Monday, 6 April 2015

Don’t worry, it’s only a Human Research Ethics Committee! (Sara Paradowski)

Photo by Sylwia Bartyzel | unsplash.com
After working in the area of research governance for nearly 6 years, I’ve noticed that there’s one area of research that causes a strong emotional response from just about every researcher.

They’re usually stressed, frustrated, and/or anxious about it.

What’s causing these emotions?

One thing and one thing only: a potential close encounter with a Human Research Ethics Committee (HREC).

I have thought about this a lot. Why are people so worried about an HREC review?

So, I thought I’d pass on a few tips to hopefully assist with navigating and writing a human research ethics application.


Who is on an HREC?

A standard HREC must have eight members, with gender balance, as well as consideration of internal and external members. There must be a Chair, a lawyer who is external to the institution, a male and female layperson, a pastoral carer, a health professional, and two researchers with current experience in areas relevant to the types of applications being reviewed.

While HRECs have a really important role in reviewing human research and ensuring compliance and ethical conduct in line with the National Statement, they are also a group of people with different professional and personal backgrounds, ethical values, and opinions. It’s important to remember this.

Tips for a smooth application journey

There are certain things  in the research design that regularly receive feedback or requests for clarification from the HREC.

Here are four areas that it pays to spend time on when you’re completing a human ethics application:

1. Think through managing risks to participants

An HREC will review the benefit and risk to participants when they review a study.

That’s not to say that a project can’t involve risks. It’s saying that a project needs to have some benefit either to the participant individually (possibly through providing individual results to participants), or the community (research community and/or public community).

If a project does contain risk to participants (psychological risk, legal risk, social risk, physical risk), the researcher should acknowledge this risk, and work out the best ways to mitigate it. For example, you could refer participants to a counselling service if they become distressed, or ensure staff are trained and experienced in taking blood to ensure it’s as painless as possible for the participant.

2. Be clear on how the recruitment process will work

How will you recruit your participants? I find this is the question that people put the least thought into, and often provide very little information.

Recruitment must be fair and coercion free. There’s lots of ways to recruit participants, including online, through social media advertisements, posters, or use of existing databases to obtain contact details of potential participants.

If a dependent or unequal relationship exists between a participant and the researcher, then this needs to be appropriately managed (such as involving an external person in the recruitment process). It might be an unequal or dependent relationship, for example, if a lecturer wants to recruit their students or if a doctor wishes to recruit their patients.

Let’s take the teacher-student relationship: the teacher is required to make it very clear that students don’t have to take part in the research and that, if they choose not to take part, it will not affect their grades in the class or have any negative impact on their education. In other words, the teacher must ensure students take part in the research voluntarily.

3. Know how to gather informed consent to participate in the study

Navigating the consent process can be difficult, but I find most researchers put a lot of thought into how to inform participants fully about the research, and obtain consent appropriately.

There’re lots of different consent pathways. Chapter 2.2 and Chapter 2.3 in the National Statement are good places to start when designing your consent process.

4. Will you reimburse?

If you wish to provide payment for participation in your study, it shouldn’t appear as an incentive to take part. It should be a reimbursement for time or travel expenses. For example, if you only specify that you wish to give participants $100 for taking part, it will appear as an incentive. However, if you word this differently, and specify why you wish to give participants $100 (e.g. for participation in 2 focus groups and one survey that will take 4 hours of their time), this is much more appropriate.

National Statement on Ethical Conduct in Human Research 

Finally, if you’re wondering where to start when designing your research, please review the National Statement. Familiarise yourself with the contents page and read the chapters that’ll give you a good overview of the requirements. Sections 1 and 2 are a great place to begin!

What if I need help?

If you are concerned about your application, or have any questions, please contact the Ethics and Integrity team. We’re here to help!

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Sara Paradowski joined La Trobe in November 2013 as the Senior Human Ethics Officer.

She has worked in a research ethics environment for nearly 6 years, and has previously worked with a Human Research Ethics Committee, an Animal Ethics Committee, and an Institutional Biosafety Committee. These experiences provide her with a broad knowledge of research governance.

Sara’s role at La Trobe University is to provide executive support to the University Human Ethics Committee (the registered HREC at La Trobe), and advice on human research ethics to the institution's students and researchers.

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