Based on my experience as a research assistant, the first step in conducting research is to submit all documents (such as a proposal, consent forms, case record forms, questionnaires, data sharing agreements, research collaboration agreements, etc.) to the research ethics review committee. These documents must address all the processes and information to be collected in the study, including disease status, home address, geolocation, contact numbers, and other data within the database. After obtaining approval from the research ethics review committee, the research team can commence data collection. Assuming all these processes are completed, the answers to each question are provided below:
Should you give the data out?
Yes, you should provide the data to the Western research team because the project has already received approval from the research ethics review committee. Furthermore, you have obtained consent forms from individual patients who meet the project’s criteria.
How do you not violate any of the General Principles of Informatics Ethics?
To avoid violating the General Principles of Informatics Ethics, these are some suggested actions that your should do:
– Requesting the Certificate of Approval (COA) to verify that the project has undergone review by the research ethics review committee.
– Establishing a data sharing agreement (DSA) and a research collaboration agreement (RCA) between your organization and the Western research team’s organization.
– De-identifying the data to protect patient privacy.
– Using encrypted methods to secure data from unauthorized access.
– Monitoring the Western research team to ensure they use the provided data in accordance with the terms of the agreements.
If you want to provide the data to them, what and how will you do it?
As mentioned in the previous response, the steps you should follow are as follows:
– Ensure project approval and establish the necessary agreements (DSA/RCA).
– Review and study the protocol and case record forms.
– Obtain consent from eligible participants who are in the project’s criteria.
– De-identify the data to protect participants’ privacy.
– Provide only the data specified in the case record form.
– Restrict data access through encryption to authorized individuals.