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This form should be submitted electronically to Leigh Taylor, Secretary of the Faculty Research
Ethics Committee, ( Leigh.Taylor@uwe.ac.uk
) together with all supporting documentation (see below). A paper copy with signatures should be sent to Leigh Taylor, Secretary of the Faculty
Research Ethics Committee, Faculty Research Office Frenchay Campus, within 5 working days of the electronic version.
You are advised to read the guidance notes attached to this form.
Please provide all the information requested and justify where appropriate
– the spaces will expand to provide additional space.
For further guidance please contact your AHOD RKE, Dept Ethics Lead, Academic Supervisor or Leigh Taylor ( Leigh.Taylor@uwe.ac.uk
) or telephone 0117 328 1170.
Project Details:
Project title
Project funder
Proposed project start date
Anticipated project end date
Applicant Details:
Name of Principal
Investigator (applicant)
Faculty and School
Status ( Staff/
Postgraduate Student/
Undergraduate Student)
Email address
Contact postal address
Contact telephone number
Name of co-researchers
(where applicable)
(for completion by SRESC)
Date received:
SRESC reference number:
Scrutiny – Cttee/CA
Outcome:
Applicant informed:
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Applicant Details continued:
For student applicants only:
Name of Supervisor (for
PG and UG student applicants) ¹
Supervisor’s email address
Supervisor’s telephone number
Details of course/degree for which research is being undertaken
¹For student applications supervisors should ensure that all of the following are satisfied before the study begins:
The topic merits further research
The student has the skills to carry out the research
The participant information sheet or leaflet is appropriate
The procedures for recruitment of research participants/donors and obtaining informed consent are appropriate
Appropriate arrangements have been made for the processing, storage and disposal of human tissue samples.
Supervisor comments:
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Details of the proposed work:
1 Aims and objectives of, and background to the research:
2 Research methodology to be used (include an explanation of why donated human tissue is required for your research and describe any information you intend to collect about the research participants/donors.):
3 Selection of participants/donors:
Will the participants be from any of the following groups?
(Tick as appropriate)
Children under 18
Adults who are unable to consent for themselves ²
Adults who are unconscious, very severely ill or have a terminal illness
Adults in emergency situations
Adults with mental illness (particularly if detained under Mental Health Legislation)
Prisoners
Young Offenders
Healthy Volunteers
Those who could be considered to have a particularly dependent relationship with the investigator, e.g. those in care homes, medical students
Other vulnerable groups
( ² Please note, the Mental Capacity Act requires all intrusive research involving adults who are unable to consent for themselves to be scrutinised by an NHS Local Research Ethics Committee –
Please consult the Chair of your Faculty Research Ethics Sub-Committee or Amanda Longley or
Alison Vaughton (RBI) for advice)
If any of the above applies, please justify their inclusion in this research
Note: If you are proposing to undertake research which involves contact with children or vulnerable adults you will generally need to hold a valid Criminal Records Bureau check.
Please provide evidence of the check with your application.
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4 Please explain how you will determine your sample size, and identify, approach and recruit your participants/donors:
5 Please describe how you propose to collect, process, store and dispose of the human biological samples.
6 What risks, if any, do the participants/donors face in taking part in this research and how will you minimise these risks?
7 How will you seek informed consent from the participants/donors (include copies of participant information sheets and consent forms)?
8 Please explain how confidentiality will be maintained, and if samples will be anonymised:
9 How have you addressed the health and safety concerns of the participants/donors, researchers and any other people impacted by this study?:
10 Please describe how you will maintain data protection:
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11 How will the results of the research be reported and disseminated ? (Select all that apply)
Peer reviewed journal
Conference presentation
Internal report
Dissertation/Thesis
Other publication
Written feedback to research participants
Presentation to participants or relevant community groups
Other (Please specify below)
12. Other ethical issues: (please describe and address any ethical issues not already covered in your application for example relating to the importation or export of human biological samples, any material transfer agreements.)
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Checklist
Please complete before submitting form (insert N/A if not applicable)
Is a copy of the research proposal attached?
Yes/No
-
- If you have already obtained other external ethics approval is a copy attached?
Will the human blood or other relevant material be rendered acellular within 5 days?
Have you explained how you will select the participants/donors?
-
-
Have you described how you will collect, process, store and dispose of the human tissue samples?
Have you described the ethical issues related to the well-being of participants/donors?
Have you considered health and safety issues for the participants/donors and researchers?
Have you included details of data protection including data storage?
-
-
-
Have you described fully how you will maintain confidentiality?
Is a participant/donor consent form attached?
Is a participant/donor information sheet attached?
Is a copy of any questionnaire/interview or personal data sheet attached? -
Declaration
Principal Investigator
Signed
Date
Supervisor or module leader (where appropriate)
Signed
Date
-
-
-
-
The form should be emailed to Leigh Taylor, Secretary to the Faculty Research Ethics
Committee at Leigh.Taylor@uwe.ac.uk
. A paper copy with signatures should be sent to Leigh
Taylor, Secretary of the Faculty Research Ethics Committee, Faculty Research Office, Frenchay
Campus, within 5 working days of the electronic version.
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These notes are intended to be read when completing the application form for ethical review of human tissue research using ‘relevant material’. For a definition of what is meant by ‘relevant material’ see: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
You should familiarise yourself with the Human Tissue Authority (HTA) Codes of Practice on
Research; Consent; Disposal, Import and Export which can be found at: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm
Please note that UWE does not currently hold an HTA License for storage of human tissue.
Please ensure that you have considered whether you need approval for your research from a
‘recognised REC’ via the NRES system. If you are uncertain please seek advice from your Dept
Ethics Lead, AHoD RKE or Centre Director in the first instance or contact NRES at http://www.nres.nhs.uk/ .
1. If your research involves NHS patients (including tissue or organs obtained from them), you will need to obtain NRES approval.
2. If you intend to collect any relevant material and store it for more than 5days then you will need NRES approval.
3. If you wish to collect human blood from healthy volunteers to analyse intact cells you will need to apply for NRES approval even if you intend to use it within a short period of time.
4. If you wish to collect human blood from healthy volunteers as control groups for a study that also uses materials collected from NHS patients then you should apply for approval to do this at the same time as you submit your NRES application.
5. If you wish to collect human blood or any other relevant material and render it acellular within
5 days you may apply for ethical review and approval from FREC using this form.
6. If you wish to import human tissue for your research you may apply for ethical review and approval from FREC using this form.
If your project is approved you will need to complete a registration form to register your research on the UWE Human Tissue Research Register. The registration form may be obtained from your Dept Ethics Lead Dr Lynne Lawrance Lynne.Lawrance@uwe.ac.uk
or
Leigh.Taylor@uwe.ac.uk
.
External ethics approval
Where the work has already been subjected to ethical scrutiny, for example by an NHS Local
Research Ethics Committee through the National Research Ethics Service (NRES) you should indicate this on the form.
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If your research involves NHS patients (including tissue or organs), or NHS Data you will need to get NRES approval. The UWE procedures recognise the burden placed on the researcher in applying for NRES approval. In order to assist PIs in this as far as possible, you should apply for
NRES ethics approval first (using the IRAS form) and submit a copy of the application and the letter of approval to your FREC or to UREC (as applicable). This approach has been designed to retain the right of ultimate ‘sign off’ by the University without having to go through a separate protracted University process. UREC has established a panel of volunteers to assist staff and students in making applications to the NRES, by supporting applicants on a one-to-one basis, please contact Leigh Taylor ( Leigh.Taylor@uwe.ac.uk
) for details. However it is important that
PIs conducting research in the NHS appreciate that both UWE and NHS Ethics clearance will be needed and are separate. Achievement of the one does not guarantee success with the other.
If you have already received ethical approval from an external research ethics committee you should provide evidence of this with your application to UREC/FREC. You will need to register your research on the UWE Human Tissue Research Register after you obtain NRES and UWE approval to proceed.
If you obtain human tissue samples from a licensed Research Tissue Bank which has generic ethical approval you will need to register your research at UWE but you may not need to submit your project for further ethical review. See: http://www.nres.npsa.nhs.uk/applications/guidance/research-guidance/#useofhumantissue
If you are a collaborator on a project which has received ethical approval and you wish to transfer human tissue samples to UWE you will need to register your research at UWE and submit a copy of any Material Transfer Agreement, the ethics application and approval to FREC.
Doctoral and M Level student applications
For student applications the PI is usually the supervisor who should ensure that all the following are satisfied before the study begins:
 The topic merits further research
 The student has the skills to carry out the research
 The participant/donor information sheet or leaflet is appropriate
 The procedures for recruitment of research participants and obtaining informed consent are appropriate.
 Appropriate arrangements have been made for the processing, storage and disposal of human tissue samples.
Declaration
This should be completed once all the following questions have been answered. Where the application is from a student, a counter-signature from the supervisor is also necessary.
Question 1: Details of the proposed research – Aims and objectives of the research
This should provide the reviewer of the application with sufficient detail to allow him/her to understand the nature of the project and its rationale, in terms which are clear to a lay reader.
Do not assume that the reader knows you or your area of work. It may be appropriate to provide a copy of your research proposal.
Question 2: Details of the proposed research – Research methodology to be used
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You should explain how you plan to undertake your research. Explain why donated human material is required for your research and describe any information you intend to collect about the participants/donors. Where applicable a copy of any interview schedule/questionnaire/personal data sheet should be attached.
Question 3: Participant details – Participants from vulnerable groups
You must indicate if any of the participants in your sample group are in the categories listed.
Any Department of Health funded research involving participants who might not have the capacity to consent may need to go through the new Social Care Research Ethics Committee, unless it is already being reviewed through NRES. If your research subjects fall into any of the specified groups you will need to justify their inclusion in the study, and find out whether you will require a Criminal Records Bureau check.
Members of staff requiring CRB checks should contact Claire Holmes
(Claire.Holmes@uwe.ac.uk) in Human Resources. CRB checks for students will usually be organised through the student's faculty, but students in faculties without a CRB countersignatory should contact John Rushforth the University's lead countersignatory.
Please note: Evidence of a CRB check should take the form of an email from the relevant CRB countersignatory confirming the researcher has a valid CRB check for working with children and/or vulnerable adults. It will be the responsibility of the applicant to provide this confirmation.
Question 4: Participant details – Determination of sample size, identification and recruitment of participants
In this section you should explain the rationale for your sample size and describe how you will identify and approach potential participants/donors and recruit them to your study.
Question 5: Collection, processing, storage and disposal of human biological samples
You should explain what samples will be collected, who will collect them and how they will be collected. Describe the arrangements for processing the samples (eg rendering them acellular), storing and disposing of them.
Question 6: Risk and risk management – Risks faced by participants/donors
Describe ethical issues related to the physical, psychological and emotional well being of the participants, and what you will do to protect their wellbeing. If you do not envisage there being any risks to the participants/donors please make it clear that you have considered the possibility and justify your approach.
Question 7: Informed consent and withdrawal
Informed consent is an ethical requirement of the research process. Applicants should demonstrate that they are conversant with and have given due consideration to the need for informed consent and that any consent forms prepared for the study ensure that potential research participants/donors are given sufficient information about a study, in a format they understand, to enable them to exercise their right to make an informed decision whether or not to participate in a research study. You should make clear whether consent being sought is project specific or generic.
Consent must be freely given with sufficient detail to indicate what donating human tissue for the study will involve. Withdrawal from future participation in research is always at the discretion of the participant. There should be no penalty for withdrawing and the participant is not required
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You should describe how you will obtain informed consent from the participants/donors and, where this is written consent, include copies of participant/donor information sheets and consent forms. Where other forms of consent are obtained (eg verbal, recorded) you should explain the processes you intend to use. (See also Data access, storage and security below).
Question 8: Confidentiality/anonymity
You should explain what measures you plan to take to ensure that the information provided by research participants is anonymised and how it will be kept confidential. In the event that the data are not to be anonymised, please provide a justification.
Question 9: Risk and risk management – Potential risks to researchers
Describe any health and safety issues including risks and dangers for both the participants and yourself (if appropriate) and what you will do about them. This might include, for instance, arrangements to ensure that a supervisor or co-researcher has details of your whereabouts and a means of contacting you when you conduct interviews away from your base; or ensuring that a ‘chaperone’ is available if necessary for one-to-one interviews.
Question 10 : Data access, storage and security
Describe how you will store the data, who will have access to it, and what happens to it at the end of the project. If your research is externally funded the research sponsors may have specific requirements for retention of records. You should consult the terms and conditions of grant awards for details. For all research the University has recently agreed a policy on research data management ( http://info.uwe.ac.uk/secretariat click on records management, then guidance) which you are advised to read before completing your application.
It may be appropriate for the research data to be offered to a data archive. If this is the case it is important that consent for this is included in the participant consent form. For guidance on ensuring that consent for archiving of data is acquired see [new webpage – under construction].
The Data Protection Act 1998 requires individuals to be made aware of how information about them will be managed. For further guidance on the collection of personal data for research purposes and compliance with the Data Protection Act see http://www.uwe.ac.uk/finance/sec/dp/intranet/docs/F29.pdf
Question 11: Publication and dissemination of research results
Please indicate in which forms and formats the results of the research will be communicated.
Question 12: Other ethical issues
This gives the researcher the opportunity to raise any other ethical issues considered in planning the research or which the researcher feels need raising with the Committee. This might include a description and explanation of the import or export of samples. Please describe and attach copies of any material transfer agreements.
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Please address any enquiries about the application process which are not covered in these notes either to the contact (named below) for the Faculty Research Ethics Sub-committee to which you are submitting your application or to Alison Vaughton at rbi.rss@uwe.ac.uk
.
Research Ethics Committee contacts:
University Research
Ethics Committee
(UREC)
Name
Alison Vaughton
(Clerk)
Faculty Research Ethics Committees
FBL Linda Millward
(Secretary)
CAHE/FACIE
(Creative Arts)
CAHE/FACIE
Patrick Lansley
(Secretary)
Viv Calway
(Secretary) (Humanities &
Education)
FET Carolyn Webb
(Clerk)
HLS Leigh Taylor
(Secretary)
Email rbi.rss@uwe.ac.uk
Telephone
0117 32 82872
Bbs.researchethics@uwe.ac.uk
0117 32 82600
Patrick.Lansley@uwe.ac.uk
Vivien.calway@uwe.ac.uk
Leigh.taylor@uwe.ac.uk
0117 32 84746
0117 32 84223
Fetresc.enquiries@uwe.ac.uk
0117 32 83102
0117 32 81170
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