Dr Kathryn Snow is an epidemiologist whose work focuses on vulnerable populations.
She has a particular interest in tuberculosis, viral hepatitis, adolescent health, and the health of people in criminal justice settings.
Kat advises colleagues from diverse backgrounds on research ethics, study design, and data analysis.
She tweets from @epi_punk.
The word “ethics” strikes fear into the hearts of most early career researchers.
Some of the reasons are beyond our control, but there’s actually a lot we can do to make our own experiences of the ethics approval process less painful.
I’m writing this from two perspectives: as an early career researcher (I finished my PhD in 2019), and as a committee member (I’ve sat on an ethics advisory group since the start of my PhD in 2014).
The job of ethics committees is to identify the possible risks in a project, and then assess whether the research team:
- are aware of the risks.
- are taking appropriate steps to minimise them.
- have a plan to handle anything that does go wrong.
To do this, ethics committees need information. If you want your ethics application to get through the process as quickly as possible, you need to give the committee enough detail so that they understand your project and how you are managing any risks.
Getting your application as right as possible the first time makes the whole process go more quickly. If you don’t provide enough information, the committee will come back with questions. You may need to resubmit your application to the next meeting, which could be a month or two away.
Spending more time on your application for the first meeting can save you months later on!
Here are the main questions ethics committees will ask themselves when they assess your project:
- Are there any risks to the researchers? (e.g. Injuries in the lab, safety risks travelling to study sites, exposure to distressing topics during interviews or data analysis.)
- Are there any risks to the study participants? (From the study procedures themselves; risks to their privacy; risks of distress if they are asked about or exposed to upsetting content)
- Are there any risks to third parties? (i.e. people who aren’t directly participating)
- Could anybody’s privacy be invaded by the data collection process?
- Are there other staff in a lab who might be hurt if there were an accident?
- Are the research team aware of these risks, are they taking steps to minimise them, and do they have a plan if things go wrong?
The only way for the ethics committee to assess this is from the information you put into your application. Carefully think through your project and ask yourself those questions. And then put all of the answers into your application.
Here’s an example:
I am planning a project at the moment that involves interviewing health care providers about vulnerable people that they work with.
What are the risks to me? There aren’t any physical safety risks – I’ll be sitting in my office on the phone.
What about psychological risks? Could I be distressed by the content of the interviews? It’s possible. Some of the people I’ll interview are working with clients who have experienced child abuse, and some of their stories about their work might be upsetting.
What am I doing about these risks? I’m conducting interviews on the phone, rather than travelling to other people’s workplaces or homes. I won’t ask specifically about any distressing topics (minimising the risk), although they might come up anyway. If I get upset about the content of the interviews, I will probably be okay: I’ve worked in this area for many years, and I have strategies for dealing with it when my work upsets me (taking a break, talking to a colleague on the same project later on to help me process my feelings about it).
All of this goes into my application! I don’t write “I will conduct interviews with providers” and then say there are no risks, or that I have managed the risks. I give the committee all the details about each of the foreseeable risks I’ve identified, and exactly what I’m doing about them.
What about the risks to my participants? They could also find the content of the interviews upsetting. Again, my interview tool doesn’t ask directly about any distressing topics (minimising the risk), but it may come up. What’s my plan if my participants get upset? I’ll offer to change the topic, take a break, or stop the interview entirely. I mention this risk in the consent form, and the form will tell participants that they will have these options if they feel distressed. I will repeat this to them verbally at the start of the interview, and remind them that they don’t need to discuss anything with me that they don’t want to. Again, all these details go into my application.
What about risks to other people? Some health care providers might tell me private or sensitive information about their clients, by giving me specific examples instead of talking in general terms. To avoid this, I will ask them at the start of the interview not to talk about specific individuals, but to rather keep their answers general. If a participant does start to talk about an individual, I’ll remind them that this isn’t appropriate. I’ll also erase that part of the recording later on, so that those information isn’t transcribed. Again, all these details go into my application so that the ethics committee can see that I’m aware of the risk and I have a plan to manage it if it occurs.
As a committee member, I see applications get into trouble for a few common reasons.
The first is a lack of information, giving a very brief description of what will be done, without enough detail for the committee to understand the risks and what is being done about them.
The second is inconsistency, when a researcher says one thing on their application form, and something else in their consent form. Check carefully for consistency across all your documents before you submit.
A third is when a researcher proposes to do something that directly goes against the national ethical standards for research (e.g. collecting data without consent when they could get consent, or storing sensitive data in an insecure manner). Do not do this.
Some general tips:
- Find out the deadlines for your committee now, and start your application well in advance. It’s very hard to do a good job at the last minute, especially if you need details from your supervisor or other people in the project.
- Ask a colleague for a previous successful application for a similar project. Take note of the risks they identified, and how they managed them. Look at their consent forms and other documents, and see what you can adapt and reuse.
- Use grant applications for the project as a source of information on background, aims, methods, and outcomes. The format and level of detail required by the ethics committee is often similar.
- Read your country’s ethical guidance for research projects: this is what the ethics committee is working off. Think about which issues apply to your project, and how you can meet each of the standards. Spell this out for the committee.
- Find out whether your institution has specific requirements regarding wording in consent forms, storage of data, handling chemicals in the lab, etc. In your application, tell the committee that you are aware of these requirements and say how your project will meet them. Make sure that your consent forms and other documents are consistent with your institution’s standards. If your institution offers templates, use them!
- Ethics committees also assess the technical soundness of the research because poor quality research wastes time and resources, and exposes people to risks that aren’t justified by adequate benefits. Most committees include statistician and methods experts specifically for this reason (I’m one of them). Give a detailed explanation of your methods, and make sure they are appropriate to your research question. Get advice from a methods expert or a statistician to check that your project is sound – it’s much better to identify problems at the planning stage, rather than after you’ve gotten approval and collected your data.
- If you are doing an application for the first time, get help from your supervisor or thesis advisor. They shouldn’t make you do the application on your own. The more help you can get before you submit, the more quickly your project will get approved.
Also I suggest doing the ethics training offered by your institution, or professional body. Recently I attended ANU’s Human Ethics training session. While I occasionally teach ethics, and have been a Chief Investigator on a project, I still found it useful. https://services.anu.edu.au/training/aries-human-ethics-training-sessions
Another useful resource is The Research Ethics Application Database (TREAD), an online database of successful research ethics applications from around the world, some of which include supporting documents such as consent forms and information sheets. (TREAD is also glad to have new submissions so if you have made a successful application, please consider sharing your paperwork – fully anonymised of course.) Info here https://tread.tghn.org/
LikeLiked by 1 person