1. Community consent in the Born in Bradford birth cohort study. Pauline Raynor Neil Small Email: Pauline.Raynor@bradfordhospitals.nhs.uk N.A.Small@bradford.ac.uk www.borninbradford.nhs.uk

2. What Born in Bradford is. We started recruiting pregnant mothers in March 2007 and our first babies in May. We are seeking to recruit all newborn babies born in Bradford Royal Infirmary with the aim of having a cohort of 10000 babies and their parents Up to the end of December 6,300 mothers and babies recruited over 1,200 fathers Over 6,000 babies have been born

3. Infant Mortality Rate, Bradford and England and Wales

4. What this graph means 2006 England and Wales average mortality rate – 5.06 per 1000 live births. Bradford 7.21 2002 5.48 in England and Wales compared with 9.42 in Bradford (and the gap seems to be growing) There are about 5500 births a year – a rate of 9.5 means a baby dies about every week (if it was average then it would be every 2 weeks) 5.06 means 28 deaths under age 1 7.21 means 40 deaths under age 1

5. Infant Mortality by Deprivation within Bradford 1993-97 to 2001-05

6. Setting the agenda: Infant Mortality Commission - 2006 Chaired by a lawyer and made up of bereaved parents, members of voluntary organizations, health / public service professionals and politicians this took evidence from interested parties, including many members of the public. “that we are still trying to solve this distressing problem a century after the first report was published powerfully underlines just what a complex problem infant mortality remains”

7. Main challenges 1.Getting people to join the study 2.Keeping people in the study 3.Putting the lessons of the study into practice. Role of public and study members If we are just doing to then we will meet none of these challenges If we are just doing for we might get 1), possibly 2) If we are doing with we might get all three

8. Gaining approval and consent Gain cooperation and subsequent approval from Research Ethics Committee Development of Consent Form for parents

9. Early Consultation Informed and involved the Research Ethics Committee (REC) before the study started Recognised the need to build a trusting long term relationship with the local REC Discussed potential problems around ethics approval when dealing with a longitudinal study Suggested ways to overcome these together

10. Progress Complete new application one year after study began as project progressed Regular updates to REC Ensure Chief Investigators of nested studies appear at REC meetings in person to answer any questions Have used amendments for most nested studies – Avoided need for participants to sign consent forms repeatedly for each contact or participation in nested studies – Avoided delays with lengthy form filling and resources involved in having separate ethics applications for all nested studies

11. User Friendly Patient Information Sheet (PIS) Consultation with over 200 people from a range of groups informed the content and layout of the PIS: – Ante natal groups in the community – Bradford Royal Infirmary ante and post natal wards – Statutory sector provision – Children’s Centres – ‘Upfront’ Teenage Advisory Unit – Senior schools – girls aged 14 to 16

12. Non English speaking participants Over 50% Mirpuri and Urdu speakers in cohort – Translated PIS and Consent Form into suitable Urdu – Provide CDs with Consent Form in Urdu, Mirpuri and Syleti alongside a short explanation of what the project involves Unable to offer interpreters in all languages on the day of recruitment (over 45 languages spoken) – Produced statements explaining recruitment process in three most prevalent languages apart from South Asian languages – Czech, Polish, Slovakian

13. Consent Form Liaised with other researchers working on other cohort studies about their experiences and problems around consent – Gain wide ranging consent if you can to avoid having to go back to participants again and again Looked forward to linking of medical records and education records and included this in the form Lot of effort with Patient Information Sheet Consideration of non English speaking mothers

14. Community Consent Seek community views and input Understand patterns of influence within different communities Recognise there might be different ethical structures and assumptions

15. Deciding on the detailed focus of the study Meetings with neighbourhood and voluntary sector organisations, as well as professional groups, and local elected officials helped identify priorities. Considerable emphasis on continued communication. Monitoring progress Advocacy and Scrutiny Committee, chaired by people independent of the study and including parents, local people and those with a particular expertise such as in ethics and in the law, this advises on all new studies, and recommends if they should be supported. The Advocacy and Scrutiny Committee act as an independent voice, they provide a level of community consent for study.

16. Half-full or half-empty So far Born in Bradford has done well on communication and consultation in developing the study and in keeping members in touch with progress. It is developing collaboration – there is an executive role for the Advocacy and Scrutiny group and a route for new proposals (including from the public and study members) to seek to be included. This offers the possibility for user led–research. The Advocacy and Scrutiny Group are particularly valuable in scrutiny – they can be a route to accessing community members/organisations re advocacy Achieving the project aims requires support and input from large numbers over long periods

17. Website address – www.borninbradford.nhs.uk www.borninbradford.nhs.uk Born in Bradford, a cohort study of babies born in Bradford, and their parents: Protocol for the recruitment phase – http://www.biomedcentral.com/1471- 2458/8/327 http://www.biomedcentral.com/1471- 2458/8/327