Consent is required from human participants before data can be collected or published. Obtaining informed consent to facilitate data sharing and publication involves:
- Developing an information sheet about maintaining confidentiality, data publication and sharing so participants can make an informed decision before consenting to participate. Your information sheet should be approved by JCU's Human Research Ethics Committee (HREC) as part of the ethical clearance process (refer below).
- Stating the possibility of future data publication and sharing, conditions for access (refer below) and de-identification processes (refer below)
- Seeking prior approval from HREC for consent forms and information sheets.
The Australian National Data Service provides some example sentences in their guide (pp. 14-15) - the examples listed below are appropriate in different contexts (e.g. open and conditional access):
I agree that research data gathered for the study may be published provided my name and other identifying information is not used. Other genuine researchers [may] have access to this data only if they agree to preserve the confidentiality of the information as requested in this form.
If explicit consent for sharing is not obtained at the time of the study, it may be possible to seek a waiver from reviewers or to go back to participants for additional consent.
The National Statement on Ethical Conduct in Human Research (p. 36) raises the ethical issue of obtaining consent for secondary use of data or information. It is, for example, usually impractical to obtain consent for secondary use of data routinely collected during delivery of a service and respect for participants needs to be demonstrated in other ways.
Sharing existing data without explicit consent is a possibility if all of the following conditions for a waiver of consent, as outlined in Section 2.3.10 of the National Statement of Ethical Conduct of Human Research, are met:
- involvement in the research carries no more than low risk to participants,
- the benefits from the research justify any risks of harm associated with not seeking consent,
- it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records),
- there is no known or likely reason for thinking that participants would not have consented if they had been asked,
- there is sufficient protection of their privacy,
- there is an adequate plan to protect the confidentiality of data,
- in case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them (for example, via a disease-specific website or regional news media),
- the possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled, and
- the waiver is not prohibited by State, federal, or international law.
JCU researchers and HDR candidates should always consult their College / Centre Human Ethics Advisor, and the JCU Connect Ethics and Research Integrity team for specific advice.