ethics, there remain indelible images seared into psyche general population. Those new find themselves asking such as, What are ethical guidelines regulations research, How they enforced whom, do we ensure participants? answer, large part, oversight actions institutional review board. article focus familiarizing reader board its role protecting rights welfare humans participating subjects Food Drug Administration–regulated radiopharmaceutical

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Institutional review board (IRB) and ethical issues in clinical research

Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. Intern...

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ژورنال

عنوان ژورنال: Journal of Nuclear Medicine Technology

سال: 2022

ISSN: ['0091-4916', '1535-5675']

DOI: https://doi.org/10.2967/jnmt.122.264034