(Human) ethics applications with a minimum of pain



If you wander into a university tea-room and say you are writing an ethics application, you are sure to attract sympathetic looks and a range of horror stories. Everyone seems to know of someone who took 27 tries and two years to get their application through, and a number of researchers are firmly convinced that the sole reason for the ethics application process is to impede their research.

I’ve been a member of human research ethics committees for three different universities for some 15 years and this has not been my experience. I must have been involved in reviewing close to 2,000 applications and I don’t remember a committee ever having refused an application outright, although two or three researchers have decided to withdraw their applications.

I’ve been told by a significant number of experienced researchers that completing the ethics application form helps them to clarify exactly what it is that they hope to find out. I want to help you have a good experience too. There is quite a lot to ethics applications, so this post will look at the general process and the next one will look specifically at the information you provide for participants, since this is what causes most people (including ethics committee members) the most angst.

There is some Australian-specific information here, but the basic principles will apply fairly universally.

Why do I need to do an ethics application?

We have responsibilities towards our research participants. People are giving up their time (and sometimes also putting themselves at risk) to enable you to do your research. We need to ensure they can give free and informed consent to their participation and ensure their safety, particularly vunerable groups.

We must provide fair access to the benefits of research to all participants. In the past researchers have denied participants access to a life-saving procedure or product on the grounds that s/he needs to have a control group (see for example the Tuskagee Syphilis Study and the New Zealand National Women’s Hospital experiment).

Finally, there are regulatory issues. if you are associated with an Australian univerity, funding groups like the ARC and NH&MRC can pull all their research grant funding from a university if one just person is found to be in breach of the National Statement on Ethical Conduct in Human Research.

Contrary to popular belief, looking at your research design & methodology is part of the committee’s role. It’s unethical to conduct research which cannot achieve what it says it aims to do. To put this another way: if you tell your participants that their participation in the research will help you to determine X, but the design of your research will not, in fact, allow you to determine X, you are recruiting participants under false pretences (aka lying to them).

Stress free applications!

I recommend all research students read sections 1 & 2 of the National Statement on Ethical Conduct in Human Research and any other parts that are relevant to your particular research. The statement explains what can and can’t be done – and why; it will help you to understand the reasoning behind the questions on the application forms.

It’s important to follow the processes which are in place in your university so you don’t slow the process down. Download the current version of the application form and the guidelines that go with them from your university website and read them carefully.

DO NOT (yes, I know I am shouting) accept the copy that your supervisor or friend kindly emails to you. It could be out of date and you may fail to provide critical information as a result.

When you start to fill out the form, read the questions carefully and answer them fully and write the answers in language that people who are not specialists in your field can understand. DO NOT just attach your research proposal and expect the ethics committee members to refer to it for answers. They may have 15 or 20 applications to read and at best they will become very, very grumpy about your application and at worst will send it back for you to do again.

If you are confused, ask the secretary of your ethics committee or a committee member for help. They would much rather that you ask and get it right! This can help you avoid…

Common Problems

Not enough detail about recruitment:
“students” is not an acceptable answer to the request to “describe how you plan to recruit participants.” We need to know which students, how you plan to identify them, how you plan to approach them, and whether there is a conflict of interest – particularly if they are in a dependent relationship with you (ie are they students that you teach, whose work you mark or over whom you have some other kind of power).

Erroneous assumptions: Just because you have access to particular databases in your work, does not mean that you can simply use them to access potential participants for your research. Doing this without permission puts you in breach of most privacy legislation.

Incomplete questions: If the form asks you to respond Yes or No, it is quite possible that there may be a section which requires you to provide justification of your answer. Check this, or it’s likely you will get your application back again.

Not enough detail: If you are doing research overseas, just telling us how much money (whether in the local currency or in AUD) you are planning to pay participants is not enough. Are you paying them enough to buy a cup of coffee – or a new home? We need to know whether you are offering too much inducement to engage in risky behaviour.

Justification not provided for potentially sensitive data collection methods: If you need to deceive participants (eg by not tell them that you are observing them or not telling them exactly what you’re looking for) you will need a good reason.

Not enough reason given for keeping identifiable data: You will need to explain why you need that information, especially if it is potentially sensitive information such as sexual orientation, ethnicity, religious affiliation, age etc. “Because the study I am trying to replicate collected it” is not good enough.

Not understanding the significance of anonymity vs confidentiality: Anonymous data (ie data that is collected without any identifying information attached to it) is reasonably problem free. You can ask all sorts of controversial or sensitive things as long as you cannot link responses to the person who made them. If you collect sensitive data and you know who gave it to you, you need to think about how to maintain confidentiality.

If you are de-identifying your data you need to be clear about who will be able to put the identifiers back. Note also that removing names doesn’t necessarily de-identify data for high profile people. Most organisations only have one CEO and Australia has only ever had one female prime minister. In this kind of situation, you ask for permission to publish the names of the interviewees and provide them with a copy of the transcript of their interview for approval.

I hope this post helps you start to sort through your ethical issues – does anyone have any questions or problems? Ask us in the comments.