Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2012 Jan;62(1):3-12.
doi: 10.4097/kjae.2012.62.1.3. Epub 2012 Jan 25.

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

Affiliations

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

Won Oak Kim. Korean J Anesthesiol. 2012 Jan.

Abstract

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. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.

Keywords: Ethics; Human; Institutional review board; Research.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Chronicle of scandals and responses are presented.

References

    1. Emanuel EJ, Crouch RA, Arras JD, Moreno JD, Grady C. Ethical and Regulatory aspects of clinical research: readings and commentary. Baltimore: Johns Hopkins University Press; 2003. pp. 7–20.
    1. Dunn CM, Chadwick GL. Protecting study volunteers in research. 3rd ed. Boston: CenterWatch; 2004. pp. 14–61.
    1. Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274:1354–1360. - PubMed
    1. Amdur RJ, Bankert EA. Institutional review board: member handbook. 3rd ed. Boston: Jones & Bartlett Publishers; 2011. pp. 12–15.
    1. Lo B. Ethical Issues in clinical research: A practical guide. Philadelphia: Lippincott Williams & Wilkins; 2010. pp. 3–4.

LinkOut - more resources