Information for Survey Participants

There are separate surveys for:

• Members of the general public
• Parents & prospective parents approached to take part in the SMA newborn screening pilot
• Members of the SMA community (people and families affected by SMA)
• Health care professionals

This information explains your rights as a participant. You will also be shown this information at the start of each survey. You will then be asked if you are happy to continue.

Who is running this research survey?
Professor Felicity Boardman and Dr Corinna Clark at the University of Warwick. You can read about our research here www.warwick.ac.uk/SMAscreening. This study was approved by the Biomedical & Scientific Research Ethics Committee (BSREC) at the University of Warwick (18/11/22). Novartis (manufacturer of one of the SMA treatments) provided funding for the research but are not involved in any part of the study.
Who can take part?
This survey is open to any UK resident over the age of 18 years old. There are separate surveys for different groups of people (see list above). The eligibility criteria for each survey are detailed within each survey, but if you are unsure which survey to complete please contact and we will be happy to help you.
Will my information be confidential?
This survey is anonymous. The full answers you give will be kept secure on encrypted servers at the University of Warwick. At the end of the survey we may ask if you would like to take part in an interview - if you answer yes, you can supply your email address (which will be stored separately to your survey responses) or you can contact us directly at .
Are there any benefits or risks to me taking part?
You will contribute to the UK NSC review of whether SMA should be part of routine newborn screening, which will have implications across the UK (and other countries considering screening for SMA). Some people may find answering questions about screening for SMA distressing. If the survey raises any issues that you would like to discuss, or for further information on SMA, please contact SMA UK (www.smauk.org.uk) or your GP. You can contact the research team via
What if I don’t want to answer any of the questions, or I change my mind about taking part?
You can select ‘prefer not to answer’ for any question you do not want to answer. We would appreciate feedback on any questions that you did not want to answer to improve future surveys. You can stop completing the survey at any point. If you do not press send at the end of the survey then your answers will not be recorded. As the survey is anonymous, once you have pressed send it will not be possible to remove your answers.
How will my answers be used?
The results of the surveys will be summarised and used in our report to the UK NSC, and in other reports, publications, and presentations, to scientific audiences, SMA support organisations, and the general public. Research is a task that we perform in the public interest, which means we may want to use some of the data for teaching, future studies, and to share with other researchers (e.g., in online databases). Only de-identified data would be used. If you are interested in our results please look at our website www.warwick.ac.uk/SMAscreening for updates or contact the team ( ).
What if I have a question or complaint about something in the survey?
Contact the research team via . To contact a senior University representative who is independent of the study: Head of Research Governance, Research & Impact Services, University of Warwick, Coventry. CV4 8UW. Tel: 024 76522746 researchgovernance@warwick.ac.uk
I’d like more information
Please go to our website www.warwick.ac.uk/SMAscreening

Interview Information Leaflet

We invite you to take part in this study, where we will gather and summarise the views of different groups of people towards the introduction of genetic screening, in newborn babies, for Spinal Muscular Atrophy.

This leaflet will provide information on why the study is being conducted and what you will be asked to do if you choose to take part. You can also contact the researchers directly if you have any questions (see who do I contact).

Please take the time to read the following information carefully before deciding whether you would like to take part.

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Why are we doing this study?

The UK National Screening Committee (NSC) and NICE (who advise the Government about screening and healthcare) are currently reviewing whether Spinal Muscular Atrophy (SMA) should be added to the conditions that newborn babies are routinely screened for.

The UK NSC would like to understand the views of members of the public, the SMA community, health care professionals, and families going through the Oxford SMA newborn screening pilot, towards this proposed change to newborn screening.

You do not need to know anything about SMA or screening to take part.

We are conducting surveys (see our website) and interviews with different groups of people. Surveys are a useful way to get answers from many people to a set of pre-defined questions. Interviews, on the other hand, are a really valuable way for us to understand, in detail, the range of thoughts and emotions that people have about making decisions (such as whether they support genetic screening).

Who is running the study?

This survey study is being run by Prof Felicity Boardman and Dr Corinna Clark at the University of Warwick. Our research explores people’s views towards screening and the use of genetics in healthcare. To read more about our research, please see our website.

This study was approved by the Biomedical & Scientific Research Ethics Committee on 18/11/22. Novartis (manufacturer of one of the treatments for SMA) provided funding to enable this research to be conducted, but they are not involved in any part of the research.

What will I have to do?

If you choose to take part, we will arrange a suitable time to speak with you. This can be online (e.g., via zoom, MS Teams), in-person (at your home or another location convenient for you), or over the telephone.

You do not need to know anything about SMA or screening. We will either send you a brief background summary to read or ask you to watch a video presentation before the interview.

We will also ask you to sign a consent form stating that you agree to take part.

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During the interview we will ask questions, such as…

…do you think screening for SMA should be offered to the parents of every newborn baby in the UK?

…what do you see are the main advantages or disadvantages to screening for SMA in newborns?

…what do you think are the most important things to consider when making decisions like this?

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The interview will be recorded and will take between 30 to 60 minutes. After the interview is complete, it will be typed up word-for-word (transcribed). At this point, any information that could identify you will be removed so that the interview transcript is completely anonymous. You will be given the opportunity to check the transcript to make sure it is accurate and that you are happy with the contents.

Do I have to take part?

No, you do not have to take part. You can also change your mind about taking part at any point and are free to withdraw your consent without providing a reason.

If you wish to withdraw your consent after the interview has taken place then, depending on the stage of analysis and publication, we will destroy any information you have provided us with (it will not be possible to remove information once analysed or published).

What are the benefits to taking part?

Your views will help to shape the future of newborn screening in the UK. Summaries and anonymous excerpts of interviews will be presented to the UK National Screening Committee and NICE. These organisations will take your views into consideration when they review whether screening for SMA should be offered to parents of all newborns in the UK.

As a thank you for your time we can send you a shopping voucher for £20.

What are the risks from taking part?

We may ask questions about screening that you may not have considered, or present viewpoints different to yours. This may be a particular concern for people who are having a baby, or considering having a baby. Some people living with, or who have a family member with SMA, might find talking to a researcher about their experiences distressing, even if they do not expect to. You can, however, decline to answer any questions during the interview. You can also end the interview at any point.

If you do have any concerns or the interview raises any issues for you, then please contact your GP, healthcare team, or see the section below - who do I contact...

How will the information be used?

Your answers will be combined with everyone who we interview and who completes the survey, and will then summarised to describe the range of opinions towards screening for SMA. The results of this study will be used to inform future Government screening policy, to produce research articles in international scientific journals, and for teaching.

How will my information be kept safe?

Your data will be treated as strictly confidential in line with the Data Protection Act, 1998.

All names and identifiers will be removed or disguised in the written transcript and your transcript will be given a unique identifier and stored on password protected computers managed by the University of Warwick. All audio recordings of the interviews will be destroyed after transcription. Once we have published the results, we destroy the encrypted file containing your contact details and it will no longer be possible for us to link your transcript to you.

When the study has been completed, the anonymised transcripts will be archived so that other researchers may analyse the data in the future. You will have the option to refuse the archiving of your interview transcript when you consent to take part.

Are there any eligibility criteria to take part?

We welcome any UK resident over the age of 18 years who is able to communicate in English. For any additional criteria please see relevant page (SMA Community, Health Professionals)

Who do I contact if I have any questions or concerns?

For any questions or concerns about this study, please contact us at SMAscreening@warwick.uk, or via the contact form on our website.

More information about Spinal Muscular Atrophy can be found at the following links:

nhs.uk/conditions/spinal-muscular-atrophy-sma

smauk.org.uk (SMA UK also have a support line on 01789 267 520)

Should you have a complaint about the way you have been dealt with as a part of this study, or any harm you might have suffered, you can contact the Head of Research Governance below, who is a senior Warwick official entirely independent of the study.

Deputy Director/ Head of Research Governance, Research & Impact Services, University House, University of Warwick, Coventry,

CV4 8UW. Tel: 024 76 522746

Email:

Thank you for reading this leaflet. If you would like to take part please contact us at .