Research Bioethics Consultation: More potential than sequencing genomes 

1. Research Bioethics Consultation:More potential than sequencing genomes  Benjamin S. Wilfond MD Seattle Children’s Hospital Treuman Katz Center for Pediatric Bioethics Center for Clinical and Translational Research University of Washington Division of Bioethics, Department of Pediatrics Center for Genomics and Health Equity, Department of Bioethics and Humanities Regulatory Support and Bioethics Core, Institute of Translational Health Sciences

2. Research Consultation Definition “An advisory activity available throughout the lifecycle of a study. It involves interaction with the researcher or others stakeholders in the research enterprise and one or more individuals knowledgeable about the ethical considerations in research, regarding an ethical question related to any aspect of planning conducting, interpreting, or disseminating results of research related to human health and well being. The purpose of the interaction is to provide information; identify, analyze, and or deliberate about ethical issues; and recommend a course of action” Beskow et al. IRB: 2009

3. IRB University of Wisconsin University of Arizona NHGRI NICHD NHLBI Research Bioethics Consultation NIH Clinical Center University of Washington (ITHS) My perspective influenced by overlapping roles • Clinical Ethics Committees • University of Wisconsin • University of Arizona • NIH Clinical Center • Seattle Children's Hospital Data Monitoring Committee NHLBI NICHD Cystic Fibrosis Foundation

4. Research Bioethics Consultation at NIH Clinical Center • Modeled as a corollary to clinical bioethics consultation because all “patients” are research subjects • Serves as a mechanism for discussion about ethical issues related to research and provides advic • May result in further bioethics scholarship and research collaborations • Supplementary to IRB oversight • Consultants were generally members of IRBs • Roles as IRB member and consultants were generally distinct even if the same person might play both roles (not at same time) • As IRB chair, I might ask for bioethics consult • As consultant, I might recommend that an issue be discussed with IRB

5. “Which one of these is not like the other?” • Research Bioethics Consultation • Biostatistics Consultation • Clinical Bioethics Consultation • Institutional Review Board • Data Monitoring Committee • Community Advisory Committee • Scientific Integrity Office • Conflict of Interest Committee • Human Resources • Consult Liaison Psychiatry • Legal Counsel

6. Clinical Bioethics committee Hospital Administration External Oversight Bioethics Consultants Care Providers And Families Research IRB Institutional Administration External Oversight Bioethics Consultants Researchers And Families Research Bioethics Consultation: Bioethics Committee and IRBS

7. Clinical and Translational Science Awards • Sponsored by National Center for Research Resources • “translating discovery into medical practice” • Plan for 60 awards by 2012 • Awards address regulatory and ethical issues • Regulatory Knowledge and Support • (Required CTSA Key Function) • Research Design, Epidemiology, Biostatistics and Clinical Research Ethics • (Optional CTSA Key Function) • 36 of 48 Institutions within 46 CTSAs have consult services • 9 were established prior to CTSA funding • Half are in very early stages of development

8. Features of consultation services • Diverse clients • Broad topical and temporal scope beyond “IRB” issues • In-depth discussion of “fine grained concerns” • Unique or unresolved issues

12. Challenges for Consultation Services • Quality may be variable • Training of consultants • Quality of Advice • Current quality improvement mechanisms • Institutional peer review • Publications • Acceptability may be variable • Institutions • Investigators • IRBs • Ethics committees

13. Confidentiality is a key issue • Confidentiality of consult discussion vs institutional responsibilities • Different consult services have different group rules • Explicit confidentiality vs Explicit disclosure of reports • Scope and limits of confidentiality • “That consult occurred “vs “specific recommendations” • Responsibility to report extreme misconduct or harm?

14. Our approach at the ITHS • Presumption of confidentiality • Promotes willingness to use consult service and trust • Deliberative engagement about confidentiality and sharing information • Importance of engaging other stakeholders in the consult • At discretion of requestor • Permission requested for sharing some consult data with institution or other consultants

16. CTSA Clinical Research Ethics Key Function Committee Consultation Working Group • Published Consultation/IRB paper (Beskow) • Conducted survey of CTSAs about structure and function of consultation services • Establishment of Consult Standardization and Data-sharing Project • Pre-Conference Workshop at ASBH meeting in Oct 2010 • CRE KFC Annual meeting Nov 2010

17. Conclusion • More than one approach will be used depending on time, interest, resources, experience and personalities • Consultation is not a necessary service and IRBs, IRB Staff, and IRB committee members can fill that role as needed • IRBs should also engage ethical issues • Competition with IRBs is not intrinsic to consultation services • Can be complementary to IRBs and IRBs may use consult service • Can provide added value to researchers and institution • Features of biostatistics and clinical bioethics consults • IRB always has regulatory authority • In contentious issues, consult service can be a facilitator and mediator of a tentative plan (similar to clinical consultation) • Limited confidentiality can further both investigator and institutional objectives