Guidelines for writing recruitment documents & consent forms

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KING’S COLLEGE LONDON COLLEGE RESEARCH ETHICS COMMITTEES
(CREC)
GUIDELINES FOR WRITING RECRUITMENT DOCUMENTS, INFORMATION
SHEETS & CONSENT FORMS
The following guidelines are to assist you in writing information sheets, consent forms and
recruitment posters/leaflets/emails. A template Information Sheet and Consent Form can be
found here: www.kcl.ac.uk/innovation/research/support/ethics/applications/apply.aspx
INFORMATION SHEETS
The Information Sheet for participants and the consent form comprise the last section of the RESC/REP Application
Form A. The information sheet is vital and must be completed carefully following the guidelines given below and using
the template Information Sheet as a guide. The Information Sheet(s) should always be included with your application in
order that the reviewing subcommittee or panel can see how you are presenting the project to potential participants.
The template Information Sheet can be found here:
www.kcl.ac.uk/innovation/research/support/ethics/applications/apply.aspx
You must provide separate Information Sheets where the differences between participants or different sections of the
research require it (e.g. an Information Sheet for a child and a separate one for his/her parents/guardians, or an
Information Sheet for those filling in a questionnaire and a different one for participants being interviewed).
The consent form and Information Sheet should be written clearly. The writer should use:
*
simple words, sentences and paragraphs (take care to use language that is appropriate for the
participant group)
*
requests rather than commands
*
the active voice (e.g. we will book) rather than the passive voice (e.g. appointments will be booked)
*
a personal approach (e.g. we, you, your baby) rather than the impersonal (e.g. student, subject, they,
those, he or she).
*
paragraphs (do not use the bullet points given in the template, these are guidance notes, not text for
participants).
Jargon and acronyms should be avoided or accompanied by a clear explanation in everyday language. The whole
Information Sheet should be understandable to a lay person.
The template Information Sheet provides a guide to the content expected. You should include the black text in your
sheet except in exceptional circumstances. The red bullet points indicate the subject areas that should be covered, but
you do not have to use them as subheadings. You must ensure that the information is directed at participants
throughout. Where text on the template documents is highlighted in green, this will need to be amended or deleted
according to the nature of your project. The Information Sheet should be designed by you as a helpful document that is
appropriate for your participants, so do not feel constrained by the template format. See ‘Preparing an Information
Sheet for Participants’ page on the Research Ethics website for more guidance:
http://www.kcl.ac.uk/innovation/research/support/ethics/training/infosheet.aspx
Research Ethics reference protocol number: (note that this will be provided to you after you submit your
application. Until you have been provided this number the Information Sheet should make it clear where this
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reference number will be inserted in the document, once full ethical approval has been granted. After full ethical
approval has been granted, the reference number must be included on Information Sheets and consent forms).
Please note that the RESC/REP will only approve Information Sheets that include the following:
Title of the Study (this should be in lay language)

You should begin by making it clear that this is a study in which the volunteer is being requested to participate
and that such participation is entirely voluntary. This paragraph has been inserted into to the template
Information Sheet for your convenience, but may be amended where necessary.

Explain - in straightforward, lay language - the nature and aims of the research project and describe any
possible benefits.

Where the project is being funded by a body/organisation other than KCL, (such as a charity, organisation,
research council or by a private company), identify who the funder is.

As part of ensuring informed consent is obtained, your anticipated plans for dissemination/publication should
be described.

Who you are recruiting (who should, and who should not, take part).

What will happen if the participant agrees to take part (when, where, etc) and how long their involvement will
last for.

Any risks (e.g. the limits to confidentiality, the circumstances where they may be a need for disclosure of
information to a third party, possibility for distress) or inconveniences/discomfort that may be reasonably
anticipated.

Possible benefits (it is good practice to offer participants a copy of the final report and in such cases you
should indicate how participants can access this). Any other benefits stated must be honest and realistic.

State the arrangements for ensuring anonymity and confidentiality and how far these can be realistically
guaranteed (if there are possible limits to this). If you are giving participants a choice of full anonymity, partial
identification or full identification, this should be made clear. To ensure compliance with the UK Data
Protection Act 1998 participants must be informed of what information will be held about them and who will
have access to it (this relates to information that is identifiable or could potentially be linked back to an
individual).

Explain that the participant can withdraw themselves from participation at any time and that they can also
withdraw their data (including any limitations e.g. after anonymisation or statistical analysis). If limitations
apply you should state a date beyond which withdrawal of data is no longer possible.

Give the name, telephone number, KCL email address and departmental postal address of who to contact to
obtain further details about the study (this should usually be the researcher) and who to contact in an
emergency. Please be aware that the use of a researcher’s personal contact details may cause problems.
Please note, the name of the Principal Investigator must always be stated.

State what compensation arrangements are available in the event of injury. In the case of drug company sponsored research, the Information Sheet should state that the company concerned has agreed to
compensate participants who may be harmed without them having to prove negligence.
Volunteers involved in research conducted by King’s College London within the UK may be offered cover by
the College's own No Fault Compensation insurance but only if the principal investigator is either employed
by the College or is a student at the College and the study has full ethical approval. If you wish to offer ‘Nofault’ compensation to participants then select ‘Yes’ at 8.4 of the application form and ensure that the
following phrase is on the participants’ Information Sheet: ‘If this study has harmed you in any way, you can
contact King's College London using the details below for further advice and information: NAME &
CONTACT DETAILS OF RESEARCHER (if staff project)/SUPERVISOR (if student project).’
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Please note that the above wording should be included at the very end of the Information Sheet directly
before the name and contact details of the supervisor/staff member responsible for the study, as this
individual should be the contact for complaints relating to the study. It must also be clear that the Principal
Investigator, as the primary researcher, should be the first point of contact for those with general queries
relating to the study.
Additional Notes
1. When an outside agency is being used to transcribe data, you must inform participants of this.
2. Where necessary, explain research procedures such as randomised control trial, anonymisation etc in nontechnical terms.
3. Some researchers may find it helpful to include all information about a study in one letter to potential participants.
In such cases the researcher must ensure that the required components for an Information Sheet are present within
the letter.
4. If the study is self-completion questionnaire based but is not seeking sensitive personal information it should still
be stated on the Information Sheet that submission of a completed questionnaire implies consent to participate.
5. For questionnaire studies using online data collection methods, such as Survey Monkey, where it is possible for the
researcher to access data from partially completed questionnaires (where the individual has navigated away from
the questionnaire web page prior to reaching the end of the questionnaire and pressing the ‘submit’ button) the
wording used regarding the consent process must be carefully considered, making it clear what data will be
accessible to the researcher, what data will be used towards the study, and what the procedures are in terms of
data withdrawal. Further guidance on the use of data collected from online data collection methods can be found in
Section 7.1 of the Guidelines for REC/REP Application Form A.
6. For studies using online data collection methods, ensure it is clear to participants what sort of data the website
administrators/owners will have access to.
7. Where recruitment documents are to be translated into the participant’s own language, you will not be required to
submit copies of the translated documents for review, only the English language versions. However it is the
responsibility of the researcher to ensure that appropriate and accurate translations of the English language
documents which are then approved, are used throughout the study once it formally commences. The researcher
must provide assurances to the reviewers that the translated version will be an accurate translation of the one
approved/submitted as part of the application.
8.
Explicit consent for data processing is required when collecting information classified as ‘sensitive personal data’*
which is identifiable or could potentially be traced back to an individual. (‘Explicit consent’ is normally considered to
be specific, written consent). As such, participants will need to give explicit consent for researchers to process
sensitive data and permission for this should be sought on the consent form (sentence provided on standard
consent form template). In the case of self-completion questionnaires where no consent form is to be used the
following statement should be included in the body of the questionnaire:
‘ I consent to the processing of my personal information for the purposes of this research study. I
understand that such information will be treated as strictly confidential and handled in accordance with the
provisions of the Data Protection Act 1998.’
*The Data Protection Act, 1998 classifies sensitive personal data as consisting of information as to ‘(a) the racial or ethnic origin of the data
subject, (b) his† political opinions, (c) his religious beliefs or other beliefs of a similar nature, (d) whether he is a member of a trade union
(within the meaning of the Trade Union and Labour Relations (Consolidation) Act 1992), (e) his physical or mental health or condition, (f)
his sexual life, (g) the commission or alleged commission by him of any offence, or (h) any proceedings for any offence committed or
alleged to have been committed by him, the disposal of such proceedings or the sentence of any court in such proceedings’.
(http://www.legislation.hmso.gov.uk/acts/acts1998/19980029.htm ). † ‘His’ should also be taken to include ‘her’.
CONSENT FORMS
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The RESC/REPs acknowledge that each study has different requirements and that researchers need to communicate
with a wide variety of potential volunteers. Although you are asked to retain the substance of the 2 clauses in the
template consent form provided, you are free to modify the language if it is in any way inappropriate for the intended
participants. You should also ensure that both the name of your project and the reference protocol number (once
assigned) are added to the consent form.
Optional Clauses
Depending on the nature of your study and the participants you wish to recruit you should consider including some of
the additional optional clauses listed at the end of the template consent form (inserting them into the main body of the
consent form). This is not an exhaustive list and you should consider whether you need to amend any of these
statements or design different ones that are more applicable to your research. Please remember to remove the
optional clauses from the bottom of the consent form if you do not intend to use them.
There may be occasions when a written explanation signed by the participant will be inappropriate or difficult or even
impossible to obtain. When this is the case, the applicant should make it clear in their application how they will attempt
to obtain fully informed consent and how it will be recorded.
N.B. investigators proposing research on vulnerable groups are strongly advised to seek expert advice about
their proposed work and the issue of consent before proceeding.
Please note that when using consent forms, the BDM RESC requires that the boxes be initialled by participants.
POSTERS, LEAFLETS, EMAILS & USE OF SOCIAL MEDIA FOR PARTICIPANT RECRUITMENT
Recruitment of participants should be undertaken in such a way that participation is truly voluntary and there is no
coercion, either explicit or implicit. Ideally individuals should be able to take a positive step to participate rather than
have the discomfort of declining a direct approach. The use of indirect approaches rather than face to face individual
requests to potential volunteers is generally preferred, although it is also understood that the nature of the research
may not lend itself to indirect approaches. When recruitment is to take place ‘door-to-door’, it is expected that potential
participants are made aware of the study in advance. Posters and leaflets may be used to recruit participants. The
material can fall into several categories:
a) Posters displayed within the College
b) Posters displayed in other institutions (although recruitment on NHS premises may sometimes require NHS REC
approval, and usually R&D Office approval from the relevant NHS Trust)
c) Leaflets
d) Advertisements in newspapers, magazines etc
e) Internet adverts for internet surveys
Care should be taken when writing copy to consider the nature of the target group, and ensuring that appropriate
terminology is used. This is especially important for material likely to be seen by vulnerable groups, and especially for
advertisements that are to be published in large circulation magazines etc.
Characteristics of a good poster/leaflet or advert
The material should be visually attractive with a short clear heading in the form of an invitation and may include
illustrations. Sufficient information should be given for potential participants to know roughly what is involved. When
there are a large number of exclusion criteria it is sufficient to state any generalisable criteria within the poster and
include more specific details in the Information Sheet so as not to confuse or put off potential participants. Adequate
information for making contact should be given.
Requirements
The College RESCs/REPs requires that all posters/leaflets meet the following requirements;

They must carry identification to allow reference to the records held by CREC.
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
The minimum requirement is: RESC ref no *** (*** = reference number)

Any mention of reimbursement of costs and financial incentives must comply with the guidance given in the
Guidelines for RESC/REP Application Form A (section 8).
Please note:
1. A copy of the poster must be submitted with the application.
2. You must obtain the relevant permission for posters to be displayed in other institutions outside King's College
London.
Recruitment emails
Circular emails should meet with all requirements in guidelines for posters. Additionally, they should be short, the
subject box should contain a short description of the study followed by ‘ – circular’, and the email should start with the
sentence:
'Circular email for use for recruitment of volunteers for study ref: [INSERT ETHICS REFERENCE NUMBER], approved
by [INSERT NAME OF ETHICS SUBCOMMITTEE/PANEL]. This project contributes to the College's role in conducting
research, and teaching research methods. You are under no obligation to reply to this email, however if you choose to,
participation in this research is voluntary and you may withdraw at anytime.'
Please see the following page for specific guidelines on sending a recruitment email to staff or students at King’s
College London: https://internal.kcl.ac.uk/it/email/mailinglists/global/Recruitment-of-volunteers.aspx
Online recruitment methods
Information to be distributed via methods such as Twitter, Facebook or other social media should (within the
restrictions of the medium) meet with all requirements in guidelines for posters. The text of such posts or tweets
should be submitted to the RESC/REP for approval along with that for traditional media.
Where applicable, the subject box should contain a short description of the study, and the post should start with the
sentence:
‘Information regarding recruitment of volunteers for study ref: [INSERT ETHICS REFERENCE NUMBER], approved by
[INSERT NAME OF ETHICS COMMITTEE]. This project contributes to King’s College London's role in conducting
research, and teaching research methods. You are under no obligation to reply to this post, however if you choose to,
participation in this research is voluntary and you may withdraw at any time.'
Where length restrictions do not allow full details to be provided, a link should be included to an appropriate website,
email address or other point of contact where further details can be obtained.
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