Occasionally (not often), research ethics committees will ask a researcher to change their study design, in order to address an ethics concern before approval will be issued. One commonly cited example of this is when committees request a change from opt-out to opt-in sampling techniques.
Research ethics committees are entitled to withhold their approval if you do not make their required changes. But before things get to that stage, there is a lot you can do:
- If you are asked to make a major change, first consider very carefully why the committee has asked for that change. You may want to contact them directly to find out more, and talk to an experienced colleague.
- Ask yourself very honestly whether they might have a point. Remember that ethics reviewers, looking with fresh eyes and with specific training in research ethics, might pick up a problem that no one else has spotted.
- Consider what would happen if you did make the changes they have required. Would the required changes have an adverse effect on the quality of your research? Or the timescale? Or the costs? What would you need to do in order to implement the changes they are requiring?
- Get advice from as many people as you can - from experienced colleagues, experts in ethics in your institution, and from your funder if need be.
- Can you find a compromise solution - a way forward that might satisfy the committee? Something that has been done in other research?
- Can you show a precedent for your proposed way of working in other studies that have received ethics approval? This might not be enough to persuade a committee, but it may help your case.
- Do you need to consult with your funder at this stage? You will if your proposed compromise solution differs significantly from the design that was funded, or if it has implications for the study’s budget or timescale. Equally, you may find it helpful to get their advice and support as you prepare your response. See our section on going back to the funder.
If you decide that you cannot take on board the required changes, prepare a detailed response using academic references as appropriate. Be polite; explain your position and if at all possible suggest a compromise, with clear reasons for your suggestion. Before you submit your response, you should contact the committee (speak to the chair if possible) to ask more about the required change, and talk to them informally about your suggested compromise. They will not be able to give you an answer, but it may help you think about what you need to address in your response.