FAQs about taking part in OSPREA studies
Q. What is OSPREA?
OSPREA stands for the Oxford Safety Pregnancy Alliance.
We are a team of doctors, scientists, researchers, midwives, nurses and support staff who are working together with women to lead research into women’s’ health in the areas of reproduction, obstetrics and gynaecology. We are primarily based within the John Radcliffe Hospital in Oxford. We aim to conduct high quality studies that help improve the care of women before, during and after pregnancies, and their babies during and after pregnancy. OSPREA is involved in a number of research studies to improve the care of pregnant mothers and their babies. We rely on pregnant women and their babies to help us continue our work.
Q. What are Clinical Trials?
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for use in humans. Clinical trials are one of the final stages of a long and careful research process. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards, known as a protocol, are set to ensure they are well designed, protect the participant and help produce reliable and meaningful results. The process often begins in a laboratory, where scientists first develop and test new ideas.
Clinical trials help to find out if:
- treatments are safe
- treatments have any side effects
- new treatments are better than the standard available treatments
A clinical trial may find that a new strategy, treatment, or device
- improves patient outcomes;
- offers no benefit; or
- causes unexpected harm
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.
Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
All of these results are important because they advance medical knowledge and help improve patient care. These studies also may show which medical approaches work best for certain illnesses or groups of people
Q: What does getting involved in research mean?
A: Participation could be as simple as providing a blood sample or answering a questionnaire, to having additional scans or being offered nutritional supplements. For more details, take a look at our current trials page. In addition you might be asked:
- For your permission to be contacted about taking part in research studies in future.
- For permission for researchers to use your health records for their research studies. This is done securely and anonymously.
- We sometimes ask people who have said they are happy to be more involved with our work to help us talk about studies at events, or provide information about what participation in a study meant to them.
To hear patients talk about their experience of participating in research, please visit healthtalkoline.org or the National Institute for Health Research.
Q: Is there any risk to me or my baby if I decide to participate in research?
A: If there are any risks involved in taking part in a study, these will be explained to you before you agree to take part. All our research studies have been approved by Research Governance and Ethics Committees who ensure that studies put the health and wellbeing of patients first. If you agree to take part in a study, your hospital doctor or GP will be informed and they will advise you accordingly if they feel you should not participate.
Q: Do I have to take part in research?
A: It is up to you to decide whether or not you wish to take part. You may speak to your consultant, GP, family and friends , before you decide. If you decide not to take part, this will not affect the care you receive in any way.
Q: Will I be paid for participating in research?
A: You may be able to claim travel expenses for the additional ultrasound and follow-up appointments. There are no other payments.
Q:What are the benefits of participating in research?
A: Taking part in research will not usually benefit you or your baby directly. However, your participation may lead to improvements in healthcare for other babies and expectant mothers in your community. In addition, you will benefiting others and medical science, may gain access to new treatments and will gain useful information about your health and help with decision-making.
Q: Will my baby and I receive additional treatment (scans, appointments) if I participate in research?
A: This depends on the study, some of the research simply requires the analysis of samples which are routinely provided by you throughout your pregnancy, while others will include some additional scan or appointments. You may receive additional “contact time”, such as more frequent monitoring and increased access to nurses/ staff.
Q: How much time will it take up if I decide to take part in research and how often will I have to come to the hospital?
A: It depends on the nature of the research, some clinical trials require additional attendance at hospital/ GP surgeries, whilst others may simply require telephone or email contact. We aim to be flexible as possible to ensure that as many people as possible can take part.
Q: If I do decide to join in with research, will my participation and the information obtained be kept confidentially?
A: Yes. We follow ethical and legal practice and all information about you and your baby will be handled in confidence. The research team has a duty of confidentiality to you as a research participant. All of the information collected will be made anonymous. The information and samples that relate to you will be coded and stored with a study number so that you cannot be identified from them but it will allow us to link together the different types of information you provide.
Detailed information about our data management policy is available upon request.
Q: What will happen to the results of the research study?
A: The results will be prepared for publication in scientific journals and presentation at international meetings. We can provide you with a copy of the papers after publication if you wish. Your name will not appear in any report or publication. Some of the data from the study may be included in the PhD thesis of one or more of the researchers. However, your identity will be protected at all times.
Q: What will happen to any samples I give?
A: For confidentiality reasons, your name will be removed by the OSPREA team from all biological samples and replaced by a number. The results from any tests carried out on samples will have no bearing on your current or future clinical care.
Q: Do I have to inform my GP or other hospital staff/ consultants that I am participating in research?
A: It is our responsibility to inform your hospital doctors and GP that you have agreed to take part in research. This ensures that your baby is healthy at the time of participation and remains well throughout the research period. If the research did identify any problems we would also inform your hospital doctors and GP so that they could monitor and/ or investigate as appropriate.
Q: What if I agree to take part in a research study and decide I do not want to continue?
A: If you are participating in a research study and decide you do not want to continue, you can drop out at any time. You do not have to give a reason why. This will have no effect on your clinical care.
Q: What if I join a research study and have concerns about my participation?
A: If you have concerns about the way you have been approached or treated during the course of the study, you can contact the Clinical Director, Women’s Services, Oxford University Hospitals NHS Trust and Head of the University Department of Women's & Reproductive Health on 01865 221003. If you wish to complain about any aspect of the way in which you have been approached or treated, you should contact the University of Oxford Clinical Trials and Research Governance office on 01865 743005. If you remain unhappy and wish to complain formally, you may also follow the normal NHS complaints procedure. In the event that something does go wrong and you are harmed during the research and this is due to someone‘s negligence then you may have grounds for a legal action for compensation against University of Oxford but you may have to pay your legal costs. Compensation for harm arising from an accidental injury and occurring as a consequence of your participation in the study will be covered by the Oxford University Hospitals NHS Trust.
Q. How do I let OSPREA know that I am interested in finding out more?
A. You can contact us by telephone on (01865) 572258, email us at osprea@wrh.ox.ac.uk or fill out our contact form page. If you are visiting the scan department at the John Radcliffe Hospital you can ask a member of staff to ask us to come and speak to you personally.