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  • Service manual
  • User research

Getting informed consent for user research

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Whenever you do user research, you must get the participant’s ‘informed consent’. This means getting a record from them to show they understand your research and agree to take part.

By getting informed consent, you’ll help make sure that:

  • participants understand what they’re signing up to, making your sessions more effective
  • your research is ethical
  • you comply with data protection law

You need to get consent from all research participants, even if they work for your organisation.

What informed consent is

For consent to be informed, participants must understand:

  • who is doing the research
  • the purpose of the research
  • what data you’re collecting
  • what will happen during the research
  • how you will use the results of the research, and who you’ll share them with
  • that their participation is voluntary, and that they can stop or withdraw their consent at any time
  • how long their data will be kept
  • what their rights are and how they can complain

You must also let participants know:

  • whether the session is being observed (and who’s watching)
  • whether and how the session is being recorded

You must also tell participants how you’ll handle their personal data, including:

  • which organisation is responsible for their data (known as the ‘data controller’) so the participant knows who to contact if they want to stop taking part in the research or make a complaint
  • any other organisations that will be processing the data, for example transcription services, or staff from a design agency working in your team

Getting informed consent

We recommend that you provide participants with an ‘information sheet’ during recruitment.

This is a document that gives them the information they need to give their informed consent, and tells them about their rights.

Information sheets also help to ensure that participants:

  • are prepared and not surprised by the research activities they will be involved in - make sure you give them the sheet before the research session
  • know how you will be recording the sessions and any data you want to collect
  • do not feel pressured to agree to things they’re not comfortable with

Designing your information sheet

Write your information sheet in language your participants can understand.

Check with your organisation’s data protection expert or legal adviser that your document complies with the law.

When you provide the information sheet to participants, make sure it’s in a format they can use. For example, you can send a printed information sheet by post, attach it to an email, or offer to read it aloud during a phone call.

Managing user research data

When running your sessions, you’ll collect research data like:

  • notes, photos, audio or video recordings
  • responses from any questionnaires you receive
  • copies of paperwork

You must carefully manage the research data you collect . This includes using it only within the consent you get and deleting it when you no longer need it.

Collecting and keeping evidence of consent

Write your consent form in language your participants can understand, and provide it in a format they can use.

For face-to-face research sessions, the simplest way to collect evidence of consent is to have the participant sign a paper consent form. You can scan and keep a copy of this consent, and then shred the paper version.

For remote research sessions, you can send the participant the consent form by email or post, and ask them to reply confirming their consent. You can then keep a copy of the correspondence.

You could also get verbal consent on the recording, as long as the participant has read the consent form you’ve sent them.

For online surveys, you can provide information and collect positive confirmation of consent as the first step.

You can also collect and record verbal consent from a participant. You can then keep a copy of the consent script and the part of the recording which provides evidence of consent.

You must keep evidence of the consent you get from each participant, and what they have consented to.

Keep the record of consent with the research data it covers. And make sure you can match the record to the data. For example, by using the date it was collected, the research round number and the participant number to name the scan of a consent form.

Getting consent from disabled people

If you’re doing a research session with a disabled person, make sure they can use and understand the information sheet and consent form. This is important to make sure you get their informed consent.

If someone has a visual or cognitive impairment, you can offer to read the form aloud and ask if they need help signing it. You can also check before the session whether they need a digital version so they can read it using assistive technology.

If someone has a motor impairment they might not be able to sign the form themselves. You can record them giving you verbal consent instead.

 Getting consent for children or vulnerable adults

If you want to do research with children or vulnerable adults (people who are unable to take care of themselves or are at risk of harm or exploitation), you need to get informed consent both from the participant and from a parent, guardian, carer or other responsible adult.

If you have any concerns about this, find out what’s best practice in your department or organisation.

Withdrawing consent

Participants’ participation is voluntary and they can stop or withdraw their consent at any time.

As well as making this clear during recruitment, you should remind participants at the beginning and end of their research session, and at any point during a session if you’re not certain you have the participant’s continued consent. For example, if they seem uncomfortable with a research activity or confused about how you will use the data you’re collecting.

If a participant withdraws their consent during a research session, you must stop and delete any research data you’ve collected.

Dispose of paper notes in confidential waste and securely delete relevant recordings, files and database entries.

You must do the same if the participant withdraws their consent after the session, or if you find you have some research data without any associated consent.

You must name and organise the research data you collect in a way that allows you to respond if a participant withdraws their consent.

Related guides

You may also find these guides useful:

  • Finding participants for user research
  • Managing user research data and participant privacy

You might also want to read about the:

  • Nuremberg Code 1947
  • Helsinki Declaration 1964
  • Economic and Social Research Council framework for research ethics

Added extra information on withdrawing consent.

+ Show all page updates (2)

Added guidance on getting consent from people with disabilities.

Guidance first published

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Informing participants and seeking consent

With the Medical Research Council (MRC) we provide an online tool that gives guidance on consent and the preparation of information for participants. We do not expect applicants to simply follow a template, so our guidance will help you to design appropriate and proportionate information.

Our online consent guidance:

  • provides information on the principles of consent and how these principles relate to the preparation and use of participant information and consent forms
  • recommended content of participant information and consent form as well as information about the design and style of a participant information sheet and consent form
  • covers consent in adults, children, young people and adults not able to consent for themselves (in both emergency and non-emergency) and takes into account UK-wide requirements
  • has separate sections that provide examples, templates and useful links
  • may be downloaded as a PDF, if required.

Other resources:

  • Applying a proportionate approach to the process of seeking consent . This guidance complements the existing  HRA online guidance for consent and participant information sheets  and reinforces our view that people who volunteer to take part in research should be provided with succinct, relevant, user-friendly information in a proportionate manner.  We are reviewing this guidance to bring it in line with General Data Protection Regulations (GDPR). In the meantime, please ensure that you also refer to the HRA’s specific GDPR guidance . 
  • Participant information quality standards and design review principles . These outline what’s expected of research in regard to how participants are informed and how consent is obtained. The standards and principles align with the other guidance we have available relating to participant information and consent, including the HRA online guidance for consent and participant information sheets .
  • Informed consent in Clinical Trial of an Investigational Medicinal Product  (CTIMPs).
  • Making written information easier to understand for people with learning disabilities . This guidance is for people who commission or produce Easy Read information – Revised Edition 2010.
  • Joint HRA and MHRA statement on seeking consent by electronic methods . This joint statement, supported and endorsed by the Devolved Administrations, sets out the legal and ethical requirements for seeking and documenting consent using electronic methods. The primary focus is clinical trials of investigational medical products (CTIMPs) but the basic principles can be applied to all research conducted within the United Kingdom. This statement is aligned with the existing HRA online guidance for consent and participant information .
  • GDPR resource for children and young people . This engaging and age-appropriate resource has been created by the HRA, Penta Foundation, University College London and UK Research and Innovation MRC Clinical Trials Unit, to help children and young people understand what will happen to their personal data if they take part in a research study. The HRA recommends that sponsors use this resource as the basic for any GDPR information provided to children as part of the consent process for taking part in research.

Related links

  • Our role protecting research participants
  • HRA publishes new proportionate consent guidance
  • Privacy notice
  • Terms & conditions
  • Accessibility statement
  • Feedback or concerns

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UCL Research Ethics

Producing participant recruitment documents

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Recruitment documents help people make informed choices about whether to participate in a research study. Find out how to write a Participant Information Sheet, example forms and further guidance.

Writing a Participant Information Sheet

Participant Information Sheets must be designed to assist participants to make informed choices. Potential recruits must be given sufficient information to allow them to decide whether or not they want to take part. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated include consideration of an appropriate process for witnessing the consent.

Researchers must take the steps necessary to ensure that all participants in the research understand the process in which they are to be engaged, including why their participation is necessary, how it will be used, and how and to whom it will be reported so that the prospective participant can make an informed decision about whether they really do want to take part.

It is highly recommended that the information provided is presented on headed paper and is accurate, clear and simple so that someone with a reading age of 8 would understand the contents (use short words, sentences and paragraphs). The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon and abbreviations, bias, coercion or any inappropriate inducements.

What should the Participant Information Sheet include?

  • A friendly invitation to participate.
  • A brief and simple explanation of the purposes of the research and a statement explaining how the participant was chosen and how many other participants will be involved in the study.
  • A statement that participation is voluntary; refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; and the participant may discontinue participation at any time without penalty or loss of benefits.
  • A thorough explanation of the expected duration of participation in the research and the procedures to be followed.
  • A description of any reasonably foreseeable risks or discomforts and any benefits to the participant. For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  • A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
  • It is considered good practice for researchers to debrief participants at the conclusion of the research and to provide them with copies of any reports or other publications arising from their participation.
  • If appropriate, a statement indicating that the data might be used for additional or subsequent research.
  • An explanation of who to contact for answers to pertinent questions about the research and the rights of the participant and who to contact in the event of a research-related injury to the participant.
  • If applicable, a statement declaring that each researcher who may have access to children (aged under 18) or vulnerable adults has undergone a satisfactory criminal records check.
  • Remember to thank your participant for considering taking part in the study and include a statement indicating that the research study has been approved by a UCL Research Ethics Committee.

Language and layout

It is highly recommended that the information provided is presented on headed paper and is accurate, clear, and simple. The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon, and abbreviations, bias, coercion, or any inappropriate inducements.

The following points should be considered when writing an information sheet:

  • Use clear, non-technical language. We recommend that you refer to the  Plain English Campaign
  • Use appropriate language for the target audience. For example, consider the different ways needed to communicate with primary school children as opposed to their teachers, or people with expertise in the area of study as opposed to people with no such knowledge
  • Divide the text into paragraphs for ease of reading
  • Consider using sub-headings for clarity, such as questions and answers
  • Make sure the font and font size are legible.

Ask someone else to review your information sheet before it is circulated.

Recruitment documents i.e., invitation letters/ emails, recruitment posters etc 

In your ethics application, you will need to upload any materials that you plan to use to advertise your study and invite potential participants. Examples include: invitation letters or emails to gatekeeper organizations or potential participants, sample social media advertisement posts, recruitment posters or leaflets. Please ensure your materials include the following information:  

  • Clearly state that this is a UCL research project, and that it is a PhD/master’s project (where relevant). 
  • Provide a clear overview of the project’s background.
  • Outline what will be expected of the participants and what the inclusion/exclusion criteria are. 
  • Specify whether you plan to compensate the participants for the time, and/or whether you plan to pay for travel expenses (where relevant). 

If you plan to post in any online groups, pages, or forums, please ensure you obtain permission from the admins or owners before posting.

Further guidance

  • Guidance on obtaining consent from research participants online (for online and in-person study designs) , Authors: Dr Pippa Lally, Behavioural Science and Health, and Jack Hindley, Information Services Division, UCL
  • Recording & Obtaining Consent , UCL Research Ethics Committee Guidance Note 2: Extract from Nuffield Council on Bioethics website

Example forms (annotated)

  • Template Participant Information Sheet  (Word)
  • Template Consent Form  (Word)

Page last updated: August 2024

Template participant consent form and participant information sheet

Providing information about the research to participants, and gaining consent from participants before their involvement is a critical part of conducting ethical research.

Participant information sheet

All participants need to be provided access to an information sheet, and to understand the full details of the research, and how they will be involved. Please use the following template:

  • Template participant information sheet
  • Template participant information sheet veterinary research

Participant consent form

Before research begins, it is important to first obtain participant’s consent on the basis of their full and proven understanding of what the research will entail. Please use the following template:

  • Template participant consent form

These templates should be followed as far as possible, as these have been developed using national guidance and expert input from Committee members and Lay Members. However, there may be times when it is appropriate to deviate from the templates in order to meet the needs of a specific research population.

The  Health Research Authority  and  UK Research and Innovation  webpages contain further guidance and templates on good practice when consenting participants.

Good practice in consenting participants

You should consider innovative ways of providing consent that are appropriate to your research population, for example, in addition to participant information and consent forms, could you provide the information using visual methods, such as a recorded video, or a study leaflet. Could you develop your forms in partnership with the communities who will take part in the study? Please see the 'informed consent' section of the  research ethics handbook for further guidance.

Back to: Research

Participant information sheets & informed consent forms

How to provide information and seek consent from research participants.

Potential participants need information on which to base their choice to take part in clinical research. It is important that information given to participants before obtaining their written informed consent is clear and concise and fully explains all aspects of the research. 

The HRA (Health Research Authority) provides detailed guidelines to help avoid delay at sponsor and ethics review. Make sure that you use the latest version.

Please also refer to: 

Guidance for researchers seeking sponsorship

File

Template consent form

Participant information sheets.

Providing an information sheet is just one part of seeking the consent of participants. The REC will consider the whole process.

  • The level of detail should be appropriate to the complexity of the study.
  • Write in simple, non-technical terms that a lay person will understand.

Discussion is the most effective way to ensure consent is 'informed'. It is important that the person seeking consent spends time going through written information and does not simply give it to the participant to read on their own. This should be outlined at the top of the information sheet, perhaps suggesting how long it may take.

Depending on your research goal, you may need to consider a number of information sheets as follows:

  • participant information sheet for adults
  • information sheet for parents/guardians (if involving children/young people)
  • information sheet(s) for children/young people
  • consultee information sheet (for consultees of adults lacking capacity to consent)

Information sheets for minors

Where the Clinical Trial Regulations apply (ie for CTIMPs), a minor is defined as someone under the age of 16. Where common law applies (all research not covered by the regulations), the law states that the age of majority is 18.

Be clear in all documentation about whether you are seeking consent or assent (seeking the child’s agreement) and, if in doubt, contact the Research Governance, Ethics & Assurance Team .

Consent requires a full explanation of the study. Assent requires a clear explanation (comprehensible rather than comprehensive) as consent will be sought from the parent.

Information sheets should be designed for each appropriate age range to reflect comprehension and development, for example:

  • children or young people 11–15 years
  • children 6–10 years
  • children 5 years and under: predominantly pictorial, with very simple sentences to be shown/read to the child. Parents need to provide consent since assent is not sought from children under 5.

Ideally such material should be shorter than that designed for adults, whilst retaining all relevant information.  

Informed consent forms

The consent form is to be designed so that the participant is consenting to everything described in the text of the information sheet. The purpose of the form is to record the participant’s decision to take part.

For some studies, specific text may be needed to cover important issues, especially if additional elements are optional for the participant. These may include:

  • additional invasive tests or samples required for study purposes only (ie additional to normal care)
  • consent to use of audio/video-taping, with possible use of verbatim quotation or use of photographs
  • transfer of data/samples to countries with less data protection
  • agreement to receive individual feedback from testing
  • requirement to contact their GP

For University-sponsored studies where samples are collected, specific wording is required. The first statement is essential; others may be used (and adapted) where required for a particular study.

  • I consider these samples a gift to the University of Oxford and I understand I will not gain any direct personal benefit from this.
  • I understand that data obtained from my samples may be used for commercial purposes and that I will not gain any financial compensation should this occur.
  • I give permission for genetic testing to be carried out on these samples.

You should consider whether leftover samples taken for research could be a valuable resource to other researchers in the future. If so, then retention should be covered in the protocol and information sheet, and the following statement included on the consent form:

  • I give consent for samples to be retained and used in future research studies.

 Depending on your research goal, you may need to consider a number of forms as follows:

  • consent form for adults
  • consent form for parents/guardians (if involving young people)
  • assent form (for young people who are agreeing to take part)
  • consultee declaration form (for adults lacking capacity to consent)  

RGEA TEAM   

Related links

  • Study preparation
  • Research governance & classification

researchers and participants around a table

Research participant information and consent

Informed consent is the process of voluntary agreement by a fully informed competent person to participate in research.

Potential participants must be given sufficient participant information to allow them to decide whether or not they want to take part in a research study.

Where research involves personal contact with the researcher such as face to face interviews, focus groups, direct observation, physiological measurements or other methods of data collection involving personal contact, participants should be given a participant information sheet (or leaflet) and would normally be asked to sign a consent form. In most cases, consent should be actively provided by the participant, but there are instances when implied consent can be used, e.g. an online survey that doesn’t collect any personal or sensitive data and is low risk.

A consent form should be a short document (normally one page but may need to be longer depending on the complexity of the study) containing explicit statements of what taking part in the research project involves and what will become of the data collected.

Writing a participant information sheet

The template for producing participant information includes some standard sections which you cannot omit but also sections which you can amend or exclude depending on your study. The guidance will help you produce the participant information by providing further explanation of parts of the participant information.

The advantage of a written Information Sheet is that you and your participants have a record of all the relevant information about the study. In most cases this is supplementary to, rather than replacing, a discussion between the researcher and the potential participant.

For some participants such as very young children, a written information sheet is not appropriate (although for children, their guardian should receive written information about the study). For other participants the information may be presented in a letter or email rather than as an 'Information Sheet'.

The participant information sheet should be designed so that potential participants of your research project can give informed consent to participate in the project.

The participant information information should:

  • Provide sufficient and appropriate information on which they can base an informed decision, including any risks and benefits
  • Be written in language that potential participants could reasonably be expected to understand
  • Be free from coercive language and promises that cannot be kept or unjustified claims of benefits
  • Be provided for each data collection tool separately so if the research involves both interviews and focus groups, there must be participant information for each activity
  • Be provided for each group of participants so for example, students receive information relevant to them and staff likewise.

Informed consent

The consent form should have tick boxes to allow the participant to consent to each of the statements and, when appropriate, allow the participant not to take part in certain aspects of the study by either agreeing or disagreeing to a statement, e.g. not consenting to their data being used in future research. Both the participant and the researcher obtaining consent should sign the form. Two forms should be signed so that the participant can be provided with a signed copy to keep for their records.

Clear evidence must be obtained that the participant has given informed consent to take part in the study. This will normally be in the form of a signed consent form although other evidence may be acceptable (for example by audio recording consent). It is recognised that there are some rare instances when it will not be possible or appropriate to ask for written consent (e.g. where there are cultural or political concerns with signing contract-like documents).

Read the guidelines on verbal consent covered under our Ethics guidance and resources page .

Opt-in consent is City’s preferred approach, as Opt-out does not reflect a conscious decision by those invited to accept or decline an invitation to participate in research. Requests for opt-out consent will only be considered in exceptional cases and a full explanation should be provided.

Download the informed consent template

Please bear in mind that the template does not cover all eventualities and needs to be tailored depending on the type of study, but, it suggests some potential scenarios.

The consent form should include the following statements:

  • I confirm that I have had the project explained to me, and have read the participant information sheet, which I may keep for my records. I have been given the opportunity to ask questions and have had them answered to my satisfaction.
  • If applicable, a statement asking the participant to consent to audio and or video recording.
  • I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project without being penalized or disadvantaged in any way.
  • I agree to take part in this study.
  • A statement that asks the participant to agree to City, University of London recording and processing this information about them and that they understand that the information collected in the study will be used only for the purpose(s) set out in the consent form.
  • A statement that asks the participant to confirm that they understand how their data will be handled (e.g. stored, destroyed, sharing, what it will be used for).

In addition to the above it would be expected that explicit consent for the following is obtained where applicable:

  • Reuse of data and an explanation what the data will be used for, as well as reassurance that the data will only be reused in studies which have been given ethics approval.
  • The use of direct quotes.
  • Sharing data outside the research team (e.g. with collaborators).
  • If using anonymous online/paper surveys, a statement that asks the participant to confirm that they understand that their data cannot be withdrawn and/or when it is no longer possible to withdraw their data, e.g. once the data has been anonymised.
  • A statement that asks the participant to confirm that they understand that their anonymous data will be made open access, e.g. to underpin journal publication or to meet funding requirements.

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Consent forms and participant information sheets

  • Research Governance

The University of Cambridge expects that free and informed consent will normally be obtained from all human participants in research at an appropriate point in the research process. Where it is not possible, due to the nature of the research or participants, it is normally expected that the project will undergo the appropriate ethical review process to approve the use of participant data without free and informed consent.

Failure to obtain free and informed consent may unnecessarily restrict your ability to use data, publish results and share data.

While it is sometimes possible to obtain oral consent for research (e.g. where data is collected through audio or video recordings) it is normally most appropriate to obtain consent through provision of a participant information sheet (PIS) and consent form in either written or electronic form.

As part of the University's guidance for researchers on the use of personal data, guidance has been provided to help with the preparation and use of PIS and consent forms. For this guidance please see:

  • Section G - Participant Information Sheets
  • Section H - Consent Forms
  • Section I - Data Sharing and Re-use
  • Section J - Further Guidance

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Templates and documents to download

Template participant information sheets and consent forms.

  • Template participant information sheet
  • Easy-read participation information sheet
  • Template participant consent form
  • Template participant consent form - low risk observations
  • Easy-read participant consent form
  • Consent for questionnaires/surveys  (includes example introductory paragraph)

Data Management

Basic Data Management Plan template

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Oxford University Hospitals NHS Foundation Trust

  • Research and Development
  • OHSRC research grants

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Informed consent is at the heart of ethical research .

Informed consent should be freely given and each participant should be fully informed .

Informed consent must be obtained from every participant , unless they are incapacitated (see below), or the research involves use of patient-identifiable information without consent.

  • Confidentiality Advisory Group - www.hra.nhs.uk

Informed consent is a process by which a subject voluntarily confirms willingness to take part in Clinical Research, after having been informed of all aspects relevant to their decision to participate.

Written and verbal versions of the information will be presented to the subject detailing no less than:

  • the exact nature of the research
  • the implications and constraints of the protocol
  • the known side effects and any risks involved
  • the fact that they are free to withdraw from the trial at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.

Written participant information sheets must have the approval of a Research Ethics Committee (REC).

  • Participant Information Sheets - researchsupport.admin.ox.ac.uk

Participants must be allowed as much time as needed to consider the information, and to question the investigator, their GP or other independent parties. Consent will be documented on a consent form (also approved by a REC), which is signed and dated by the participant and the person who presented informed consent.

  • Informed Consent Forms - researchsupport.admin.ox.ac.uk

A copy of the signed form will be given to the subject.

Persons taking informed consent must be appropriately trained and authorised to do so by the Chief / Principal Investigator. The research team should be aware that the participant information sheet should, at all times, reflect the full information available for the research. Any new information should be promptly addressed in an amendment, reviewed by OUH R&D Department when the Trust is Sponsor, then submitted to the relevant REC, MHRA and the relevant NHS trusts for approval.

Consent in CTIMPs involving incapacitated participants

The Clinical Trials Regulations 2004 allow for inclusion of incapacitated adults in a CTIMP so long as:

  • consent is given by a legal representative on behalf of the participant
  • the trial relates directly to the condition from which the participant suffers; and
  • the benefits outweigh the risks, or produce no risk at all.
  • Medicines for Human Use (Clinical Trials) Regulations 2004 - www.legislation.gov.uk

The Clinical Trials Amendment (No. 2) Regulations 2006 allow for inclusion of incapacitated adults in emergency research without consent by their legal representative if:

  • treatment is required urgently
  • the nature of the trial is such that urgent action is essential e.g. clinical trials in emergency care settings
  • obtaining consent from a legal representative is not reasonably practicable, and
  • a REC has given approval.
  • Medicines for Human Use (Clinical Trials) Amendment (No. 2) Regulations 2006 (pdf) - www.legislation.gov.uk

The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 extends the exception to minors as clinical trial participants.

  • Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (pdf) - www.legislation.gov.uk

Consent in clinical research involving incapacitated participants

Research Studies involving adults aged 16 or over who lack capacity must comply with the Mental Capacity Act 2005 .

  • Mental Capacity Act - researchsupport.admin.ox.ac.uk

In this section

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  • Evidence & Evaluation
  • Research ethics guidance

Templates: Consent Forms

Share content.

Consent form guidelines 

(This accompanies Core Document, Sections E, F, and G)

The informed consent process requires that prospective participants, and/or their legal guardians/advocates, are provided with sufficient information about a research project to make a knowledgeable decision about whether or not they want to take part. Consent forms can be provided together with the information sheet but consent should not be sought until after the participant has read and had time to consider all the information provided.

This template is designed primarily for those doing qualitative interviews with adults from non-vulnerable populations and dealing with non-sensitive topics, or children where parental consent is also being sought. The points listed on the template below are for illustration only. You may alter the wording to suit your project as you see fit. For example, the form would be different in the case of focus groups or quantitative research. If conducting research with vulnerable populations and/or sensitive topics, please see template 4 and 5 for further details.

A consent form is not simply about a person giving you permission to involve them in research/evaluation, it is an agreement between the researcher/evaluator and the participant outlining the roles and responsibilities they are taking towards one another throughout the whole of the process. The researcher/evaluator should retain one copy of the consent form signed by both themselves and the participant. The participant should also be given a copy of the consent form as a record of what they have signed up to.

Download Template 4

Download Template 5

research consent form uk

Understanding health research - MRC

Consent for research.

If you intend to recruit people as participants in your research, then appropriately informed, voluntary consent is the most likely way for you to do so. Consent plays a key role in ethical research and in ensuring research participants are treated fairly and with respect. The consent process should help potential participants understand what taking part in your research will mean for them, enable them to make an informed choice about whether to take part (or not) and feel free to express these wishes.

You can learn more about the ethical and legal principles of consent as well as how to structure and design materials to support the consent process in MRC and HRA consent and patient information sheet preparation guidance .

You can find guidance on involving specific populations in your research (for example adults who cannot consent, children and young people) in the MRC Ethics Series .

You can learn more about UKRI’s expectations for involving people in research from the good research resource hub Human participants in research .

If you will use or share identifiable data in your research, consent plays an important role. However, consent is unlikely to be your lawful basis under GDPR. You can learn more about lawful basis in Using data about people in research .

Consent is not the only way to ensure research is ethically and or legally acceptable. There are options to allow human samples or data about people to be used in research without consent. You can find further details about this in:

  • page two of our consent summary . This explores the legal exemptions which allow you to use human samples without consent, where obtaining consent is not practicable
  • ‘accessing identifiable information’ without consent in the using information about people in health research guide.

Last updated: 11 January 2023

This is the website for UKRI: our seven research councils, Research England and Innovate UK. Let us know if you have feedback or would like to help improve our online products and services .

The University of Manchester


Research Ethics Consent Form Template

Guideline

School of Arts, Languages and Cultures  





12/09/2018


https://documents.manchester.ac.uk/display.aspx?DocID=17575




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research consent form uk

Consent forms for SACT (Systemic Anti-Cancer Therapy)

research consent form uk

Useful links

Patient information about cancer drugs 

Immunotherapy and its side effects  

About cancer registration  

Patient information about your type of cancer   

We are working with Guy’s and St. Thomas’ NHS Foundation Trust to produce national standardised SACT regimen-specific consent forms.

We want to support clinicians in ensuring all patients are fully informed when consenting to SACT. These forms are endorsed by the UK Systemic Anti-Cancer Therapy Board (UK SACT Board).

Who has approved the content in these forms?

The programme is being led by a dedicated Cancer Research UK funded oncology pharmacist at Guys’ and St. Thomas’ NHS Foundation Trust.

All forms are independently checked by an oncology/haematology pharmacist, oncology/haematology consultant and member of the UK SACT Board.

The consent forms and guidance document are available to download in PDF format. Forms are grouped by tumour-site.

If you have specific queries or are looking for something not covered here, please email the pharmacist.

[email protected]

SACT Form update

SACT consent forms are currently being reviewed on a rolling schedule. Please see FAQs for order of roll-out. Republication dates may exceed the date of review indicated on each form. All forms are valid until new versions are available.

What's new?

  • 18th June 2024:  : Guidance on consent for SACT reviewed and updated
  • 11th June 2024:   Urology – Germ cell cancer: Forms updated
  • 14th May 2024:  Neuroendocrine and adrenal cancers: Forms updated
  • 13th May 2024 : Urology Prostate cancer: New form added for Darolutamide -Docetaxel with ADT
  • 8th May 2024:  Breast – New forms added and some forms updated
  • 27th March 2024: Sarcoma – New consent forms uploaded
  • 22nd March 2024: Acute Lymphoblastic Leukaemia (ALL) – New consent forms uploaded
  • 21st March 2024: Guidance on electronic consent for SACT reviewed and updated
  • 15th March 2024 : Skin cancer (non-melanoma) SACT consent forms updated
  • 29th December 2023 : Updates to Lenvatinib and Atezolizumab + Bevacizumab for HPB

Frequently Asked Questions (FAQs)

Which tumour site group’s forms are available and when will they be reviewed.

The regimen-specific forms have been published for the following tumour site groups. Each group of forms will be reviewed on a rolling schedule every three years. The process by which each group of forms is revalidated may result in the republication dates exceeding the date of review indicated on each group of forms. All forms are valid until new versions are made available.

Acute Lymphoblastic Leukaemia (ALL)  In development
Acute Myeloid Leukaemia  Apr-21 Apr-24
Brain & CNS Apr-23 Apr-26
Breast  Mar-20  Mar-23
Children & Young Person ALL Aug-23  Aug-26
Children & Young Person Generic  Sep-22  Sep-25
Chronic Lymphocytic Leukaemia (CLL)  Nov-23 Nov-23
Chronic Myeloid Leukaemia (CML)  Jul-23  Jul-26
Colorectal  Jun-22  Jun-25
Gastrointestinal Stromal Tumour (GIST)  Jul-23 Jul-26
Generic English SACT & Immunotherapy  Nov-23 Nov-26
Generic Welsh SACT & Immunotherapy  Dec-16 Dec-19
Gynaecological  Jan-21 Jan-24
Head & Neck  Aug-22 Aug-25
Hepatobiliary Aug-17 Aug-20
Kaposi Sarcoma  Jul-23 Jul-26
Lung  Oct-22 Oct-25
Lymphoma  In development
Multiple Myeloma  In development
Myeloproliferative Neoplasms (MPN)  Jun-19 Jun-21
Neuroendocrine & Adrenal  Jan-19 Jan-22
Oesophagogastric  Aug-17  Aug-20
Sarcoma  In development
Skin – Melanoma  Feb-21 Feb-24
Skin – Non-Melanoma  Nov-18 Nov-21
Supportive Medicines  Jul-20 Jul-23
Thyroid  Mar-22 Mar-25
Urology – Bladder  Mar-21 Mar-24
Urology – Germ Cell  Mar-21 Mar-24
Urology – Prostate  Aug-22 Aug-25
Urology – Renal Cell Carcinoma  Aug-22 Aug-25
Urology – Small Cell   Aug-22  Aug-25

Please check the website regularly (e.g. once a month) for new forms and updates.

What happens when a new regimen is commissioned before the consent form group is due to be revalidated?

We are working to develop and publish consent forms in time with publication of positive NICE (England), AWMSG (Wales), SMC (Scotland) and HSCNI (Northern Ireland) determinations.

What should I do if I cannot find the regimen-specific form that I need?

We encourage Trusts to use the generic SACT or immunotherapy forms where a regimen-specific form is not available. Please get in touch with the project lead pharmacist so that this can be discussed with the tumour-specific lead consultant for development. Contact details for the project lead pharmacist are found at the end of this document.

When will consent forms for the haematology groups be available?

CML, CLL, MPN, and AML consent forms have now been published. ALL, lymphoma and myeloma consent forms are in development.

How have the forms been developed and what is the governance process?

The forms are based on the Department of Health consent form 1. The template form has been approved by the UK Systemic Anti-Cancer Therapy Board. Each hospital/Trust will need to ensure that the forms are approved for use locally by their governance or consent committee, whichever is most appropriate for the individual organisation. Please refer to the Guidance on Consent for SACT available on this website here .

Are the consent forms a legal document? 

The consent form is not a legal document, but it represents best practice and conforms with and complements the guidance documents available to clinicians taking consent. Several guidance documents have described best practice in the area of consent with respect to law, ethics, training and experience required and the need for documentation that consent has taken place.

We explored informal counsel with a medico-legal advisor, in response to the issue of the Montgomery judgement. The following has been taken from their reply:

The consent forms are developed to ensure a high level of consistency in the information giving and discussion with the patient. Your Trust Governance and/or consent committee must agree before you use these forms.

How do I give a copy of the completed form to the patient?

The patient can be given a photocopy or print out of the completed form. For trusts using electronic consent systems, there may be different mechanisms for providing the patient with a completed form depending on the system used, such as through secure email or a mobile application. We recommend retaining the original form in the patient’s records, or a scanned copy in the patient’s electronic records.  

Will the consent forms be made available electronically?

Due to the complexity of the IT infrastructure, numerous electronic patient records and SACT prescription systems across the NHS, the project team cannot provide one single national electronic consent solution. An electronic consent working group was subsequently formed as part of the project. The working group developed and published the ‘Guidance for the Implementation of CRUK SACT Consent Forms Electronically’. It is intended for use by NHS SACT providers wishing introduce electronic consent to decide which electronic consent solution would be the most appropriate for their individual needs. Guidance for the configuration and maintenance of electronic consent forms, including adoption of the CRUK consent forms electronically, is provided in this document. The document can be found on the CRUK SACT consent form webpage under the accordion ‘Guidance on Electronic Consent for SACT’ here .

Can I use the CRUK consent forms, branding and footer on our local electronic consent system?

The CRUK regimen-specific consent forms may be used within local electronic consent systems. As the forms have been through a robust governance process to ensure their consistency and quality, the following disclaimers should be used depending on the applicable scenario. The following disclaimers will be included in the next version of the Guidance on Electronic Consent along with CRUK brand guidelines for logo use.

Use of the consent forms without amendments:

The CRUK logo and consent form footer can be included in electronic consent forms where the content of the forms is used unamended in its entirety. The format, font or colours can be changed if necessary, but the text and CRUK logo should be unamended. The footer at the bottom of each page of the consent form includes the names of those who have prepared, checked and approved the forms, as well as the details of version and date.

In this instance, please include the following disclaimer:

When amendments are made to the consent form contents:

Where providers base their electronic consent forms on the CRUK consent forms but change some of the content for technical or clinical reasons, the CRUK logo and consent form footer should not be used.

The following disclaimer should be included within the e-consent system in a way that makes it clearly visible to both clinician and patient.

Will the consent forms be made available in Welsh and/or other languages?

The generic SACT and generic immunotherapy consent forms have been translated to Welsh. It is recommended that these forms are used to supplement the English regimen-specific consent forms when a Welsh language accompaniment is required. The project team continues to investigate avenues through which the translation of consent forms can be achieved.

Will chemo-radiotherapy consent forms be developed?

These forms are designed specifically for taking consent for SACT. For instances where the SACT is given in combination with radiotherapy, the radiation therapy will need to be consented for separately. The Royal College of Radiologists (RCR) have developed national site-specific radiotherapy consent forms. These can be found here . The RCR plan to develop chemo-radiotherapy consent forms, but this is an ongoing piece of work for which timelines have not yet been confirmed.

Do you have children and young people (CYP) SACT consent forms?

The Children and Young People Generic Form was published in 2021. The ALL in Children and Young People form was subsequently published in 2023. We subsequently plan to develop national SACT regimen-specific consent forms for TYA groups.

Where can I find more information about the regimen-specific consent forms?

Further information can be found on www.cruk.org/sact_consent . You can also email [email protected] or [email protected] if you have any queries and with any comments.

Download these FAQs

Last updated: 9 January 2024

Guidance on consent for SACT

Guidance on remote consent for SACT

Guidance for SACT by Healthcare Improvement Scotland

Guidance on Electronic Consent for SACT v02

Last updated: 18 June 2024

Generic forms

Generic SACT form

Generic checkpoint inhibitor immunotherapy form

Welsh Generic SACT form

Welsh Generic Immunotherapy form

Last updated: 14th November 2023

Children and Young People (age 0-24 years)

ALL in Children and Young People

Children and Young people generic form

Last updated: 10th August 2023

Acute Lymphoblastic Leukaemia (ALL)

Blinatumomab

Clofarabine, Cyclophosphamide and Etoposide

Inotuzumab Ozogamicin

Nelarabine, Cyclophosphamide and Etoposide

UKALL14 Consolidation 1,2 and 4

UKALL14 Consolidation 3

UKALL 14 Intensification CNS Prophylaxis

UKALL 14 Maintenance

UKALL 14 Phase 1 Induction

UKALL 14 Phase 2 Induction

UKALL 14 Intrathecal Systemic Anti-Cancer Therapy

UKALL 60+ Intensive (Philadelphia Negative)

UKALL 60+ Non-Intensive Intensive (Philadelphia Negative)

UKALL 60+ Philadelphia Positive

Download all Acute Lymphoblastic Leukaemia (ALL) forms

Last updated: 22 March 2024

Acute Myeloid Leukaemia (AML)

Azacitidine

Azacitidine +  Venetoclax

AIDA (All- transretinoic acid and Idarubicin)

ATRA (All-transretinoic acid)

High dose cytarabine (ARA C) + Amsacrine

DA (Daunorubicin and Cytarabine)

Etoposide (po)

Gemtuzumab ozogamicin with daunorubicin and cytarabine

FLAG - Idarubicin

Gilteritinib

Gemtuzumab +  chemotherapy

High dose cytarabine (ARA C)

Hydroxycarbamide

Liposomal daunorubicin + Cytarabine ( Vyxeos)

Low dose cytarabine ( ARA C)

Low dose cytarabine ( ARA C) + Venetoclax

Midostaurin + chemo (DA + HD Ara C)

Midostaurin (+/- chemotherapy)

Mitoxantrone

Download all AML cancer SACT forms

Last updated: 17th August 2023

Brain/CNS cancers

Carboplatin-Etoposide

Procarbazine-Lomustine-Vincristine (PCV)

Temozolomide

Temozolomide+Radiotherapy

Download all Brain/CNS cancers SACT forms

Last updated: 25th July 2023

Breast cancers

AC (Doxorubicin-Cyclophosphamide)

Abemaciclib

AC-Docetaxel

Atezolizumab - Paclitaxel albumin-bound

Bevacizumab

Capecitabine

Carboplatin

Cyclophosphamide-Methotrexate

Docetaxel-Capecitabine

Doxorubicin

EC (Epirubicin-Cyclophosphamide)

EC-Carboplatin-Paclitaxel

EC-Docetaxel

EC-Docetaxel-Trastuzumab

EC-Paclitaxel

EC-Paclitaxel-Trastuzumab

Epirubicin-CMF

FEC-Docetaxel-Trastuzumab

FEC-Paclitaxel-Trastuzumab

FEC-PPH (Paclitaxel-Pertuzumab-Trastuzumab)

FEC-TPH (Docetaxel-Pertuzumab-Trastuzumab)

Gemcitabine-Carboplatin

Gemcitabine-Paclitaxel

Kadcyla® (trastuzumab emtansine)

Liposomal doxorubicin (Myocet®)

Liposomal doxorubicin (Myocet®)-Cyclophosphamide

Paclitaxel albumin-bound

Paclitaxel albumin-bound - Carboplatin

Paclitaxel-Trastuzumab

Palbociclib

Pembrolizumab – Carboplatin – Paclitaxel - EC

Pembrolizumab - Paclitaxel

Pembrolizumab – Paclitaxel Albumin Bound

Pertuzumab-Trastuzumab

Sacituzumab Govitecan

TC (Docetaxel-Cyclophosphamide)

TCarboH (Docetaxel-Carboplatin-Trastuzumab)

TCarboPH (Docetaxel-Carboplatin-Pertuzumab-Trastuzumab)

TPH (Docetaxel-Pertuzumab-Trastuzumab)

Trastuzumab

Trastuzumab Deruxtecan

Tucatinib, trastuzumab and capecitabine

Vinorelbine (IV)

Vinorelbine (Oral)

Vinorelbine-Capecitabine

Last updated: 8 May 2024

Chronic Lymphocytic Leukaemia (CLL)

Acalabrutinib

Bendamustine – Rituximab

Chlorambucil

Chlorambucil – Obinutuzumab

Chlorambucil – Rituximab

FCR (Fludarabine – Cyclophosphamide – Rituximab) 3 Days

FCR (Fludarabine – Cyclophosphamide – Rituximab) 5 Days

Idelalisib – Rituximab

Venetoclax – Ibrutinib

Venetoclax – Rituximab

Venetoclax – Obinutuzumab

Zanubrutinib

Download all chronic lymphocytic leukaemia cancer SACT forms

​Last update: 20th December 2023

Chronic Myeloid Leukaemia (CML)

Interferon-Alfa

Peginterferon-Alfa

Download all chronic myeloid leukaemia cancer SACT forms

Colorectal cancer

Aflibercept irinotecan-fluorouracil folfiri, bevacizumab chemotherapy, capecitabine mitomycin, capecitabine-mitomycin radiotherapy.

Capecitabine and Radiotherapy

Carboplatin and Paclitaxel

Cetuximab +/- chemotherapy, cisplatin-capecitabine.

Cisplatin-Fluorouracil

Encorafenib and Cetuximab

Fluorouracil Modified de Gramont

Fluorouracil and folinic acid weekly, fluorouracil pvi +/- radiotherapy, irinotecan capecitabine (capiri), irinotecan fluorouracil (folfiri), mitomycin-fluorouracil radiotherapy, nivolumab and ipilimumab.

Oxaliplatin-Capecitabine (CAPOX)

Oxaliplatin-Fluorouracil_(FOLFOX)

Oxaliplatin-irinotecan-fluorouracil (folfoxiri), oxaliplatin-raltitraxed (tomox), panitumumab +/- chemotherapy.

Pembrolizumab

Raltitrexed

Regorafenib

Trifluridine and Tipiracil (lonsurf®)

Download all colorectal cancer SACT forms

Last updated: 14 July 2022

Gastrointestinal stromal tumors (GIST)

Download all gastrointestinal stromal tumours (GIST) SACT forms 

Last updated: 18th August 2023

Gynaecological cancers

BEP (5 day)

Carboplatin-Paclitaxel

Cisplatin + Radiotherapy

Cisplatin-Etoposide

Cisplatin-Fluorouracil + Radiotherapy

Cisplatin-Paclitaxel

Cisplatin-Topotecan

Doxorubicin-Cisplatin

EP (Etoposide-Cisplatin)

Etoposide (oral)

Gemcitabine

Gemcitabine-Cisplatin

Liposomal doxorubicin (Caelyx®)

Liposomal doxorubicin (Caelyx®) - Carboplatin

Paclitaxel (day 1, 8 & 15)

Topotecan (IV)

Download all gynaecological cancers SACT forms

Last updated: 16 February 2021

Head and neck cancers

Carboplatin + Radiotherapy

Carboplatin-Fluorouracil

Cetuximab - Carboplatin - Fluorouracil

Cetuximab - Cisplatin - Fluorouracil

Cetuximab + Radiotherapy

ECarboF (epirubicin-carboplatin-fluorouracil)

Methotrexate

TCarboF (docetaxel-carboplatin-fluorouracil)

TPF (docetaxel-cisplatin-fluorouracil)

Download all head and neck cancers SACT forms

Last updated: 5th September 2022

Hepato Pancreato Biliary (HPB) cancers

Atezolizumab and Bevacizumab

Capecitabine + Radiotherapy

Fluorouracil (Modified de Gramont)

Gemcitabine-Capecitabine

Gemcitabine-Paclitaxel albumin-bound (Abraxane®)

Oxaliplatin-Fluorouracil (FOLFOX)

Download all Hepato Pancreato Biliary (HPB) SACT forms

Last updated: 29th December 2023

Kaposi sarcoma

Pegylated Liposomal Doxorubicin (Caelyx)

Download all Kaposi Sarcoma SACT forms

Last updated 10th August 2023

Atezolizumab, bevacizumab, carboplatin and paclitaxel

Atezolizumab, carboplatin and etoposide

Atezolizumab

CAP (cyclophosphamide-doxorubicin-cisplatin)

Carboplatin, pemetrexed and pembrolizumab

Carboplatin, paclitaxel and pembrolizumab

Carboplatin-Pemetrexed

Carboplatin-Vinorelbine

CAV (cyclophosphamide-doxorubicin-vincristine)

Cisplatin-Pemetrexed

Cisplatin- pemetrexed - pembrolizumab

Cisplatin-Vinorelbine

Dacomitinib

Larotrectinib

Nintedanib-Docetaxel

Osimertinib

Pemetrexed (maintenance)

Ramucirumab-Docetaxel

Selpercatinib

Topotecan (oral)

Vinorelbine (oral)

Download all lung cancer SACT forms

Melanoma skin cancer

CVD (cisplatin-vinblastine-dacarbazine)

Dabrafenib-Trametinib

Dacarbazine

Encorafinib-Binimetinib

Ipilimumab-Nivolumab

Talimogene laherparepvec (Imlygic®)

Vemurafenib

Vemurafenib-Cobimetinib

Download all melanoma skin cancer SACT forms

Myeloproliferative Neoplasms (MPN)

Interferon alfa

Ruxolitinib

Thalidomide

Download all Myeloproliferative Neoplasms (MPN) SACT forms

​Last updated: 21 June 2019

Neuroendocrine and adrenal cancers

Capecitabine and Streptozocin

Capecitabine and Temozolomide

Carboplatin and Etoposide

Cisplatin and Etoposide

Cyclophosphamide, Vincristine and Dacarbazine (CVD)

Etoposide, Doxorubicin, Cisplatin (EDP) +/- Mitotane

Fluorouracil, Carboplatin and Streptozocin (FCarboSt)

Fluorouracil, Cisplatin and Streptozocin (FCisSt)

Fluorouracil and Irinotecan (FOLFIRI)

Gemcitabine and Capecitabine

Oxaliplatin, Irinotecan and Fluorouracil (FOLFOXIRI)

177-Lutetium Dotatate

Download all Neuroendocrine and adrenal cancers SACT forms

The published forms listed here are not exhaustive for neuroendocrine cancers. They reflect mostly (but not exclusively) those regimens for gastroenteropancreatic neuroendocrine tumours.  The regimen-specific consent forms for neuroendocrine cancers of other areas of the body can be found within their respective anatomical groups.

Last updated: 14 May 2024

Oesophago-gastric cancers

Capecitabine-Cisplatin + Radiotherapy

Cisplatin-Capecitabine-Trastuzumab

Cisplatin-Fluorouracil (+/- Radiotherapy)

Cisplatin-Fluorouracil-Trastuzumab

Docetaxel-Oxaliplatin-Fluorouracil (FLOT)

ECarboX (epirubicin-carboplatin-capecitabine)

ECF (epirubicin-cisplatin-fluorouracil)

ECX (epirubicin-cisplatin-capecitabine

EOF (epirubicin-oxaliplatin-fluorouracil)

EOX (epirubicin-oxaliplatin-capecitabine)

Fluorouracil PVI + Radiotherapy

Irinotecan-Fluorouracil (FOLFIRI)

Paclitaxel-Carboplatin + Radiotherapy

Download all oesophago-gastric cancers SACT forms 

Last updated: 20 December 2018

Carboplatin - Etoposide

Cyclophosphamide - Etoposide

Cyclophosphamide - Oral prednisolone

Cyclophosphamide - Topotecan

Doxorubicin - Cisplatin

Doxorubicin - Dacarbazine

Doxorubicin - Ifosfamide

Etoposide (Oral)

Gemcitabine - Dacarbazine

Gemcitabine - Docetaxel

IE and Methotrexate

IVADo - IVA

Mifamurtide

Pegylated Liposomal Doxorubicin and Ifosfamide

Pegylated Liposomal Doxorubicin

Trabectedine

Vincristine and Cyclophosphamide

Vinorelbine and Cyclophosphamide

Download all Sarcoma forms

Last updated: 27 March 2024

Thyroid cancer

Cabozantinib

Dabrafenib and Trametinib

Entrectinib

Download all thyroid cancer SACT forms

Last updated: 5 April 2022

Urology-Bladder cancer

Accelerated M-VAC (methotrexate-vinblastine-doxorubicin-cisplatin)

Gemcitabine-Radiotherapy

Mitomycin-Fluorouracil +/- Radiotherapy

M-VAC (methotrexate-vinblastine-doxorubicin-cisplatin)

Download all urology-bladder cancers SACT forms

Last updated: 03 August 2022

Urology-Germ cell cancer

BEP (Bleomycin-Etoposide-Cisplatin)

Carboplatin (Etoposide-Bleomycin)

TIP (Paclitaxel-Ifosfamide-Cisplatin)

VIP (Etoposide-Ifosfamide-Cisplatin)

VeIP (Vinblastine-Ifosfamide-Cisplatin)

Download all urology-germ cell cancer SACT forms

Last updated: 11 June 2024

Urology-Prostate cancer

Abiraterone + Prednisolone

Apalutamide

Cabazitaxel + Prednisolone

Darolutamide

Darolutamide and Docetaxel with ADT

Docetaxel + Prednisolone

Enzalutamide

Download all urology-prostate cancer SACT forms

Last updated: 13th May 2024

Urology-Renal cell cancer

Generic TKI & IO

Avelumab - Axitinib

Gemcitabine-Doxorubicin

Lenvatinib-Everolimus

Nivolumab - Ipilimumab

Download all Urology-Renal cell cancer SACT forms

Last updated: 7th December 2023

Urology-Small cell cancer

Download all Urology-Small cell cancer SACT forms

Last updated: 10 August 2021

Skin cancer (non-melanoma)

Alemtuzumab

Capecitabine-Cisplatin

Chlorambucil +/- Prednisolone

CHOP 21 + Rituximab (CHOP-R)

CVP (Cyclophosphamide-Vincristine-Prednisolone)

Interferon alfa-2a (Roferon-A®)

Liposomal Doxorubicin (Caelyx®)

Methotrexate (Oral)

Pentostatin

Vismodegib  

Download all skin cancer (non-melanoma) SACT forms

Last updated: 15 March 2024

Supportive medicines

Denosumab (Xgeva®)

Zoledronic acid

Download all supportive medicines forms

Last updated: 07 August 2020

Publishing, additions and updates

We are publishing forms by tumour site, the first were for breast cancer in May 2016. We will publish new forms for other tumour sites regularly.

Recent additions and updates will be highlighted on the "What's new?" section on this page, and details of when forms have been last updated is stated in each section. Please check for updated versions and ensure that you use the latest version of each form.

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Read a world first population based study of 30-day mortality following SACT in England

Read our blog on the study’s findings and how the work will help improve patient case

View the NHS Trust and national SACT 30-day mortality data published by Public Health England

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Example consent form for activities and events

Every group or organisation in the UK has a duty to safeguard children and young people in their care. This includes making sure that all children who attend events and activities are kept safe.

If your group or organisation provides events or activities for children and young people, you should gain consent from parents or carers for their child to participate. It's also important to gather the necessary information to keep children safe during the activity.

Different sectors will also have specific guidance for organising events and activities, including around gaining consent.

> Read more about safer activities and events guidance

We've created this example consent form which you can use to help you make sure you collect the information you need. You should tailor it according to the context and needs of your organisation.

We've also included information about when it’s appropriate to gain a child or young person's consent (in addition to parental consent) and what to do when a parent or carer is not willing to give consent for an activity.

This example consent form should be used in conjunction with our photography and sharing images guidance  and our other information and resources on safeguarding .

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Our team of information specialists are on hand to find the answers to your questions.

Related resources

Two young people walking down the street

Provides advice on keeping groups of children and young people safe during activities, events, visits, outings and overnight stays whether they’re regular or one-off.

Group of children in football kit listening to a team talk from their coach.

Safeguarding and child protection training to help you plan and deliver enjoyable and safe sports events.

From £25 to £225

Photographer working in a field

Guidance about taking, sharing, using and storing images of children. Includes information about CCTV and livestreaming online events and activities.

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Working together to work wonders by providing proposal development support to enhance UTMB's research enterprise.

Request our services, announcements, new research consent form templates.

June 3, 2024 • 2:09 p.m.

The Institutional Review Board has posted updated research consent form templates and new detailed drafting guidance.

Designed with updated instructions and a newly designed key information section, these templates ensure clarity and compliance for both researchers and participants. Enhance transparency with our user-friendly and informative forms.

The new documents can be found at on the IRB  Forms Page.

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  1. FREE 6+ Research Consent Forms in PDF

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  2. FREE 8+ Research Consent Forms in PDF

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  3. FREE 6+ Research Consent Forms in PDF

    research consent form uk

  4. 9+ Research Consent Form Templates

    research consent form uk

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  6. FREE 45+ Consent Forms in PDF

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COMMENTS

  1. Getting informed consent for user research

    Whenever you do user research, you must get the participant's 'informed consent'. This means getting a record from them to show they understand your research and agree to take part.

  2. PDF informed Model Consent Form

    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 ...

  3. Informing participants and seeking consent

    Applying a proportionate approach to the process of seeking consent. This guidance complements the existing HRA online guidance for consent and participant information sheets and reinforces our view that people who volunteer to take part in research should be provided with succinct, relevant, user-friendly information in a proportionate manner.

  4. Writing a Participant Information Sheet and Consent Form

    Recruitment documents help people make informed choices about whether to participate in a research study. Find out how to write a Participant Information Sheet, example forms and further guidance.

  5. PDF Participant Information Sheet and Consent Form Templates

    Participant Information Sheet and Consent Form Templates The information provided to participants is crucial for a number of reasons: It explains to individuals everything that will happen to them, should they consent to participate; it allows them to weigh up the risks and benefits of taking part; and it ensures that the information provided to them is fully documented from a legal ...

  6. Informed consent

    What is informed consent? Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.

  7. Template consent forms and information sheets

    Template participant consent form and participant information sheet Providing information about the research to participants, and gaining consent from participants before their involvement is a critical part of conducting ethical research.

  8. Participant information sheets & informed consent forms

    Participant information sheets & informed consent forms. How to provide information and seek consent from research participants. Potential participants need information on which to base their choice to take part in clinical research. It is important that information given to participants before obtaining their written informed consent is clear ...

  9. Consent

    Informed consent should take into account the long-term use of participant research data, including the potential for further data linkage and preservation of data when obtaining consent. Participants need, as far as possible, to give specific consent if data are to be archived and shared.

  10. Research participant information and consent

    Where research involves personal contact with the researcher such as face to face interviews, focus groups, direct observation, physiological measurements or other methods of data collection involving personal contact, participants should be given a participant information sheet (or leaflet) and would normally be asked to sign a consent form. In most cases, consent should be actively provided ...

  11. Consent forms and participant information sheets

    Consent forms and participant information sheets The University of Cambridge expects that free and informed consent will normally be obtained from all human participants in research at an appropriate point in the research process. Where it is not possible, due to the nature of the research or participants, it is normally expected that the project will undergo the appropriate ethical review ...

  12. Consent to research

    Learn about the ethical considerations and guidelines for obtaining consent in medical research. Part of our Consent to research guidance.

  13. Templates and documents to download

    Easy-read participation information sheet. Template participant consent form. Template participant consent form - low risk observations. Easy-read participant consent form. Consent for questionnaires/surveys (includes example introductory paragraph)

  14. Consent

    Informed consent is at the heart of ethical research. Informed consent should be freely given and each participant should be fully informed. Informed consent must be obtained from every participant, unless they are incapacitated (see below), or the research involves use of patient-identifiable information without consent. Informed consent is a ...

  15. PDF Sample Research Participant Consent Form Researcher to note

    Sample Research Participant Consent Form Researcher to note. ample Research Participant Consent FormResearcher to note:You can use a 'tick box', 'initial box' or 'de. e YES/NO format' for participant answers to statements. Whichever you use, there must be a. rk in response to each of the 'please indicate' items:There should be ...

  16. Templates: Consent Forms

    A consent form is not simply about a person giving you permission to involve them in research/evaluation, it is an agreement between the researcher/evaluator and the participant outlining the roles and responsibilities they are taking towards one another throughout the whole of the process. The researcher/evaluator should retain one copy of the consent form signed by both themselves and the ...

  17. PDF INFORMED CONSENT FOR RESEARCH PURPOSES

    re notified of the participant's involvement in a research study. This notification can be by means of including a copy of the participant's signed informed consent form and associa UHBW staff are responsible for attending relevant informed consent and study specific training and f ll understanding of the protoco 5. Abbreviations and ...

  18. Content: Consent Form

    Content: Consent Form. A consent form should normally be used to record the consent process and a participant's agreement to take part in your study. A signature on a consent form alone does not constitute legal or ethical consent, for more guidance please visit our section on ' Principles '. When designing your consent form you should consider ...

  19. Consent and Participant Information Guidance

    Participant Information Sheet and consent form templates We have provided a framework to help you start to develop your Participant Information Sheet. We suggest that you use this framework in association with the guidance provided on this site.

  20. Consent for research

    Consent for research. If you intend to recruit people as participants in your research, then appropriately informed, voluntary consent is the most likely way for you to do so. Consent plays a key role in ethical research and in ensuring research participants are treated fairly and with respect. The consent process should help potential ...

  21. Research Ethics Consent Form Template

    In our continuous effort to improve our site, we look forward to hearing your thoughts, questions and feedback .

  22. Consent forms for SACT (Systemic Anti-Cancer Therapy)

    Standardised SACT regimen-specific consent forms for Clinicians and healthcare professionals involved with consenting and treating patients with SACT.

  23. Example consent form

    This example consent form should be used in conjunction with our photography and sharing images guidance and our other information and resources on safeguarding. Download the resource. Download example consent form (PDF) Subscribe. If you provide activities for children and young people you must gain consent from parents/carers for their child ...

  24. New Research Consent Form Templates

    The Institutional Review Board has posted updated research consent form templates and new detailed drafting guidance.

  25. August 2024

    We're not around right now. But you can send us an email and we'll get back to you, asap.