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Guidance on Conducting Research Involving Human Genetic Resources in
People’s Republic of China (China)
1. Introduction
Research involving human subjects in China is governed by a number of laws,
regulations, and guidelines administered by the Chinese Ministry of Health (MOH),
Ministry of Science and Technology (MOST), and the State Food and Drug
Administration (SFDA)1. In general these requirements are similar to those involving
human subjects in research in the United States.2 Harvard Principal Investigators (PI)
collaborating with Chinese scientists should inquire whether these scientists have
complied with applicable Chinese law in conducting the study. At a minimum, any
research involving human subjects in China must show that a local Ethics Committee
(EC) covering the collaborator or collaborating institution has approved the project. This
approval must be obtained prior to initiation of any research involving human subjects.
Harvard PIs who wish to conduct human subject research in China also must submit an
application to the Committee on the Use of Human Subjects (CUHS) at Cambridge or the
Institutional Review Board in Longwood, whichever is applicable, for review and
approval before starting their research. To facilitate timely approval of such research a PI
should include the Chinese Ethics Committee approval letter (original and translation),
and any supporting documentation such as the consent forms (original and translation),
from their collaborating institution in China.
2. Genetic Research in China
Any research involving genetic resources in China is subject to additional requirements
of the “Interim Measures for the Administration of Human Genetic Resources
(Measures)”.3 The Measures were implemented by the Chinese General Office of the
State Council for the purpose of ”efficiently protecting and rationally utilizing human
genetic resources in the People’s Republic of China, strengthening the research and
development of human genes and promoting international cooperation and exchange on
the basis of equality and mutual benefits.”
The Measures regulate the export from China of human genetic material and data. The
Measures uses the term “human genetic resources” rather than the more common term
1
For a complete listing see: International Compilation of Human Research Standards; 2013 Edition.
Compiled By: Office for Human Research Protections (OHRP) U.S. Department of Health and Human
Services.
http://www.hhs.gov/ohrp/international/intlcompilation/intlcomp2013.pdf.pdf
2 Various Chinese regulations cover subjects such as the protection of human subjects, requirement
for obtaining informed consents, registration of new or investigational drug and device studies,
protection of the privacy of human subjects, and obligations to report adverse outcomes.
3 For a full test of the provisions of the Measures see:
http://www.eastlaw.net/service/datacnlaw/code/HR/interimadmin.htm
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“human genetic materials” in order to broadly regulate genetic research. The term
“human genetic resources” is defined in the Measures as: “genetic materials such as
human organs, tissues, cells, blood specimens, preparations of any types or
recombinant DNA constructs, which contain human genome, genes or gene products as
well as to the information related to such genetic materials”. The exportation of human
genetic data is regulated by the Measures even if all human specimens remain in China
and only genetic data are exported.
3. Permit and Registration
A key provision of the Measures is its Articles-4 mandating a registration and permitting
process if “human genetic resources” are being taken out of China.
Article 4: The State adopts a reporting and registration system on important
pedigrees and genetic resources in specified regions. Any institution or individual
who discovers or holds important pedigrees and genetic resources in the specified
regions shall immediately report to the relevant departments. No institution or
individual may sample, collect, trade, export human genetic resources or take
them outside the territory of the People’s Republic of China, or provide them to
other countries in any form without permission.
The permitting and registration requirements are specified in Article 9 of the Measure
which states: “Where human genetic resources in China are involved in any international
collaborative project, the Chinese collaborating party shall be responsible for going
through the due formalities of application for approval”.
To meet the legal requirements established under the Measures; all Harvard University
PIs who conduct human research in China, that are subject to the provisions of the
Measures, must request that their Chinese collaborator, apply for and obtain all necessary
approvals prior to conducting the research in China. A copy of the approval letter must
be submitted to the CUHS or IRB before final approval is granted.
Notes:
- As defined in the Measures, human genetic resources include “information related to
such genetic materials. Therefore, if a Harvard University researcher intends to receive
only data (e.g. for analysis, validation, trending, comparison, etc.) the provisions of the
Measures nevertheless apply and the researcher must request that the Chinese
collaborator obtain a permit for exportation of such information.
1. These provisions for permitting apply regardless of whether or not the materials
or data have been deidentified, or if the research project has been deemed as
“exempt” for the purpose of IRB approval.
2. Human Genetic Resources Administration of China (HGRAC) is the entity in
China charged with the review and approval of the applications.
4. Penalties
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The “Measures” establish specific penalties for violation of its provisions. These are
articulated under Article 21 that states: “If any Chinese institution or individual, in
violation of the provisions stipulated in the Measures, exports the human genetic
materials without authorization by hand carrying, mailing, or transporting, the human
genetic materials shall be confiscated by the Chinese Customs and the institution or
individual shall be punished ranging from administrative sanctions to prosecution by the
judicial department according to the seriousness of the circumstances: if anyone, in
violation of the provisions stipulated in the Measures, provides human genetic materials
to foreign institutions or individuals without permission, the human genetic materials
shall be confiscated and the institution or individual shall be fined, if the circumstances
are serious, he shall be investigated for legal responsibility according to the Chinese
law. If anyone exports the human genetic resources outside China by hand carrying,
mailing, or transporting without authorization, the human genetic materials shall be
confiscated by the Chinese Customs and he shall be punished or put under the
prosecution of the judicial department according to the seriousness of the
circumstances”.
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