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Rethinking Ethics Review. Dr Sarah JL Edwards Senior Lecturer in Research Ethics and Governance. Contents . Problematic role of investigator Common law protection of subjects General protection through regulation Selective assessment and supervision

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Rethinking ethics review

Rethinking Ethics Review

Dr Sarah JL Edwards

Senior Lecturer in Research Ethics and Governance


Contents
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?


Role of investigator
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)


Common law protection
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


General protection by regulation
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


Selective assessment
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?


Limitations
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


Duplication of purpose and effort
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


Conclusions
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?


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