Pioneering Ethics in a Longitudinal Study : The Early Development of the ALSPAC Ethics and Law Committee

Available Open Access under CC-BY-NC licence. The Avon Longitudinal Study of Parents and Children (ALSPAC), also known as Children of the 90s, is a world-leading birth cohort study that uniquely enrolled participants in utero and obtained genetic material from a geographic population. It instigated the innovative but controversial ALSPAC Ethics and Law Committee. This book describes in detail the early work of this Committee, from establishing the core ethical principles necessary to protect participants, to the evolution of policies concerning confidentiality and anonymity, consent, non-intervention and disclosure of individual results, data access and security. Quotes from interviews with early members of the Committee reflect not only on its pioneering work but also on the unusual style and inspirational leadership of the first Chair, Professor Michael Furmston. This will be of interest to those involved in other cohort studies in understanding the evolution of ethical policies as ALSPAC developed.|Available Open Access under CC-BY-NC licence. The Avon Longitudinal Study of Parents and Children (ALSPAC), also known as Children of the 90s, is a world-leading birth cohort study that uniquely enrolled participants in utero and obtained genetic material from a geographic population. It instigated the innovative but controversial ALSPAC Ethics and Law Committee. This book describes in detail the early work of this Committee, from establishing the core ethical principles necessary to protect participants, to the evolution of policies concerning confidentiality and anonymity, consent, non-intervention and disclosure of individual results, data access and security. Quotes from interviews with early members of the Committee reflect not only on its pioneering work but also on the unusual style and inspirational leadership of the first Chair, Professor Michael Furmston. This will be of interest to those involved in other cohort studies in understanding the evolution of ethical policies as ALSPAC developed. PIONEERING ETHICS IN A LONGITUDINAL STUDY Contents List of figures and photographs Figures Photographs List of abbreviations Authors and contributors, with current positions Acknowledgements Foreword Preface Personal perspective Introduction Part One. ALSPAC Ethics and Law Committee: a new concept 1. Preliminaries and pioneers: framing the questions 2. Informal or casual: an unusual style Study participants Length of service Minutes 3. Advisory to independent: a missed opportunity Institutional Review Board status 4. Bureaucratic battles: liaison with Local Research Ethics Committees Part Two.Policy development: a case of case law 5. Confidentiality and anonymity: a rod for their own backs The ‘Ethical Divide’ The ‘500 rule’ Questionnaires Text data Genetic data Data access 6. Informed consent: too much information From whom? To what and by what process? How much explanation is necessary? Other aspects of consent 7. Child protection: an observational study? Family Liaison Team Research clinics Psychologists’ sessions Questionnaires 8. Disclosure of individual results: foreseen feedback and incidental findings Foreseen feedback Incidental findings 9. Disclosure of individual results: participants’ requests 10. Participants’ problems: people not policies Requests for help Partner issues Abuse of clinic staff Child’s death Miscarriage Guarantee of anonymity 11. External databases: anonymous linkage Health records Education records Part Three. Beyond policy: a broad remit 12. Retention of the Cohort:incentives or inducements Incentives The Discovery Club The prize draw 13. Commercial collaborations: selling our souls Medical Research Council terms and conditions of grant Genetic Knowledge Park Phenome scan 14. Comprehensive oversight: undocumented and unacknowledged Pilot studies Questionnaires Research clinics Sub-studies Comprehensive oversight 15. Influence beyond ALSPAC: extension of expertise European Society of Human Genetics House of Lords Science and Technology Sub-Committee Joint Human Genetics Commission and National Screening Committee UK Biobank and the Nuffield Trust National Children’s Study Conclusions Postscript Notes References Appendix 1: ALSPAC Steering Committee: founding members Appendix 2: ALSPAC Ethics and Law Committee members: appointed 1990–2005 Appendix 3: Letter to participants: further information concerning confidentiality Appendix 4: Young Mothers paper by Elizabeth Mumford Appendix 5: The Children of the Nineties study (ALSPAC) and collaboration with pharmaceutical companies Principles underlying research in ALSPAC Support for research in ALSPAC Benefiting from the results of ALSPAC’s research Adding value to ALSPAC Conclusion Index Untitled

Available Open Access under CC-BY-NC licence. The Avon Longitudinal Study of Parents and Children (ALSPAC), also known as Children of the 90s, is a world-leading birth cohort study that uniquely enrolled participants in utero and obtained genetic material from a geographic population. It instigated the innovative but controversial ALSPAC Ethics and Law Committee. This book describes in detail the early work of this Committee, from establishing the core ethical principles necessary to protect participants, to the evolution of policies concerning confidentiality and anonymity, consent, non-intervention and disclosure of individual results, data access and security. Quotes from interviews with early members of the Committee reflect not only on its pioneering work but also on the unusual style and inspirational leadership of the first Chair, Professor Michael Furmston. This will be of interest to those involved in other cohort studies in understanding the evolution of ethical policies as ALSPAC developed.

An examination of the early work of the innovative Avon Longitudinal Study of Parents and Children Ethics and Law Committee. It will help anyone involved in other cohort studies to understand how ethical policies evolve.