Abstract
The freedom to choose is integral to our daily lives, directs our interactions with patients, and is a key component of our conduct of human-subjects research. Most of the historical errors and atrocities in human experimentation had at their core a failure of consent. In response to those events, national and international law developed to direct researchers to a process of informed consent to participate in research. The application of this process, though, can be challenging. What does this process look like? Does it require written documentation, and if so what type? Who can give informed consent? Though researchers worldwide would agree on the concept of informed consent, the nuts and bolts of applying this ideal can create obstacles to researchers, confusion to subjects, and increasing regulations that may or may not help achieve the goal. I will review the current regulatory guidelines, summarize the types of consent, and consider options for improving the informed-consent process.
Footnotes
- Correspondence: Margaret J Neff MD MSc, Division of Pulmonary and Critical Care Medicine, Department of Medicine, and with University of Washington Human Subjects Committee D (Biomedical), University of Washington, 325 9th Avenue, Box 359762, Seattle WA 98104;, Email: mneff{at}u.washington.edu.
Dr Neff presented a version of this paper at the RESPIRATORY CARE Journal Symposium at the 53rd International Respiratory Congress of the American Association for Respiratory Care, held December 1-4, 2007, in Orlando, Florida..
The author reports no conflict of interest related to the content of this paper..
- Copyright © 2008 by Daedalus Enterprises Inc.