title: Ethical considerations in clinical research on herbal medicine for prevention of cardiovascular disease in the ageing.
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.
  
  
  OBJECTIVE
  To review ethical issues and discuss considerations when such research is proposed.
  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.
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan; Leading Program, Graduate School of Biomedical Sciences, Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan.
authors.forename: Nut
authors.initials: N
authors.lastname: Koonrungsesomboon
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan. Electronic address: karbwangj@nagasaki-u.ac.jp.
authors.forename: Juntra
authors.initials: J
authors.lastname: Karbwang
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D004992:Ethics, Medical; D029001:Herbal Medicine / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection; D008517:Phytotherapy / Q000941:ethics; D010919:Placebos
chemical_list: D010919:Placebos
keywords: Ageing; Cardiovascular; Ethics; Herbal medicine; Herbs; Prevention