John R. Hoffman is a Professor of Biology, public speaker and a scientist examining the recovery of the nervous system after injury. Since 2006 he has written several unpublished manuscripts and he is currently working on the first Nathaniel Smythe novel and short story collection. He spends his spare time with his family and running.

14 Human Subject Regulations

Objectives

By the end of this lecture, the student will be able to:

  1. Describe the historical development of guidelines on the use of human subjects in the United States.
  2. Identify and explain the three basic ethical principles established in the Belmont Report.
  3. Describe the importance and process of informed consent.

Current Human Subject Regulations Part 1

Part 1 of this mini-lecture provides a brief history of human subject guidelines and regulations. In Part 2, we will examine the actual implications of the human subject regulations. The handout for this presentation can be downloaded and printed.

Current Human Subject Regulations Part 2

This mini-lecture examines the application of the Belmont Report and Common Rule in an institution’s protection of human research subjects. The handout for this presentation can be downloaded and printed.

Reading:
Pearlman, D. (2004). Ethics in Clinical Research: A history of human subject protections and practical implementation of ethical standards.  SoCRA Source – May, 2004 – pp. 37 – 41.

Assignment: Is the Common Rule Enough?

In your small discussion group: Discuss whether the presence of the ethical guidelines put forth in the Belmont Report and implemented into the Common Rule are necessary and/or sufficient to ensure the safety of human research subjects

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