内容紹介
Ethical Guidelines for Clinical Trials in Medical Research Involving Human Subjects
Summary
In Japan, investigator-initiated clinical phase Ⅳ trials must follow the Ethical Guidelines for Medical and Health Research Involving Human Subjects, issued in December 2014. In addition, researchers must follow the Helsinki Declaration. In these clinical trials, academia-industry collaborations involving funding and technical support are required to develop better evidence-based medicine. Nevertheless, instances of publications reporting biases or misconduct in the research process occur frequently, which may lead to other problems due to lack of transparency. To address this issue, an institutional framework must be developed and maintained in which investigators maintain a high level of ethical adherence to protect the welfare of research subjects while carrying out research scientifically and appropriately under a conflict of interest(COI)disclosure. All authors must be seriously committed to greater responsibility, accountability, and transparency in collaborating with the industry.
要旨
臨床研究の主たる目的は,疾病の予防法,診断法および治療法の改善であり,そのために産学連携が必須となる。特に,市販後医薬品を用いた介入研究は根拠に基づく医療の原動力になることから,販売促進の絡みから企業の関心も高く,それらの実施から結果公表の過程で企業が深くかかわり社会問題化しやすい。臨床研究と疫学とを統合させた新倫理指針が2014年12月に公表された。論文公表を前提とした研究実施計画概要の公的データベースへの登録義務化,研究の質と信頼性を確保するために,研究者と所属研究機関の長の責任所在の明確化と管理体制の強化充実が大きな要といえる。信頼性の高い介入研究を行うために産学連携にかかる研究者の利益相反(COI)状態をいかに管理するか,その在り方について私見を交えて最近の動向を概説したい。
目次
Summary
In Japan, investigator-initiated clinical phase Ⅳ trials must follow the Ethical Guidelines for Medical and Health Research Involving Human Subjects, issued in December 2014. In addition, researchers must follow the Helsinki Declaration. In these clinical trials, academia-industry collaborations involving funding and technical support are required to develop better evidence-based medicine. Nevertheless, instances of publications reporting biases or misconduct in the research process occur frequently, which may lead to other problems due to lack of transparency. To address this issue, an institutional framework must be developed and maintained in which investigators maintain a high level of ethical adherence to protect the welfare of research subjects while carrying out research scientifically and appropriately under a conflict of interest(COI)disclosure. All authors must be seriously committed to greater responsibility, accountability, and transparency in collaborating with the industry.
要旨
臨床研究の主たる目的は,疾病の予防法,診断法および治療法の改善であり,そのために産学連携が必須となる。特に,市販後医薬品を用いた介入研究は根拠に基づく医療の原動力になることから,販売促進の絡みから企業の関心も高く,それらの実施から結果公表の過程で企業が深くかかわり社会問題化しやすい。臨床研究と疫学とを統合させた新倫理指針が2014年12月に公表された。論文公表を前提とした研究実施計画概要の公的データベースへの登録義務化,研究の質と信頼性を確保するために,研究者と所属研究機関の長の責任所在の明確化と管理体制の強化充実が大きな要といえる。信頼性の高い介入研究を行うために産学連携にかかる研究者の利益相反(COI)状態をいかに管理するか,その在り方について私見を交えて最近の動向を概説したい。