This document sets out the Good Scientific Practice for all TAMRI research staff and scientific visitors (“Researchers”). The document is a modified version of the WEHI’s Good Scientific Practice. All TAMRI researchers are expected to maintain the highest standards of professional conduct in scientific research including:
1. Adherence to safety regulations. In order to ensure the safety and compliance of all research activities within TAMRI, it is expected that all researchers adhere to the regulations concerning occupational health and safety, as well as the proper handling of hazardous materials including ionising substances, toxic chemicals, recombinant DNA technology, and waste disposal. Any experiment involving human subjects or human material, as well as experiments involving animals, require prior approval from the relevant ethics committees. The head of a research group is responsible for ensuring that all members of their group are well-informed about these requirements, diligently follow them, and obtain the necessary approvals before commencing any research program.
2. Safe environment. All TAMRI researchers are accountable for fulfilling their obligations in maintaining a healthy and safe working environment, as mandated by policies and legislation.
3. Open culture. As a general guideline, research findings and methodologies should be subject to scrutiny by colleagues within the Institute and, through suitable means such as publications, patents, presentations, and interviews, be made accessible to the broader scientific profession and community. However, it is important to refrain from discussing research findings in the public domain until they have undergone rigorous peer review. Prior to public release, it is necessary to assess and determine which parties should be informed first, taking into consideration factors such as direct impact or significant commercial implications, including notifying relevant stakeholders or a stock exchange.
4. Registration. It is mandatory for researchers to register clinical trials with an established registry, such as the Clinical Trials register (www.clinicaltrials.gov) which is recognized for this purpose.
5. Confidentiality. Strict confidentiality must be observed for data that are confidential or of a private nature, including information obtained from individual patient records or population data. Confidentiality must be respected for information received under a third-party confidentiality agreement. In certain cases, confidentiality may also be necessary for a limited duration when conducting research with commercial interest or under a commercial agreement.
6. Collaboration. When researchers plan to start a collaborative research project with another organization, they must take prompt action to facilitate prior agreement between institutions regarding research management. Institute researchers are obligated to adhere to the terms stipulated in such agreements.
7. Suspect of research misconduct. If researchers suspect or become aware of research misconduct having taken place or likely to occur, it is their duty to report it. This can be done by engaging in discussion with the Executive Director or a designated person responsible for handling such matters.
8. Research data. Data must be diligently and accurately recorded using a durable and secure format that ensures its safety and accessibility. It is essential to distinguish the original data from subsequent analyses and the creation of materials for publication. In cases where specific confidentiality or privacy concerns arise, the materials and data must be securely stored, ensuring their safety, and maintaining a record of authorized access.
9. Ownership of data. The Institute retains ownership of the original data resulting from research conducted within its premises. This data will be securely maintained by the Institute for a minimum of five years, starting from the publication date or the completion of the research, whichever is later. Researchers are permitted to create copies of the original data while adhering to the confidentiality policy. For ongoing studies such as population registers or clinical trials, it is crucial to securely preserve the data for a minimum of 15 years. Data from gene therapy studies, including patient records, must be permanently retained. Materials and data associated with research protected by patents should be retained until the expiration of the last patent. In the case of investigations involving research misconduct, materials and data will be retained indefinitely. Once the required retention period ends, it is mandatory to dispose of research data and materials in a safe and secure manner.
10. Data from research collaboration. In inter-institutional collaborative research programs, each participating institution bears the responsibility of retaining the data generated within its own facilities. Additionally, it is crucial for each institution to accurately document the location of any pertinent materials and data that are held at other collaborating institutions.
11. Retention of data. Whenever feasible, it is advisable to retain the original data within the research division or laboratory where it was generated. However, certain circumstances may prevent this, such as when data are derived from restricted access databases or obtained through contracted projects. In such instances, it is necessary to maintain a written record indicating the location of the original data or key information about the limited-access database from which it was extracted. This record should be kept within the research division for reference. Individual researchers may retain copies of the data for their personal use.
12. Confidential databases such as genetic registers or patient files, must be managed in a manner that effectively safeguards against unauthorized access. Robust security measures should be implemented to prevent unauthorized individuals from gaining entry. Additionally, any approved access to these databases must be diligently recorded and documented.
13. Data access. All members of the research team who actively contributed to generating the data must be provided with access to the complete dataset. Regular backup of electronic data is essential, and copies should be stored at secure separate locations, such as utilizing the institute’s IT servers.
14. Notebooks. The responsibility for recording data and maintaining laboratory notebooks lies with each individual researcher. In the event that researchers leave the institute, the laboratory heads assume the responsibility for retaining and managing the stored data.
15. Authorship carries responsibilities, accountability, and credit for a work. In cases where a work involves multiple authors, it is important to designate a corresponding author who will be responsible for documenting authorship and handling communication regarding the work with the publisher.
16. Corresponding authors have the duty to inform all co-authors each time they submit a manuscript or a significantly revised version of it. This ensures that all authors are kept informed and involved throughout the publication process.
17. Authorship attribution. Authorship should be attributed to individuals who have made substantial intellectual contributions in one or more of the following areas:
18. Agreement on authorship. It is important for collaborating researchers to reach a consensus on authorship for a publication at an early stage of the research project. Additionally, they should periodically review and reassess their decisions regarding authorship.
19. Authors’ contribution. All individuals who meet the criteria for authorship must be given the opportunity to be included as authors, and their consent to be listed as authors must be obtained. If someone qualifies as an author based on the aforementioned criteria, they should not be excluded without their written permission. In cases where they are not listed as authors, their contribution should be acknowledged in the acknowledgements section.
20. Honorary authorship. TAMRI does not accept honorary authorship. The following contributions, by themselves, do not justify inclusion as an author:
21. Acknowledgments. Ensure fair acknowledgment of other contributions. It is the responsibility of researchers to ensure that individuals who have made contributions to the research but are not listed as authors are appropriately acknowledged. This includes acknowledging those who provided key research materials. Acknowledge funding sources and affiliations. Whenever possible, publications originating from the institute should mention the affiliation with the Tâm Anh Research Institute. All sources of direct funding for the project, as well as salaries and fellowships, should also be acknowledged.
22. Authorship disputes. To avoid misunderstandings and authorship disputes, researchers should discuss authorship and author order at the project’s outset, during its progression, and when drafting manuscripts. Disputes related to scientific misconduct, such as plagiarism, honorary authorship, or ghost authorship, should be reported to a Designated Person as allegations of research misconduct. If disputes of a lesser nature arise, such as disagreements over authorship order or inclusion in acknowledgments, and cannot be resolved by laboratory and division heads, they can be referred to the Designated Person (or an alternative in case of conflicts of interest). The Designated Person, in consultation with one or more advisors in scientific integrity, will make a final decision in such cases.
23. Conflicts of interest. Any potential conflicts of interest, including shareholdings, affiliations, or financial involvement with organizations having a direct commercial interest in the research conducted by any staff, must be promptly reported in writing to the Executive Director. Additionally, researchers are obliged to disclose such interests to journal editors during the submission process and to external organizations when seeking additional funding.
24. In cases where there exists an actual conflict of interest or a perception of conflict of interest, whether personal or financial, the individual involved must acknowledge the potential conflict of interest and refrain from participating in decision-making processes concerning the matter. While it may be appropriate for the person to be present in the room to provide clarifications if needed, it is preferable for them to excuse themselves from the room during discussions and the final decision-making process.