Data Access and Use Policy for NIH-DaRS

The NIH Data Repository System (NIH-DaRS) is operated under Sector for Biostatistics & Data Repository of the National Institutes of Health (NIH), Ministry of Health Malaysia. NIH-DaRS is a platform for centralizing research data to make data more FAIR (findable, accessible, interoperable, and reusable).

Research data can be stored in various formats and for long-term data preservation. These datasets are valuable and potential for secondary data usage and translational research. Therefore, this system will assist in supporting and facilitating decision-making, policy preparation, and promoting new publications and research projects.

The major function of NIH-DaRS is to support good practice in data management and completing the research data lifecycle, namely curation, discover and reuse of data. This function will be implemented through these two activities;
 

• Deposit Data

 

• Request Data

The objectives of this document are to outline the policy associated with the usage of NIH-DaRS, namely submission of data, data and metadata, access and reuse, preservation and withdrawal.

Submission policy

 

1. All research data that was produced by ;
   • Researchers from NIH, or
   • Researchers who received funding from MOH research grant

 

2. All research data that was produced by ;
   • MOH researchers (Non-NIH) or
   • Non-MOH Researchers who are affiliated with MOH through collaboration

 

3. By default, all data deposited will be classified as restricted (Data are accessible by user only after approval of data request process while the metadata is accessible publicly). However, Depositor and PI can opt for closed access (only the metadata record is accessible publicly and data are not accessible by user completely) if the data warrant such condition (such as prior formal agreements with external collaborators, funding bodies and parties on nondisclosure of the data, national security issues, ethical reason and legal requirement)

 

4. The research must have been registered in National Medical Research Register (NMRR) and obtained ethical approval from Medical Research Ethics Committee (MREC).

 

5. Where the dataset concerns human subjects, Depositor and PI confirm that the appropriate written and informed consent and ethical approval was obtained for the collection and the handling of the data, including archiving and sharing.

 

6. The validity, quality and authenticity of the content of submissions is the sole responsibility of the Depositor and PI.

 

7. Depositor and PI represent and warrant that they are the data creators or have the permission from data creator(s) for the content that they submit.

 

8. If the submission is based upon work that has been sponsored or supported by an agency or organization other than MOH, Depositor and PI represent that they have fulfilled any right of review or other obligations required by such contract or agreement.  

 

9. Any copyright violations are entirely the responsibility of the Depositor and PI. If NIH-DaRS receives proof of copyright violation, the relevant item will be removed immediately.

 

10. Depositor and PI are obliged to read, understand and agree to the data deposit agreement before the data is deposited.

 

11. To enable NIH-DaRS to administer, curate, preserve and disseminate the materials submitted to the repository, the Depositor and PI must grant NIH a royalty-free and non-exclusive license to use and reproduce the data.

 

12. NIH-DaRS do not systematically review the content of submissions for compliance with intellectual property, privacy, or other applicable law.

 

13. NIH-DaRS does not judge nor assess the scholarly quality of deposited datasets. The determination of research quality pertaining to the dataset is at the discretion of, and responsibility of the Depositor and PI.

 

14. The submission did not contain software viruses or any other computer codes, files, or programs that are designed or intended to disrupt, damage, limit or interfere with the proper function of any software, hardware, or telecommunications equipment or to damage or obtain unauthorized access to any system, data files, or other information of NIH-DaRS or any third party.

 
Data and Metadata Policy
 

1. Research data defines as any information that has been collected, observed, generated or created to validate original research findings.

 

2. Research data must be in digital form and may be numerical, textual, image or audio-visual depending on the discipline and the nature of the research.

 

3. Any file format can be submitted. However, some functionalities, for e.g., online viewing, might not be available for certain formats which require proprietary software. Therefore, we strongly encourage data deposits to be in open, non-proprietary formats for maximum reusability and preservation of data.

 

4. Following are the recommended file formats:

 

1. Text, Page Description, Data and Microsoft Office File Formats (.pdf, .txt, .ps, .rtf, .xml, .html, .htm, .css, .doc, .docx .ppt, .pptx, .csv, .xls, .xlsx, .sav, .tex, .zip, .tab, .odt)

 

2.  Image File Formats (.tif, .jpg, .jpg2, .gif, .png, .bmp)

 

3.  Video File Formats (.mp1, .mp2, .mp4, .mov, .avi, .wmv, .flv)

 

4.  Audio File Formats (.mp3, m4a, .mp4, .aif, aiff, .wav, .wma)

 

5. Depositors may upload multiple files in a dataset.

 

6. Recommended size of data file may not exceed 10GB per single file.

 

7. The deposited data must be a collection of final version of data that exists during the last stage in the data lifecycle in which all re-workings and manipulations of the data by the researcher have ceased.

 

8. Should any revisions to final research data be contemplated, the Depositor and PI must notify NIH-DaRS.

 

9. Research data requires a minimum set of descriptive information (metadata) to be provided at the point of deposit namely title, year, NMRR number, Principal Investigator, organisation, email, corresponding person name, email and phone number, description, stakeholder(s), keyword(s) and subject(s).

 

10. Anyone may access the metadata but the metadata must not be re-used in any medium for commercial purposes.

 

11. Depositor may need to upload a copy of data dictionary related to the research data. Data dictionaries are used to provide detailed information about the contents of a research data such as the names of measured variables, their data types or formats, and text descriptions. A data dictionary provides a concise guide to understanding and using the research data.

 
Access and Reuse of Data Policy
 

1. NIH-DaRS currently offers the following levels of access restriction;
   • Restricted: Data are accessible only after approval of data request process while the metadata is accessible publicly
   • Closed: Only the metadata record is accessible publicly and data are not accessible by user completely

 

2. Requestors need to register / login to NIH-DaRS before requesting data.

 

3. All researchers are eligible to request research data under the restricted access condition. All requests will undergo approval process by NIH-DaRS

 

4. Usage of the research data are solely for the purpose of scientific publication, presentation, research project, or thesis.

 

5. Usage of the research data for the purpose of research project or thesis for diploma/degree/master/PhD are required to be registered with National Medical Research Register (NMRR) at https://www.nmrr.gov.my and obtained ethical approval from Medical Research Ethics Committee (MREC).

 

6. Requestors are highly encouraged to invite and collaborate with the original team member(s) of the research data obtained.

 

7. Commercial re-use of research data is not permitted in NIH-DaRS.

 

8. Requestors are obliged to read, understand and agree to the data use agreement before the research data is supplied.

 

9. Requestors must ensure the security of the research data obtained by taking reasonable and adequate measures to the data from loss, misuse, exploitation, ravage, unauthorized access, or disclosed to any unnecessary parties.

 

10. Requestors are aware that the breach of the data use agreement will lead to being blacklisted from obtaining and/or using any form of data from NIH-DaRS or any other form of penalty deemed suitable.

 

11. Requestors are required to update progress of data usage in NIH-DaRS for every 3 months.

 

12. For requestor using research data for scientific publications / presentations, they are required to complete the publications / presentations within 1 year after receiving the requested data.

 

13. Requestors are required to obtain approval from the Director-General of Health, Malaysia according to the appointed procedure before submitting for publication or presentation.

 

14. Requestors will acknowledge the Director General of Health, Malaysia for his permission to use the data

 

• • e.g. The authors would like to thank the Director General of Health, Malaysia for his permission to use the data from the National Health and Morbidity Survey 2015 and to present this paper. The authors also would like to express our sincere thanks to National Institutes of Health (NIH) for their cooperation and assistance for this study.

 

15. To ensure good research practice, the origin of the research data used need to be properly cited. Details of citation may include but not limited to; author/s, publication year, title.

 

16. For requestor using research data for presentations, they are required to submit a softcopy (PDF) of the final scientific presentation to NIH-DaRS.

 

17. For requestor using research data for scientific publication, research project, or thesis, they are required to submit a copy of the scientific publication / thesis abstract / technical report to:

 

18. Requestors will inform the cancellation of using the requested data through NIH-DaRS.

 
Preservation of Data Policy
 

1. All research data deposited in NIH-DaRS shall be retained indefinitely.

 

2. NIH-DaRS will try to ensure continues readability and accessibility. Items will be migrated to new file formats where possible and if deemed necessary. It may not be possible to guarantee the ongoing readability of all file formats.

 

3. Additionally, NIH-DaRS regularly backs up its files according to current best practice.

 

4. In the event of NIH-DaRS being closed down, the database will be transferred to another appropriate archive in the control or management of the National Institutes of Health Malaysia.

 
Withdrawal of Data Policy
 

1. NIH-DaRS reserves the right to withdraw the research data if any of the following occur:
   • Proven copyright violation or plagiarism
   • Legal requirement and proven violation
   • Ethical violation or falsified research
   • Threat to national security

 

2. If NIH-DaRS determines it is necessary to withdraw the research data, it will make a reasonable effort to notify the Depositor and PI.

 

3. Depositors or other users may request for withdrawal of data if there is a valid reason for removal. Request for withdrawal should be submitted via email at nihdars@moh.gov.my. The request will be reviewed and pending further investigation. If the complaint is found to be legitimate, the data will be withdrawn.

 

4. Withdrawn research data are not deleted per se, but are removed from public view.

 

5. The metadata of withdrawn research data will not be searchable.

 

6. NIH-DaRS may terminate or suspend access to the repository for any reason, including for violation of policy or other misconduct that NIH-DaRS believe to be unlawful or harmful to others.

 

7. If users wish to terminate their account in NIH-DaRS, users may notify at nihdars@moh.gov.my.