Almost every evaluation of breastfeeding programs and projects will require consideration of ethical issues, because they will involve research with consumers and/or their personal information. While the ethics approval process is sometimes considered a burden, it can be a very useful exercise in thinking through what data is really needed, and how any risk to a service user can be minimised.
The National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research provides nationally consistent guidelines on conducting ethically-sound research. The foundation of the statement is a fundamental obligation to demonstrate respect for individuals, with a particular concern for the needs of those who might be vulnerable in a research context, such as children and young people, people in dependent or unequal relationships (such as clinician and patient), Aboriginal and Torres Strait Islander people, and people with language or comprehension difficulties. Some of the following key ethical considerations to keep in mind when planning an evaluation include the following:
- processes for gaining informed and voluntary consent of service users, including not only direct input from service users, but whether personal data is used in any way which identifies or compromises the individual
- clear and sound processes for informing service users about the research, including consent processes
- the type of information to be collected
- processes for involving people who might not be able to give consent and need it to be given for them by a carer or guardian, for example, children or young people or those with a cognitive impairment
- processes for ensuring privacy, including the use of private rooms for interviews, making sure survey forms are kept safe, keeping people’s personal data secure
- attention to cultural issues in relation to priority groups, such as observance of and respect for cultural practices and/or use of researchers or translators from within a particular language or cultural group where required and appropriate
- declarations of any actual or potential conflict of interest, for example where a researcher or staff member may have a vested interest in a particular result (NHMRC 2007).
The Statement is also helpful in describing commonly used approaches to data collection which involve direct contact with individuals, including interviews, oral histories, focus groups, participant observation, or data collected apart from direct personal contact such as archival research and on-line research (NHMRC 2007).
You will need to find out which local ethics committee(s) may have an interest in your evaluation, and if required, the format and timing for making submissions. The relevant ethics committee may be attached to a government department, university or hospital. Obtaining ethics approval may take several months, so be sure to check early on whether this is required for your particular evaluation, and factor the timing into your planning.
It is worth noting that institutions may determine that some human research is exempt from ethical review.