Research Bioethics Consultation:More potential than sequencing genomes

Benjamin S. Wilfond MD

Seattle Children’s HospitalTreuman Katz Center for Pediatric BioethicsCenter for Clinical and Translational Research

University of WashingtonDivision of Bioethics, Department of PediatricsCenter for Genomics and Health Equity, Department of Bioethics and HumanitiesRegulatory Support and Bioethics Core, Institute of Translational Health Sciences

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

My perspective influenced by overlapping roles

IRBUniversity of WisconsinUniversity of ArizonaNHGRINICHDNHLBI

Research Bioethics ConsultationNIH Clinical CenterUniversity of Washington (ITHS)

Clinical Ethics Committees

University of Wisconsin

University of Arizona

NIH Clinical Center

Seattle Children's Hospital

Data Monitoring CommitteeNHLBINICHDCystic Fibrosis Foundation

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

“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

Bioethics committee

Bioethics Consultants

Hospital Administration

Care Providers

And Families

ExternalOversight

Clinical

Bioethics Consultants

IRB

Researchers

And Families

Institutional Administration

ExternalOversight

Research

Research Bioethics Consultation: Bioethics Committee and IRBS

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

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

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

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?

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

The Institute of Translational Health Sciences provides a wide range of range of resources to promote translational research. ITHS offers Research Bioethics Consultations as a resource to researchers, trainees, research staff, IRBs, research participants and their families and communities.

Bioethics consults are advisory in nature, providing an opportunity for in-depth conversation and analysis of ethical issues in clinical and translational research, and can be requested for urgent issues related to a particular research participant. Any recommendations provided are supplemental to the authority and

oversight of other groups involved in reviewing the research, like an IRB or DSMB.

Consultation discussions can take place by telephone or in-person. If requested, the consultant can provide a written report of the considerations and recommendations.

Consultation details may be discussed amongst the bioethics consultants, but these will not be discussed with others involved in the issue without the requestor’s permission.

To ensure a balanced understanding of the facts or to facilitate reconciliation of a conflict, the consultant is available talk to others involved in the issue if desired by the requestor.

In some cases, full consideration of the issue may warrant additional consultation in another area. The consultant may recommend referral to legal counsel, ombudsperson, psychiatry, human resources, etc.

There is generally no charge for research bioethics consultations. ITHS membership is not required for individuals or groups requesting consultations.

To request a consultation or to find out more: Call (206) 987-2000

Ask for the Research Bioethicist on-call Or email rsbcore@u.washington.edu

ITHS Bioethics Research Consultants Kelly Fryer-Edwards, PhD, Dept. of Bioethics and Humanities S. Malia Fullerton, PhD, Dept. of Bioethics and Humanities Tom Gallagher, MD, Dept. of Bioethics and Humanities Holly Tabor, PhD, Dept. of Pediatrics Benjamin Wilfond, MD, Dept. of Pediatrics

Research Bioethics Consultations Providing a forum for discussion and analysis of ethical

issues in clinical and translational research

EXAMPLES OF CONSULT QUESTIONS

Community Engagement • How can I establish sustainable relationships with communities? • How should I negotiate disagreements with community stakeholders? • How should I share the research data with the community?

Study Development • Should I provide incentives for participation? • What if informed consent isn't practical for my study? • When is a placebo-control ethically appropriate?

Study Implementation • What should I do if a participant doesn't have the capacity for consent? • Can I withdraw a participant against his/her wishes? • What must I do if my participants need medical care or other help?

Study Analysis • Should I tell participants about their research findings? • What if a participant requests their data be withdrawn? • Who should be an author on the publication of my study?

www.iths.org

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

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