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Legal Aspects of Clinical Trials

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  1. Legal Aspects of Clinical Trials Shekhar Potkar Director Clinical Research Pfizer Limited

  2. Why is law necessary in clinical research?

  3. Jesse Gelsinger vs University of Penn • OTC deficiency • Gene therapy experiment with Adenovirus vector • No direct benefit, minimal risks, benefit to others • Conducted by Dr Wilson, IHGT at University of Penn sponsored by Genovo • Died of jaundice, kidney failure, lung failure, brain death • Alan Milstein sued the University, Dr Wilson and Genovo • Risks not explained, negligence, conflicts of interests of Dr Wilson with Genovo • ~ 10 million in settlement

  4. Why Law in Clinical Research? • Risk management perspective • Stakeholders interests perspective

  5. Agenda • Legal agreements • Legal implications

  6. Agreements

  7. Elements of a Contract • Parties • Offer • Consideration • Acceptance • Remedy

  8. Major Agreements • Non Disclosure Agreement • Investigator undertaking/agreement • Clinical trial agreement • Indemnity and insurance • Services contract

  9. Non Disclosure Agreement • PI and Sponsor • Protection of proprietary information • Binding on site staff • Site responsibility

  10. Investigator Agreement • Undertaking by a PI to the regulatory agency • Compliance to GCP and applicable laws • Legal sanctions in case of violations

  11. Bipartite or tripartite Nature of work – responsibilities and compliance Consideration Milestones Issue resolution Publication Right to publish Data access Opportunity to review Multi center studies Intellectual property Sponsor Data protection Trial related injury Clinical Trial Agreement

  12. Indemnity/Insurance • Indemnity • Investigator, other staff and institute • Exceptions -Noncompliance/ Misconduct/ negligence • Role of a CRO • Clinical trial insurance

  13. Services Agreement CROs, Labs, SMOs • Bipartite • Nature of services e.g. monitoring, lab analysis, site management • Terms • Consideration • Remedies

  14. Legal Implications

  15. Informed consent • Autonomy • Valid consent – informed, competent (capacity), voluntary • Competence - Understanding, reasoning, values • Incompetence - Best interests, proxy, substituted judgement, advance directives • Consent form as mechanism and evidence • Battery versus Negligence - e.g. partial colectomy

  16. Confidentiality • Fiduciary role • Patient autonomy • Implied promise • Virtue ethics • Consequentialism • Balancing of public interests • HIPAA – covered entities should use PHI for TPO only, consent necessary for any other use

  17. Conflict of interests • Therapeutic misconception • Financial conflicts • Disclosure

  18. Conclusions

  19. Conclusions • Ethics and law for human subject protection • Legal framework for commercial aspects for research

  20. Role of Ethics committee • Check risk management framework • Informed consent process, • Patient confidentiality • Conflict of interest • Financial aspects including trial related injury • Publication policy