New director leads major changes in campus human research protection program
Gretchen Anding gets a good laugh from the question: When you were a little girl, did you dream of leading an Institutional Review Board (IRB) at a major research university?
“I don’t think anybody dreams of working in research compliance. And if they did, I would love to talk to them,” says Anding, who became the director of the UW–Madison IRBs on April 1.
Anding studied biology and chemistry as an undergraduate. But it was a course in bioethics that led her to pursue a Master’s degree in bioethics from the Medical College of Wisconsin, and then steered her toward a career in research compliance, first working at the Aspirus Wausau Hospital and then joining a UW–Madison IRB office in 2004. In 2010, she was promoted to Assistant IRB Director.
Now, as the director of the UW’s IRBs – the Health Sciences IRB, Minimal Risk IRB and the Education and Social/Behavioral Sciences IRB — Anding leads a busy and evolving enterprise.
In April, the IRB offices merged to create one central IRB office to support the human research protection program (HRPP) on campus.
That’s not the only big change underway. In June, the MR IRB and the ED/SBS IRB will merge to become one IRB, the Minimal Risk Research IRB. The MRR IRB – and the team supporting it – will review all minimal risk human subjects research, including educational, social, behavioral, medical records review and minimal biomedical interventional research.
Merging the IRBs is a big change on campus, but one that Anding says will allow for greater collaboration, consistency and communication in the HRPP compliance process on campus.
“We have created the central IRB office and implemented other strategies as part of a campus HRRP reorganization, with the goal of reducing administrative and research burden, while upholding the protection of human subjects, research accountability and compliance with federal regulations,” explains Nadine Connor, associate vice chancellor for research policy and compliance.
The HRPP re-organization – known as the IRB Efficiency Project – has been led by the Office of Research Compliance (ORC) within the Office of the Vice Chancellor for Research and Graduate Education. The transition began with moving the ED/SBS IRB office to the ORC in 2017, Reliance and Navigation Team (RELIANT) and the Health Sciences IRBs in 2019, and culminates with the creation of a single IRB office in 2021.
RELIANT assists researchers with collaborative and multi-site research issues, including helping identify the best single IRB review option for their studies and facilitating reliance agreements. It also supports study teams in navigating institutional requirements that lie outside the IRB approval process.
“The IRB Efficiency Project has allowed our IRB offices the chance to get to know each other and how we have operated, and how we can take components of each of our operations and highlight the great things that each office has been doing,” Anding says. “I am also looking forward to ensuring that the role of the IRB is very clear and that we are not taking on areas of research compliance outside of the IRB’s role.”
Anding is supported in her new role as director, by Casey Pellien, assistant director of the minimal risk research team, and Catherine Rogers, assistant director of the health sciences team, as well as Monica Esquibel, minimal risk research team lead, and Rebecca Hoffman, health sciences research team lead.
“Gretchen’s IRB experience and accomplishments as the IRB Assistant Director have prepared her well to take on the wide-ranging duties of the Director,” says Lynn Haynes, director of the Office of Research Compliance. “Gretchen will continue to support our progress toward a more efficient and effective IRB.”
At the UW–Madison, an IRB must review all research involving human subjects, and the research cannot begin until the IRB has reached a determination. This is true even if a researcher perceives there are no risks for people who participate in their research. It’s no small task.
In March alone, the IRB offices received initial review applications for 150 new studies, change of protocol applications for 233 previously approved studies and 109 annual renewal applications. While the number of applications ebbs and flows during the year it’s an interesting snapshot of the workload facing the campus HRPP.
Another critical component of the IRB Efficiency Project has been to establish a new IRB website. The site houses all IRB resources including a toolkit, investigator manual, reliance manual, new protocol templates, and other materials to support the research community. The toolkit is comprised of worksheets, Standard Operating Procedures and checklists that detail criteria for IRB approval, plus protocol and consent templates to help study teams create documents that meet those criteria.
“We have never had an Investigator Manual before and that we hope it provides much needed clarity in regulatory requirements, process, and workflow,” Connor notes. “The checklists used by reviewers also are now available to study teams to assist them in understanding what the reviewers and IRB are looking for when reviewing a study.”.
Another component of the IRB Efficiency Project includes updates to ARROW, an online workflow system used at UW–Madison to review and track applications for research oversight pertaining to human and animals subjects, stem cell research and biological safety. An ARROW update in March included a new protocol-based application (PBA) for human subjects research studies.
“Our goal with all of these changes is to be very transparent and available to the research community,” says Anding. “The website provides a more centralized location for information for the research community working with both IRB offices. They will have one location that they can go to and find consistent information and resources. “
Anding points to communications as an important role of her office.
“We are facilitators of a compliance process that can be complicated,” Anding says. “We need to be able to communicate regulatory information in a way that can be translated to researchers and IRB members. We also need to provide avenues and resources to make sure that research is as safe and effective as possible. It’s fun. It’s an interesting adventure. Maybe one that I had not dreamed of doing as a little girl. But one that I have been excited to do throughout my entire career.”
By Natasha Kassulke