ORAL CONSENT SCRIPTS

Guidance

The following is a general guide to writing an oral consent script and provides some suggested text and points to cover within such a script.[1]

You should submit a simple, adapted oral consent script as part of your CUREC application if you intend to use an oral consent process in your project. In practice, participants will not see this script.You can use it to confirm the terms of the research contract to them and obtain their oral consent to participate.
An oral consent process can be

  • Type 1) a written information sheet to be read at information stage, plus an oral script to gain consent from the participant, or
  • Type 2) a full oral script which captures both the information and consent stages.

How you arrange your oral process depends on how you will encounter your participants (eg email, phone, an on-the-street-meeting by chance). Between information and consent stage the participant should ideallybe givenat least 24 hours to think about whether to consent if possible, though this depends on the project design.

Please note:

  • It is highly unlikely that oral consent processes will be permissible when applying to the Medical Sciences IDREC. If in doubt, please contact the Medical Sciences IDREC for advice.
  • The recommended script wording is recommended for use in research involving competent adult participants or competent youths only. For children under 16, please see the Assent form in Approved Procedure 25 instead.

Further information on written and oral Informed Consent is available at

All sections which require amendment and/or additional information are highlighted yellow.

Optional statements are highlighted turquoise – delete if not applicable to your study.

Type 1: Oral Consentonly

[Where separatewritten participant information sheet has already been read by the participant, ideally at least 24 hours before oral consentis sought if possible.
Record this consent process using a digital recorder (if participant has consented to this) or by using aRecord of Consent Form.]

Hello again, I’m [name] from the University of Oxford and I wanted to talk to you about the project I gave you an information sheet about before. To recap, the broad aims of my project are [x].

Are you still interested in taking part in the project? [Await confirmation].Now I’d like to confirm some of the details of the project to make sure you understand what’s involved for you:

  • It’s a project about [x] and it’s being used for my [undergraduate project / my postgraduate project / a paper I’m writing].
  • If you take part, I’ll need you to [describetask/survey/interview] lasting approximately [x minutes / hours] at [location].[I may also contact you for follow-up interviews.]
  • The following risks are involved in taking part: [list risks and how you will mitigate these.]
  • You may find aspects of this interview distressing as I’ll be asking for your opinions about [sensitive issues].
  • You don’t have to say yes to taking part; you can ask me any questions you want before or throughout; you can also withdraw at any stage without giving a reason and without any negative consequences.
  • You are aware thatan Oxford University Research Ethics committee has approved this research project and how to contact me (in the first instance) or the committee in case of any concerns or complaints. I have given you the project’s ethics reference number and relevant contact details. To reiterate: their contact details are [for SSH IDREC studies]/ [for OxTREC studies].
  • [I won’t keep any of your details for longer than necessary / I won’t use your name next to data you provide, unless you insist on the opposite / I will ask your permission for quoting you directly in research publications]
  • I will safely store your data [explain how/add location] and will keep the research data for a minimum of (x) years.[2]
  • I will [audio record you / take photographs of you / video you] unless you say that I can’t.
  • You’re aware that my written work will be published online [for doctoral students or other qualifications or research where a thesis, dissertation or other research output will be published in the Oxford Research Archive].
  • The project may/will be/will not be published in a(n) [academic journal/ book / website].
  • [If collecting sensitive personal data]: Are you happy for me to collect [detail sensitive personal data]?
  • Are you still willing to take part? Do you give your permission for me to re-contact you to clarify information?

[Await confirmation]So if you’re happy with all of that, and have no more questions, let’s start.

Type 2: Full Oral Information Giving and Consent SeekingProcess

Record this consent process using a digital recorder (if participant has consented to this) or by using a Record of Consent Form.]

[Oral information giving stage]

Hello, my name is [x]. I’m doing some research and I wondered if you’d be interested in being involved.I’m currently [doing my first degree (undergrad) /a DPhil /Masters student / a researcher] at theUniversity of Oxford in [Department/Faculty]. My research is on [describe project briefly]. Can I tell you more about the study? [Await confirmation]

In my study, I want to investigate [project aims]. I’m interested in [describe topic and type of person or persons which make up planned research population]. If you choose to be apart of this project, here is what will happen:

[For interviews/surveys/ tasks:] I will[have a conversation with you/ give you a survey / task [add length, location, any follow-up interviews]where I will ask a whole range of questions about [insert range of questions].

The [answers / data] you givewill form the basis of my[undergraduate essay/ DPhil thesis / research publication]. The personal information you will share with me will not be passed to any third party. [Add by whom and how anonymised research data will be handled, describing confidentiality/anonymity arrangements.]

This research is anonymous, which means that in any publications, your name will not be used, unless you insist on the opposite. [Or: I will use your name in my publications – is that ok with you?]
The following risks are involved in taking part [list risks, e.g. an interview could cover sensitive issues.] In order to mitigate any potential risks, I will [add how you will mitigate risks].

Taking part is completely voluntary and we can stop any time you like without giving a reason and without any negative consequences.

With your permission, I would like to make an audio recording of our discussion to make sure I’m getting an accurate record of your thoughts. Alternatively, I can take notes in my notebook. Which would you prefer? I may want to re-contact you to clarify information you gave me in your interview. In that case, I will ask you if you have time to answer some more questions.

If you agree to take part in this project, the research will be written up as a [thesis / dissertation/ article / book].

[For doctoral students or other qualifications or research where a thesis, dissertation or other research output will be published in the Oxford Research Archive]: On successful submission of the [thesis / dissertation], it will be deposited both in print and online in the University archives, to facilitate its use in future research.[3]

The research may/willalso be published in academic journals / online / books.

If you have any complaints or concerns please feel free to contact me in the first instance. My mobile is [mobile number – give local number if available]. You can also reach me at [Oxford University email address].

This research project has been reviewed and approved by an Oxford University ethics committee. If, after contacting me with any concern, you remain unhappy and wish to make a formal complaint, please contact the ethics committee. Their email is . I will also give you their postal address and this project’s ethics reference number. [For applications reviewed by the Oxford Tropical Research Ethics Committee (OxTREC), please insert the contact details for the local ethics committee which has reviewed your study].

Do you have any questions?

[Oral consent seeking stage, after participant has had sufficient time to think about whether s/he wants to take part]

Do you give your permission for me to [interview you/ take your photo/ video you? Do you give me permission to audio record you?] Do you give your permission for me to re-contact you to clarify information?

[If collecting sensitive personal data]: Are you happy for me to collect [detail sensitive personal data]?

Are you happy to take part?

Ok, thanks, in which case let’s start.

1

Template_Oral_Consent_Version 1.1 October 2016

[1]The informed consent templates may not be appropriate for all types of research, e.g.ethnographic research, or where consent is obtained in an emergency setting or with elite interviewing. You should still follow relevant guidance from Professional Associations,our Best Practice Guidance and provide details in your CUREC application as to how you will obtain consent as appropriate from participants in the research.

[2] This should be a minimum of three years after publication according to University Policy, or longer depending on funder requirements.

[3] Oxford students following D.Phil., M.Litt. and M.Sc. (by Research) courses should refer to