Abstract
Research with human subjects exemplifies the perennial conflict between the good of the individual and the good of society. Policies and procedures that protect the rights and welfare of human subjects may hinder scientific research that benefits society. Due to this conflict, research with human subjects continues to be one of the most controversial topics in bioethics, despite ample government regulation, institutional oversight, and professional guidance. Nearly every week, the media brings a new issue, problem, or scandal to the public spotlight, with predictable responses from concerned citizens, compliance officials, and investigators. Concerned citizens and compliance officials often react to new developments by calling for additional regulation and oversight, while investigators frequently object that they are already inundated with red tape and that new rules will impede important scientific research without yielding significant benefits for human subjects or society (Klitzman 2015). The following examples illustrate some of the ethical dilemmas that arise in research involving human subjects.
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Notes
- 1.
Some authors use the term ‘participant’ instead of ‘subject’ because they regard the term ‘subject’ as demeaning (Chalmers 1999). Though I will sometimes use the term ‘participant’ in this book, I will, for the most part, stick with the term ‘subject.’ My reasons for this word choice are threefold. First, federal regulations and other guidance documents use the term ‘subject.’ Second, the word ‘participant’ is somewhat misleading because it implies a degree of active participation and collaboration that is not always present in research. Sometimes people are involved in research passively, e.g. when an investigator analyzes existing biological samples to discover relationships between genetics and disease. Third, ‘participant’ is a feel-good term that can obscure the very real potential for exploitation or mistreatment that can occur when investigators study people. Using the term ‘subject’ reminds us that people are being studied.
- 2.
In the U.S. committees that oversee research with human subjects are called IRBs. In other countries, they may be called research ethics boards (RECs) or research ethics committees (REBs). The points I make concerning IRBs also apply to RECs and REBs.
- 3.
Some philosophers hold that ‘ethics’ refers to the standards of conduct for a particular group or profession, i.e. medical ethics, whereas ‘morality ’ refers to more general standards. I will use the terms ‘ethics’ and ‘morality ’ more or less interchangeably in this book. I do not find the distinction between ‘ethics’ and ‘morality ’ to be very useful because laypeople usually do not make this distinction. Insisting on using a philosophical distinction which does not reflect common practice may be confusing to readers not schooled in this particular way of speaking.
- 4.
See discussion of this study in Chap. 2.
- 5.
The sample size likely to yield statistically significant results from a study is inversely proportional to the size of the effect one is attempting to detect: the smaller the effect, the larger the sample size (Blair and Taylor 2007).
- 6.
NIH is an agency within DHHS.
- 7.
Unless noted otherwise, references to the Common Rule used in this book will be to the 2009 version. The Obama Administration announced revisions to the Common Rule on January 19, 2017 (Department of Homeland Security et al. 2017), but as of the writing of this book, the Trump administration could still propose its own changes to the regulations or delay their implementation. I will discuss the federal regulations in more depth in Chap. 2.
- 8.
- 9.
Earlier versions of the revisions to the Common Rule excluded hospital quality improvement projects from federal research oversight but not the final versions. See Chap. 11.
- 10.
‘De-identified’ means that personal identifiers, such as name and address, have been removed.
- 11.
See the discussion in Chap. 11 of revisions to the Common Rule.
- 12.
By ‘policy,’ I mean a rule adopted by a government, institution, or organization, such as a statute, regulation, guideline, or code.
- 13.
A moral principle is a general rule for conduct, e.g. “do not lie” or “keep your promises.” A moral value is something that is morally good or worthwhile. Things have value for their own sake and not as a means to something else are intrinsically valuable. For example, most people would view happiness as intrinsically valuable. Things that have value as a means to something else are extrinsically valuable. For example, most people would regard money as valuable not in itself but for what we buy with it. Some things, such as knowledge and health, may be intrinsically and extrinsically valuable (Timmons 2002).
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Resnik, D.B. (2018). Introduction. In: The Ethics of Research with Human Subjects. International Library of Ethics, Law, and the New Medicine, vol 74. Springer, Cham. https://doi.org/10.1007/978-3-319-68756-8_1
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