Newsletter
Guidelines on Recruiting Study Subjects of Clinical Trials amended by Ministry of Health and Welfare
Pursuant to Article 83 of the Regulations for Good Clinical Practice, when applying for approval for a clinical trial, relevant documents such as the advertisement on subject recruitment must also be submitted for review. The Guidelines on Recruiting Study Subjects of Clinical Trials (for Pharmaceuticals) (the "Guidelines") were promulgated by the Department of Health in 2007, which set forth the relevant rules and requirements on subject recruitment and advertising. In response to the healthcare reform and amendments to the regulations on clinical trials for pharmaceuticals in recent years, and to protect the rights of study subjects, the Ministry of Health and Welfare (the "MOHW") promulgated an amendment to the Guidelines on October 26, 2021 to serve as the guiding principles when recruiting study subjects for clinical trials.
The highlights of the amendment are as follows.
I. The item of "Expected benefits of the trial" has been removed from the allowed information to be provided in a subject recruitment advertisement (Article 3).
(I) Before the amendment, a recruitment advertisement for study subjects may contain the following seven categories of information: "(i) name and address of the principal investigator; (ii) name and address of the institution/trial site; (iii) purpose and overview of the trial; (iv) main inclusion and exclusion criteria; (v) expected benefits of the trial; (vi) expected cooperation from the subjects; and (vii) contact person and contact information". According to the MOHW's relevant interpretations, the information categories listed above represented the recommended content of a recruitment advertisement, and not the mandatory information that must be provided therein.
(II) The purpose of removing the category of "expected benefits of the trial" from the scope of allowed information in a recruitment advertisement is to prevent the study subjects from forming any inaccurate expectations or conclusions on the potential risks of participating in the clinical trial after reading the expected benefits of the trial.
II. The item of "fees and subsidies" has been removed from the forbidden information that is not allowed to be provided in a subject recruitment advertisement (Article 4).
(I) Before the amendment, recruitment advertisements were prohibited from emphasizing that subjects would receive free medical care or any fees or subsidies.
(II) This amendment removes the item of "no emphasis on fees or subsidies". Accordingly, where the conclusion of proper evaluation finds that it is necessary to disclose the fees and subsidies offered by the trial (such as transportation reimbursement, nutrition subsidy, inconvenience allowance) in the recruitment advertisement, subject to the review and approval of the institutional review board/ethics committee ("IRB/EC"), such information can be provided in the recruitment advertisement. Nevertheless, it is still not advisable to disclose the pecuniary amount of such fees and subsidies in the recruitment advertisements as such disclosure might skew the focus of the trial.
III. Methods and Channels of Publishing the Recruitment Advertisements (Articles 5 and 6)
(I) Before the amendment, study recruitment advertisements were not allowed to be posted on campuses of junior high schools, elementary schools or kindergartens.
(II) After this amendment, in order to strengthen the protection of minors and to prohibit the recruitment of study subjects under the disguise of press conference or job recruitment, subject recruitment advertisements are banned in all campuses of primary and secondary educational institutions, press conferences, and social networking sites that are designed for sharing information on job opportunities, except for trials that are clearly beneficial to the health rights of specific populations or people with special diseases. However, if the content of the subject recruitment advertisement has been reviewed and approved by the IRB/EC, there is, in principle, no restriction on publishing such advertisement in print, via electronic media or public social networking sites.
IV. Additional Information to be Provided in Recruiting Advertisements (Article 7)
This amendment adds that subject recruitment advertisements shall be published with the wording "approved by the IRB/EC" and with "the date of the version of the advertisement material", and the content of the advertisement cannot be modified when being reposted or reproduced. However, the publication of the advertisement shall still comply with Item 5, Article 4 of the Guidelines and shall not emphasize that the clinical trial has been approved by the health authorities or the IRB/EC, so as not to mislead the subjects into forming inaccurate impression on the potential risks of the trial.
Where a recruitment advertisement for subjects of clinical trial is in contravention of the Guidelines, it may potentially violate the Medical Care Act and the Regulations on Human Trials, and the competent authority may impose a fine of not less than NT$10,000 and not more than NT$10,000 on the violator pursuant to the Medical Care Act and may suspend the clinical trial or the review thereof.
If you have any questions about this amendment, please do not hesitate to contact our Medical and Pharmaceutical Practice Group.