Abstract
Background
Cardiovascular
disease (CVD) in the ageing is a major public health problem worldwide.
The nature of most CVD is subclinical with pathological processes that
can span over years. Use of preventive measures could be an appropriate
approach to prevailing over CVD in the ageing, and herbal medicine is
one of the promising preventive approaches and is currently of interest
among medical societies. In the evidence-based era, herbal medicine is,
however, often underestimated and approached with skepticism, mainly due
to the paucity of scientific evidence. Properly designed clinical
trials on herbal medicine for prevention of CVD in a geriatric
population are thus of importance and of clinical value.
Purpose
To review ethical issues and discuss considerations when such research is proposed.
Chapters/sections
Four ethical issues, including the scientific
validity of research, risk-benefit assessments, subject selection and
vulnerability, and informed consent, are structured and extensively
discussed in this article.
Conclusions
Ethical
core considerations of prevention research of CVD on herbal medicine
involve particular attention on the scientific validity of research,
risk-benefit assessments, subject selection and vulnerability, and
informed consent. These issues and considerations are keys, although
they must be adapted to an individual research setting in which a
clinical study is proposed.
Keywords
- Ethics;
- Cardiovascular;
- Prevention;
- Herbs;
- Herbal medicine;
- Ageing
Abbreviations
- CVD, cardiovascular disease;
- EMEA, European medicines agency;
- HPLC, high-performance liquid chromatography;
- ICF, informed consent form;
- LAR, legally acceptable representative;
- SDM, surrogate decision maker
- Corresponding author. Tel.:
+81 95 819 7558; fax: +81 95 819 7846.
Copyright © 2015 Published by Elsevier GmbH
