Purpose of this best practice: All study team members must be aware of institutional requirements for all generally recognized Johns Hopkins affiliated bodies for data sharing.
Positions and Responsibilities
- Principal Investigator (PI): The Principal Investigator (PI) must maintain compliance with training requirements for Human Subjects Research. The PI is responsible for ensuring that grants, data use agreements and IRB applications all include appropriate, compliant data sharing plans. The PI is responsible for initiating the IRB application and maintaining records of compliance with all policies.
- Study Coordinator (SC): The Study Coordinator (SC) must maintain compliance with training requirements for Human Subjects Research. The PI will likely delegate the responsibility for assuring study team compliance to the SC.
- Data Manager (DM): The Data Manager (DM) must maintain compliance with training requirements for Human Subjects Research. The DM must also be familiar with relevant institutional policies and is responsible for ensuring that data sharing complies with the institutional policies.
- Data Analyst/Biostatistician (DA/B): The Data Analyst / Biostatistician (DA/B) must maintain compliance with training requirements for Human Subjects Research. The DA/B needs to be aware of relevant institutional policies and is responsible for ensuring that data sharing complies with the institutional policies.
Best Practices
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All data sharing must comply with Johns Hopkins policies regarding privacy (e.g., HIPAA), security, confidentiality, and intellectual property.
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Once a researcher has published the results of an experiment, it is generally expected that all information about that experiment, including the primary data, should be freely available for other researchers to use.
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Researchers should be aware of data retention policies.
Institutional Review Board (IRB) approval may serve as documentation of compliance with institutional policy.
Useful Links:
- Johns Hopkins University, School of Medicine Policies
- Johns Hopkins Medicine IRBs
- Johns Hopkins Bloomberg School of Public Health IRB
- Johns Hopkins Homewood IRB
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Johns Hopkins University Intellectual Property Policy]