Guidance on Conducting Research Involving Human Genetic Resources in People S Republic

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

1 China Genetic Resources Research Guide “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

2 [Type text] [Type text] [Type text] 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”.

3 China Genetic Resources Research Guide