Silent stoma study.
CUREC Approval Reference: R82054/RE001
1. Introductory paragraph
You are being invited to take part in a research project. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part.
2. Why is this research being conducted?
Permanent stoma formation following bowel conditions or trauma can affect one’s quality of life. One important aspect of quality of life is sexual well-being, which often goes unaddressed in clinical care settings. People with a permanent stoma reported concerns related to their body image, dating, and forming new romantic relationships, as well as maintaining existing relationships. It is not known yet what are the most important concerns of people with a permanent stoma regarding sexual well-being, and what are their information needs on the topic. Information about you, and your concerns related to how stoma has impacted your sexual well-being will help us understand more about what people experience, and what information needs they have to address such concerns.
3. Why have I been invited to take part?
Because you have a permanent stoma, you are over 18 years old and speak conversational English we would like to hear from you and your experiences of sexual well-being after the stoma.
4. Do I have to take part?
No. It is up to you to decide whether to take part. Once you have completed the anonymous survey you cannot withdraw because we will not be able to identify which responses came from which participant.
5. What will happen to me if I take part in the research?
This study is a two-phase study. The first part is an online anonymous survey that will take approximately 20 minutes to complete. If you wish to take part in the second phase you would have a telephone interview. You can choose to only take part in the first phase – if you choose this, then once you complete the survey you have completed the study.
If you also agree to take part in a telephone interview following the survey, you will be asked to tick an additional consent box and enter your email address. I will contact you around 3 months from after the survey to check if you still consider taking part in this second phase of the study. With your consent, I would like to audio record the interview so I can have an accurate record of our conversation. Before the interview you will have a pseudonym allocated to maintain your privacy and confidentiality. If you still agree to take part in the second phase, I will ask a few questions that will be based on the findings from the surveys. These questions will be related to your experiences around how stoma affected your sexual well-being, your dating, your existing or future relationships, as well as your information needs on this topic from care providers. You will only disclose as much as you feel comfortable and the interview will be paused or stopped if you wish to. You will also be asked for permission to use quotes from your interview in future publications, although these quotes will be under your pseudonym and make it very hard for people to identify you. You may withdraw from taking part in the interview phase without giving any explanation. However, your data collected in phase one will still be used.
6. What are the possible disadvantages and risks in taking part?
There are no disadvantages in taking part and the risk of being recognised from quotes provided during the interview are minimal.
7. Are there any benefits in taking part?
While there are no immediate benefits for those people participating in the research, it is hoped that this research will lead to a better understanding of this under-researched topic and development of educational programs for care providers that answer the main sexual well-being concerns of people living with a permanent stoma.
8. What information will be collected and why is the collection of this information relevant for achieving the research objectives?
We will not collect any data that could directly identify you if you only complete the anonymous survey. For those who indicate they wish to have a telephone interview, we will only keep your email/telephone number until the interview has taken place or if you decide you do not wish to proceed with an interview. The interview will be audio recorded and securely stored on university servers until transcribed. The files will be transferred securely to a third party approved by the University for transcribing. Immediately after transcription the audio files will be deleted. The verbatim transcripts of the interviews will be securely stored on encrypted files on University servers for a period of 3 years. Your IP address will not be collected or stored. We will take all reasonable measures to ensure that data remain confidential. The responses you provide will be stored in a password-protected electronic file on University of Oxford secure servers and may be used in academic publication and conference presentations. Anonymised research data will be stored for 3 years after publication or public release of the work of the research.
The researcher and transcriber will have access to the research data, however the transcriber will receive data that is not containing your name.
9. Will the research be published? Could I be identified from any publications or other research outputs?
The findings from the research may be written up in academic publications, conference presentations, and a report commissioned by an external organisation that funded the research.
No personal/identifiable data will be published.
10. Data Protection
The University of Oxford is the data controller with respect to your personal data, and as such will determine how your personal data is used in the research. The University will process your personal data for the purpose of the research outlined above. Research is a task that is performed in the public interest. Further information about your rights with respect to your personal data is available from the University’s Information Compliance web site at https://compliance.admin.ox.ac.uk/individual-rights.
11. Who is funding the research?
This study is funded by an Investigator Initiated Study grant from ConvaTec.
12. Who has reviewed this research?
This research has received ethics approval from a subcommittee of the University of Oxford Central University Research Ethics Committee. (Ethics reference: xxxxx).
13. Who do I contact if I have a concern about the research or I wish to complain?
If you have a concern about any aspect of this research, please contact Dr Simona Fourie email@example.com /Tel 01865231461, and I will do my best to answer your query. I will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with. If you remain unhappy or wish to make a formal complaint, please contact the Chair of the Medical Sciences Interdivisional Research Ethics Committee at the University of Oxford who will seek to resolve the matter as soon as possible:
Email: firstname.lastname@example.org; Address: Research Services, University of Oxford, Boundary Brook House, Churchill Drive, Headington, Oxford OX3 7GB
14. Further Information and Contact Details
If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact:
Dr Simona Fourie
Radcliffe Department of Medicine| Investigative Medicine
University tel: 01865231461
University email: email@example.com