如若受试者中途撤回知情同意，申办者还能使用撤回同意前收集的数据吗？
文摘
教育
2024-09-21 20:01
北京
第十五条 基于个人同意处理个人信息的，个人有权撤回其同意。个人信息处理者应当提供便捷的撤回同意的方式。个人撤回同意，不影响撤回前基于个人同意已进行的个人信息处理活动的效力。
REGULATION
(EU) 2016/679 General Data Protection Regulation
Article 17 Right to erasure (‘right to be forgotten’)1.The data subject shall have the right to
obtain from the controller the erasure of personal data concerning him or her
without undue delay and the controller shall have the obligation to erase
personal data without undue delay where one of the following grounds applies:(a)(b)......(f)
3.Paragraphs 1 and 2 shall not apply to the
extent that processing is necessary:(d) for archiving purposes in the public
interest, scientific or historical research purposes or statistical purposes in
accordance with Article 89(1) in so far as the right referred to in paragraph 1
is likely to render impossible or seriously impair the achievement of the
objectives of that processing;
V. FREQUENTLY ASKED QUESTIONS 12. How
should data be handled when an enrolled subject decides to withdraw from a
trial?Under FDA regulations, data collected on
subjects up to the time of withdrawal from clinical investigations of drugs and
devices conducted under an IND or IDE must remain in the study database (see,
e.g., 21 CFR 312.62(b) and 812.140(a)(3)). If a subject withdraws from a study,
removal of data that were already collected would undermine the scientific
validity, and therefore the ethical integrity, of the research. Such removal of
data could also put enrolled subjects, future subjects, and eventual users of marketed
products at an unreasonable risk and could compromise FDA’s ability to perform its mission to protect public health and safety
by assuring the safety and effectiveness of regulated medical products.
Q&A中的语音部分属于个人观点，仅供参考。我会尽可能多的列举出能找到的法规依据作为支持，但如果有漏掉或者不正确的地方，欢迎大家给我留言指正。
