 Home > Active Ingredient News > Drugs Articles > Regarding human genetic resources, the Ministry of Science and Technology has issued another important notice!

Regarding human genetic resources, the Ministry of Science and Technology has issued another important notice!

 Last Update: 2022-04-29
 Source: Internet
 Author: User

Tags

process engineering internships

what lye mean

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

Recently, the Ministry of Science and Technology issued a notice on the public solicitation of opinions on the Implementation Rules for the Regulations on the Administration of Human Genetic Resources (Draft for Comments) (hereinafter referred to as the "Implementation Rules")
.

The "Implementation Rules" plan to stipulate that China's human genetic resources shall not be provided to foreign countries

my country's human genetic resources shall not be provided to foreign countries

According to the Implementing Regulations, human genetic resources include human genetic resource materials and human genetic resource information
.

Human genetic resource materials refer to the genetic materials such as organs, tissues, cells and other genetic materials that contain human genome, genes and other genetic materials

The "Implementation Regulations" plan to stipulate that the collection, preservation, utilization and external provision of China's human genetic resources shall respect the privacy rights of human genetic resources providers, obtain prior informed consent, ensure the health of providers and protect their legitimate rights and interests, and shall comply with scientific research activities.
related requirements and technical specifications, including but not limited to standards, norms, regulations,
etc.

The "Implementation Rules" intends to clarify the subject qualifications
.

The collection, preservation and provision of China's human genetic resources within China must be carried out by China's scientific research institutions, colleges and universities, medical institutions and enterprises

Overseas organizations, individuals and institutions established or actually controlled by them shall not collect or preserve China's human genetic resources within the territory of China and shall not provide China's human genetic resources to foreign countries

The China Human Genetic Resources Management Office of the Ministry of Science and Technology has formulated the Frequently Asked Questions and Answers for Human Genetic Resources Management in response to the common questions that applicants consult when handling the administrative approval and filing of human genetic resources for applicants to refer to during the application process
.

1.
Collection approval

1.
Does a long-term large-scale cohort study need to apply for a collection permit and a preservation permit at the same time?

A: No, projects with specific research purposes can be reported for collection, but if the samples need to be stored for a long time, they should be stored in an approved repository
.

2.
How to fill in the number of collection cases for the collection license declaration associated with the international cooperation license?

A: For collections related to international cooperation licenses, if the types or quantities specified by the Ministry of Science and Technology are involved, a collection license declaration should be made, and the collection volume should be consistent with the total amount of international cooperation license declarations
.

3.
Does collecting only ECG data count as human genetic resources?

A: Only data without human genetic resources information is collected, which is not within the scope of human genetic resources management
.

4.
Can hospitals with foreign-invested components apply for collection licenses?

Answer: Foreign organizations, individuals and institutions established or actually controlled by them (ie foreign units) are not allowed to collect or preserve China's human genetic resources within the territory of China
.

2.
Preservation approval

1.
How many preservation approvals can a unit apply for?

Answer: Under the premise of the approved preservation permit, in principle, a legal entity can only carry out one preservation permit activity.
During the implementation of the activity, if the duration of the activity and the preservation plan are changed, an application should be submitted to the Ministry of Science and Technology for change approval
.

2.
When is the annual report required to be submitted?

Answer: According to the "Notice of the Office of the Administration of Human Genetic Resources of China on Submitting the Annual Report on Deposits and the Summary Report on International Cooperation in Scientific Research" (http:// the depository institutions The previous annual report should be submitted by January 31 of each year
.

3.
Approval for international cooperative scientific research

1.
The summary report is required to be submitted "within 6 months after the end of international cooperation".
What does "end" mean?

A: The implementation period of international cooperation in the approval decision shall prevail
.

2.
How to deal with the remaining samples of international cooperation?

Answer: For the remaining samples that still have research value, in principle, they can be returned to the provider of human genetic resources samples; or they can be temporarily stored for a certain period of time according to the temporary storage location and time submitted at the time of declaration, and then destroyed according to relevant regulations
.

3.
Which units are "other units"?

A: Units other than clinical trial sponsors, medical institutions (team leader units), contract research organizations, and third-party laboratories are all “other units”
.

4.
In the clinical trial, the sponsor, contract research organization and other cooperating parties are all Chinese units, and only the EDC supplier is a foreign unit
.

Do I need to apply for international collaborative scientific research approval?

8.
Can the approved international cooperation projects continue to carry out clinical trials and screen subjects for enrollment during the application change process?

A: For those who have obtained permission to use Chinese human genetic resources to carry out international cooperation involving changes, the research can be carried out according to the original approval before obtaining the approval decision for the change, and the changed matters should be carried out after the approval of the approval decision to change
.

9.
Is it necessary to apply for international cooperative scientific research approval for an ongoing clinical trial project that has become a foreign unit due to the nature of the partner unit?

Answer: If you need to apply for the approval of international cooperative scientific research, you should suspend the project first, and continue to work after the international cooperative scientific research approval is approved
.

10.
How to apply for a project that exceeds the implementation period of the international cooperative scientific research approval decision, if it has not ended yet?

A: According to Article 26 of the Regulations of the People's Republic of China on the Administration of Human Genetic Resources, a summary report on international cooperation should be submitted
.

4.
Filing of international cooperative clinical trials

1.
Is it possible to start the trial after the system displays the international cooperative clinical trial record number without waiting for the announcement?

A: After submitting an application for the filing of an international cooperative clinical trial, after the formal examination is passed, the system automatically generates a filing number and the filing is successful, and the international cooperative clinical trial can be carried out
.

2.
The project has been filed for international cooperation, but it needs to be approved for international cooperation in scientific research due to changes in conditions.
What should I do?

Answer: The international cooperative research content on file should be terminated in a timely manner, a summary report should be uploaded, and the corresponding research content should be carried out after obtaining the approval of the international cooperative scientific research
.

V.
Information provided to the outside world or open for use for record

1.
When publishing articles abroad or participating in international conferences involving the open use of human genetic resources information, how to back up and record the information?

Answer: The applicant first logs in to the online backup platform (https://202.
108.
211.
75).
For the first login, registration is required, submit information backup and confirm that the backup is successful.
After obtaining the information backup number, log in to the online filing platform (https://grants.
most .
gov.
cn) fill in the filing application through the natural person account authorized by the unit legal person account, and then submit it to the Ministry of Science and Technology through the unit legal person account.
After obtaining the record number, the human genetic resources information can be opened for use
.

2.
If a data statistics company needs to receive information on human genetic resources, does it need to back up and record the information?

A: If a foreign unit other than the cooperating parties needs to receive information on human genetic resources, it needs to back up and record the information
.

3.
For a clinical trial of an international cooperation, whether the summary report or other trial data is provided to other units (for the Chinese unit) other than the parties to the cooperation, is it open for use, and does it need to be backed up and filed?

A: It does not belong to external provision or open use, and does not require information backup and filing
.

4.
Can the end time for the external provision of information backup and filing be later than the deadline for international cooperation?

Answer: Yes
.

5.
Can a foreign entity serve as an applicant for information backup and filing?

A: No, the application should be made by the Chinese data information owner
.

6.
If the published articles involve the open use of human genetic resources information, when should the information be backed up and filed?

A: Before the data information leaves the country
.

7.
How should the real-time outbound data information be backed up and filed?

Answer: If the genetic data information is involved, the data type, total number of cases, units/specifications, etc.
of the data to be exported should be backed up, and the data volume of the entire project should be estimated for data filing.
After the filing is passed, the data should be backed up regularly.
When the amount of data to be backed up is expected to exceed the amount of filing data, filing changes are required; if no genetic data information is involved, information backup and filing are not required
.

8.
If there are different recipients, does the information need to be backed up and filed separately?

Answer: The data information provided externally is backed up at one time.
If it needs to be provided by multiple external parties, it should be filed multiple times according to different recipients
.

9.
When submitting project data to other national management departments in stages, is it necessary to back up and record the declaration information?

A: To provide information on human genetic resources to foreign parties other than the parties to the cooperation, it is necessary to back up and record the information
.

10.
An international cooperative clinical study is divided into two applications, the registration and the exploratory part.
When the data information involved is provided to the outside world, do backup and filing need to be applied separately?

A: It is necessary to carry out information backup and filing separately
.

11.
Is it necessary to back up and record the information when using the published human genetic resources data?

A: Information backup and filing are not required
.

12.
What are the requirements for filling in the storage location for information backup and filing?

A: If the filing type is external, fill in the URL if you choose network transmission, and fill in the address if you choose physical storage medium; if the filing type is open for use, fill in the database name
.

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.