B1185 - ALSPAC Ethics and Law Committee the first 16 years of ethical protection for an epidemiological birth cohort - 16/06/2011

B number: 
B1185
Principal applicant name: 
Kate Birmingham (University of Bristol, UK)
Co-applicants: 
Michael Furmstone (University of Bristol, UK), Prof Jean Golding (Not used 0, Not used 0)
Title of project: 
ALSPAC Ethics and Law Committee: the first 16 years of ethical protection for an epidemiological birth cohort.
Proposal summary: 

I have been systematically working through the early ALSPAC Ethics and Law Committee documents for the ALSPAC Archive which is to be housed in the University of Bristol Library Special collections (alongside the Brunel collection and Penguin books). I am now thoroughly familiar with this material and would value time to write up the extent of the committee's early work. I propose to write a brief monograph which will systematically describe and classify the work of the committee during its first 16 years when the study participants reached an important legal milestone, summarising the ethical issues, discussion and outcomes and putting the committee's work into the legal and ethical context of the time. After appropriate review, I would hope to submit this to the Leverhulme Trust who have provided funding for work on the ALSPAC Ethics archive.

The Committee is considered by many as innovative, not only as it was the first ethical committee set up to provide legal and ethical advice for such a longitudinal study but also as ALSPAC was designed from the outset to utilise genetic data. In contrast to clinical genetics, the ethical issues generated in the context of such a population study had hardly been addressed previously.

The Committee has influenced other longitudinal epidemiological studies since its inception, e.g. UKBiobank, which modelled its Ethics and Governance Council on the ALSPAC Committee, the National Children's Study in the USA to which I attended an early ethics advisory workshop and the Swiss Etiological Study of Adjustment and Mental Health (which failed spectacularly).

My specific goals would be:

* To document the extent of the work of the committee through systematic analysis of the minutes of the meetings and accompanying documents. This will include research that the committee initiated; the three year Wellcome funded qualitative study designed to elicit the 8 year old participants' attitude to the use of their data in genetic research (Ethical Protection in Epidemiological Genetic Research: Participants' Perspectives).

* To select topics of particular importance that the committee discussed on many occasions, not only as the children grew up but also as legal and ethical practices changed (e.g. consent, disclosure of results, genetic analyses, record linkage, open access to data). Trace the development of these discussions and the recommendations made.

* To outline the committee's influence beyond that of the cohort e.g. advice to the UK House of Lords Select Committee, the Human Genetics Commission, the Nuffield Trust and European Society of Human Genetics.

I have the opportunity to spend two months next year (September 2012 - October 2012) at the Brocher Foundation (http://www.brocher.ch), a Swiss non-profit making foundation that provides facilities for visiting junior and senior researchers to write books, articles, essays, or PhD theses on the ethical, legal and social implications of medical research.I was encouraged to apply for a 2 month visiting researcher position but thought I had absolutely no chance of being accepted as most of the current visiting researchers are relatively senior academics.I am now somewhat embarrassed at putting the proposal to the Executive committee without previous discussion and apologise for this.I do feel it would be an excellent opportunity and anticipate with careful planning, my workload can be organised so as not to disrupt the ethical process within ALSPAC.I would of course make up the hours in whatever seems the most useful way; perhaps working full time instead of half time before and/or after the proposed absence.I hope the Executive feel able to support me in this development opportunity in my other role within the School by allowing the necessary flexibility of my working hours.

Date proposal received: 
Thursday, 16 June, 2011
Date proposal approved: 
Thursday, 16 June, 2011
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