How will you manage any ethical issues?

Questions to consider:

• Have you gained consent for data preservation and sharing?
• How will you protect the identity of participants if required? e.g. via anonymization
• How will sensitive data be handled to ensure it is stored and transferred securely?

Guidance:

Ethical issues affect how you store data, who can see/use it and how long it is kept. Managing ethical concerns may include: anonymisation of data; referral to departmental or institutional ethics committees; and formal consent agreements. You should show that you are aware of any issues and have planned accordingly. If you are carrying out research involving human participants, you must also ensure that consent is requested to allow data to be shared and reused.

See UK Data Service guidance on consent for data sharing.

  https://www.etag.ee/en/research-integrity/

SAMPLE 1:

Research will include sensitive data as it will contain human subject identifiable data.

The research will include data from subjects being screened for STDs. The final dataset will include self-reported demographic and behavioural data from interviews and laboratory data from urine specimens. Because the STDs being studied are reportable diseases, we will be collecting identifying information. Even though the final dataset will be stripped of identifiers, there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and documentation available only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technology; and (3) a commitment to destroying or returning the data after analyses are completed.

SAMPLE 2:

I have sensitive data as it will contain human subject identifiable data.

Access to research records will be limited to primary research team members. Recorded data will have any identifying information removed and will be relabelled with study code numbers. A database which relates study code numbers to consent forms and identifying information will be stored separately on password-protected computers in a secured, locked office. To maintain the privacy of the participants, any report of individual data will only consist of performance measures without any demographic or identifying information.

SAMPLE 3:

In our work, we use laboratory mice for experiments. All animal procedures are already approved by the Estonian National Committee for Ethics in Animal Experimentation. As we don’t handle patient-related data, there is no need for anonymization. The data is accessible only for researchers how are involved with the project. However, the data will be available from the project’s PI on reasonable request.