"Ethical Consideration on the Researches Using Human Biological Specimen-Revision Suggestion and Enlightenment of ""Common Rule"" for Subject Protection in the United States" / 中国医学伦理学

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) proposedRespect 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.