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Ethics Research: Evolution or Revolution

Ethics Research: Evolution or Revolution. Karine Morin Ethics Office, CIHR*. * Views expressed in this presentation do not necessarily represent those of CIHR. outline. 3 broad topics (non-mutually exclusive) protection of human subjects privacy research integrity conflicts of interest

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Ethics Research: Evolution or Revolution

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  1. Ethics Research: Evolution or Revolution Karine Morin Ethics Office, CIHR* *Views expressed in this presentation do not necessarily represent those of CIHR

  2. outline • 3 broad topics (non-mutually exclusive) • protection of human subjects • privacy • research integrity • conflicts of interest • a “new” research ethics • openness and transparency

  3. protection of human subjects • expansion of drug trials (thalidomide & pregnant women) • A tarnished past: WWII & the Cold War • Nazi Germany • US Tuskegee trial and radiation experiments • Montreal’s psychiatric experiments

  4. protection of human subjects • evolution of guidelines… • Nuremberg Code • Declaration of Helsinki • CIOMS/WHO • ICH-GCP • (UNESCO Decl. on Bioethics and Human Rights)

  5. protection of human subjects • US vs Canadian models

  6. TCPS • guiding principles: • respect for human dignity • respect for free & informed consent • respect for vulnerable persons • respect for privacy & confidentiality • respect for justice and inclusiveness • balancing harms and benefits • minimizing harm • maximinizing benefit • sections on… • ethics review • clinical trials • conflict of interest • …

  7. from TCPS to CGSB… • governance of ethical review & oversight of clinical trials • composition of research ethics board (REB) • conduct of ethics review and oversight of clinical trials • REB documentation & communication with investigators, regulators • written policies & procedures • system to foster continual improvement of ethics reviews

  8. protection of human subjects • recent evolution: HGP & biobanks • First, free and open access to genome data has had a profoundly positive effect on progress. The radical ethic of immediate data deposit, adopted by the Human Genome Project in 1996 and now the norm for other community resource projects, empowers the best brains on the planet to begin work immediately in analysing the massive amounts of genomic data now being produced. It is a very good thing that the ‘race for the genome’ in 1998–2000 resulted in the human genome sequence being immediately and freely available to all, rather than becoming a commercial commodity.

  9. CIHR Best Practices for Protecting Privacy in Health Research • Element #1   -  Determining the research objectives and justifying the data needed to fulfill these objectives • Element #2   - Limiting the collection of personal data • Element #3   - Determining if consent from individuals is required • Element #4   - Managing and documenting consent • Element #5   - Informing prospective research participants about the research • Element #6   - Recruiting prospective research participants • Element #7   - Safeguarding personal data • Element #8  - Controlling access and disclosure of personal data • Element #9  - Setting reasonable limits on retention of personal data • Element #10 - Ensuring accountability and transparency in the management of personal data

  10. research integrity • research misconduct means "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results."

  11. research integrity

  12. a shift in research ethics… a different kind of scandals

  13. more scandals…

  14. … continuing scandals • Committee staff began this investigation in May • 2007 after a study was published in the New England Journal of Medicine, showing a link between the diabetes drug Avandia (rosiglitazone) and heart attacks. However, the reviewed evidence suggests that GSK knew for several years prior to this study that there were possible cardiac risks associated with Avandia

  15. scientific community taking the lead…

  16. conflict of interests

  17. a new paradigm • openness and transparency • trial registry • standardized results & outcomes (and protocols) • broad access (… including data)

  18. trial registration • Declaration of Helsinki, Paragrap 30 • Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

  19. trial registration

  20. CONSORT

  21. PROCTOR • Public Reporting Of Clinical Trials Outcomes and Results • towards international standards for results disclosure • building on trial registration • Declaration of Helsinki • Ottawa Statement • WHO International Standards of Trial Registration • International Committee of Medical Journal Editors (ICMJE) • CONSORT • What’s next? public health studies? AJPH 2007 Vol 97, S1

  22. CIHR Policy on Access to Research Outputs • Peer-reviewed Journal Publications • Grant recipients are now required to … ensure that their peer-reviewed publications are freely accessible through the Publisher's website or an online repository as soon as possible and in any event within six months of publication. • Under the second option, grant recipients must archive the final peer-reviewed full-text manuscripts immediately upon publication in a digital archive, such as PubMed Central or institutional repository. • Publications must be freely accessible within six months of publication, where allowable and in accordance with publisher policies. • Grant recipients may also wish to submit their manuscripts to a journal that provides immediate open access to published articles (if a suitable journal exists). CIHR considers the cost of publishing in open access journals to be an eligible expense under the Use of Grant Funds. • Grant recipients must now acknowledge CIHR contributions in all peer-reviewed publications, quoting the funding reference number.

  23. CIHR Policy on Access to Research Outputs • Recognizing that access to research data promotes the advancement of science and further high-quality and ethical investigation… • As a first step, CIHR will now require grant recipients to deposit bioinformatics, atomic, and molecular coordinate data into the appropriate public database… immediately upon publication of research results (e.g., deposition of nucleic acid sequences into GenBank). • CIHR now requires grant recipients to retain original data sets arising from CIHR-funded research for a minimum of five years after the end of the grant. This applies to all data, whether published or not.

  24. CIHR Policy on Access to Research Outputs

  25. SPIRIT - research protocols

  26. research ethics – evolution or revolution… from protection… • …too openness & transparency

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