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Annex 1: Bath Spa University Research Ethics Approval Form


This form forms part of the University’s Process and Procedure for the Approval of Research Activity.


Approval for research in undergraduate and taught postgraduate programmes is normally dealt with at School level, through the research approval form below. Where necessary, the proposal will be referred to the School Ethics Sub-Committee.


Approval for research carried out by BSU employees and PhD students should be approved through School Ethics Sub-Committees, using the University Research Ethics Approval Form.


Where necessary, Research Ethics Approval forms will be referred to the University Research Ethics Sub-Committee for additional consideration.


Where research projects are subject to external approval, such as the NHS or professional bodies, the School responsible must ensure that this approval is sought and given. Where approval for a project has been given by a Research Ethics Committee at another university, as may be the case with a collaborative project, the School Ethics Sub-Committee must be provided with proof of this.


Research that is subject to ethical approval means all research that involves human participants or data (both existing and new) pertaining to human participants as subjects undertaken as a part of formal University activity. The phrase ‘human participants’ refers to persons used in all types of research. Qualitative based research projects may include personal interviews, questionnaires, interviews, focus groups, observation of groups etc. Quantitative and experimental research may include questionnaires, surveys, trials etc.


Research activities put forward for formal ethics review:



Decisions made by School and University Ethics Committees are binding, and failure to comply with decisions may be regarded as misconduct in research.

The process to be followed is set out below:


Type of Activity

Process

Undergraduate Student projects

Complete form and checklist and submit to supervising tutor

Postgraduate Student projects (taught programmes)

Complete form and checklist and submit to supervising tutor

Postgraduate Student projects (research programmes)

Complete form and checklist and submit to Director of Studies for consideration by the Ethics Sub- Committee

All staff engaged in research activities

Complete form and checklist and submit to Director of Research for consideration by the Ethics Sub- Committee

Bath Spa University Research Ethics Approval Form


Student/Staff name

James Caspian

Programme and/or module

PR7102

Title of the proposed research project:

An examination of the experiences of people who have undergone reverse Gender Reassignment Surgery and/or have reversed a gender transition.

Number and type of proposed participants

Between one and four people who have undergone reverse Gender Reassignment Surgery as part of reversing a gender transition, or who have reversed a gender transition socially and/or medically without necessarily reversing surgery at least two years prior to interview.

How is permission being sought from the participants and/or their parents/carers?

Through being given an information sheet about the research and an informed consent form to sign.

How is participants’ anonymity to be preserved?

Through using pseudonyms and disguising any information obtained that may lead to them being identified.

Describe the research methods proposed (e.g. interviews, classroom observations)

Interviews done via internet, telephone or in person.

List the ethical issues and potential risks associated with the research methods outlined above (e.g. confidentiality) and how you propose to deal with each of these.

Confidentiality : All information and data will be treated as confidential. Anonymity is a key part of this (see above) and data will be coded and stored to preserve anonymity and kept securely using passwords and will only be seen by the researcher, and will be destroyed when the research has been written up.

Consent: Informed consent in writing will be sought and may be withdrawn at any time including retrospectively and any data collected would be destroyed.

Protection from harm – of participants: Participants will be asked to ensure that they have access to psychological support both during and after the research should this be


necessary should their participating trigger an emotional

response, and this possibility will be discussed with them – of the researcher: an anonymous email address will be used to retain anonymity for the researcher during the research.

Dissemination: the intention to publish and possibly present the research at a conference will be disclosed to the participants from the beginning as part of the consent process.

Ethical standards: those of the United Kingdom Council for Psychotherapy and Bath Spa University will be observed at all times and ethical issues will be reviewed on an ongoing basis throughout the research.

Value: The potential value of the research will be made clear to participants.

Openness and honesty: Participants will be informed of the research rationale and methods at the beginning.

Describe how your

Reported by a paper being written up about the research.

findings will be

Disseminated by being submitted to professional journals for

reported or

publishing and to a conference on transgender healthcare.

disseminated


Funding – Detail the funding and projected costs of your project

N/A

RSA – State the amount of RSA time to be allocated to your project

N/A

I have read the University’s Process and Procedure for the Approval of Research Activity

James Caspian.

23rd October, 2016.

(please sign and date)




Ethical Review of Research Projects – Checklist


Supervising Tutor/ Director of Studies Approval level required (Y/N)

a)

proposals using human participants for research

Y


b)

proposals for participants

research

that

intends

to

use

undergraduate

students

as


N

School Ethics Sub-Committee approval required

c)

procedures involving any risk to a participant’s health (for example intrusive physiological or psychological procedures)

Y


d)

research involving the donation of bodily material, organs and the recently deceased


N

e)

proposals which involve financial payments or payments in kind to participants above reimbursement of expenses


N

f)

proposals wishing to use children under the age of 16 or those over 16 who are unable to give informed consent (e.g. people with learning disabilities; see Mental Capacity Act 2005) as participants


N

g)

research proposals to be carried out by persons unconnected with the University, but wishing to use staff and/or students as participants


N

h)

proposals which investigate existing working or professional practices at the researcher’s own place of work (including staff surveys)


N

i)

research where the safety of the researcher may be in question;

Y


j)

proposals which require participants to take part in the study without their knowledge and consent at the time


N

k)

research involving prisoners and young offenders


N

University Ethics Sub-Committee approval required

l)

research involving access to records of personal or sensitive confidential information, including genetic or other biological information, concerning identifiable individuals


N

m)

surveys, questionnaires and any research, the nature of which might be offensive, distressing or deeply personal for the particular target group

Y




Document checklist for submission


I have completed and include the following documents with this form

Information Sheet

Consent Form

Debriefing

N

Research design documentation e.g. interview schedule; questionnaire

School Ethics Sub-Committee Use Only:


Comments on the ethical issues raised by the proposed research and how well they have been addressed

This is an ethically complex research project. The research project was initially approved by the ethics committee, however when the researcher attempted to recruit participants none were forthcoming. The researcher now wishes to amend the focus of the project to include those who have had surgery but not reversed it and to advertise on an International website.


Engaging in a potentially ‘politically incorrect’ piece of research carries a risk to the University. Attacks on social media may not be confined to the researcher but may involve the University. This needs to be assessed by the University Ethics Committee.


The researcher states that there may be issues in advertising on this website from trans activists. He refers to the risk of attack on social media and his attitude to this is that he doesn’t engage in this form of communication and so it is unlikely to affect him. He needs to rethink this. He also needs to rethink the face to face interviews; given his concerns with the sensitive nature of the topic and the lack of screening in place, how can his safety be guaranteed?


There is no mention of the emotional or psychological impact of the research on the researcher. He is a psychotherapist and he should consider having some debriefing mechanism in place for himself.


He also needs to make it very clear to the participants what will happen to the data. He guarantees that the data will be seen only by the researcher. This is not accurate. Given the context in which the study will be undertaken, the data will need to be made available to the supervisor(s), the examiners and will also feature in the dissemination through journal articles and conference presentations.


Identified ethical issues which need further consideration:

  • Explanation needs to be provided as to why the research material is ‘minimised, dismissed and politically incorrect’. Further consideration then needs to be given to the ethical implications of this.

  • Risk to the University – the posting of unpleasant material on blogs or social media may be detrimental to the reputation of the University. This needs to be assessed and addressed.


  • Risk to the researcher – the posting of unpleasant material on blogs or social media needs to be considered further. Whilst not a social media user comments may be placed elsewhere which could be upsetting to the researcher. Therefore, he needs to provide details about how he intends to protect himself from harm, both from personal attack and from cyberbullying.

  • Risk to the researcher - Provide evidence that the researcher has discussed the study with a professional (medical or psychotherapy practitioner) known to him and can confirm that he can draw on their support where necessary

  • Risk to the researcher - it is stated that interviews might take place in the interviewee’s home or a friend’s home. The risks of this and how they will be mitigated need to be addressed.

1) Safeguarding the participant - there needs to be written confirmation not just that personal therapy will take place for the participant but what that therapy will be so that it can be assessed as appropriate. There then needs to be confirmation that support is available where necessary throughout the duration of the project and beyond it.

  • It is stated that interviews will be recorded on cassette tapes – how and where will these be stored, how will the raw data be destroyed.

  • Change the information provided about confidentiality to reflect the fact that the data will be made available more widely than he describes.


This was further discussed with the Dean of the Institute of Education and the ethical approval form has been declined. This is a complex project and the risks are too great to the University and the researcher. Working on a less ethically complex piece of research to complete the Masters would be more appropriate.

PASS

I am satisfied that the ethical issues raised by the proposed research project have been addressed and give approval for the project to go ahead


CONDITIONAL PASS 1.

The ethical issues raised by the proposed research project have not been adequately addressed and require re-submission to the IfE Ethics Sub-Committee. The following adjustments need to be made:



1.

2.




REFERRAL

The ethical issues raised by the proposed research project require referral to the University Ethics Sub-Committee.

YES


Signature and Date: (Chair of School level committee)


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08/11/2016

Signature and Date: (Dean of School)

DECLINED



A copy of this form should be retained by the Director of Research in the School

Comments on the ethical issues raised by the proposed research and how well they have been addressed


Either:

I am satisfied that the ethical issues raised by the proposed research project have been addressed and give approval for the project to go ahead


Or: 2.

The ethical issues raised by the proposed research project have not been adequately addressed and require re-submission to the committee.



Signature and Date: (Chair of University Ethics Sub- Committee)



University Ethics Sub-Committee Use Only:


3.

4.


A copy of this form should be retained by the Vice-Provost, Research & Enterprise