|At a June 9 meeting of the advisory committee to the NIH director, Dr. Hannah Valantine gives an update on disparity in grant review.
Crucial topics at home and abroad headlined
the most recent meeting of the advisory
committee to the NIH director (ACD).
At NIH home base, the Clinical Center’s
leadership began to undergo some of its first
significant restructuring since opening in
1953, in response to recommendations by the
ACD-appointed Red Team [see sidebar 1].
In the extramural community, persistent
disparities in funding outcomes for African-
American grant applicants will be studied
further following new analysis by NIH’s Office of Scientific Workforce Diversity [see
Globally, the Zika outbreak has spread to
Puerto Rico with no signs of slowing. Newly
confirmed facts about the virus’s impact
on fetuses, newborns and pregnant women
require immediate and comprehensive
research, according to updates by leaders of
NIAID and NICHD [see sidebar 3].
These issues, reports on the Cancer
Moonshot and Big Data to Knowledge
and more packed the 1½-day ACD agenda
Hopeful Signs on the Funding Front
As is customary, NIH director Dr. Francis
Collins began the meeting with a broad view
of current events and what’s happened since
the group last gathered in December. He
welcomed new ACD members Dr. Geoffrey
Ginsburg of Duke University and Dr. Linda Griffith of MIT. Collins also talked about recent NIH senior staff appointments and searches under way.
Representatives from NIH legislative and budget offices gave updates and forecasts as well. Attendees were encouraged to hear that another $2 billion increase in the NIH appropriation has been proposed—for the second year in a row—by the Senate for fiscal year 2017. Collins praised success of bipartisan efforts on NIH’s behalf by Sen. Roy Blunt (R-MO) and Sen. Patty Murray (D-WA). The House of Representatives version was expected by the next week. A $1.9 billion emergency supplemental request for Zika is still pending.
Collins also summarized NIH’s “shared efforts in global health research” with the Bill and Melinda Gates Foundation. Bill Gates visited NIH in April at the annual day-long meeting to discuss the joint enterprise. Among topics covered were the human papillomavirus vaccine efficacy trial, collaboration on HIV vaccines, cookstoves and environmental toxin reduction and vector-based interventions for malaria containment.
“If you look at the sources of funds, when you add NIH and the Gates Foundation together you have more than 50 percent of the total world investment in global health research,” Collins noted.
PMI Proceeds Apace
Acknowledging the unprecedented speed with which the Precision Medicine Initiative Cohort Program is moving toward its first ambitious goals, Collins reiterated the program’s core values: Cohort “participants are partners” not patients; the group “needs to reflect the rich diversity of America”; data sharing “has to be swift both to the researchers and to the participants, according to what they wish to know about themselves”; and privacy and security are being “built into every component and taken with the utmost seriousness.”
|Enjoying a light moment at the most recent ACD meeting are (from l) NIH principal deputy director Dr. Lawrence Tabak, NIH director Dr. Francis Collins and ACD members Dr. Russ Altman of Stanford University and Dr. Cori Bargmann of Rockefeller University.
PHOTOS: ERNIE BRANSON
Hearing the guiding principles re-emphasized, ACD member Dr. Russ Altman enthused, “That’s incredibly exciting. It’s like the Athenian model of democracy, where there are no representatives,” we’re all at the table together.
|New ACD members Dr. Linda Griffith of MIT and Dr.
Geoffrey Ginsburg of Duke University engage in their
“This notion of having the participants as partners means that when you’re thinking about what the science is that you’re going to do, that it has to be both kick-ass science and it has to build the relationship with the participants—and we’re sort of more used to doing the kick-ass science,” explained NIH deputy director for science, outreach and policy Dr. Kathy Hudson. “These two things are going to have to go hand in hand from the beginning, which in some cases means that the really satisfying science might come a little bit later, in order to make sure we’re
building the relationship, figuring out
what people’s preferences are, making
sure that we don’t do anything that
threatens the trust that we so desperately
hope to build.”
The PMI cohort’s first big component—
the biobank—was launched, with
$142 million over 5 years awarded to the
Mayo Clinic to collect and store biospecimens.
A PMI advisory panel and a central
institutional review board with expertise
in mHealth, bioinformatics, health
disparities, epidemiology, genomics and
other areas have also been established.
“We are trying to make PMI not just a
great research project but also a motivator to
fix a problem across the country in terms of
electronic health records that are not as usable
as people wish they were,” Collins said.
By July all the pieces will be decided; the
goal, by year’s end, is to have 79,000 individuals
“We are poised at an exciting moment,”
Video of ACD proceedings is online
Recommendations by ‘Red Team’ Set in Motion
The Red Team, a working group assembled by the ACD to evaluate the hospital following a problem last year in the CC pharmaceutical development section, reported findings at a special ACD meeting in April.
|Dr. Richard Marchase, vice president for research at the University of Alabama at Birmingham, worked on the Red Team.
“Our current structure—the way that we currently attempt to manage the Clinical Center—makes it very difficult to achieve our end result,” said NIH principal deputy director Dr. Lawrence Tabak, giving context for the first major realignment of CC governance since the largest research hospital in the world opened.
Outlining three guiding themes—all with the overarching principle to “fortify a culture and practice of safety”—Tabak gave an update on progress NIH has made on the report’s recommendations:
- A central Office of Research Support and Compliance was formed to set policy and standards and assure quality; Dr. Kathryn Zoon was appointed as its interim director.
- A CEO position was established with authority over all NIH staff using the hospital; a search committee to fill the post will be co-chaired by NIAID director Dr. Anthony Fauci and NIAMS director Dr. Stephen Katz.
- A clinical practice committee composed of senior clinical and lab experts is forming, to provide real-time input to leadership on patient care and safety.
- A new external hospital board will hold its first meeting in July.
“Science and safety must go hand in hand,” Tabak emphasized. “There can’t ever be tradeoffs between innovation and safety and compliance. Our collective goal will be to exceed—not just meet—all safety and compliance standards and become a leader in the discipline of safety science.”
See the Red Team implementation slides at http://acd.od.nih.gov/presentations/062016_RedTeam.pdf.
Drilling Down on
|NIBIB director Dr. Roderic Pettigrew (l) and CSR director Dr. Richard Nakamura (r) offer insights on
the NIH grant review report.
Diversity in the scientific workforce
became a concern several
years ago and rose on the
ACD’s agenda after release in
2011 of the NIH-commissioned
Ginther study, which found that
applicants were less likely
than whites to be awarded R01
grants from NIH during fiscal
years 2000 to 2006.
An ACD-assigned working
group on AA/B funding disparities
followed up on Ginther,
analyzing data from fiscal years
2010 to 2015.
AA/B submit fewer applications,
fewer applications per
AA/B applicant are submitted
and fewer of their applications
get discussed, AA/B applications
are scored lower and
fewer resubmissions come from
that community. Cumulatively,
the odds of an AA/B scientist
being funded are 35 percent
less than for a white scientist.
Summarizing key findings by
a core team from that group,
NIH chief officer for scientific
workforce diversity Dr. Hannah
Valantine said, “There is a
disparity in every stage of the
application from submissions
to funding…This work needs to
continue to be done and NIH
needs to continue a vigilant eye
on the issue.”
Valantine’s working group
interventions to narrow the gap,
including targeted mentoring/
coaching on submissions. Also,
the group initiated with the
Center for Scientific Review
an anonymized application
study—a randomized controlled
trial—to determine potential
bias in peer review.
Collins said NIH has funded
many programs over many
decades to recruit more
into science, and that success
of past efforts has been difficult
to gauge because “they were
often not conducted in a
rigorous way where you can tell
“We’re not going to do it that
way any more,” he stressed.
“We’re determined…We will
expand the things that are
working and we will kill the ones
that are not.”
Valantine’s ACD slides are
online at http://acd.od.nih.
Zika Virus Threat Grows
The Zika outbreak continues to spread—and
its effects worsen—since the virus re-emerged
last year in Latin America and the Caribbean,
according to NIAID director Dr. Anthony Fauci,
who teamed with NICHD acting director Dr.
Catherine Spong to update day 2 of ACD on
NIH’s efforts to address the outbreak.
|On day 2 of ACD, NICHD acting director Dr.
Catherine Spong teams with NIAID director
Dr. Anthony Fauci to provide an update on
the Zika outbreak.
As of June, 48 countries/territories—39 in the
Americas/Caribbean—have active Zika virus
transmission. The virus itself is considered relatively
mild and most infected individuals recover
from it within days, Fauci explained. However,
devastating Zika-associated birth defects, a
potential link to Guillain-Barré syndrome, Zika’s
capability of being transmitted sexually and
other as yet unknown health effects due to the
infectious disease have escalated it as a top
global research priority and health threat.
“The impact on pregnancy goes far beyond
what we’re seeing with microcephaly,” Spong
said. “Many gaps exist about what to expect in
pregnancy. We need more data.”
Several vaccine development trials are in
various stages of being launched by NIAID with
collaborating institutions. In addition, NIAID,
NICHD and NIEHS have partnered on a Zika in
Infants and Pregnancy (ZIP) trial of up to 10,000
participants to identify and document the virus’s
effects on pregnant women and their fetuses
Zika update slides are online at http://acd.
od.nih.gov/presentations/062016_Fauci.pdf and http://acd.od.nih.gov/presentations/062016_