informed Model Consent Form

INFORMED CONSENT FORM TEMPLATE

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Informed consent form

Addressing future reuse of research data

This template can be used by researchers to gain informed consent to conduct research that collects data

from people using questionnaires, observations, interviews, diaries, focus groups, video recordings, etc. It

pays particular attention to ensure that research data can be curated and made available for future use,

as well as addressing all standard requirements of a consent form. Also, this version of our template is

consistent with our current knowledge of the requirements of the General Data Protection Regulation

(GDPR) which comes into effect from 25 May 2018.

The informed consent form should be accompanied by an information sheet that

describes:

1. General information about the research and the collected research data

• Purpose of the research

• Type of research intervention, e.g. questionnaire, interview, etc.

• Voluntary nature of participation

• Benefits and risks of participating

• Procedures for withdrawal from the study

• Usage of the data during research, dissemination and storage, including how the information will

be shared with participants and any access and benefits-sharing that may be applicable (e.g.

traditional knowledge under the Nagoya protocol)

• Future publishing, archiving and reuse of the data, explaining to participants the benefits of data

sharing and indicating whether research data will be deposited in a recognised repository,

naming the organisation responsible for the repository (e.g. UK Data Service, your institutional

repository, etc.)

• Contact details of the researcher, as well as their organisation, funding source, how to file a

complaint.

• This is a template to assist researchers in the design of their informed consent form. You must

adapt this template to the requirements of your particular study, using the notes and suggestions

provided.

• Before using this template, check whether your organisation provides a template consent form and

if so, incorporate their requirements into the form (e.g. with regards to data protection).

Template form

April 2018

INFORMED CONSENT FORM TEMPLATE

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2. Additional information if personal information is collected from participants (for example their

name, where they live, information that can disclose their identity)

• How personal information will be processed and stored and for how long (e.g. signed consent

forms, names or email addresses in online surveys, people’s visuals in video recordings)

• Procedures for maintaining confidentiality of information about the participant and information that

the participant shares

• Procedures for ensuring ethical use of the data: procedures for safeguarding personal

information, maintaining confidentiality and de-identifying (anonymising) data, especially in

relation to data archiving and reuse.

3. General Data Protection Regulation considerations

• Researchers undertaking research within or outside the EU, and where personal data will be

stored within the EU, need to comply with the requirements of the GDPR from 25 May 2018

• Researchers will need to identify for which of the six lawful reasons

personal data will be

processed; this will inform what the information sheet and the informed consent form should

include

• If the reason is consent, it needs to be freely given, informed, unambiguous, specific and

affirmative; participants need to be able to withdraw their consent for the processing of personal

data (this will not affect the lawfulness of the processing up to that point)

• The information sheet should also contain some specific information including:

o The contact details of the Data Controller (the entity that determines the reason for

processing personal data, this can be a responsible person within the researcher’s

organisation or the researcher), and the organisation’s dedicated Data Protection Officer

o Who will receive or have access to the personal data, including information on any

safeguards if the personal data is to be transferred outside the EU

o A clear statement on the right of the participant to request access to their personal data

and the correction (rectification) of removal (erasure) of such personal data

o A reminder that the participants have the right to lodge a complaint with the Information

Commissioner’s Office (ICO).

o The period of retention for holding the data or the criteria used to determine this. (If data

are to be archived for re-use, then the retention period should be indefinite.)

https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/

INFORMED CONSENT FORM TEMPLATE

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Informed Consent for [name of study]

Please tick the appropriate boxes

Yes

1. Taking part in the study

I have read and understood the study information dated [DD/MM/YYYY], or it has been read to me. I

have been able to ask questions about the study and my questions have been answered to my

satisfaction.



I consent voluntarily to be a participant in this study and understand that I can refuse to answer

questions and I can withdraw from the study at any time, without having to give a reason.



I understand that taking part in the study involves […………………………………………………].

If there is a potential risk of participating in the study, then provide an additional statement:

I understand that taking part in the study has [………………………………….] as potential risk.



2. Use of the information in the study

I understand that information I provide will be used for […………………………………….……].



I understand that personal information collected about me that can identify me, such as my name or

where I live, will not be shared beyond the study team.



If you want to use quotes in research outputs, add: I agree that my information can be quoted in

research outputs.

If you want to use named quotes, add: I agree that my real name can be used for quotes.

If written information is provided by the participant (e.g. diary), add: I agree to joint copyright of the

[specify the data] to [name of researcher].



At times this should be restricted to the researcher only.

List the planned outputs, e.g. reports, publications, website, video channel etc., using the same terms as you used in

the study information sheet.

Consider whether knowledge sharing and benefits sharing needs to be considered, e.g. for indigenous knowledge.

Describe in a few words how information is captured, using the same terms as you used in the information sheet, for

example: an audio-recorded interview, a video-recorded focus group, a survey questionnaire completed by the

enumerator, an experiment, etc.].

For interviews, focus groups and observations, specify how the information is recorded (audio, video, written notes).

For questionnaires, specify whether participant or enumerator completes the form.

For audio or video recordings, indicate whether these will be transcribed as text, and whether the recording will be

destroyed.

Notes

1. Black text forms the standard content of a consent form

2. [Insert specific information in the highlighted square brackets]

3. Text notes in the grey boxes provide guidance only and are to be removed in the final consent form

4. Blue text indicates optional statements to add

INFORMED CONSENT FORM TEMPLATE

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3. Future use and reuse of the information by others

I give permission for the [specify the data] that I provide to be deposited in [name of data repository]

so it can be used for future research and learning.



4. Signatures

_______________________ ____________________ ___________

Name of participant [IN CAPITALS] Signature Date

For participants unable to sign their name, mark the box instead of signing

I have witnessed the accurate reading of the consent form with the potential participant and the

individual has had the opportunity to ask questions. I confirm that the individual has given consent

freely.

______________ _________ ____________________ _________ __

Name of witness [IN CAPITALS] Signature Date

I have accurately read out the information sheet to the potential participant and, to the best of my

ability, ensured that the participant understands to what they are freely consenting.

_______________________ ___________________ _ ________ __

Name of researcher [IN CAPITALS] Signature Date

5. Study contact details for further information

[Name, phone number, email address]

Specify in which form the data will be deposited, e.g. de-identified (anonymised) transcripts, audio recording, survey

database, etc.; and if needed repeat the statement for each form of data you plan to deposit.

Specify whether deposited data will be de-identified (anonymised), and how. Make sure to describe this in detail in the

information sheet.

Specify whether use or access restrictions will apply to the data in future, e.g. exclude commercial use, apply

safeguarded access, etc.; and discuss these restrictions with the repository in advance.