(Human) ethics applications with a minimum of pain



This post deals with the information you provide to your potential participants when you are recruiting for your research project. Two items come into this category: an information sheet about your project and the consent form itself.

I have seen the information sheet referred to in various ways: as the “Plain Language Statement” (PLS), the “Participant Information Sheet” (PIS) and the “Information Sheet for Participants” (ISP). Your university could easily have a slightly different name for it, but it’s the thing you give people to tell them about your research – the document that provides them with all the information they need to enable them to give free and informed consent.

The consent form is evidence that your potential participants have read the information you have provided and agree to participate.

The information sheet

Here is a checklist that will help you to write an information sheet that the ethics committee will like:

1. Do check the ethics committee website to see if they provide sample information sheets and/or a checklist for writing them. If they exist, use them!
2. Do make sure you invite people to participate, rather than just describing your project. Do not say: thank you for agreeing to participate. This is manipulative.
3. Do not offer blatant inducements to participate – such as payments that more than cover the costs in participating or expensive gifts. Do not start your advertising posters “Win X by participating”. Offering financial inducements to participate contravenes the National Statement.
4. Do use language that your target audience can be expected to understand, not the explanation you provided in your research proposal.
5. Do make it clear that the research is for your degree and who your supervisors are.
6. Do not make unrealistic claims about the potential benefits to either the participants themselves or humanity in general. There may be no benefit to individual participants apart from the satisfaction of knowing they have helped others. If this is the case, say so. Many people are quite happy to help others and happy that their opinions are of interest to researchers – your research doesn’t need to sound earth-shattering in order to get people to participate. If you are testing an anti-cancer drug, you need to be more specific in your claims than “Participation in this research may result in a cure for cancer”. Try “Your participation in this research will allow us to test the effectiveness of drug X on cancer A.”
7. Do state clearly exactly what is involved in participating: where, when and for how long the participant will be required and what they will be required to do. Mention specifically anything that is risky or sensitive. Note that sensitive includes anything that requires removal of clothing and being touched anywhere except of the extremities of the body. If you are asking participants to put themselves at risk or give you sensitive information, it is important that they have plenty of time to consider whether or not they want to participate, so the information sheet must warn them of this and be distributed before they arrive at the data-gathering venue. Do word this in the second person not the third (ie use “you” rather than “participants”).
8. Do tell them where their data will be stored, for how long, in what form and who will have access to identifiable information. If you think you might like to use the data in future research, you will need to tell participants this and get specific permission to do so.
9. Do provide useful contact details for people who have questions about the research – yours and your supervisors’. Do not provide your home landline number.
10. Do make sure that the spelling, grammar and punctuation are correct and that the text is free from typographical errors. This is a public document going out on the university’s letterhead and it won’t be approved if it’s not professionally presented.
11. Do include the university’s compulsory complaints clause. It will allow people who are unhappy with the way your research is being carried out to let the university know – although we would hope that no-one will need to use it. Do not alter the wording of this clause without consulting the secretary – you need to provide justification for changing it.
12. Do make sure that you have suitable information sheets for everyone who needs to give consent for the project. This includes parents or guardians, the people in charge of the venues where you want to recruit and administrators of any database you want to use. It is not OK to just put posters up in your fencing club’s rooms or to wander around handing out fliers at your gym, even if you are a member of the committee that runs it. It is also not OK to use email or address lists that you have access to for other purposes to recruit for your research without getting permission – this often constitutes a breach of privacy legislation and might well result in one of those complaints we hope not to get. And do make it clear how you got participants’ details if you are contacting them individually.
13. Do make it clear that participation is voluntary and how they can withdraw. If you are conducting an anonymous survey, it is not possible to withdraw once the survey is submitted, so do not tell potential participants that they can withdraw any time! In writing withdrawal criteria, do not assume that participants will necessarily want to withdraw from an interview just because they become upset when talking about a sensitive issue – they should also be offered options like skipping questions (unless not having answers to all questions will invalidate your data) or resuming the interview at a later date.
14. Do provide information about where participants can go to get support/help if they become upset or experience any negative consequences from their participation (eg an allergic reaction to a drug being tested). Some committees insist that this be included in all information sheets while others will waive it if you are collecting eg anonymous information about favourite toothpaste brands. There may be a standard wording or you may be able to vary it depending on the likelihood of problems – so you may be able to say “it is unlikely that you will become upset but if you do…”. Note that: (1) the fact that you are a qualified counsellor does not make you the appropriate person to provide this kind of support in the context of your research; (2) university counselling services are normally only available to members of the university community; (3) if it is likely that participants will become upset as a result of their participation, you should check with the support services you are listing to make sure that it is OK to list them.
15. Do include any exclusion and/or inclusion criteria – age, gender, health status etc – as well as other provisos eg advice from a medical practitioner about undertaking vigorous exercise.

The consent form

Note that you do not (normally, in Australia) need a consent form when you are collecting anonymous data. It is assumed that participants provide consent by submitting their survey forms (either in paper or on-line). Your information sheet should, however, state that this is the assumption.

A consent form should make it clear who is consenting and to what (so include the title of your research) and state that they have had the research explained to them to their satisfaction. It may or may not require witnessing, depending on the kind of research you are doing and the local requirements. Note that if it does require a witness, you as researcher are not appropriate, although in some circumstances you may be required to sign that you have explained the research to the participant.

If there are several parts to your research eg an interview, a focus group and a named survey, then you should list each separately, especially if it is possible to participate in some but not all of them.

There are some items to which participants need to give specific consent, usually because of legal requirements. In Australia, participants must give specific consent to both audio and video recording. Other likely activites are any invasive procedure, any trial of drugs or other therapies and any activities that could put participants at physical risk (eg vigorous exercise). You may be required to include specific wording that acknowledges the identified risks – ask for advice from the Secretary.

I hope this helps and look forward to questions and comments