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OCR for page 33
The pursuit a'?c] cliffi~sion of k'~owlecige enjoy a Place of distinction ill
American culture, and the public expects to reap cor~si`Jerab/e ber~efitirom
t/'e creative arid innovative co'?tributior~s of scientists.—l',tegrity ir,
Scientific Research, 2002
.~] SctEN(~s REsEARCI]
Biomedical research is in a period of rapid change, as tecl~nological
advances enable the stuffy of complex biological systems. Taxis ability has
fueled tire launch of projects tint are large in scope, involve store cross-
disciplinary research and promise faster improvements in Truman health.
Supporting taxis new science will require major
changes in planning, 'resources, and ~T~anagen~ent.
Large-Scale Biorne~lical Science: Exploring Strategies
for Futile e Research (2003) describes how tire
National l~stitutes of Healths (NIH) anal owe- feder-
*~nCieS shouI(] tI0~10P
n~e open aLud cyst:
at`c n~elhodl for assess
researsc}~ t'pportu '~ Hi es
al agencies show select, fund, implement, and e`7r,0rging fFOR7 the sc;~
evaluate large collaborative projects, and flow fir commun;~.
their staffs sI~ouIc] be trained and retained.
Among tile recon~me',dations, agencies should develop a snore open and
systematic metI~od for assessing research opportunities emerging From the
scientific community in which a large-scale approach is lilcely to prove
more effective titan traditional research efforts. Projects must leave clear
but flexible plans that cover everything from flow they are initially organ-
ized to flow tizzy will be phased out wilen goals are met. To ensure that
a
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Representative terms from entire chapter:
improve tire
fit' 1~-~- }. (~'~ :~Al. [.~)'ES IN ~! ALTO!
l~igI~-caliber scientists ant! managers will want to participate, funding agen-
cies ant! universities sI~ouict develop new approaches for assessing team-
work and ~nanagement, as well as novel ways of rewarding accomplish-
n~ent in such positions. Universities, for example, could revise policies on
tenure and promotion to recognize the value of contributions to colIabo-
rative research. Cooperation between academia and industry sI~ouict ire
encouraged in orcler to speeci research and development and recluce the
overall cost of future large-scale projects.
Tire National l'~stitutes of Heath leas a remarkable recorc! of success.
But concerns leave arisen Bleat tire agency leas grown too fragmented ant!
unwieldy, ant! that its current organizational structure cannot accommo-
date tire increasing pace of scientific discoveries. Acting on sucks concerns,
Congress asIcec! for acIvice on the organization ant] management of tire
NIH. Enhancing the Vitality of the National Institutes of Health: Organizational
Change to Meet New Challenges (2003) concludes that important changes are
needecI and provides a blueprint for strengthening tire agency's operations.
In particular; it recommends modifications that will better enable NIH to
pursue innovative interdisciplinary research treat
reflects strategic objectives and cuts across all of
its institutes ant! centesis. One fruitful area for
such "trans-NIH" research is obesity, which is
associated witty healths problems Such as Impart disease, diabetes, ant!
arthritis) treat concern numerous of tire agency's branches. NIH also should!
establish a special projects program, unpiler tire clirecto~'s authority, to fund
cutting-edge ~ esearch treat is t~isI
my 9~-~S A.~D rI_~_~E RESI<~] E.~N'Y{~<~3~-
of clinical trials sometimes greatly limits tl~e numbers of research subjects
available. Small Clinical Prials: Issues airy Challenges (200 t ~ concludes treat
properly clesignec! trials may provide substantial eviclence of efficacy ant!
ire warrantee! unpiler certain conditions. Situations in which small trials may
be appropriate include evaluating treatments for rare clisorclers, studying
unique patient populations (such as astronauts or members of isolated
communities), assessing inclividually tailorec! therapies, and r esponcling to
urgent threats to public I~ealtl~. Tile report describes ways to design and
analyze trials to obtain reliable and valic! results widen oddly limiter! nu'n-
bers of participants are available. These include carefully defining tire
research question and tailoring Else study design, clarifying sample ct~arac-
teristics ant! methods, performing corroborative analyses to evaluate tire
consistency and robustness of results, and exercising caution ilk i~terpret-
ing tile results before attempting to extrapolate or generalize tile findings.
The report also recommencts tight mole research be conducted! on tire
development and evaluation of alternative experimental clesigns ant! analy-
sis methods for trials wield small sample sizes.
Research On stem cells, primitive types of cells that transform in tire
body to become different I
[~I 1----E [~ CA I.~s IN A-
meciical treatment even cure for millions of people wire suffe'. from heart
disease cardiovascular disease AlzI~eimers disease cancer spinal-cord
injuries' ant! numerous othe'- disorders. But many people leave No-al and
ethnical cowers about sucks research especially regarding tire use of steno
cells obtainer! from human embryos The Promise of Stem Cells: From
Research to Medical Therapies (2002) clan ides what is I
HEALER-] 5( IENCES ,QND 7~E ~~-I'\~H F.~\Y['EPI3~S'L
only to better diagnostics but also to new meti~octs of treating and event
preventing TSEs. Another apl~roacl~ is to identify easier-to-spot surrogate
markers treat indicate the presence of prions or TSEs. The report stresses
that funcling should lee expancled for basic research, as it will be virtually
~ , , ~
.. . ~ . ~ . .. . . . . . .
~n~poss~l~le to devise useful diagnostic tests Without a getter uncterstan0-
ing of tire structural and functional properties of prions anti bile ,natI~ogen-
esis and epidemiology of TSEs.
Being male or female is an important basic Truman variable that affects
healths and illness throughout life. But taxis realization leas been slow in
coining, as scientists until recent years largely ignored stuclies of tire
effects of sex at Else basic cellular and molecular levels. Exploring the
Bio/ogica/ Co'~t~ibr~tio'?s to Human Hea/t1~: Does Sex Matter? (2001) Previews tire
current understanding of sex differences and determinants at tire biologi-
cal level, identifies barriers to research in taxis area, and ~ eco~n~nends ways
to eliminate those barriers. It concludes treat there is now sufficient i~nowI-
edge to validate tl~e stucly of sex differences Alice to eatable tire generation
of hypotheses. The next step is to move from the descriptive to the exper-
ime~tal and establish tire cor~clitions that must be in place to facilitate anc!
encourage stucly of the origins and mechanisms of sex differences. Sex clif-
ferences sl~ouIc! be stucliecl across tire entire lifespan. Interdisciplinary
efforts will be neecled, anti studies to account for sex differences bigly
require innovative clesigns, metl~ods, Alice Knocked systems. Meeting tl~ese
needs wit! require additional resources. Among oxides recomn~encIations,
clinical researchers sixfold attempt to identify tire e~doc~i~e status of
research subjects, and longitudinal studies should be designed to enable
Men and women differ in brain organization for language. Men (lelt image) rely
on the left inferior frontal gyrus to carry out language tasks, such as dete~rni~ing
if two nonsense words rhyme. Women (right image) use both the left and the
right inferior gyri to carry out the same task. Shaywitz et al. (1995) Nature
373:607-609. SOURCE: Exploring the Biological Contributions Human Health:
Does Sex Matter?, 2001.
|~.~.~i 1~-~E i4I>~-~ AM iS~.S IN HE,iNt71-]
analysis of data by sex. Once studies are conclucted, data regarding sex ctif-
ferences, or flee lack thereof, should ire made readily available ilk tire scien-
tific literature. As research advances, care shod be taken to recluce tire
potential for discrin~i~ation leased on identified sex differences.
Space travel is inherently risIcy, and plans for humans to venture into
creep space for prolonger] periocIs hoic! special health risks. Safe Passage:
Astronaut Carefor Explorations Missions (2001) presents a vision for protect-
ing the Seattle of voyagers on long-duration missions (a year or more)
beyond Earths orbit. Requestec! by flee National Aeronautics anti Space
Administration (NASA), the r eport concludes that not enough is yet known
about tire risks of prolonged missions, or about ways to
mitigate tl~ose risks, to enable humans to travel and
work safely in deep space, and that everything reason-
able should be clone to gain tire necessary information
before humans are sent on such missions. NASA should
clevelop a comprehensive system that will provide cur-
rent astronauts, those in training, and former astronauts
with tire full cor~tinuu~n of healths care, wirily s~multane-
ously collecting and analyzing all medical cIata relevant
to space travel. Tire agency also sI~ouic! develop a to~g-
tern~ strategic research plan designed to obtain missing
information about the health risics of space to aver, includ-
ing both biological and behavioral problems, and about
methods to ameliorate tire risks. To erasure that activities proceed ifs tire
most timely and coordinates! fashion, NASA sI,ouIc! develop a single o~ga-
nizatio~al unit, either within or outside tire agency, treat leas authority over
and accountability for all aspects of astronaut health.
t~ ~~t kt~i~ tNViRONMENT
Protecting tire safety and privacy of inclivicluals who volunteer to par-
ticipate in medical research is essential. But recent years leave seen grow-
ing concerti that protections systems Slave failecl to keep up witty tire reali-
ties of contemporary research. In response to a request from the
Department of Health and Human Services, the lOM leas issued two reports
acIciressing how to improve tire structure and function of protection pro-
grams. Tire first, Preserving Public Truest: Accreditation and Human Research
Participant Programs (2001), examines the role that accreditation, that is,
tile process by which organizations that conduct research achieve inde-
pendent certification of their operations by meeting explicit performance
HE St IE,\~s ANI) 7~E ~£.~-APC [-! ~.'~Y~3~
stanclarcis, can play in enhancing protection. It previews a number. of d-aft
pet furnace standards that leave been proposed anti ~ ecomme~ds ways to
improve tire strongest of tire stancIards, pilot test totem, and ultimately
move them into practice. Accreditation efforts sI,oulci be evaluated after
several years to determine tI~eir impact on protecting the piglets ant! inter-
ests of participants in medical research, and tire accreditation process
sl~ouic' be revised as needed. Tire second! report, Responsible Research: A
The Phases of Human Research. Responsible Research: ,4 Systems Approach to Protect-
ing Research Participants, 9()()2, page 41.
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Systems Approach to Protecting ResenrcI~ Participants (2002), reviews in go eater
breach and depth low else current system operates and flow it goes away,
offers several broac! recommendations for reform, and snakes numerous
pr actical suggestions for builcling more robust protection programs.
Because no single cause explains failures in protecting participants,
changes will be needed on many fi onts. At tile national level, for example,
Congress should ~ equire that evenly organization conducting r esearch with
lean subjects, r ega~ dress of flee fuming source, Rio so under the auti~or-
ity of a comprehensive research participant protection program, which
would be subject to federal oversight. W~tl~in institutions, ultimate ~ espon-
sibility for an effective program of protections must lest witty tile l~igl~est
levels of a r esearcI~ or~anization's leadership.
Most Americans willingly support public investments in research. TIley
will continue their support only if they can trust tire scientific community.
This crucial link makes it imperative that botch inclividual scientists acid
i~stitutior~s conduct their ~ esearcI~ r esponsibly. Integrity in Scientific
Research: Creating- an Environment That Promotes Respo'?sib/e Concoct (2002)
reviews what is lcnown about factors treat eatable and encourage inclividu
Open-systems Model of the Research Organization. SOURCE: Integrity in
Scientific Research: Creating an Environment That Promotes Responsible
Conduct, 2002, page 7.
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Organizational Processes
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ads, regardless of their role in tire research organization or albeit bacI<-
grounds, to carry out their jobs in tire blest possible mantles: Since each
participant brings unique qualities to tire research environment, tire con-
straints nest Connie from tire environment itself. Tire report calls on
research institutions to clevelop policies and procedures that promote
research integrity, to provide menses of research teams Title tire tools
and support systems they need to conduct research responsibly, and to
conduct education and training efforts to Whelp everyone it~volveci Mom stu-
cle'~ts acid trainees to senior scientists and top-level administrators)
increase their understanding of tire whys ant! bows of responsible
reseal. Leaclers shouIc! set the tone by their
own actions, explicitly enciorsi'~g and participat-
in., in activities designed to promote research
integrity. It also is vital that institutions continu-
ally evaluate their efforts, using a process of self-
assessment and external peer review, in orcler to
iclentify potential organizational or operational
improvements. Incleed, mucks remains to be
te~s should set shed he
by their own act'nns,
ex:pl;~ly elld(')~Sing and
p p at ~ ~ ~ ~ i ~ ~ ct i ~ i ~ ~ ~ ~
designer] to prologue
research integrity
learned in taxis area, and public agencies and private foundations sl~ould
increase their support for research on factors that can promote integrity in
research across different clisciplines ant! institutions.
PROMO]~G TIMELY DIS(~10~S
EM ta' i<~If ~
IOM's Roundtable on Environmental Healths Sciences, Research, and
Medicine, was organized in 1998 to provicle a structures] opportunity ant]
neutral setting for people from different scientific disciplines and organi-
zational perspectives to cliscuss sensitive ant! clifficult issues of mutual
interest. By bringing together participants fiom tile academic community,
tile fecleral government, inclustry, and otiose areas who are actively
engages] in activities related to environmental health, research, and mecli-
cine, tile Roundtable Whelps in iclentifying problems current, ongoing, or
likely to arise within the next several years and in discussing ways to solve
Rinse problems. Tl~e Rouncitable does not provide formal advice or recom-
menclations, but shares knowleclge and pleas. Tire nature of the delibera-
tions and tire neutrality of tile setting facilitate fresco thinking.
Tire first Roundtable workshop explored tile connection between
human heat ant! tile natural environment that sttrrouncts people, tl~e
i: I~E Fawn CKIl1~%A] iS~.S IN ~-,1~
''built" environment that Flay leave clesigned and constructed, and tire
social environment in wl~icl~ they interact wield one another: 1~ Rebuilding
the Unihy of Health and the Environment: A New Vision of Environmental Health
for the 21st Century (2001), participants suggest treat tire infrastructure for
linking environmental Stealth and public stealth is not worI
~~-Al11-! St IE.~S A,\~) 74-~E -Aim ~ [~s~r[~3~
ration obtain ant' disseminate information and flow this information ant'
older factors influence behavior cl~ange. Recent events sucks as tile spread
of West Nile virus ant! the deliberate clistribution of potent forms of
anthrax bacteria through tile mail, underscore tile need for tile scientific
community to improve its risk communication. In a workshop titles]
E'~vironn?ental Health lubricators: Bridging the Chasm of Public Health and the
Environment, (2002) workshop participants examined the issues of imple-
menting a national environmental I~ealtl~ mo'~ito~ing system that would
expanse current human exposure monitoring ant! l~ealth surveillance
efforts.
clinical Re~h
lows Clinical Research Roundtable explores tile challenges facing tile
field anti discusses approaches bleat Piglet be taken to improve the environ-
ment for the concluct of a broad agenda of higI~-quality clinical research.
Participants come from tile academic health community, federal agencies
sponsoring and r egulating clinical research, pi ivate-secto~^ sponsors of clin-
ical research, foundations, public and private insurance programs and
health plans, corporate purchasers of health care, and groups representir~g
else interests of patients. WorIcsI~ops convened by the Rouncitable cover a
broac] range of worI
[~1~I'V([ 7 ICE F'>~-' IRE~ C~t [~',!~s IN I lI.AL7YI-!
BASIC
BIOMEDICAL
RESEARCH
BLO(::K 1: \
Translation
from in Vitro
and animal
to human
studies
/
CLINICAL
SCIENCE AND
KNOWLEDG E
,~
Translation |
of new
knowledge
into clinical
practice
/ GOAL: ~
Enhanced \
public health;
safer, cheaper,
more effective
\ new treatments /
The Translational Blocks. SOURCE: Exploring Challenges, Progress, and New Models for
Engaging the Public in the Clinical Research Enterprise: Clinical Research Roundrable
Workshop Summary, 2()()3, page 1 ().
to tire etI~ical underpinnings of clinical research. Tire Roun~itable also co~-
ducts activities to enlace mutual u~dersta'~di'~g between, tile scientific
community ant! tire general public, while improving the public's uncler-
standing of and participation in clinical studies.
Organizations that purchase I~ealtI~ care, such as employers, ant! organ-
izations cleat pay for health care, such as insurance companies and health
plaits, often lack else information Alley need to malce sound decisions.
The Role of P`~'cl~asers apace Payers i!? the Clinical Research E'~te~prise (2002) sum-
marizes discussions during a Roundtable workshop devoted to this issue.
Hotly purchasers and payers call for acIditional research to cletermi'~e what
clues and does not work in treatment diagnosis ant! prevention.
Taxis evaluative research compares existing therapies to new treatments.
They also cite a need to translate clinical r esearcI~ more effectively so that
consumers and health ca'e providers can make decisions based on tire best
available eviclence and to transform tire healths care culture into a team
effort. Employers anc! insures s recognize tire national trenc! toward a con-
sumer-ciriven health care system ant! affirm tire important contributions
tight tizzy can matte in pro'~oti~g health by educating tile people Riley serve
and encouraging healthy lifestyle behaviors. Of particular note both
employers anal insurers express a com~itn~ent to searcI~i~g for solutions
to national I~ealtI~ care problems and then working together to apply them.
Although laypeople once played only a limited role in else clinical
research enterprise as volunteers in clinical trials recent years have
brought a sea of cleanse to public participation. Consumers now demanc! a
role in the formulation of the research agenda anti in the clesign review
and pursuit of research. Exploring CI~a//enges, Progress, anc! New Models for
Engaging the Public in the Clinical Researc/? Enterprise (20033 summarizes
icleas explored during a worl~sI~op on taxis issue. Engaging tile public
alillougI~ posing certain difficulties is cleemect a strategic imperative.
The public can help in translatin research findings into practice in speed-
MA 5( IENt~S A,\~) ]-~- Rr5~-~u '''3
ing up the clinical research process, acid in making else ~-esearcI~ enterprise
mole efficient. For exan~ple, public support for and participation in AIDS
trials and research on coronary heart clisease leas led to declines ifs tire
numbers of cleaths from Rinse diseases. Titus, the national movement
toward `'participant-centered research" is widely applauded. To foster
increased public participation, sever al strategies should be employed.
These approaches inclucle striving to gaily and maintains tire publics trust
in medical `-esearcI~, establishing two-way methods of communication
between scientists and consumers, acid mounting educational programs to
provide consumers with factual information about clinical research that
does not raise unrealistic expectations.
T 5TWDI:ES AND ~~G ~~S
The National Institutes of Health supports a number of "centers of
excellence" at leading academic institutions to focus r esearch on particular
diseases. In recent years, centers often have begun with a mandate Tom
Congress ilk response to lobbying by patient or professional groups. But
some government officials anti other observers have expresser! concern
about whether establishing new centers is the best way to advance
research. At the ~ equest of Congress, the IOM is reviewing, flow flee NIH cur-
~e~,tly uses ce~,te~-s of excellence as a ~necl~anis~ for conducting research.
Tire study committee is exami~i~g, among oilier twigs, the criteria ant!
procedures user! in decicling to establish centers, flow they are designee!
ant] acItninistered, flow mucks they cost, flow they are evaluatecI, and flow
Riley compare with Oliver mechanisms of research support. In its report, the
committee will offer recommendations for improving tire use of centers of
excellence, given the many factors that must be taken into account in a
specific area of research, i~clt~cti'~g tire burden of clisease, tire state of tire
science, the adequacy of the research infrastructure, tire presence of prom-
ising research opportunities, and the need for interclisciplirlary approacI~-
es to tire problem.
The IOM is also continuing its work on the protection of Truman partic-
ipants in research. A study now unpiler way is examining the special issues
and challenges ilk protecting indiviclual cI~ilcIre~ in clinical research wilily
encouraging responsible research to promote tire health and well-being of
all children. Another stucly involving children will look at the nations sys-
tem for tracking the safety of pediatric medical crevices.
Thieve is a pressing need for safer, snore effective, snore acceptable
methods of co~traceptio~, especially ~~ tire ctevelopi~g world. Witty sup-
~5
[~;~/3~~r 7~E I holist 6~Al iS~t,~§ IN ~~-AL711
port From the Bill and Melinda Gates Foundation, the IOM is studying novel
approaches to contraceptive research Receipt advances in the biomeclical
sciences leave provicled exciting new opportunities to gain a better uncler-
stancii'~g of tile basic I'iology of reproduction, and Vilest advances nary lead
to the discovery of new targets fo'- contraception. In particular; tire tools
ant! technologies of genomics ant! proteomics, new fields focused on flow
human genes ant! proteins function, could be brought to bear on the cievel-
opme~t of radically new al)proacl~es to contraception. Novel models fo'
the clevelopme~t of c:l~-ugs ant! other products also may provide insight for
creating i~ovative contraceptives, once potential targets leave been iclen-
tiffed. Tire study committee will summarize tire current state of contracep-
tive research, identify problems tight impecle advances in contraception,
and malice recommenciatio'~s for priority areas for future research
ant! development.
In older men, testosterone replacement therapy (TRT) Nay offer a
nears of preventing or treating osteoporosis and officer age-associated
conditions. Given this promise the government is considering a large-scale
clinical trial of TRT. But sucks therapy Solids some r isks, particularly ~ egard-
ing prostate ant! cancer otoscopes. At the request of tl~e National Institute
on Aging, tire IOM is r eviewing cur r ent knowledge about tire potential ben-
eficial and adverse heat effects of TRT in olcler melt. If conclucti'~g a large-
scale clinical trial is fount! to be war r anted, tire stucly committee will offer
recom~ne~dations off flow surly a study sl~ould be designed, concluctecI,
and evaluated.
Every year in tire United States, an estimated 10,000 inclividuals suffer
a spinal core! injury. There are 500 to 800 cases annually in New YorIc alone.
Recently, some states leave allocated funds to support research to improve
treatment and ultin~ately find a cure for such injuries. New York has
launcl~ed a research p~-ogra~n clirectec! specifically at finding a cure for the
paralysis caused by spirea] cold injury, and its legislature leas turned to the
lOM foil guidance. A study committee is reviewing current k~owleclge
~ega~di'~g spinal cocci injury. It will identify gaps ill Ic'~owledge, describe
tire technological barriers treat hinder research, and l~igI~light areas treat are
ripe for future investigation. Tire committee also will identify special
strengths and resources treat New YorI; can big to bear in searching for
ways to cure spinal cord injury paralysis.
Recent decacles leave seen a significant decline in tire number of pl~ysi-
cian-scientists in tl~e United States. As physician-scientists are considered
~6
~~"AL1M St Il`-,`~-S AND 710~ ~~t ~ [Ai\7'~3~
critical for the translation of basic discoveries fiom tire bench to tire becI-
sicie taxis trend is troubling. Psychiatry leas been licit especially starch.
Tire IOM is reviewing the forces treat discourage psychiatry residents from
pursuing research training and examining tire experiences of residency
programs that successfully incorporate such training. A serious obstacle is
tire growing shortage in tire availability of training programs. Moreover;
the extensive core requirements for psychiatry residents (especially ifs chilc!
psychiatry malce it difficult for then to find time to incorporate traipsing
in research. Tire study committee s analysis will suggest strategies to make
it easiet for psychiatry residents to participate in research trai~i'~g pro-
g'-ams and pursue careers as pl~ysicia~-scientists.
A person s behavior a'~c! social circumstances leave a remarI
Selected Recommendations for Food ant! Nutrition
The Role of Nutrition in Improving Human Health: Research agencies should give high
priority to the role calf nutrients in human health and the relationship of intake to chronic
diseases. For macrunutrients, give priority to long-term, dose-response studies to identify the
requirements for individual n~acronutrients such as omega-3 fatty acids, that are essential in
the diet for all life-stage and gender groups, especially children and the elderly, and to
elegance understanding of the beneficial roles of dietary fiber in human health; as well as
provide definitive information on the form, frequency, intensity, and duration of physical
activity to successfully~manage body weight in both children and adults. (Dietary Reference
Intake for Energy, Carbohydrate, Fiber, Fat, Fatty Acing, Cholesterol, Protein, and Amino
Acids, 2002)
The Function of Micronutrients: Research priority should be given to studies to identify and
further understand the functional (e.g., cognitive function, regulation of insulin, bone health,
and immune function) and biochemical endpoints that reflect sufficient versus insufficient
body stores of vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, man-
ganese, molybdenum, nickel, silicon, vanadium, and zinc for various age and gentler groups;
and studies to further identify and quantify the effects of interactions between individual
micrc~nutrients in the diet as well as interactions between micronutrients and other food com-
ponents, the food matrix, and food processing techniques. (Dietary Reference Intakes for
Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, iodine, Iron, Manganese,
Molybdenum, Nicl
