Abstract
History has shown that without explicit and enforced guidelines, even well-intentioned researchers can fail to adequately examine the ethical pros and cons of study design choices. One area in which consensus does not yet exist is the use of placebo groups in vitamin supplementation studies. As a prime example, we focus on vitamin D research. We aim to provide an overview of the ethical issues in placebo-controlled studies and guide future discussion about the ethical use of placebo groups. Research in the field of vitamin D shows variation in how placebo groups are used. We outline four types of control groups in use: active-control, placebo-control with restrictions on supplementation, placebo-control without supplementation restrictions, and placebo-control with rescue repletion therapy. The first two types highlight discrete ethical issues: active-control trials limit the ability to detect a difference; placebo-control trials that restrict supplementation potentially place subjects at risk of undue harm. The final two, placebo-control without supplementation restrictions or with rescue repletion therapy, offer potential solutions to these ethical challenges. Building on this, guidelines should be established and enforced on the use of placebo in supplementation studies. Furthermore, the field of vitamin D research has the potential to set an example worthy of emulation.
Highlights
The field of research ethics has advanced remarkably in the past century
As a prime example of such issues, we focus on vitamin D research
Nutrients 2018, 10, 347 provide an overview of the ethical issues involved in placebo-controlled studies in vitamin D research, and guide future discussion about the ethical use of placebo groups
Summary
The field of research ethics has advanced remarkably in the past century. From deliberately infecting poor immigrants with yellow fever in the early 1900s, to the atrocities of Nazi “research” during World War II, to observing the natural progression of untreated syphilis among. African-American sharecroppers and withholding effective treatment from them, human research has grown to be much more humane, driven and accompanied by the development of the field of research ethics. In spite of this important growth, unanswered ethical questions remain within research. Ethical issues will likely persist, as researchers struggle to balance conflicting interests and priorities. It is, vitally important that these ethical questions be actively discussed and consensus built around proper conduct. Nutrients 2018, 10, 347 provide an overview of the ethical issues involved in placebo-controlled studies in vitamin D research, and guide future discussion about the ethical use of placebo groups
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