Getting women’s perspective into the clinical research agenda: salutary lessons from a British social movement Naomi Pfeffer Honorary Research Fellow, University College London Bioethics and Women Revisited Vienna May 2010

Brief history of CERES Established in 1988 as ‘Standing Committee of User Organizations to monitor research into pregnancy, childbirth, and new developments in reproductive technologies’. 24 patient organisations represented at initial meeting. Name changed to CERES (Consumers for Ethics in Research) (also goddess of growing plants and motherliness). Civil society organisation awarded charitable status. Decision to close in 2006 taken in light of notorious ‘first-in-human’ trial conducted by Parexel.

Why CERES? Consumers should be involved at all stages of research, including its design. This will increase the quality of research, its relevance to health care, and acceptability to actual and potential research subjects. Research needs to reflect the priorities of health service users and their communities. Researchers and their sponsors need to be accountable to the public and participants in research. Information on research should be readily available to the public. All research should respect the people who are the subject of research and should only be undertaken with their free and understanding consent (or in exceptional circumstances by a suitable proxy). Researchers and health professionals who undertake research should publish the results and promote those findings which have the best results for patients. People who participate in research should be entitled to know the results of research in which they are involved.

What CERES did Responded to public consultations on conduct of medical research; Sat on official committees; Published information material on informed consent for public and research subjects; Produced guidelines for investigators on how to produce clear information; Held public meetings with patient groups – ‘consciousness raising’; Published a newsletter.

Public meetings With patient groups About research scandals On good practice

Salutary lesson 1 There is no single woman’s view on medical research

The CLASP trial (collaborative low dose aspirin study in pregnancy) In favour of study (National Childbirth Trust): Well-designed large-scale RCT exploring an important concern Pregnant women may take aspirin on the basis of hearsay rather than good evidence Against study (Pre-eclampsia and Toxaemia Society): Research should explore causes of pre- eclampsia such as diet Safety of aspirin in pregnancy unproven MRC refused to fund paediatric follow-up

Conflict is political Medicalise or de-medicalise pregnancy and childbirth? Pro- or anti- science and medical technology?

Salutary lesson 2 What is the purpose of increasing women’s presence in medical research? Good science? More appropriate health care? Create new markets? Equal opportunities (rights/responsibilities)? Feminism?

Salutary lesson 3 Agenda setters or handmaidens? Critics or collaborators? Participants or research subjects?

Salutary lesson 4 Targets shift!

Initial focus was on relationship of research subject and investigator

Classic welfare-state social structure

Evolving landscape Globalisation and restructuring of pharmaceutical industry through out-sourcing Globalisation and restructuring of regulatory framework Emergence of state-sponsored ‘consumerism’ associated with rise of managerialism and privatisation of welfare states Civil society organisations abandon activism and become state-sponsored service providers