Nationwide survey on informed consent and ethical review at hospitals conducting post-marketing studies sponsored by pharmaceutical companies

Hisashi Urushihara, Yuka Murakami, Kenji Matsui, Shimon Tashiroc

Research output: Contribution to journalArticle

Abstract

Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

Original languageEnglish
Pages (from-to)63-71
Number of pages9
JournalYakugaku Zasshi
Volume138
Issue number1
DOIs
Publication statusPublished - 2018 Jan 1

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Ethical Review
Marketing
Informed Consent
Pharmaceutical Preparations
Pharmacists
Hospital Societies
Codes of Ethics
Japan
Surveys and Questionnaires
Clinical Trials

Keywords

  • Ethical review
  • Informed consent
  • Post-market study
  • Research ethics

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

Cite this

Nationwide survey on informed consent and ethical review at hospitals conducting post-marketing studies sponsored by pharmaceutical companies. / Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiroc, Shimon.

In: Yakugaku Zasshi, Vol. 138, No. 1, 01.01.2018, p. 63-71.

Research output: Contribution to journalArticle

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