|
overview
the independent ethics committee (iec) at scrc was established in october 2008 in compliance with the "operational guidelines for ethics committees that review biomedical research" proposed by the world health organization (who), the "universal declaration on bioethics and human rights" by the united nations educational, scientific and cultural organization (unesco), the "ethical review of biomedical research involving human subjects" by china's ministry of health, the ich gcp and the chinese gcp. it operates according to a set of written standard operating procedures, with full respect to science and human rights. the iec is responsible for the review of clinical research conducted in shanghai and across china. the iec abides by the constitution and the laws that pertain to research conduct.
the committee is an independent body consisting of specialists in ethics, medical research, clinical practice, law and lay representatives, and is chaired by dr. ching-li hu, member of the unesco international bioethics committee, former assistant director-general of who, and member of the ethics committee, ministry of health.
mission
to provide protection for the rights and welfare of human subjects participating in the research through the initial and ongoing review of clinical research.
function
with the principle of fairness, independence, diversity, transparency and non-profit, the shanghai clinical research center independent ethics committee is set up to provide the following services:
1. independent ethics review
2. patient oversight for safety
3. international cooperation and exchanges
4. ethic related education and training
documents for review
- ethical review application for researches involved human being
- study protocol
- case record form
- informed consent form
- cv of principal investigator
- statement of planned tasks
- letter of intention for co-operation
- site list
- investigator brochure
- product literature
- insurance policy (if any)
- materials provided to research subjects
- profile of site
download forms
address for communication:
independent ethics committee
shanghai clinical research center
building 10, no 140 tianlin road, shanghai, 200233
iec office contact nos.
tel: 86-21-33676540
email: hongxia.zhang@scrcnet.org |
