Assignment: IRB Ethical Guidelines

Assignment: IRB Ethical Guidelines

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a description of two ways in which the Walden University’s IRB ethical guidelines may impact the selection of a research population, research setting, and/or research design as you develop your ideas for your prospectus.  Be specific, explaining how the guidelines apply to your study, not just research in general.

Readings

• Creswell, J. W. (2014). Research design: Qualitative, quantitative, and mixed methods approaches (4th ed.). Thousand Oaks, CA: Sage.
  • Chapter 4, “Writing Strategies and Ethical Considerations (pp. 77-103)
• Perlmutter, D. D., & Porter, L. (2005, December 12). Thinking beyond the dissertation.  The Chronicle of Higher Education. Retrieved from the Walden Library databases
• Walden University. (2014). Office of research integrity and compliance: Institutional review board for ethical standards in research. Retrieved from http://academicguides.waldenu.edu/researchcenter/orec
• Walden University. (2015). Online writing center: APA style.  Retrieved fromhttp://academicguides.waldenu.edu/writingcenter/apa

Media

• Walden University (Producer). (2010). Institutional Review Board (IRB) frequently asked questions. [Online tutorial]. Retrieved from http://academicguides.waldenu.edu/researchcenter/orec

• 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

  Go to:

  Historical Views on Human Subject Research

  Studies on human are imperative for medical progress and have expanded our understanding and capability to treat serious diseases and entities. However, research with humans needs to take into account the ethical dimensions of the reasons for running an experiment and the proper procedural steps to ensure that the results reflect good science. Protecting human participants in research is our top priority and has been given great consideration in the ethical conduct of research because the exact risks and benefits of research are uncertain.

  “All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood” (Article 1 of the United Nations Universal Declaration of Human Rights). These rights have often been ignored in public perceptions of human research. Beginning in the seventeenth century, the scientific revolution brought about a method of investigation using controlled observation and reporting of result to the public as proof. The numbers of participants involved in early experiments were small and most often included the researchers themselves or their families. The most typical and famous example of this was when Edward Jenner tested a smallpox vaccine on his son and on the neighborhood children in the early modern times. The progression to the current status of protecting human research participants has been the consequence of historical events in the twentieth century. There have been many groundbreaking events that have affected the public’s perception of human clinical research. The history of human subject abuses, scandals, tragedies and the responses to them are shown in Fig. 1 in chronological order.

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