University of Salford · Web viewGuidance Notes for Completing the School Research Ethical...

Guidance Notes for Completing the School Research Ethical Approval Application Form

The following notes have been compiled to act as a guide for applicants pursuing ethical approval from the joint School Research Panel. Each section below refers directly to the relevant sections within the application form and outlines the minimum information that is required.

NOTE: It is essential that the reviewers on the Research Ethical Approval Panel have sufficient information to make an informed decision regarding the application. Applications containing insufficient information will be returned to the applicant and will need to be resubmitted – thereby resulting in a delay in obtaining ethical approval.

Section 1: Title of proposed research project

The title of the research project needs to be clear and succinct, giving an idea to the reader exactly what the project involves. A title to a study should not contain any acronyms but all of the words should be explained in full in the first instance (then abbreviated).

Section 2: Project summary

You need to provide a short overview of the research study describing the aims, research question(s), what you are intending to do, who it will involve, and how you hope to achieve the aims.

Section 3: Project objectives (3-5 clear bullet points are recommended)

Summarise the main objectives or outcomes expected of the research study.

For example:

To generate an understanding of certain issues ... To evaluate a particular phenomenon or service … To highlight the differences between … To describe/understand the experiences of … To measure the difference between X and Y … To improve knowledge regarding …

Research, Enterprise and Engagement Ethical Approval Panel, Research Ethics, 15th March 2018, v. 3.0. [http://www.salford.ac.uk/ethics]

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Research Ethics Guidance Notes

For the School of Health Sciences, and the School of Health & Society

Section 4: What is the

rationale which led to the study?

Providing a rationale for the study refers to the presentation of a clear and comprehensive summary of background research/literature which has informed the development of your study. In this section you need to generate an argument concerning the work that has been done previously, what we already know about the topic being researched, what the gaps are in the current research knowledge, and why your study is of particular importance.

Please complete this section in language which is understandable to a lay person and try to avoid, where possible, the use of complex scientific terminology. All research publications need to be clearly referenced and a full list of references included in section 13.

Section 5: Research Methodology

This section provides a summary of the methods you are going to use to perform the research study and the approach which you will take. You should briefly address the following:

Identify the research methodology you have adopted, such as epidemiology, phenomenology, cross-sectional study, etc., and make it clear to the reader why your chosen method is important.

Define your inclusion and exclusion criteria. Describe the method you will be using to gather data i.e. any data collection tools,

interview guides, questionnaires, etc. Whatever method you use, you must include a copy of the instrument or, at least, a draft copy of any instrument or interview guide. This should be included in the appendices of the application, and it must have a date and version number which matches the document checklist.

Explain how the data will be analysed – for example, by using quantitative data packages such as SPSS, applied statistical tests, and/or using qualitative techniques such as thematic, content, explanation building analysis, etc.

Provide an indication of the project duration or project schedule in your research strategy or as an appendix.

Section 6: Recruitment strategy, how many participants will be recruited and/or involved in the study, and the rationale for this number


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Recruitment:You need to clearly identify a recruitment plan and add supporting material (e.g. copies of posters, newspaper adverts, website, and letters, etc.) which will be used to attract research participants. You need to explain how and where the participants will be recruited, and the recruitment methods that will be used. What age group do you intend to recruit, and how will research participants communicate that they are interested in being involved?

In the majority of research studies, research participants should be recruited voluntarily by advert or poster – although you need to be aware that this can be a slow process. If you are contacting participants directly by letter then you need to describe where you will get their names and addresses from. Ideally you should not be given a list of names to contact as this information is confidential to the target organisation/participant. It is recommended that letters are distributed by a third party who is privy to this information and to ask participants to reply directly to you providing their own contact details.

If you are considering recruiting a cohort of students who are undertaking a specific course, then you need to have any recruitment letters and information sheets distributed by the programme leader in advance of data collection. This is in order to give participants time to consider whether they wish to be involved.

Organisational agreement will need to be sought from the Programme Leader for permission to recruit participants during class time and, once received, you should contact the Module Leader/Lecturer out of courtesy. Please do not approach people directly or use a global email address to recruit your participants.

If you plan to use posters to recruit participants, please ensure that they include the following details:

A clear study title An inoffensive image Clear aims of the study The University contact details of the researcher and supervisor The current University logo (available here)

Confidentiality:It is essential that you assure research participants that their involvement will be confidential (where at all possible). This means that no other person should know that they are involved in your research study unless the participant themselves disclose this fact. If you are recruiting participants to a group interview, then you need to confirm that all group participants have agreed to keep the identity of other members of the group confidential.


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http://www.salford.ac.uk/about-us/corporate-information/corporate-identity/toolkit

Informed Consent:A key ethical requirement for recruiting participants for research is that they are fully informed of what the study entails, what their participation will involve, how long the study will take, what difference it will make to them, and that their participation is voluntary. Once a person understands the nature of the research study, and their involvement in it, they can then make an informed decision regarding whether they wish to participate and provide their informed consent (i.e. their agreement to be involved having been provided with all of the facts concerning the study).

In this section you need to describe the process by which you are going to ensure a research participant provides informed consent. This must include providing the patient with an information sheet in clear, easy to understand format. Whilst wherever possible a minimum of 24 hours should be given between the potential participants being given the PIS and signing the consent form, we appreciate that this not always possible. In cases where the applicant thinks this may be a problem, please declare it on the application giving sound reasoning for your decision (you need to make clear the timeframe that an individual will be given to consider their involvement.)

You should make it clear who will see the research data you collect and the results, i.e. you, your supervisor and any other people involved in your data collection, for example, technicians or audio transcribers.

Once a research participant has decided to be involved in the research study informed consent must be obtained. The Health Research Ethical Approval Panel prefers to see written consent from research participants (where at all possible), and the University-approved Consent Form should be used. A blank template is available on the University Ethics website.

Where written consent is not appropriate and/or available, please give a coherent reason as to why this is the case and provide an explanation of how you will obtain and record informed consent.

For research surveys, in which questionnaires are posted to participants, it is presumed that participants consent to being involved in the research once they have returned a completed questionnaire. Written consent is not required in this case. Similarly, for online surveys it is assumed that participants have consented to take part if they complete the survey. However, it is good practice to include a check box to say ‘I have read the study information [insert date and version number of PIS] and consent to take part in the survey’.

It is equally as important that the research participant understands that they can withdraw from a research study at any time without any consequences. Even after data has been collected a participant can ask for their data not to be included and subsequently destroyed. This is stipulated on the written consent form and the participant information sheet, but you need to mention it in your description of how informed consent is to be obtained.


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It is

essential that a person who is being approached to be involved in a research study is considered mentally competent to provide informed consent. Where this is in question, then further safeguards need to be described and an argument presented as to why it is important for these people to be involved in the study.

Number of participants:For quantitative studies the number of participants should be sufficient to produce meaningful results. Often a power calculation will ensure appropriate numbers.

You need to provide a clear rationale why you chose the size of sample for your study. Identify whether a power calculation was performed/appropriate and how this was determined. The committee acknowledges particularly for PGR student research that large samples may be unfeasible, but the rationale as to how you determined the size of your study sample needs to be explained and what problems a small sample may have on the study findings acknowledged. One method of determining a sample size could be to use similar numbers recruited within previous work/studies that have been shown to be appropriate to substantiate the study findings.

Section 7: Organisational agreement for the research study to take place

Whilst the ethics committee does not advocate approaching and gaining consent from outside organisations to undertake research prior to ethical approval being granted, it is recommended that the applicant considers how they will obtain agreement and what strategies they have developed to enable this. For example, it is acceptable that applicants approach organisations to seek advice about the process of gaining provisional support for the study and whether or not they have their own ethics approval process prior to applying for University approval.

The strategy ensures that the organisation is receptive to the applicant’s project and would, in principle, be willing to approve the project once School ethical approval has been obtained. Please include e-mails/letters of agreement as appendices.

Section 8: Ethical Framework

Researchers should attempt to follow an ethical framework that is profession specific. Research within the NHS should be governed by the Research Governance Framework for Health and Social Care.


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Section 9: Data

protection issues

Protecting sensitive data needs to be considered and the ways in which you can ensure participants’ data remains confidential, such as the names/contact details of research participants and/or personal information disclosed within a research study. You need to describe the methods you will use to achieve this. The Health Research Ethical Approval Panel recommends the following:

All research participants will be provided with a research code, known only to the researcher, to ensure that their identity remains anonymous and confidential.

Names and contact details of research participants should be stored on a password- protected computer (consider the use of UoS shared drives), and accessed only by the researcher and others as appropriate.

All data collected such as questionnaires, interview recordings, transcripts, should be anonymous and coded. Hard paper copies of data, including consent forms, should be stored in a locked filing cabinet within a locked room which is only accessible to the researcher.

Data stored electronically must be on a password-protected computer, or password protected University F drive or other shared drive, which is only accessible to the research team.

All data transported on laptops, computer discs, CDs and USB memory sticks should be anonymous, identified only by a code, and encrypted to protect against loss.

Any publication of data should be written in a way which disguises the identity of the research participants involved. Data should not be used which can identify an individual unless prior consent has been obtained from the individual involved.

Data should be stored and archived for a minimum of 3 years, after the graduate award has been made, to allow verification of data from external sources if necessary, or longer if used for further res

Data sharing to allow secondary analysis for another member of the original research team should be consented for. The data should, where possible, be fully anonymised in order for this to happen.

Re the above, for RC funded projects, grant holders should check archiving expectations with the relevant funder. Further information can be found at: http://www.salford.ac.uk/research/research-data-management/preserve

Section 10: Other ethical issues to consider

There are a number of other ethical issues that you need to consider and explain in this section if they are relevant to your study. How each of these issues is mitigated for so that risk of harm or discomfort is reduced should be described. This should be considered for the participants and the researcher.


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http://www.salford.ac.uk/research/research-data-management/preserve

Language Barriers:Participants must be able to understand the study. It is unethical to exclude participants if their first language is not English – unless your study is particularly focusing on English-speaking individuals. Therefore, you must identify whether non-English-speaking people could be part of your sample and what steps you will take to make sure that they can participate in the study, understand the information provided, and be able to provide their informed consent.

Minority Groups: It is important to ensure that minority groups are considered and, where appropriate, equally represented within a research study sample. You need to identify how you will make sure that your sample is representative of the wider population, and that there are sufficient numbers of minority group participants to ensure that your findings can fully represent a particular group. This may involve participants who are blind/deaf, and it is important to clearly explain the methods taken to involve all participants whilst ensuring that they are adequately informed.

Addressing Sensitive Issues:The researcher needs to demonstrate that they are aware that when participants recollect/describe bad experiences, discuss sensitive information/feelings, that this could impact negatively upon the research participant. A clear explanation should be provided which describes how this impact will be minimised or prevented e.g. using a sensitive interview approach, stopping an interview if the participant is distressed, providing contact details of an appropriate support service to the participant in order to discuss any issues further with a professional.

Researcher skills and training: If the researcher proposes to carry out a procedure which they have learned as part of their programme of study, for example finger-pricking, then the student must submit confirmation that they have undertaken this training to the panel as part of their application. If relevant to their application, students should also indicate if they have a current DBS check.

Failure to consider ethical issues adequately will result in your application being returned for resubmission or amendments.

Section 11: Incentives/reimbursements

If reimbursements/incentives are being offered to the participants, please identify how this is being funded and what is in place to ensure participants who receive extra financial support are not affected.


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Section 12:

Dissemination strategy

Please provide details of the dissemination processes that are in place for the participants and the research community i.e. thesis, dissertation, articles, conference presentation, report, etc.

Section 13: References

You should provide a full list of references which support the background argument and rationale outlined in section 4.

NOTE: Please ensure that all supporting documents such as copies of recruitment material, questionnaires, interview guides, participant information sheets, consent form, and risk assessment form are submitted and clearly indicated on the document checklist of the application form.

Guidance Notes for Completing the 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.

Study Title

Does this explain the study in simple English? The title used needs to be in ‘lay’ terms so that it is easy to understand for everyone. One consistent title should appear on all your study documents and be self-explanatory. Any acronyms need to be written out in full in the first instance.


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

You should explain that there is a withdrawal timeline and that the possibility to withdraw will be based upon this. You also need to explain that there may be withdrawal of information issues based on certain constraints, for example:

‘Focus groups data is difficult to withdraw once the group has taken place. Interview data cannot be withdrawn once a report of the research has been sent for publication.’


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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 intend as a thank-you should be detailed in the information sheet.

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.


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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:

For PGR Students:

‘If you have a concern about any aspect of this study, you should ask to speak to the researcher (insert name and contact number) who will do their best to answer your questions. If you remain unhappy and wish to complain formally you can do this by contacting the Research Supervisor (insert name and contact number). If the matter is still not resolved, please forward your concerns to Professor Susan McAndrew, Chair of the Health Research Ethical Approval Panel, Room MS1.91, Mary Seacole Building, Frederick Road Campus, University of Salford, Salford, M6 6PU. Tel: 0161 295 2778. E: [email protected]’

For Staff:


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mailto:[email protected]

‘If you have a concern about

any aspect of this study, you should ask to speak to the researcher (insert name and contact number) who will do their best to answer your questions. However, if you remain dissatisfied and wish to complain formally, please forward your concerns to Professor Susan McAndrew, Chair of the Health Research Ethical Approval Panel, Room MS1.91, Mary Seacole Building, Frederick Road Campus, University of Salford, Salford, M6 6PU. Tel: 0161 295 2778. E: [email protected]’

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 Caldicott principles and/or Data Protection Act 1998.

A safeguarding statement must be added where appropriate. For example:

‘I am aware that if I reveal anything related to criminal activity and/or something that is harmful to self or other, the researcher will have to share that information with the appropriate authorities.’

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:

i. Individual participant research data, such as questionnaires/interviews/samples/ x-rays will be anonymous and given a research code, known only to the researcher/research teamii. A master list identifying participants to the research codes data will be held on a password protected computer accessed only by the researcher/research team iii. Hard paper/taped data will be stored in a locked cabinet, within locked office, accessed only by researcher/research teamiv. Electronic data will be stored on a password protected computer known only by researcher/research team.

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 ethical approval will be sought.


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mailto:[email protected]

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 it will be disposed of securely (the Joint School Research Ethics panel 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) (Please note this is an optional section and only needs including where applicable)

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.

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.’ Please ensure if stating this you give a specific timeframe for withdrawal (for example, 1 month after interview)

Or

‘If you withdraw from the study the data collected up to your withdrawal will remain part of the study.’


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Please note if using focus

groups it is very difficult to remove one person’s contribution and, in light of this, it is probably best to go for the 2nd option.

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 enquiries.

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.


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