Need to know if your research study will pass federal-regulations muster? Suzanne Rivera is your woman. The director of UCI’s Research Conduct Administration—a branch of the Office of Research Administration led by Assistant Vice Chancellor Christina Hansen – helps UCI faculty members navigate the oft-tricky terrain of research regulations that govern patient safety, animal welfare and social/behavioral research.
Rivera began her UCI career in 1996 as the human research education and review officer, helping ensure that studies utilizing human subjects met appropriate safeguards. She now heads the Research Conduct Administration Office, which supports three Institutional Review Boards. These local committees are made up of faculty, clinicians and laypeople who review all proposed UCI human subjects research to ensure that the safety and welfare of the subjects are protected. Two of the IRB committees review biomedical research and the third reviews social/behavioral research. Rivera’s office also supports the animal care and use committee and a biosafety committee that oversees research involving use of recombinant DNA.
One of her responsibilities is to be in regular contact with federal authorities to keep abreast of the constantly changing rules, regulations and ethical concerns involved in a research project or clinical trial.
“We do everything we can to help keep UCI research kosher,” she says.
Rivera describes herself as a fervent list maker who “enjoys order.” However, her to-do lists don’t always turn out as planned.
“A typical day involves my being pulled off of my regular duties to respond to an urgent request for assistance from a faculty member, or a potential crisis such as a funding deadline or an unannounced audit from a federal agency,” she says. “If there is anything that’s predictable about my job, it’s that it is entirely unpredictable.”
Challenges of her position, she adds, include the immense time crunch involved in providing assistance to several researchers at once.
“Our faculty are involved in diverse areas of research and they all have specific needs, such as satisfying terms of a grant proposal or being in a competitive race with researchers from other universities to answer a specific question,” she notes. “This job is not a matter of simply pushing paper around. We need to have a measure of expertise in all kinds of scientific research—from behavioral studies to trials of treatments for life-threatening diseases—in order to be of optimal service to our researchers.”
Not that she minds her workload. The perks, she notes, include learning firsthand about the leading-edge research that is taking place on campus. She sits in on an estimated 50-60 protocol discussions each month.
Rivera herself has a substantial background in research protocol. After obtaining a master’s degree in social welfare from UC Berkeley, she was nominated to serve in the Presidential Management Intern Program, a prestigious executive management training program. She served in the U.S. Department of Health and Human Services, where she provided technical assistance to grantees and learned how to ensure that a government-funded program was compliant with federal regulations.
After her internship, she worked for the department’s regional office in San Francisco for two more years as an employee and then found herself moving to Irvine after her husband, Michael Householder, got accepted to UCI’s English and Comparative Literature doctoral program. Her social work training and federal internship experience made her a shoo-in for her initial role as human research and education review officer.
Rivera also enjoys sharing her considerable knowledge with UCI students. She teaches an undergraduate course on safety and ethics in research, and also serves as a guest lecturer on similar subjects. She says she relishes the interaction that teaching provides.
“Much of my time is spent helping researchers understand the rules so they can conduct research in a way that’s consistent with federal requirements. In my work with faculty I don’t often get to engage in dialogue about the philosophy of ethics. Teaching is a lot of fun.” Current hot ethical topics include xenotransplantation, where the tissue of one species is transferred to another species.
“We’re working with research regulations that were enacted in the late 1970s, trying to apply them to situations that nobody even dreamed of when they wrote them,” she says. “It has created many ethical dilemmas. The scientific landscape always moves much faster than bureaucracy, so it’s difficult for people to keep pace.”
Rivera knows all about trying to keep pace, being the proud mom of a one-year-old daughter and a six-year-old son who keep her Irvine home hopping. Both attend UCI’s Montessori school and are the sole recipients of her and her husband’s free time, she says with a wry grin.
Reflecting on her position, Rivera emphasizes that the primary role of her office is to act as a service provider.
“For example, we can give researchers feedback on a draft protocol before it’s submitted to a committee, and help them identify problems or omissions that would hold up approval for the project,” she says. “We’re also available to perform educational sessions to research units and be guest lecturers in classes.
“We take great pride in helping UCI faculty get their research projects up and running.”