1.1 The data is expected to be used for biomedical studies that target at genes, environmental factors or their interactions susceptible to common diseases in the Taiwan population. All data users (applicants who obtain and analyze the data) cannot submit the data to any databases or any research consortiums without agreement from Taiwan Biobank.

1.2 To avoid fraud and misuse, the data is limited to the researchers from qualified institutes that have well-established biomedical researches. All applicants should provide such information (eg. research grants, scientific publications, etc.) at the time of filing applications.

1.3 The data are released anonymously. All information related to individual identification is removed before data release. All data users have the obligation to protect the subjects' privacy in all aspects.

1.4 All applicants should file their applications through their institute and Taiwan Biobank will be signed for the data release and usage if the application is approved.

1.5 The application should include a study protocol that includes the following 7 parts:

1. Primary investigator's name, Institute name

2. The objectives of the study, data items to be obtained, and the usage of the data

3. A management and security plan for storage and usage of the data

4. The duration of the study

5. The funding of the study

6. Commercial usage and royalties, if any

7. An approved document of Institute Review Board

2.1 All applicants have equal right to apply for the data regardless of race, gender and nationality. However, some constrains may be applied wherever Taiwan Biobank have contracted with other data users and institutes.

2.2 The major considerations of application review include:

1. The study purpose is in line with the main purposes of Taiwan Biobank

2. The study protocol is of scientific merit

4. The applicant has records of using data from Taiwan Biobank (if applicable)

3.1 All of the applications should be sent to the Data Release Group (DRG) of Taiwan Biobank (biobank@gate.sinica.edu.tw). DRG is responsible for (1) the application filling and review processes, (2) data release and (3) monitoring the data usage after the data is released. To complete the application filling process, applicants are encouraged to communicate with DRG for preparing the mandatory documents. Once all of the mandatory documents are received by DRG, the review process will be initiated.

3.2 The review implemented at two levels: scientific review and ethical review. Each application will be sent to independent reviewers for scientific review. The scientific review comments will be sent to the Ethics and Governance Committee (EGC) of Taiwan Biobank for further consideration. Then EGC will carry out ethical review and make decisions. DRG, on the behalf of EGC, will inform the applicant(s) the decision. The review will take one to two months.

3.3 For denied applications, the applicant(s) could file an appeal within 30 days of receiving the notice. Applicants should send their appeals to DRG. EGC will review the appeals and make decisions.

3.4 For approved applications, DRG will work with the applicant(s) for data release. A data management service fee should be paid to DRG. Applicants are required to review and sign “Contract for data and information usage” before the data release. Taiwan Biobank holds the right to terminate the contract if the data users (applicants) are found to violate the right and obligation described below.

3.5 Taiwan Biobank enforces no interest conflicts policy that all reviewers and staffs involved in the review process should maintain no conflicts of interest with the applications.

3.6 Taiwan Biobank enforces information open policy that information (name of applicants’ institute and the research topic) of an application will be publically posted if the application is approved and the data is released.

4.1 The data should be used within the scope of usage described in the approved application (defined in the study protocol). The data users are required to obtain approval for modification of the scope of usage before using the data beyond the original scope of usage.

4.2 All data users should follow the local laws and regulations for data protection and implement data security plan. Data users are required to provide proof or evidences of implement of data security plan upon the request of Taiwan Biobank.

DRG will assist the data users to select samples with specified conditions and schemes. All data are released anonymously; all subjects will be relabeled. Data will be transferred to a compact disk (CD) and mailed to the applicant.