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How to Write an Ethics Application That Gets Approved

Within any field of study, research is essential to collecting data. Data helps researchers draw conclusions about particular research questions which, in turn, can lead to further questions and hypotheses and, even better, potential answers to questions outlined in the research guide. In some instances, research may require participants. As such, it is essential to make sure that you submit a good ethics application that will increase the chances of your research being approved. Before we discuss the steps to writing a successful ethics application that gets approved, let us first define ethics.

Ethics deals with morals and principles. It is concerned with what is morally right versus what is morally wrong. Ethics is applied to not only research questions and proposals but also to everyday life.

Some examples of ethical dilemmas include:

You find a wallet on a train seat next to you. Do you keep the wallet and its contents, or do you turn it in at the train station lost and found?
You did not study for your math exam, but one of your friends has acquired the answer sheet and offers it to you. Do you use the answer sheet and cheat on the exam, or do you decline the offer and report your friend for cheating?
You want to conduct an experiment involving human participants, but you know that there are potential risks involved in the experiment. Do you tell the participants the potential risks before you begin the experiment, or do you continue with the experiment with the risks involved?

In your case, you are most likely seeking ethical approval from an ethics committee so that you can perform an experiment. This experiment may involve other researchers and participants, so it is necessary for an ethics committee to review and approve of your experiment before you begin. In order to have your application approved, there are several steps you must take in completing your application.

Factors that will increase your application's chances of being approved

Clearly outline and define your research proposal.

Part of your ethics application is to explain your study. This is an opportunity for you to explicitly outline what your research proposal is and the procedures that will be involved in the research. It is important to be completely transparent and to include every step of your procedure. The ethics committee will be analyzing the details and assessing the risks involved in your study. To avoid your research proposal being rejected or delayed in the reviewal process, ensure that you have included all of the necessary information.

This is also your time to justify your research proposal, explaining why it matters and what benefits the research could potentially have for your field. An ethics committee is going to determine whether the potential risks will outweigh the potential benefits of your experiment. Therefore, be sure to outline who and what will benefit from your findings, but take care to not exaggerate, as honesty is important when submitting your application for review. Exaggeration of the truth could lead to potential harm down the road. Some potential questions to answer include:

Who will be involved in the study, including participants and researchers?
Were all of the participants and researchers involved in your study informed of the contents and risks of your study, and did they voluntarily consent to take part in your study?
What techniques and methods will you be using to gather your data?
Why are you gathering this particular data?
How will you use this data in your study?
Who will have access to the study data?

Use plain language

There is a lot of information to include in an ethics application, and it is unlikely that everybody who reads your application will be an expert in your field. Therefore, you should never assume language that is commonly used in your field of study is easily accessible to everyone else. For example, if you are writing an ethics application that is based in a STEM field, complicated scientific terms or acronyms may not be immediately recognized or understood by application reviewers.

To avoid potential confusion, you should always use clear, simple language to describe and define your study. In doing this, the ethics committee can read and understand your work clearly. It is also essential to do this when gaining consent from your participants so they are fully informed about their role in the study. Using simple language will also decrease the application and reviewal process time.

Acquire informed consent from participants

This step will come before you submit your ethics application to the ethics committee, but it is one of the most essential steps in the application process. Any and all potential harm that could be done to participants needs to be explicitly outlined. If you do not acquire informed, voluntary consent from your participants, then your ethics application will be rejected because there is a possibility of harm being done to your participants.

For example, the famous Milgram experiment was a topic of ethical debate after it was released. The social psychology experiment had two groups of participants. The student group was informed they were going to be shocked by the teacher group, but the shock was fake and did not cause any actual harm. However, the teacher group was not informed of this, and teacher participants believed that they were actually eliciting shocks to students. This caused serious psychological harm to teacher participants once the experiment was over and the truth was revealed, making this an unethical research experiment. So, before you submit your ethics application, consider the following:

Do your participants know all of the potential risks involved in participating in your study?
Are you prioritizing the physical and mental well-being of your participants in the study?

Identify any and all potential risks

As we just discussed, gathering informed consent from participants is essential to getting approval from the ethics committee. This includes educating your participants on the potential risks that they may face throughout the study. As such, we are now going to discuss what you should be thinking about in terms of assessing risk. Since the ethics committee is going to evaluate how many potential risks are involved in your study, complete transparency is necessary. This includes any risk that could be done to you, your fellow researchers, and your participants. The ethics committee is also going to look to see how you are working to minimize those risks. As such, it is important for you to have plans in place to combat anything that may go wrong in your study. Below, we have provided questions to ask yourself as you prepare your ethics application.

Risks to yourself

Are there any risks in the experiment that are unique to you?
Are there any risks involved with the location or setup of the experiment?
Will any part of the experiment cause you physical or mental harm?
Are you taking steps to minimize the risks to yourself?
What plans do you have in place if you are negatively affected during the experiment?

Risks to your research team

Have you informed your researchers of the procedure and the potential risks that they may face? Remember, informed consent does not just apply to the participants, but it also extends to anyone else involved in the experiment, including fellow researchers.
Will your research team face any risks that are unique to them?
Is the experiment environment safe and secure for your researchers?
Does your research team have plans to combat potential harm if something unexpectedly goes wrong?
Are you respecting the researchers' privacy?

Risks to your participants

Are you protecting the privacy of your participants?
Is there any equipment or method that could potentially cause mental or physical harm to your participants?
Are they aware they can withdraw from the study at any time, no explanation needed?
Do the participants know how their involvement is affecting the experiment?
How will you protect your participants if they are exposed to risks? Are you prepared to lose participants or accommodate their needs?

Other things to consider

Although we have outlined and discussed the most essential information to include in your ethics application, there are some other factors you will want to consider and address in your application. Doing this the first time you submit your ethics application will make for a quicker and more efficient application review process, as the ethics committee will not have to send your application back asking for more information. Here are some other things to consider in your ethics application:

How will everyone involved in the study get to the research location? This may not be the first thing you think of, but it should be considered when you are reviewing costs and transportation for your study.
Are there any outside parties that could be negatively affected by your experiment, mentally or physically?

Final review

Once you think you have included the necessary information in your ethics application, it is time for you to review your materials. You should review your materials carefully and take on a critical eye, putting yourself in the shoes of an ethics committee member. Consider the following as you finalize your application:

Is there any other information you can think of that a committee member might want to know, or have you included everything?
Are you using plain, easily understood language?
Are you being clear and concise, or is there room for improvement?
Are you consistent in your application, ensuring that you have outlined a clear procedure?
Have you considered the potential risks involved in your experiment and created potential solutions to any problems that may arise?
Are you being honest? Honesty and transparency are key to writing a good ethics application that will get approved.

Were you able to check off every question on the list? If so, then you are ready to send your ethics application to the committee. Approval can be a long and sometimes difficult process, but if you have followed our advice, then your process should be simpler and, hopefully, easier. Congratulations, you are one step further in achieving your research goals!

Header photo by Markus Winkler

The Research Whisperer

Just like the thesis whisperer – but with more money, how to write a successful ethics application.

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 .

Photo from Bernard Hermant | unsplash.com

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.