Posted: December 27th, 2014

participant information sheet

participant information sheet

Example Participant Information Sheet

Informed consent from research participants is crucial. Therefore your information sheet must use language that is readily understood by the general public.

Overview of the Participant Information sheet
The information sheet should provide brief and clear information on the essential elements of the specific study: what the research is about, the condition or

treatment under study, the voluntary nature of involvement, what will happen during and after the research has taken place, what treatment (if applicable) will be

withheld, the participants responsibilities, the potential risks, inconvenience or restrictions balanced against any possible benefits and the alternatives. It should

allow the participant to decide whether the study is of interest to them and whether they wish to read and discuss it further.

It is recommended that the researcher follows the structure below to guide them in developing an appropriate information sheet.

Study Title
Does this explain the study in simple English? One consistent title should appear on all your study documents and be self-explanatory. Any acronyms need to be written

out in full.

Invitation paragraph
You need to explain that you are asking the participant to take part in research. For example:

I would like to invite you to take part in a research study. Before you decide you need to understand why the research is being done and what it would involve for you.

Please take time to read the following information carefully. Ask questions if anything you read is not clear or would like more information. Take time to decide

whether or not to take part.

You might want to add a couple or sentences explaining about the study here.

What is the purpose of the study?
Purpose is an important consideration for participants, and we recommend you present it clearly and succinctly, in the context of other work in the field. Primarily

the purpose may be educational, such as undertaking a research study as part of a course. If this is the case, then this purpose should be made clear.

Why have I been invited?
You should explain briefly why and how the participant was chosen and how many others will be in the study.

For example explain clearly why you have chosen to recruit participants within a particular ethnic group, or age group, healthy volunteers, students on a particular

course, males or females and why you are studying this particular population group.

Do I have to take part?
You should explain that taking part in the research is entirely voluntary. The following is an example:

It is up to you to decide. We will describe the study and go through the information sheet, which we will give to you. We will then ask you to sign a consent form to

show you agreed to take part. You are free to withdraw at any time, without giving a reason. (if applicable – this will not affect the standard of care you receive).

What will happen to me if I take part?
To answer this question, try to ‘put yourself in the subject’s shoes.’

This section should include:
•    how long the participant will be involved in the research
•    how long the research will last (if different)
•    how often they will need to attend, meet a researcher, visit a clinic or their GP (if appropriate)
•    how long these visits will be
•    what exactly will happen, for example: access to personal information, questionnaires, interviews, discussion groups, measurements, blood tests, sample

collection, x-rays etc.

Use the most appropriate format to demonstrate their involvement (diagrams/tables). The detail will depend on the complexity of the study. It may help if the

information is displayed in a flow chart or grid indicating what will happen at each visit, where appropriate.

It should be clear which procedures are over and above those used in standard treatment or management. It is also essential to explain whether any normal treatment

will be withheld for all or part of the study. Long-term monitoring/follow up should be mentioned.

If the study will involve video/audio-taping or photography, you should explain what is intended, including the confidentiality issues. Specific consent will be needed

if material of any sort will be published that identifies the subject.

You should set out simply the research methods you intend to use.

Expenses and payments?
You should explain if any expenses (for example travel, meals, child-care, compensation for loss of earning etc.) are available. You should consider whether any gifts

or vouchers which you intent as a thank-you should be detailed in the information sheet.

What will I have to do?
Set down briefly and clearly what you will expect from the research subjects, such as lifestyle, medical health or dietary restrictions, attending scheduled visits,

keeping diaries, filling out questionnaires etc.

What are the possible disadvantages and risks of taking part?
Any risks, discomfort or inconvenience should be briefly outlined. You should consider carefully how to explain any risks involved in your study, as this can be

difficult.

Risks may include possible side effects from medication, potential injury from exercise trials, or the use of additional ionising radiation within x-rays, or distress

from recollecting unpleasant memories and feelings.

For example if you are discussing or exploring sensitive issues with a participant that could upset them then you need to identify this so the participant is fully

aware. After the research is completed make appropriate support services available for the participant to access if further support is required.

What are the possible benefits of taking part?
Explain these, but where there is no intended benefit for the participant, this should be stated clearly. It is important to not exaggerate the possible benefits. It

would be reasonable to say something similar to:

We cannot promise the study will help you but the information we get from the study will help to improve the treatment of people with (name of condition)
Or
We cannot promise the study will help you but the information we get from the study will help to increase the understanding of (name the focus of the research)

What if there is a problem?
You should inform participants who to go to if they have a complaint about the research study, their experience, and/or the researcher. A contact number should be

given. This may be the researcher in the first instance, who can try to resolve the problem. However a participant may not wish to complain to the researcher if he/she

is the object of the complaint, and may wish to make a more formal complaint for example:

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (contact number).

If you remain unhappy and wish to complain formally you can do this through… (add appropriate contact details of NHS, Private facility, University complaints

procedure).

You need to identify the appropriate complaints procedure and provide the contact details/location of where this can found, for example: NHS Complaints Procedure (or

Private Institution), University Complaints Procedure, Supervisor’s name and contact details etc. For University-based projects, if the participant does not wish to

discuss their complaint with the researcher, they should be directed to the supervisor in the first instance and then to the College Research and Innovation (R&I)

Manager.

In addition to identifying a clear complaints procedure you need to identify appropriate redress and/or compensation that would be available if the research

participant came to any harm as a result of the research study. As a student of the University and/or NHS employee you need to fully explore the compensation

arrangements. If there are no such compensation/insurance/indemnity schemes in place then this needs to be clearly explained.

Will my taking part in the study be kept confidential?

You should tell the participant how their confidentiality will be safeguarded during and after the study. You may wish to tell the participants how your procedures for

handling, processing, storage and destruction of their data match the Cadicott principles and/or Data Protection Act 1998.

The participant should be told:
•    how their data will be collected.
•    that it will be stored safely, giving the custodian and level of identification, for example:
o    individual participant research data, such questionnaires/interviews/samples/ x-rays will be anonymous and given a research code, known only to the researcher
o    A master list identifying participants to the research codes data will be held on a password protected computer accessed only by the researcher
o    hard paper/taped data will be stored in a locked cabinet, within locked office, accessed only by researcher
o    electronic data will be stored on a password protected computer known only by researcher
•    What it will be used for. For example it must be clear if the data is to be used for future studies and whether further RGEC approval will be sought.
•    Who will access to view identifiable data (authorised persons such as researchers within the team, supervisors, sponsors and for monitoring the quality,

regulatory authorities /R&D audit).
•    How long will it be retained and that is will be disposed of securely (the College RGEC recommends a minimum of 3 years)

Example introductory statement includes:

All information which is collected about you during the course of the research will be kept strictly confidential, and any information about you which leaves the

hospital/surgery/university will have your name and address removed so that you cannot be recognised.

Involvement of the General Practitioner/Family Doctor (GP)
Some studies require that the research participant’s GP be informed if they are involved in studies that may affect their normal health status. You need to explain to

the research participant if their GP needs to be contacted and seek their consent to do this. You should clearly explain what information will be exchanged.

There are other studies/circumstances which may not impact on the health of the participant therefore it would not be appropriate for you to contact their GP, or in

some cases it may not be possible.

What will happen if I don’t carry on with the study?
There are different positions to take on what will happen if a participant withdraws from a study and it up to the researcher to determine what is applicable to their

study and ensure that this is clearly communicated to the participant prior to them agreeing to take part. Three possible scenarios include:

If you withdraw from the study all the information and data collected from you, to date, will be destroyed and you name removed from all the study files.
Or
If you withdraw from the study we will destroy all your identifiable samples/ tape recorded interviews, but we will need to use the data collected up to your

withdrawal.
Or
You can withdraw from the study/treatment but keep in contact with us to let us know your progress. Information collected may still be used. Any stored blood/tissue

samples or taped interviews that can still be identified as yours will be destroyed if you wish.

What will happen to the results of the research study?
Participants often want to know the results of the study in which they were involved. You should tell participants what will happen to the results, whether they will

be published and how the results will be made available to them. You should add that they will not be identified in any report/publication unless they have given their

consent.

Who is organising or sponsoring the research?
The answer should include the organisation or company sponsoring the research and funding the research if these are different (e.g. Research Charity, academic

institution, NHS employee).

Further information and contact details:
The additional information that participants require can sometimes be divided into the following four categories. You need to identify where to locate additional

information or who to contact to address the different enquires.

1.    General information about research (e.g. list relevant documents or websites)
2.    Specific information about this research project (e.g. contact details of researcher)
3.    Advice as to whether they should participate (e.g. contact details of a different  health care professional who can provide impartial advice)
4.    Who they should approach if unhappy with the study (e.g. contact details of complaints procedure if not listed earlier)

A minimum prerequisite in this section is that the contact details of the researcher (email address) should be clearly identified.

UG PROJECT PROPOSAL FEEDBACK  (DEVELOPMENTAL)

Student Name:    Rawan Hadi Khalil
Supervisor Name: Aarti Vyas-Brannick
Evaluation of the effectiveness of the Performance Appraisal System in Ithmaar Bank

Questions to Consider    Feedback
TITLE
•    Is the title appropriate to the degree?
•    Does the title suggest a well-scoped piece of work?
•    Does the title suggest that there is a research question or issue to be addressed (and will not just lead to a descriptive piece ABOUT a topic)?
The area of research is manageable within the timeframe – taking due regard of the primary research (time & access) limitations. The project is manageable

within the scope as indicated,

BACKGROUND CONTEXT AND AIMS/OBJECTIVES
•    Is the project ‘doable’ by one student in the time available – about 6 months (note – student should be doing roughly 1/1.5 days a week)?
•    Do the research aim/questions/objectives fit in with the project title and do they link together coherently?
•    Is the research “gap”/ research idea justified and viable?
•    Are there enough/too many questions/objectives. (Most students set out to do too much)? 3-5 are appropriate in most cases
( See comments above and below), and also our previous discussions.
LITERATURE/FRAMEWORK
•    Has the student begun to identify a relevant, up-to-date literature from a range of reliable sources? (academic journals not just newspapers or entirely

company reports etc)
•    Has the student begun to tell the story of how the literature fits together/develops over time?
•    Has the student identified a way to address their questions through the adoption of frameworks/theories from the literature? (see Project Handbook for further

guidelines)
Literature is relevant however you will have to consult more specifically on the CIPD/ Appraisal literature and theory.

RESEARCH DESIGN/ METHODOLOGY
•    Has the student identified research design/  methods (which must include collection of primary/new data) that will lead to them being able to address their

research question and is ‘doable’?
•    Have the specified the intended sample
•    Is data access realistic? Do they have access to the data or is this likely to be possible?
•    Do they have an idea how they are going to analyse and interpret such data
•    Have students considered ethical issues and completed an ethics checklist (plus Participant Information Sheet & Consent Form)?    You should have an indication

of the proposed sample size and sampling strategy.
The student needs to clarify the comments under ‘risk management’
There is currently no Participant Information Sheet or Consent Form.
Some elements of the ethics form are ticked ‘no’ when you should be  able to tick ‘yes’. These are questions to ensure that you have read the rules and regulations and

understand the ethical implications. You  also need to add information to sections on page 1.

PROBLEMS/ PLANNING (may be necessary if not done for initial proposal)
•    Are they being realistic in identifying problems that are likely to arise?
•    Has the student drawn up a realistic timetable, building in appropriate milestones from the Programme Schedule?
•    Has the student considered risk and resource management issues? See Project Handbook for further guidelines

You need to produce a more detailed plan to keep you on track. You particularly need to review the ‘risk’ factors , especially if the questionnaires or sufficient

questionnaires are not completed.

WRITING
•    Is the proposal written in the kind of academic writing style you would expect their final project to be written in?
•    Is the English well-expressed?
•    Has the student adopted the Harvard referencing style correctly?
It would be helpful to get some greater support to enhance and refine your academic writing skills , in order to provide greater clarity to your arguments.

Supervisor Notes:
1.    See Project handbook in terms of the guidelines given on writing the proposal (see Section 5.1)
2.    As a general guide, the Research Proposal, it is suggested that:
•    One side of A4 (250 words) be devoted to section a, b and c (re title, aims & objectives and background)
•    One side of A4 (250 words) be devoted to section d (literature review)
•    One side of A4 (300 words) be devoted to section e and f (methodology and planning)
This is all approximate and the proposal may vary between 2 to 3 sides of A4 (750-1000 words). Please do NOT submit more than this as it is not required.
3.    In addition to this, students are expected to include: (a) their references and (b) their Ethics form (for you to sign off, return and for them to include in

the Project). Please see Handbook for details given to students The Ethics Checklist, and examples of PIF and CF, and guidance, can be found here

http://www2.mmu.ac.uk/rke/ethics-/)
4.    This feedback is developmental in nature (not formally marked). However, if you feel that the students project is not viable, please indicate this and ask the

student to resubmit the proposal within a negotiated timeframe – typically 2-3 weeks
5.    Please do indicate on an Engagement form that students submitted the Proposal on time OR any reason given by students that they did not.

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