一、 Scope and Limitations

This document is applicable to domestic and international research institutions and biomedical-related industry organizations. It outlines the principles for applying to the "Mei Chao Health Resource Center" (hereinafter referred to as "the Center") for the use of data, biological specimens, and related information for research or biotechnology development purposes. According to Article 15 of the "Human Biological Database Management Act," biological specimens, except for their derivatives, must not be exported abroad. International transmission of data from the biological database and the export of the aforementioned derivatives require approval from the competent authority.

二、Application Principles

2.1 Eligibility of Applicants

Domestic and international research institutions and biomedical-related industry organizations are eligible to apply to this database for biological specimens, data, and information. Applicants must provide relevant qualification documents at the time of application. Additionally, the database does not accept applications from individuals.

 

2.2 Data

• This database may provide de-identified biological specimens, data, and related information within the approved scope after the applicant's application content has been reviewed and approved.

• It is legally prohibited to directly provide biological specimens to foreign institutions; if derivatives of biological specimens need to be exported or if data needs to be transmitted internationally, approval from the competent authority is required.

• This database must ensure that the manner of providing data does not violate personal data protection or other legal regulations.

 

三、Application Procedure

3.1 To apply for the use of data, information, and biological specimens, the applying institution should fill out and provide the information in detail using the forms and formats provided by this database, including:

• "Application Form for the Use of Data from the MJ Biobank"
• "Format for the MJ Biobank Utilization Plan"

The proposal must thoroughly document the following content:

(1) Institution name;
(2) Name of the project leader/person in charge;
(3) Research objectives and methods;
(4) Intended use of the data/specimens;
(5) Management of the data/specimens after acquisition;
(6) Expected duration of use;
(7) Source of funding;
(8) Anticipated commercial benefits and feedback;
(9) Proof of approval from the ethics committee of the original institution;
(10) Other relevant information that may facilitate the review.

3.2 Once the information is complete, please mail it to the Administrative Department of the Mei-Zhao Human Biobank at the Interpretive Foundation to facilitate the subsequent review process.

 

四、Review Principles

When reviewing applications for database access, the following factors are considered crucial:

(1) Whether the research purpose of the application is related to biomedical research and development or disease prevention measures, aligned with enhancing global human health and well-being as promoted by this database.

(2) The scientific rationale and feasibility of the proposed research.

(3) Adequacy of data protection measures by the applicant.

(4) For repeat applicants, consideration of their past compliance with database obligations.

(5) Verification of the level of data protection under the laws of the applicant's country for applications from foreign institutions.

 

五、Review Procedures

5.1 Application Review Process

Applicants submit their applications as announced by this database. Upon receipt, staff will confirm whether the application is complete; if not, they will notify the applicant to correct and complete the submission. Once the application is complete, it will be sent in writing to the members of the Ethics Committee for initial review and feedback. The administrative staff will compile these responses and convene regular meetings of the Ethics Committee to confirm and discuss all applications, reaching a consensus on approval. Applications approved by the Ethics Committee will have all submission materials archived for regulatory inspection. The database will then notify the applicant to sign the "Bio-Specimen, Data, and Information Usage Agreement" and pay the management service fee. Only after these steps are completed will the database provide access to the approved data.

5.2 Appeals Process

For applications that have been denied, the applicant may submit an appeal within thirty days of receiving notification. Upon acceptance of the appeal, the database will forward it directly to the Ethics Committee for deliberation and decision.

 

六、Data Release Operations

6.1 Contract Signing and Fee Payment

6.1.1 "Bio-Specimen, Data, and Information Usage Agreement"

Once the application is approved, the administrative staff of this database will notify the applicant to sign the "Bio-Specimen, Data, and Information Usage Agreement."

6.1.2 "Management Service Fee"

This database will charge a "Management Service Fee" for the storage and management of bio-specimens, data, and related information, based on the fee standards at the time of approval.

6.2 After the contract is signed and payment is made, the database and the applicant can begin the data release process to obtain the approved bio-specimens, data, and related information.

6.3 Data Provision Method

After review and approval, the database will filter and select data and information that meet the application criteria, de-identify it, and assign a serial number before providing it to the applicant on a disc. The same process applies to bio-specimens, which must also be de-identified and stored under appropriate temperature conditions before being handed over to the applicant. Detailed procedures and any required cooperation from the applicant will be communicated by the administrative staff at that time.

 

七、Management Plan for Users of Specimens and Information

7.1 Compliance with Approved Usage Scope

Applicants must adhere to the usage scope and purpose approved by this database at the time of application, and may not use the materials outside of the approved scope without prior approval. If there is a need for usage beyond the approved scope, a request for a change in usage must be submitted and approved by this database.

7.2 Responsibility for Data Security

Applicants are responsible for the custody of bio-specimens, data, and related information and must comply with relevant laws and the information security management regulations of this database. According to Section 18 of the "Information Security Regulations for Human Biological Data Banks," applicants must cooperate with the annual information security audit plan established by this database, which may include periodic special audits as necessary. Audit records will be permanently retained.

 

八、Publication of Research Results

When applicants publish research results using this database, they must acknowledge the database's assistance in the research and comply with the provisions regarding "Publication and Disclosure of Research Results" in the "Bio-Specimen, Data, and Information Usage Agreement." Additionally, in accordance with Article 22 of the "Regulations on the Management of Human Biological Data Banks," the Interpretive Foundation will regularly publish research conducted using this database and its results on the foundation's website by the end of January each year. At that time, applicants must provide relevant information or explanations.

 

九、Commercial Use Benefit Sharing

9.1 Applicants must include a benefit-sharing plan with their application materials. If the original application lacks this plan or if the proposed plan is deemed unreasonable, they may be required to revise it.

9.2 Applicants must accurately report their commercial use of the materials to this database, with specific procedures established by contract between the database and the users. When the database acts as a user, the return rate or fixed fees will be determined by the Ethics Committee.

9.3 To ensure compliance with the benefit-sharing obligations, this database has the right to request relevant financial information from the applicant. Based on this financial information, the benefit amount will be determined according to the contractual agreement.

9.4 This database will allocate no less than 50% of its commercial use proceeds to benefit the population.

 

十、Compensation Agreement for Participant Data Breach

10.1 This database will enter into the "Bio-Specimen, Data, and Information Usage Agreement" with applicants to regulate the use of data obtained.

10.2 In the event of a data breach involving participant information, this database will address the situation in accordance with the "Regulations for Participant Rights Relief in the Mega Gene Bank," the "Bio-Specimen, Data, and Information Usage Agreement," and other relevant laws.

 

十一、Data Comparison Procedures

This database will comply with national policy regulations and will only accept encrypted comparisons with government-approved databases (e.g., death registries). Applicants must provide a detailed explanation in their application proposal submitted to this database. Upon approval from the Ethics Committee, the database will conduct the comparison as required, ensuring that no identifiable personal information is provided to the applicants. Furthermore, comparisons with other databases will not be permitted, including encrypted comparisons that produce only aggregated data files.