ABSTRACT
In recent years, foreign countries are gradually implementing broad consent to improve the utilization of medical data and biological samples, but broad consent may face ethical issues such as imperfect notification and affecting the rights of subjects. There are already relevant regulations and practices on broad consent in foreign countries. The concept of broad consent is not clearly defined in China′s laws. At present, the treatment of biological samples can be roughly divided into four categories in practice, and there is potential application space for broad consent. The specific scope of broad consent should be clarified, distinguished from donation behavior, and the implementation of broad consent should be explored on the basis of protecting the rights of subjects.
ABSTRACT
Taking the occurrence and development of general consent as the research object, this paper compared the differences between the ethical characteristics of broad consent and informed consent of specific research through the analysis of the content revision process of broad consent in the U.S. Broad Rules, and tried to explore the feasibility of implementing broad consent in Chinese medical institutions.
ABSTRACT
With the rapid development of network technology,the data sharing and health research provides an efficient and convenient way for medical research and clinical guidance.In order to know patients' opinions on informed consent and data sharing,we investigated first-class hospitals in the coastal and inland areas with a total of 397 patients participating the questionnaire on clinical health and data sharing,reusing the remaining clinical blood samples in scientific researches,and the acceptance degree of broad consent investigation and related influencing factors.It was found that patients with strong consciousness of informed consent right tended to choose a simpler way of informed consent based on the analysis.Patients preferred social benefits than personal benefits with a strong spirit of dedication to the community.Medical institutions in China rarely applied broad consents and took relervant summative researhes,compared with the European and American countries' promotions at the national level.The research afforded the evidence,from most of patients' point of view to ethics committee in the review of such kind of studies to understand the public data sharing in privacy protection and broad consent of the individual opinion,in order to facilitate the rational development and promotion of health data sharing in China ethically.
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.