Rethinking Ethics in Research: The Role of Investigators and Regulatory Challenges

1. Rethinking Ethics Review Dr Sarah JL Edwards Senior Lecturer in Research Ethics and Governance

2. Contents • Problematic role of investigator • Common law protection of subjects • General protection through regulation • Selective assessment and supervision • Independent review by ethics committees • Limitations • Duplication of purpose and effort?

3. Role of Investigator • Prima facie duties to science and the subject • Duty to deliver good science (mainly to benefit patients in the future) • Duty to protect subject’s interests (come from professional duties of care and common regard for others) • Duties conflict except when: • Research is supposedly ‘therapeutic’ • Both win through using special study design • Subject not lose out ex ante if uncertain what is best for him • But not remove investigator’s personal benefits and potentially clouded judgements • Also, more habituated to research risks • So, need for external attention (governance)

4. Common law protection • Vested interests (and duty to so good science) already tempered by threat of negligence action • Costs to investigator and compensation for subject • But costs to each are of a different order • No estimate of probability of harm • And non-negligent harm to subject • Strict liability may not be any better • And some investigators have no professional duty of care

5. General protection by regulation • Blanket ban and restrictive rules to avoid harm • Come with sanctions but investigator still not face death! • Regulators cannot assess each and every investigator without vast expense • And so would ban some research we would want to proceed by banning others we would not • In some extreme cases, general paternalism may be warranted but certainly not in all • Yet we cannot rely solely on investigator

6. Selective assessment • Supervision of individual investigators • Role for ethics committees by • Gauge seriousness of problem • Interview investigator in person • Check information sheets and consent process • Lay member to counterbalance over-zealous investigators • Not elected representative • Laity not homogenous so reflect range of values • But not now exclude expert scientists as necessary to assess risk • And achieve a consensus?

7. Limitations • Some values excluded on principle or in practice • Size of committee is arbitrary • Review proportionate to size of problem • Balance of experts and lay • Focus on local circumstances? • Review not on-going monitoring

8. Duplication of Purpose and Effort • Regulatory assessment of each and every proposed drug trial • Ethics committee provides lay view and balances risks against expected benefit • But division of labour comes at a cost • Could in principle be combined? • Other concerns • Effect on public trust empirical question

9. Conclusions • Role of investigator problematic • Common law may not offer enough • Regulation may offer too much • Ethics review by committee can assess investigators individually and selectively • Not always mutually exclusive • Could in principle be combined?