Why should researchers support the reuse of their data for future research?
The rationale for sharing individual de-identified participant data from clinical research is to:
- Enable the comparison or combination of data from different studies
- Enable rigorous re-evaluation of research by others
- Enable new hypotheses to be tested
- Reduce duplication of research effort
- Reduce waste of public and commercial funds
- Respect the generosity of clinical trial participants, because it increases the utility of the data they provide and thus the value of their contribution
The responsibilities of researchers to facilitate the sharing and re-use of individual participant data are provided in national guidelines:
Plan to share your data from the beginning of the trial
In the planning stages of the trial, researchers should consider if they will share the research data and information generated from their trial after the trial is completed.
The details about what will be shared and any restrictions must be provided in the trial Data Management Plan or a separate Data Sharing and Access Plan. The information provided in these plans must be consistent with the Data Sharing Statement that is included in the trial’s registration.
All clinical trials that commenced enrolling participants on or after 1 January 2019 must include a Data Sharing Statement in the trial’s registration to be considered for publication in ICMJE journals. According to the Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors, an editorial published in ICMJE member journals, data sharing statements must indicate the following:
- Whether individual de-identified participant data (including data dictionaries) will be shared
- What data will be shared
- Whether additional, related documents will be available (study protocol, statistical analysis plan, etc)
- When the data will become available and for how long
- By what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism
Good examples of data sharing statements are included in the editorial.
Sharing data related to Aboriginal and Torres Strait Islander populations
Institutions and researchers should consult with Indigenous owners of the data before making any decisions about access to or reuse of data or information used in/generated by research involving Aboriginal and Torres Strait Islander peoples and communities.
For further guidance about research involving Aboriginal and Torres Strait Islander peoples, consult:
Manage data during the trial to support data sharing in the future
To promote access to the benefits of research, researchers should collect and store data or information generated by research projects in such a way that they can be used in the future.
Researchers will need to justify when it is not possible or appropriate to share data. For example respect for cultural ownership or unmanageable risks to the privacy of research participants.
To facilitate data sharing, researchers should:
- Record the type of consent obtained from each participant so that data sharing is in accordance with their permission. Where appropriate, researchers should endeavour to obtain extended or unspecified consent for future research from the beginning of the project. If not, any future research will require either a waiver of consent for a human research ethics committee or additional consent for the sharing or re-use of the data or information.
- Respect confidentiality of participants.
- Collect and store research data and information using methodology that facilitates access, search and retrieval.
- Use version control for data sets, standard operating procedures, study protocol and other essential documents.
- Protect loss of data and information by using stable storage formats and storing electronic data/information on a system that has regular back up.
- Use appropriate national and international standards for scientific terminology and information encoding.
Download Data Sharing Principles
Obtain approval and execute legal agreements before you share the data
Before actioning a data sharing request from a potential collaborator, the Sponsor-Investigator must establish that their data will be transferred, stored and used appropriately. The Sponsor-Investigator and collaborator both have responsibilities to maintain the security and confidentiality of the data and should be aware of and comply with their institution’s data sharing policies and procedures.
Data sharing minimum requirements
Researchers should discuss their data sharing requests with their institution’s legal team and have their draft data transfer agreement reviewed before it is sent to the collaborator for review. This will ensure that agreements are tailored to address specific requirements for each project.