"Ethical Consideration on the Researches Using Human Biological Specimen-Revision Suggestion and Enlightenment of ""Common Rule"" for Subject Protection in the United States"
10.12026/j.issn.1001-8565.2016.05.36
- VernacularTitle:利用人体生物标本进行研究的伦理思考--美国受试者保护“通用法则”的修改建议及启示
- Author:
Haitao LIU
;
Ningning XIONG
- Publication Type:Journal Article
- Keywords:
Research on Human Biological Specimen;
Broad Consent;
Exemption Review;
Exclusion Review
- From:
Chinese Medical Ethics
2016;29(5):849-851
- CountryChina
- Language:Chinese
-
Abstract:
The use of human biological specimen has great significance to the development of biomedicine. Meanwhile, the powerful electronic data set with sophisticated analytic techniques creates challenge to the protec-tion of private information. As for the research with human biological specimen, how to facilitate the research con-duct on the basis of ethical principles is one of the key considerations when the US Department of Health and Hu-man Service initiated the revision of Code of Federal Regulations ( CFR) -theCommon Rule for subject protec-tion. The Notice of Proposed Rulemaking ( NPRM) proposed:Respect for autonomy will be enforced by broad con-sent to enforce and waiver of consent intend to be rare;If the research risks only involve privacy protection, review process will be simplified under the premise of ensuring the implementation of privacy laws and other protective measures. The paper introduced the revisions related to the researches using human biological specimen in NPRM, analyzed the terms of broad consent, exemption and exclusion, and explored the elicitation to ethical review prac-tice in China.
