11 May ITHS Continues to Lead in Research Ethics Consultation
ITHS established its Research Bioethics Consultation Service more than a decade ago, but recent developments are setting the stage for broader national leadership and growth.
As of January 2020, Katie Porter, JD, MPH is the Director of the ITHS Research Bioethics Consultation Service. Ms. Porter has served as a consultant for over 5 years and was previously the Coordinator for the service, a role now filled by Devan Duenas, MA. ITHS Bioethics Core faculty lead, Ben Wilfond, MD, who established the consult services, will continue as a consultant, but will now focus on further integrating bioethics into the functions of the other ITHS Cores. “This shift in leadership and addition to the team provides an opportunity for more outreach within the ITHS community. I am excited for Katie and Devan and look forward to seeing the successes that will come under this new structure supporting ITHS bioethics efforts,” shared Dr. Wilfond.
Now that there is a dedicated consultation team that can focus on the service and quality of their consultations, the team can better reach those who can benefit the most from ethical analysis and advice. Ms. Porter says, “I’m able to devote time every week to our consultation service, whether that be relationship building with consult requesters, connecting with researchers, or developing educational research ethics materials.”
Research Bioethics Consultation Process
For investigators conducting clinical and translational research, identifying and addressing ethical issues involving human subjects is important to the success of a study. The Research Bioethics Consultation Service helps investigators navigate these issues when they’re planning research or implementing protocols. The service offers advice to investigators, research staff, personnel involved in the protection of human subjects, and even research participants who have ethics-related questions.
Consultations usually begin with a phone conversation between Ms. Porter and the requester to prepare for a larger meeting between the research and ethics teams. A written report often marks the close of the consultation and serves as a resource for the research team moving forward. Consultation volume can ebb and flow, but there has been general growth in recent years. “We’ve been seeing a jump in consultation requests and I hope that means we’re making better connections with the people who need our services. We’re also seeing repeat requesters and direct referrals, which tells me we’re providing value to researchers,” shared Ms. Porter.
We’ve been seeing a jump in consultation requests and I hope that means we’re making better connections with the people who need our services.
One of those repeat requesters is Fred Rivara, MD, MPH, Vice Chair and Professor in the UW Department of Pediatrics. According to Dr. Rivara, “The consults have all been extremely helpful. For example, NINDS had questioned our use of friend controls in a study. We obtained a consult and sent the results of the consult to them, allowing us to be funded by them. The consults have also proven to be a terrific learning experience for our fellows and graduate students.”
ITHS Research Bioethics Consultation on a National Level
The ITHS Research Bioethics Consultation Service started in 2007 and was one of the first research ethics consultation services in the country. Today, consultation team members are national leaders. Ms. Porter serves as Co-Chair of the Clinical Research Ethics Consultation Collaborative (CRECC), a national network which discusses challenging cases and shares consultation practice approaches to promote ethical clinical research.
At least once a quarter, the CRECC discusses a particularly challenging or unique research ethics case that is then used in the Challenging Cases series in the American Journal of Bioethics (AJOB). Dr. Wilfond is Co-Editor and Mr. Duenas is Managing Editor for the series.
For ITHS investigator Christopher DeCou, PhD, whose research involves interventions to address suicide risk, working with the ITHS Bioethics Consultation Service, CRECC, and AJOB was an invaluable experience. As he puts it, “The most helpful aspect of this service was the clear and thorough review of several possible decisions for the ethical conduct of research. Not only did they answer the questions raised during my initial request, but their team also helped me engage with a larger group of bioethics scholars to explore further the nuances of informed consent and waivers of consent for EMS patients.”
Not only did they answer the questions raised during my initial request, but their team also helped me engage with a larger group of bioethics scholars.
Ms. Porter articulates another benefit. “The CRECC allows those of us practicing research ethics consultation to share with each other, which is immensely valuable. But the AJOB series allows us to share with the broader research community. That kind of dissemination is priceless.”