Do I need ethics approval for patient engagement?

By Eva Vat, Training and Capacity lead NL SUPPORT

Before a research study can start, the appropriate approvals need to be obtained. One of the questions we often get from researchers is “do I need ethics approval for patient engagement activities?”

In this post, we’ll have a look at the ethical issues that may arise when involving patients as partners. We’ll also share our local guidelines for patient engagement in research.

How can patient engagement help make research more ethical?

Having patient input before the ethics applications shows that you have considered patient concerns. A recent study carried out by INVOLVE and the National Research Ethics Service of the United Kingdom highlighted that the information provided by researchers on public involvement can help to inform Research Ethics Committees. Literature reviews illustrate that public involvement throughout a study can help to make research more ethical by (INVOLVE, 2012):

· Making research more relevant

· Helping to define what is ethically acceptable

· Improving the process of informed consent

· Improving the experience of participating in research

· Improving dissemination of research results to both the participants and the wider public

What are key ethical issues?

There are some situations where the engagement of patients may raise ethical concerns. For example, when patient partners will be involved with collecting and analyzing data. Furthermore, the well-being and safety of patient partners are important things to consider, as well as adequate training and support.

Ethical issues that were raised by SUPPORT Units across the country include:

· Undue pressure on patients to participate

· Power imbalances

· Barriers to patient contribution and compensation

· Inadequate time and training provided to patients

· Lack of protection of personal information in sharing of research findings

· Inequitable sharing of benefits

· Respect for communication patterns favored by patients

· Lack of involvement by Research Ethics Boards

The Canadian Institutes of Health Research is currently in the process of developing ethics guidance on patient engagement for funders, institutions — including researchers — and patients interested in developing research partnerships. Keep an eye on our blog for updates.

Is ethics approval required to engage patients as partners in research?

In Newfoundland and Labrador, you do not need to apply for ethics approval to engage patients as partners in research. In reviewing the application the Research Ethics Board will need to address any ethical issues that may arise from patients being involved in conducting and managing the research. When you submit an application for ethics review for your research, you should fully describe how patients contributed or will be engaged.

Check out our recently developed guidelines for researchers who will be submitting applications for ethics review. These guidelines were developed in partnership between the Newfoundland and Labrador Research Ethics Authority (NL HREA) and NL SUPPORT. These guidelines do only apply to researchers submitting applications in Newfoundland and Labrador.

What kind of ethical issues do you see? What were your experiences using the guidelines?

Please share your questions and experiences with us.

Contact: Eva Vat, NL SUPPORTS’ Training and Capacity lead email: / phone: 709 864 6654.