Several National Taiwan Normal University (NTNU) students, accompanied by legislators and civil group representatives, recently accused an educator of coercing university soccer team members to collaborate with experiments for a research project, in which they were forced to donate blood three times a day for 14 consecutive days over years or risk flunking their courses if they did not comply. The university is accused of contravening the Human Subjects Research Act (人體研究法) and breaching research ethics.
This incident not only highlights major deficiencies in Taiwan’s regulation and enforcement of the act, but also suggests that this might be the tip of an iceberg.
The Ministry of Health and Welfare is tasked with overseeing the act, which means its head, Chiu Tai-yuan (邱泰源), cannot shirk his responsibility. I urge the health minister to review the following aspects of human subject research to find out if there are any other violations of ethics and human rights.
First, the government should swiftly and thoroughly review the Human Subjects Research Act and the Regulations for the Organization and Operation of Institutional Review Board (人體研究倫理審查委員會組織及運作管理辦法). Any terms that are outdated should be addressed.
There should also be more detailed regulations regarding who can become board members and the degree of proportional representation to ensure diversity and balance. A biannual review should be conducted to report misconducts if any.
Taiwan’s regulations regarding research and human rights have improved a lot since the passage of the act. Any laws and regulations concerning research development and human rights protection should be in line with the progress that has been made.
Second, the authorities should promptly conduct a comprehensive investigation into how many academic institutions and medical organizations are currently conducting human research and whether they comply with the law. Do the institutional review board members and administrative staff receive regular training?
The government should also establish a clear division of labor. Matters concerning medical ethics should be handled by the Department of Medical Affairs, while reports concerning drug trials and adverse effects should be handled by the Food and Drug Administration.
Third, there should be a mechanism to protect whistleblowers. The Public Interest Whistleblower Protection Act (公益揭弊者保護法) was passed in January and took effect on Tuesday. This is a huge milestone in the nation’s whistle-blower protection system.
However, the act only applies to government institutions, public organizations, state-run businesses and certain state-funded institutions, while much of the private sector is excluded. The effectiveness of the new act is yet to be seen.
The ministry should establish an independent reporting mechanism for human research to assure whistle-blowers that their identity would not be exposed. This is to avoid a recurrence of severe breaches of people’s rights in human research projects.
Chiu should make his stance clear, show his determination and set a deadline for these goals. This is crucial to upholding the nation’s commitment to promoting human rights and achieving the goal of “Healthy Taiwan.”
Huang Jin-shun is president of the Federation of Taiwan Pharmacists’ Associations.
Translated by Fion Khan
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