Obtaining Informed Consent

In this post we explore types of consent and best practice for constructing a written consent form.

Two people holding hands or shaking hands in agreement
Photo by Aarón Blanco Tejedor on Unsplash

Contents

Introduction

Once your participants have had the opportunity to review the information in your Participant Information Sheet (PIS), they may decide to take part in your study. This agreement to take part is known as informed consent and must be recorded by the researcher.

There are a number of different ways of recording consent, depending on the type of study being conducted and the specific groups of individuals who are taking part.

The main types of informed consent are:

1. Written consent

Written consent is provided by signing or marking (e.g. thumbprint) a written consent form.

2. Verbal consent

Verbal consent is provided by asking the participant a series of questions (through the use of a consent script) and recording their verbal agreement to each statement. The recording can be done either by audio recording or through the use of detailed field notes. If field notes are used, you must include the participant’s name, the date on which consent is being taken and the specific statements they are agreeing to.

3. Implied consent

Implied consent is provided by ticking a box at the beginning of a questionnaire or survey in order to verify consent. In some cases, more than one tick box may be required if there are specific inclusion or exclusion criteria that you need to verify for your study (i.e. the participant being over 18 years of age, from a specific background or the user of a specific service) Please note that a full participant information sheet must still appear before the tick box.

Notice on a wall with information/instructions
Photo by Bianca Ackermann on Unsplash

However, there are cases where it is not possible to seek informed consent from participants such as when using publicly available data sets from Twitter or performing large scale observational studies in public spaces (e.g. parks).

In these cases, although informed consent will not be taken, it’s important to consider how you will protect the confidentiality of participants. If conducting observational studies you should produce an information sheet and have this available in case you are approached by a member of the public.

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Knowledge check

Lets take a look at what you have learned. Read the case study below and choose an option from the multiple choice questionnaire below it. You may choose more than one option.

‘You want to conduct a research study about the use of illegal stimulants by various types of students and want to distribute an electronic questionnaire to find out why students take these substances and specifically how they purchase them. Given the subject matter, you feel that the best way to recruit participants would be to post your advertisement on Reddit, as accounts on this platform are anonymous and the identity of the participants would be protected. Your advertisement includes a brief summary of your research as well as a link to the questionnaire’.

“Given that the participants will all be anonymous, how will you ensure you have informed consent from all participants?” An accessible version of the above quiz question is available with the possible answers here.

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Written versus verbal consent

Depending on the study you’re undertaking and the specific group of participants you hope to recruit, you may need to decide whether written or verbal consent is more appropriate.

group sat at a picnic bench handwriting notes in exercise books whilst chatting
Photo by Alexis Brown on Unsplash

Written consent is the preferred method of the ethics committees as it assures a standardized written record of specifically what the participant agreed to. This method uses a standard template of initialled or checked boxes that correspond to specific statements which may be compulsory in order to take part in the research or optional.

Compulsory: ‘I agree to take part in the study.’

Optional: ‘I agree that my anonymized data may be shared with other researchers at the University of Manchester.’

It is recommended that you ensure all optional statements are last to avoid any potential confusion.

Verbal consent may be appropriate for studies conducted with vulnerable groups or those who require that the information is read out to them. For example, if your research focused on the lived experiences of undocumented migrants in Manchester, the participants may be leery of signing any official document. In this case, it may be more appropriate to take verbal consent. If using this method, you can adapt the template for the written consent form into a consent script where you read aloud each statement and then ask the participant to agree.

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One off versus ongoing consent

Another important consideration regarding informed consent is how many times you should seek it. For most studies, consent is sought and confirmed once at the beginning of the study and before any data collection takes place.

However, if your research study involves multiple visits, follow-up interviews or you’re involving vulnerable groups, you may choose to seek ongoing consent.

Ongoing consent is the re-affirmation that a participant is still happy to take part in your study. It can be given before each research activity (e.g. an interview or focus group) or can be incorporated as part of a longitudinal study.

Should you choose to take ongoing consent for your research, you’ll need to consider at which time points this should be done, how it will be recorded and what you will do if you are unable to contact the participant or they wish to withdraw from the study.

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Components of a good consent form

When constructing your consent form (or script for seeking verbal consent), it’s important to include statements that outline any specific requirements of the study as well as any optional requests that you want participants to consider agreeing to.

Some examples of statements that outline specific requirements might include:

  • ‘I confirm that I have read the attached information sheet (Version 2, Date 20/8/2020) for the above study and have had the opportunity to consider the information and ask questions and had these answered satisfactorily’.
  • ‘I agree to the interviews being audio recorded’.
  • ‘I agree that any data collected may be published in anonymous form in academic books, reports or journals’.
  • ‘I understand that there may be instances where during the course of the interview information is revealed which means that the researchers will be obliged to break confidentiality; and this has been explained in more detail in the information sheet’.
  • ‘I agree to take part in this study’.

Some examples of statements that include optional requests might include:

  • ‘I agree that any anonymised data collected may be shared with researchers at other institutions’.
  • ‘I agree that the researchers may contact me in future about other research projects’.
  • ‘I agree that the researchers may retain my contact details in order to provide me with a summary of the findings for this study’.

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Important tips to remember

Ensuring you have outlined all the specific requirements of participation as well as any optional requests will help your participants understand exactly what they are or are not agreeing to. To support this, please ensure you ask the participant to complete two copies of the consent form, one for you as the researcher and one for the participant to keep.

When constructing your consent form try to remember this best practice advice:

Always use a UK GDPR compliant template, which can be downloaded from the research ethics website.

Any points that are essential to participation in the study should be listed first with any optional points grouped together at the end. For additional clarity consider separating optional points into a new table.

Remove any statements which are not relevant to your study to avoid confusion. For example if you’re not planning on sharing data with others.

The template provided on the research ethics website contains words in red that need to be changed or deleted to match the specifics for your study. It also contains guidance notes (e.g. in the header) that should be removed from your final consent form.

Update the footer with a correct version number and date for your form. This will help to ensure that your participants are receiving the most up to date version, should you choose to make changes in future.

Number statements chronologically.

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Knowledge check

Let’s take a look at what you have learned. Read the case study below and choose an option from the multiple choice question below it. You may choose more than one option.

‘You want to conduct a research study that learns about the Jedi religion, how followers became involved and what types of fundamental teachings are learnt and disseminated.

To do this, you want to conduct focus groups with participants, audio record the discussions and use direct quotes. You’d also like to take photographs of the groups for your Twitter feed and blog, where you’ll include some of the quotes and also a summary of the project. In order to gain access to the group, you’re going to seek permission from religious leaders’.

“In order to disseminate your findings in this way, what must you seek consent for?” An accessible version of the above quiz question is available with the possible answers here.

Tip: If you are unsure what gatekeepers are, take a look at this post; ‘Recruitment of research participants’.

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Summary

In this post we explored best practice and considerations for obtaining informed consent including types of consent and constructing a written consent form. However, if your research is with children or vulnerable groups, there are additional considerations. We recommend you take a look at these posts next, they are linked from the further support section below.

Take a look at our further support posts linked below or go back to the full list of posts in this series here.

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