(Human) ethics applications with a minimum of pain (part one)

This post is by Judy Redman who is a Uniting Church minister and, as part of her role as a university chaplain, has been minister of religion on the human research ethics committees of three different Australian universities. She has qualifications in Agricultural Science and Human Nutrition as well as Theology and is currently working on a PhD. Her university-related work experience has also involved being a research assistant and academic editing.

In this post Judy lends you her vast experience to help you with your ethics application – thanks Judy!

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.

Related posts

The researcher’s hunch

In Memory of Mario Cugnetto

23 thoughts on “(Human) ethics applications with a minimum of pain (part one)

  1. tassie_gal says:

    All good points – I will refrain from commenting until I read part 2 as I may start ranting.

    • Judy Redman says:

      Unfortunately, part two won’t happen for a couple of weeks – I am currently in the US at a conference and I had planned to edit the draft while I had a gap in my travel, but couldn’t get internet access when I had the time, so it will probably need to wait until I get back. I’m aware that the process can be very fraught and I’d be happy to respond to comments about what I’ve written so far if you wish to make any.

      • tassie_gal says:

        I just spent 6 years working on a PhD in ethics and Epidemiology… so my rant would be more at the USELESSNESS of various processes as opposed to ethics committees themselves! (What conference you at?)

  2. Ben says:

    Great tips. I had trouble getting the ethics approved for the start of my PhD. I’ll remember this post for the next time

      • Pietro says:

        Hi Liz,Yep I can see what you are saying. The main reaosn behind my campaign is the ramifications of these actions and tendency to be publicly unsupportive which is the effect on our social standing. We basically fall right into the media\’s hands. From all the comments people have been making about my blog post (not to me, though I notice!) I\’m going to sit on this for a bit, and maybe split the campaign into two one the part about the importance of mums in society and the other about taking time to consider another mums situation before wasting valuable time, energy and social power having a go at them.Just one point of clarity I did approach love all blogs, Brit mums, Tots 100 and Cybher, and all were supportive (if there are other organisations I missed out I apologise). The campaign isn\’t specifically blogger orientated, but I thought I\’d start it here, and it has definitely been a learning experience\’!Love all blogs and Brit Mums asked me to write them something for the weekend, and you are right in that only Brit mums highlighted my post. Sally from Tots100 wrote her own post, but did let me know that she was doing so. I\’d contacted Cybher, despite knowing that it wasn\’t really suitable for them as they are specifically not just for Mums, but they have been very kind in their helpful advice. So it wasn\’t my plan for it to appear as though only one group was interested but hey, you can only try to cover all the bases can\’t you!

  3. Grant says:

    There is a need to be very mindful of confidentiality in rural communities. Particular circumstances can identify repondents in small communities. This may not be apparent to researchers used to research in larger communities. For example; identifying respondents by gender, when put together with other demographic information can often identify respondents in small rural communities. Unfortunately this is often a key question asked by reviewers which needs to be resisted.

    • tassie_gal says:

      resisted or revisited? Totally agree though – as a researcher in a rural community its something we are very aware of, and try to design studies so it does not become a problem.

      • Grant says:

        My comment comes from experience. A highly ranked peer reviewed Australian journal refused publication of an article following comments from reviewers seeking a breakdown by gender. When the editorial board was advised that this, in my opinion, would breach the ethics approval and indentify respondents the editorial board remained unconvinced. Would have been very easy to provide the information sought by the journal and breach the ethics approval. So in my case resisted is the right word. But I suppose it points to a problem. Perhaps there needs to be a mecahnism for publictions and articles to be referred back to the approving ethics committee? But this would be a massive workload.

    • Judy Redman says:

      Unfortunately, the software doesn’t let me comment below Grant’s reply to the reply. 🙁 Yes, Grant, I agree that there are some communities where providing particular information will make participants identifiable (or worse, will make it possible for people to guess wrongly about the identity of the respondents – as in “that could only be A or B and I bet it was A” and while it is perhaps not likely that the people in the relevant community will read the journal article, this is a clear problem. I suspect that an ethics committee secretary/chair might be willing to respond in this kind of situation with a letter to the journal backing up your claim, but whther thawould work or not, who knows. Reviewers sometimes make interesting comments.

      • Anonymous says:

        I think the problem is bigger than you think. I can vividly recall reading an article which was based on research where the respondents were practitioners in the same rural area in which I work. By describing the age, gender, and type of work I could clearly identify the respondents. Member’s of the respondents’ management committee were able to do the same. The respondents were critical of existing workpractices making it a very clear breach of basic ethical standards. Don’t forget just because an academic article may not be widely read by members of the general public, in this day of evidence based practice in may (likely) be read by practitioners and others with an interest and knowledge of the circumstances.

  4. Jennifer says:

    Really good advice. I’ve just been through the process and have been told I now have my formal ethics approval.Yay! Let the data collection begin. In hindsight the process really did help me to clarify what it was that I’m trying to do. Developing the plain language statements for the Participant Information and Consent Forms was really useful…now I know what to say at parties

  5. Mambo from Kenya says:

    When was this article posted.Really helpfull.Would like to make reference to it for my MBA Thesis.Thank you for the insights.

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