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Haywood takes on
regulatory affairs
Ask JR Haywood about regulations governing
research and he cites balance. The new interim assistant vice president for
regulatory affairs promises to work to balance the mission components of the
Office of Regulatory Affairs (ORA): comply with rules and regulations
governing research, protect research subjects, facilitate research.
Units in the Office of Regulatory Affairs include
- Human Research Protection Program
- Animal Care Program
- Environmental Health and Safety
- Regulatory Components of the Enterprise Business
System
The export controls and trade sanctions program is
under the direction of the associate vice president for research and
graduate studies.
“JR Haywood brings a wealth of experience and energy to
help keep MSU compliant,” says VP Gray. “We’re fortunate that he’s
willing to step into this interim position.”
“ORA has a great staff,” Haywood says. Judy McMillan,
a certified institutional review board (IRB) professional who has been
administrator of the Biomedical and Health Institutional Review Board,
recently was named director of the human research protection program (HRPP).
Peter Vasilenko remains chair of the IRBs. “Peter has worked
tirelessly toward effectiveness and national recognition of MSU’s HRPP,”
Haywood says. “I appreciate his efforts over the years as HRPP director.” In
other staff changes, Kristen Burt, who has been the education
coordinator for ORA, was named assistant to the assistant vice president for
regulatory affairs. Renee Bockes joined ORA from the College of
Business as a resource administrator. “These dedicated staff members have
been working hard to keep MSU compliant, and I know I can count on them.”
Haywood says.
It’s absolutely essential to remain compliant, he adds.
“Even doing more than is required, as the accrediting agencies for research
subjects expect, is a good thing.” But, he cautions, regulatory procedures
can stifle research if they aren’t handled carefully. Haywood believes in
“administration for research,” rather than administration of
research, and will focus on compliance while working to avoid a heavy
regulatory burden for researchers.
That kind of balance isn’t always easy to accomplish,
he concedes. “It’s been part of a national discussion for at least a
decade,” he says, citing a 1998 National Institutes of Health report that
said the heaviest regulatory burden occurs in institutions, not at the
agency level.
Haywood, who has been assistant vice president for
animal care programs, has a long-standing interest in research regulations,
with more than twenty years of involvement with animal care issues at both
institutional and national levels. That interest grew out of his own
research. A professor of pharmacology and toxicology and chair of the
department, he studies the role of the brain in high blood pressure,
specifically the impact of changes in brain chemicals. At least 40 chemicals
are present in any brain synapse, he says. Just about anything can change
the signals they release. He models sodium- and obesity-induced hypertension
to see what role those factors play in elevating blood pressure.
Haywood will continue as chair of the Department of
Pharmacology and Toxicology with extra help from associate chair James
Galligan. “This is a great department,” Haywood says. “I can’t say
enough good things about the faculty.”
The department launched a new online professional
master’s degree last fall. “So far, with news about it traveling mostly by
word of mouth, we’ve had something like 200 inquiries already,” Haywood
says. The program was designated a Professional Science Masters in
Integrative Pharmacology by the Council of Graduate Schools and enrolled its
first ten students this spring. “They’re from all over the country,” he
notes. “We hope to be able to include international students, too.”
The entire program is offered online, two courses each
semester with only a one-week on-campus residency required. The program aims
to provide opportunities for additional training that can lead to
advancement for technicians and entry level scientists in pharmaceutical and
other industries. An advisory board with industry representatives helps
guide the program.
The department has also established the In Vivo
Pharmacology Center to offer high quality standard and specialized assays,
education, and investigative and drug development services to customers. The
opportunity to hire scientists formerly employed in drug safety research and
development at Parke-Davis/Pfizer made this new facility possible, Haywood
says. Marc Bailie, who spent eleven years developing and directing
the Safety Pharmacology Group at Parke-Davis/Pfizer, directs the new center.
Teresa Krieger-Burke, with expertise in general and reproductive
toxicology and safety pharmacology, is associate director. Sarah Marsh,
a veterinary technologist with experience at the MSU Veterinary Hospital as
well as Parke-Davis/Pfizer, is laboratory manager. |
Linda Triemer
takes Chicago position
After more than five years working on regulatory
matters at MSU, Linda Triemer left in April to become director of
research integrity at the University of Chicago. There she works with the
associate vice president for research administration to oversee their human
protection program, financial conflicts of interest, and other regulatory
areas.
At MSU Triemer worked with four assistant vice
presidents and the transition from the Office of Research Ethics and
Standards to the Office of Regulatory Affairs. Although her efforts touched
all the regulatory areas, her primary focus was on programs protecting human
subjects of research.
Triemer led MSU through the process of achieving
accreditation from the Association for the Accreditation of Human Research
Protection Programs (AAHRPP). “We had our first meetings about accreditation
in June 2003,” she recalls. MSU received full accreditation in March of 2006
and last month applied for reaccreditation.
Her AAHRPP experience led to her becoming a site
visitor for the association, a role she will retain in her new position. The
University of Chicago has a teaching hospital and five institutional review
boards (IRBs), compared to three IRBs at MSU.
Triemer also led MSU’s response to new patient privacy
regulations in the Health Insurance Portability and Accountability Act (HIPAA)
as they affected research. She chaired the HIPAA board, including people who
were already working on patient privacy issues MSU and integrating that
board with the IRBs. “This is a different approach from what most
universities did,” she says. “Our goal was to keep the regulatory burden as
low as possible for researchers.”
Before coming to MSU, Triemer was director of research
and information at PRONJ, a medical peer review organization assessing
quality of care for Medicare and Medicaid patients in New Jersey. Previously
she was head of the science group for a Manhattan law firm where she advised
attorneys on the scientific evidence to be used in arguing their cases and
was a faculty member at the University of Medicine and Dentistry of New
Jersey. Her research on human exposure to volatile organics led to a
position as an environmental scientist at ExxonMobil. Her six years
there—she began a month before the Valdez oil spill in Alaska—cemented her
understanding of regulatory issues, she says. “Because industrial scientists
are often perceived as biased, it was important to address actual conflicts
of interest carefully.”
In addition to her position in the Office of Regulatory
Affairs at MSU, Triemer was an adjunct professor of epidemiology. She earned
her Ph.D. in public health sciences at the University of Illinois at
Chicago.
Despite her move, Triemer isn’t giving up her Spartan
spirit. Her husband, Richard Triemer, will remain at MSU as chair of
the Department of Plant Biology. “I’ll be back on weekends,” she says, and
promises to continue to cheer for MSU athletic teams.
“Linda was very helpful in the leadership transitions
in our compliance area and in helping develop the Office of Regulatory
Affairs into its current strong position,” says VP Gray. “We were
fortunate to have her leading our accreditation efforts. We’ll miss her, but
we wish her well in her new position.” |