Research Bioethics Consultation Service
We offer support and education to investigators by providing a forum for in-depth conversation and analysis of ethical issues in clinical and translational research.
Our research bioethics consultants offer advice to researchers, research staff, personnel involved in protection of human subjects, and research participants who have questions about any aspect of a research study. We assist when there are ethical issues that could benefit from in-depth conversation and analysis related to the development, implementation, or analysis of clinical and translational research.
Consultant recommendations are advisory and are supplemental to the institutional review board’s (IRB) responsibility for research oversight. Consultations may range from a phone conversation to a face-to-face meeting, and usually result in a written report being created for the requestor’s use.
The consultations generally are confidential, and the details are not discussed with others without the requestor’s permission unless disclosure is required by law.
How Researchers Use this Service
How Researchers Use This Service
Investigators have used this service during study development, prior to grant or IRB submission, and to consider perceived ethical issues that are anticipated to be complex such as when a placebo-controlled trial is justified. Investigators and IRBs have asked for consultations for issues where regulatory guidance is not clear or is still evolving.
Sometimes, consultations relate to a particular research participant. For example, an investigator was concerned about including a child in a study when the parents had requested that the child’s diagnosis be withheld from their child.
In some cases, researchers seek our advice when someone familiar with the research has suggested that a particular plan of action is “unethical.” Our service has been able to help the requestor decide how to respond to the concern.
Our Consultants
Our Consultants
Our research bioethics consultation service draw from the expertise of a team that includes the following consultants:
- Katie Porter, JD, MPH, Seattle Children’s (Director)
- Benjamin Wilfond, MD, Seattle Children’s
- Stephanie Kraft, JD, Seattle Children’s
- Devan Duenas, MA, Seattle Children’s (Coordinator)
Examples of Consultation Questions
Examples of Consultation Questions
Study Development
- What if informed consent is not practical for my study?
- When is a placebo-control ethically appropriate?
Study Implementation
- 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?
Community Engagement
- How should I negotiate disagreements with community stakeholders?
- How should I share the research data with the community?
Collaborations & Mentorship
Collaborations and Mentorship
The ITHS Bioethics faculty is interested in discussing opportunities to address or evaluate ethical issues related to clinical and translational research studies that are ongoing or in development. This might involve a bioethicist as part of an interdisciplinary research team, or it could involve developing an explicit, specific aim related to an ethics issues.
In some cases, these collaborations might emerge as part of a research bioethics consultation, but are distinguished because of a prolonged, prospective engagement.
We can also provide mentorship for investigators who have an interest in bioethics, either as their primary research focus or to complement related interests. The Bioethics MA program is geared to provide the foundational tools for fellows and junior faculty who are interested in bioethics scholarship.
For further collaboration or mentorship, our faculty can refer researchers to the most appropriate UW faculty, including the 50 adjunct and affiliate faculty members in the UW Department of Bioethics and Humanities.
The ITHS research bioethics consultation team also engages with collaborators across the nation. An example of such an effort is the ROMP Ethics Study, which is exploring ethical issues in research on medical practices in collaboration with Spectrum, the Stanford University CTSA, and Providence Health System in Spokane, Washington. Another example is the Clinical Research Ethics Consultation Collaborative, which is made up of approximately 45 members affiliated with various research ethics consultation services across the United States.
Fees
Fees
There is generally no charge for research bioethics consultations.
Hourly charges can be included in grant applications for projects that anticipate the need for future consultation or collaboration. Our consulting rates are:
- $200 per hour for ITHS and ITHS-associated organizations
- $275 per hour for outside organizations
Getting Started
Getting Started
To get started, please complete the “Request Services” form below. You can anticipate an initial response within one (1) business day.
Contact Us
Contact Us
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In this six part, 32 minute mini-course, Dr. Wilfond guides you to understand the background for actively including bioethical considerations in your research design.
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