A companion document to the Clinical Center 

Strategic and Annual Operating Plan 

National Institutes of Health Clinical Center 

2008 Environmental Assessment 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 

Contents 

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 

Clinical Center Strengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 

Clinical Center Weaknesses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 

Factors in the External and Internal Environments Influencing Change 

in Healthcare Delivery and Clinical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 

Societal and Value-Based Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 

Population- and Clinical Research Subject-Based External Factors . . . . . . . . . . . . . . . . . . . . 28 

Cost-Based External Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 

Medical-Practice-Based External Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 

Government-Based External Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 

Agency- (NIH-) Based External Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 

Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 

Contents i 

Executive Summary


The Clinical Center of the National Institutes of 

Health continues to face substantial challenges 

and opportunities. During the seven-year period, 

during which the budget of the National Institutes 

of Health was doubled, the Clinical Center’s budget increased substantially. For the last five years, 

however, the Clinical Center’s budget has been 

essentially flat, necessitating the implementation 

of a variety of savings, cost-sharing and efficiency 

initiatives. As a part of Clinical Center strategic 

planning activities, our organization conducts a 

thorough environmental assessment to determine 

Clinical Center strengths, weaknesses, opportunities, and threats. This document represents the sixth 

iteration of the Clinical Center’s strategic plan 

environmental assessment. The Clinical Center 

has eleven years’ experience using, evaluating and 

modifying its strategic plan. In those eleven years 

the factors influencing our environment have 

continued to change. This document: summarizes 

the new developments in the Clinical Center’s 

environment since the publication of the last 

environmental assessment; the interventions that 

have been taken to address weaknesses and bolster 

strengths; identifies changes that have occurred; and 

provides additional comments within the context 

of the original environmental assessment. 

The Clinical Center has numerous strengths, 

among them: 

■ The Clinical Center is the clinical research 

hospital supporting one of the strongest, most 

visible scientific programs in the world – the 

intramural program at the National Institutes 

of Health; 

■ The Clinical Center has a critical mass of 

world-class scientists and clinical investigators 

working closely together to develop and conduct translational clinical research; 

■ The support staff and research infrastructure 

in the Clinical Center are uniquely tailored to 

support excellence in clinical research; 

■ The Clinical Center focuses on a unique research portfolio of work that would be difficult, 

if not impossible, to conduct at other centers; 

■ The Clinical Center staff are capable of providing, and have consistently provided, the highest 

quality patient care to clinical research subjects; 

■ Unlike patient-care-oriented academic centers, 

the culture of the Clinical Center is sciencedriven; 

■ Because of its unique clinical research mission, 

the Clinical Center has organizational and 

scientific flexibility that most institutions do 

not possess; and 

■ The Clinical Center provides investigators 

access to expensive and state-of-the-art technologies that are not readily available in many 

other centers. 

These strengths, which were identified in the initial 

rendition of this document, remain evident after 

eleven years’ experience with the strategic plan. 

During the preparation of the first iteration of this 

document, self-evaluation also identified several 

organizational weaknesses at the Clinical Center, 

among them: 

■ Existing Clinical Center governance mechanisms were unclear; 

■ The Clinical Center was subject to bureaucratic inflexibility in personnel, procurement, 

and fiscal management; 

■ The Clinical Center’s physical plant urgently 

needed renewal; 

■ The Clinical Center lacked a strategic plan; 

■ Clinical Center information systems did not 

adequately support managerial and financial 

data and do not integrate clinical, research, 

managerial and financial data; 

Executive Summary 1 
■ Clinical Center successes were not adequately 

communicated to the public, to referring 

physicians, and to the insurance and managed 

care industries; 

■ Patient recruitment efforts were increasingly 

less successful; and 

■ Some customers viewed the fact that the 

Clinical Center does not offer complete, integrated medical and surgical services as an 

institutional weakness. 

Progress in Addressing Identified Weaknesses 

Over the past eleven years, many of the weaknesses 

identified in the initial environmental assessment 

have been addressed. The Clinical Center governance structure was clarified by the establishment 

of a Board of Governors, which has subsequently 

had its charter broadened to become the Advisory 

Board for Clinical Research. Over the past five 

years the Clinical Center’s governance has continued to evolve. A report issued in 2003 by the 

Institute of Medicine suggested streamlining the 

governance of the NIH clinical research enterprise. 

In addition, an advisory panel, the Blue Ribbon 

Panel on Intramural Clinical Research, convened by 

the NIH Director in the fall of 2003 once again 

assessed (and subsequently revised) Clinical Center 

governance structures. We moved into the new 

Clinical Research Center (CRC) in April of 2005. 

In addition, we replaced our Medical Information 

System with a comprehensive, mission-oriented 

Clinical Research Information System, also in 2005. 

To address the concerns inherent in tighter financial 

times, the organization has developed strategies to 

provide far more detailed financial data to both 

Institute and Clinical Center customers and 

developed some new cost-sharing initiatives with 

the NIH Institutes to address the ongoing financial constraints. These changes and the impact 

produced by these changes are discussed in detail 

in this update. 

Weaknesses Identified Since 1996 

In the eleven years since the initial draft of this 

document was prepared, several additional potential weaknesses were identified, and addressed, 

among them: 

■ Communication practices were inconsistent 

across the CC and the NIH; 

■ The Clinical Center did not routinely seek 

customer input about its services; 

■ Clinical Center customer service needed 

improvement; 

■ The Clinical Center needed to make additional 

investments to assure workforce diversity. 

■ The Clinical Center had difficulty reconciling 

competing Institute demands within a defined 

budget and had no clear cut mechanisms for 

making decisions that benefited the entire 

organization (as opposed to individual customers/stakeholders). 

■ The Clinical Center and the institutes have 

variable infrastructures to support their independent investigators and to support the 

processes of clinical research. 

■ Outpatient surgery and ambulatory care facilities are in need of redesign. 

■ The very constrained budgets of 2002 through 

2008 required the development of new strategies to gain operational efficiencies. 

■ After a peak during the budget doubling years 

(and immediately prior to opening the new 

CRC), the inpatient census has fallen, leaving 

the CC with unused capacity. 

■ Institute protocols increasingly require sophisticated and costly genetic tests that are not 

available through CC laboratories. 

■ Despite the opening of the new CRC, several 

facilities-related issues present significant 

barriers to progress, among them: the need to 

address Joint Commission requirements for 

the atrium of the new CRC, deficiencies in 

ongoing required preventive maintenance and 

ongoing repair activities in both the Hatfield 

and the Magnuson buildings, problems with 

meeting regulatory requirements for construction and renovation in the hospital, and an 

inadequate infrastructure (power, air handling 

and chilled water) in the ACRF and adjacent 

areas that were constructed in the late 1970s. 

These problems are compounded by the fact 

that many of the positions in the Office of 

Research Facilities (ORF) are currently being 

studied in the A-76 process for potential outsourcing. As a result they have had many of 

their staff leave and are unable to replace them 

until the study is complete. 

■ Changes in the ethics rules concerning stock 

holdings, consultation for industry, and other 

2 2008 Environmental Assessment 
compensated outside activities have had an 

adverse impact on recruitment, retention and 

morale. 

Progress in Addressing Weaknesses Identified 

between 1996 and 2007 

■ Through an improved and more detailed 

annual planning process, the Clinical Center 

has sought to improve communication practices and organization planning across the CC 

and the NIH; 

■ The Clinical Center has developed several 

techniques for seeking customer input and 

routinely uses these data sources for organizational improvement activities; data from the 

combined patient and employee surveys are 

being used to drive redesign of three processes 

that are important to the Clinical Center’s mission and operations; 

■ The Clinical Center embarked on a major 

customer service initiative that has produced 

tangible evidence of improved customer service; 

■ The Clinical Center has initiated a major initiative to assure workforce diversity; 

■ The Clinical Center continues to work in concert with advisory groups, such as the Advisory 

Board for Clinical Research, the Institute 

Scientific Directors, and the Institute Directors, 

as well as within its own organization to reconcile competing Institute requests, to address 

service needs for program expansions and new 

initiatives, and to maintain stewardship of its 

resources to be able to meet these expanding 

needs in a time of modest budget growth; 

■ The CC Director, working with the Clinical 

Center’s Medical Executive Committee developed two sets of standards: Standards for 

Clinical Research and Standards for Clinical 

Care. The Standards for Clinical Research 

represent the minimum infrastructural standards that all NIH clinical research programs 

should have in place to assure appropriate 

investigator support, as well as the safe 

conduct of clinical research. The Standards 

for Clinical Care represent the minimal standards for clinical care for patients at the NIH 

Clinical Center. 

■ The CC has designed, and is in the process of 

renovating, our outpatient surgery venue. This 

project should be completed in 2008. 

■ To assure efficient operations of our Departments, the CC has developed a process for 

systematically reviewing the operations of our 

departments. These operational reviews involve 

both extramural experts in the field, as well as 

intramural stakeholders. In addition, to provide ICs with better financial data, we have 

launched a Data Transformation Initiative 

that is designed to provide more precise data 

about the costs associated with CC services. 

The CC has also implemented a system of 

‘co-payments’ for ICs desiring services to support their individual research programs. 

■ To address the issue of unused capacity, the 

CC Director developed a highly successful 

program for competitive “Bench-to-Bedside” 

awards to stimulate creative translational work 

on the NIH campus. This initiative has been 

expanded to make it available to extramural 

investigators who wish to partner with intramural scientists in a translational research 

project. In addition, the Director of the 

Clinical Center has entered a dialogue with the 

NIH administration and IC leadership about 

making more of the Clinical Center’s unique 

clinical research infrastructure available to 

extramural scientists. 

■ The Clinical Center is working with the leadership of the NHGRI to develop a strategy to 

meet investigators need for genetic tests. By 

writing a series of contracts that will include 

volume discounts, we hope to be able both to 

meet these expanding needs as well as save 

resources. 

■ The Director of the Clinical Center established 

a working group, including the Director and 

Deputy Directors of the CC and ORF, as well 

as other involved customers and stakeholders in 

life safety processes in the CC. A new position 

was established by ORF. This group meets regularly and is systematically addressing the relevant construction, renovation, maintenance, 

engineering and life-safety issues to maintain 

compliance with regulatory standards. NIH 

funded a modification and the CRC atrium to 

insure patient and staff safety and that modification is now complete. 

Opportunities and Threats 

As part of its environmental assessment, the Clinical 

Center has also evaluated opportunities and threats 

that present themselves as a result of changes in its 

Executive Summary 3 
external and internal environments. Most of the 

factors initially identified as driving change remain 

present in our environment in the year 2007 and 

beyond. Among the factors initially identified from 

the external and internal environments that are 

influencing change in healthcare delivery and 

clinical research are: 

■ The dramatic changes in the political climate, 

including the ongoing wars in Iraq and 

Afghanistan, the aftermath of the heretofore 

unthinkable acts of September 11, 2001 and 

the continued threat of additional acts of 

terrorism have mandated increased attention 

to emergency preparedness in our institution, 

have required diversion of resources to NIH 

safety and preparedness activities, have resulted 

in requests for scientific and intellectual support for the revitalization of the healthcare 

infrastructure in these war-torn countries, and 

have fundamentally altered the day-to-day 

workplace lives for individuals working on the 

NIH campus. 

– To address the complex issues relating to 

hospital and community emergency preparedness in the 21st century, the Clinical 

Center, the Suburban Hospital Healthcare 

System, and the National Naval Medical 

Center formed an emergency preparedness 

partnership – the Bethesda Hospital Emergency Preparedness Partnership (BHEPP). 

This partnership, composed of three diverse 

organizations that have strikingly complementary resources, has made it possible for 

the Clinical Center to plan for possible emergency situations in an unprecedented fashion. 

– The DHHS Secretary contributed a 250-bed 

contingency station field hospital to be 

embedded at the CC for partnership surge 

capacity and the Department of Defense 

provided $5M in earmarked funding for the 

Partnership. These resources have been used 

to procure equipment and supplies, to support drills that are run jointly among the 

three partners, and to assist with ongoing 

strategic planning and preparedness assessments. In addition, these funds will be used 

to test novel technologies in emergency 

situations. In addition, the partnership conducted a feasibility study of constructing 

either bridges or tunnels from NIH to the 

other partners. 

■ The emergence of new infectious diseases, the 

resurgence of other infections, and the potential 

for the use of highly pathogenic infectious 

agents as weapons of bioterrorism presents 

substantial threats to the public health and is 

associated with an urgent need to answer 

relevant scientific questions that may make it 

possible to mitigate the damage produced by 

these infectious diseases. 

■ The declining U.S. and global economies also 

have added a degree of instability to the NIH 

fiscal outlook. 

■ Societal values are changing and these changes 

are influencing healthcare and clinical research; 

society relies increasingly on technology and 

technological advances (including those in the 

fields of medicine and biomedical research) to 

provide what has come to be the expected level 

of health, function and longevity. 

■ The population and its health interests and 

knowledge base are changing rapidly. Patients 

and clinical research subjects are becoming 

increasingly sophisticated healthcare consumers; science education in the United States 

is not keeping pace with the rest of the world 

and the U.S. population is becoming less 

“science-literate”; societal demographics are 

changing; society has become increasingly 

litigious; and interest in “alternative and complementary” medicine is increasing. 

■ Cost continues to be a primary consideration 

in healthcare delivery and clinical research. 

Clinical research is intrinsically expensive; 

healthcare inflation is high. The net effect is 

that containing costs in the Clinical Center 

environment is difficult. 

■ Medicine, the practice of medicine and the 

conduct of clinical research are changing 

rapidly. Science is becoming increasingly collaborative, and progress in biomedical research 

produces natural change in the research agenda. 

All healthcare institutions are being asked to 

measure performance and to demonstrate 

performance improvement. Patient safety and 

human subjects protection have become 

increasingly important. We are also experiencing a national shortage of anesthesiologists, 

nurses, pharmacists, phlebotomists and medical and radiological technical staff. 

4 2008 Environmental Assessment 
■ The pharmacy and biotechnology industries 

have substantial influence on healthcare costs 

and processes in American medicine. 

– Rapidly evolving biotechnology and pharmaceutical product development in the past 

decade have dramatically altered the practice 

of medicine in the United States. Many of 

these new drugs and devices represent striking breakthroughs in biomedical research and 

have had a dramatic impact on American 

medicine. Often these new drugs and devices 

are approved for single (and often narrow) 

indications, but may have the potential for 

substantially broader use. Because of the 

risks inherent in the process, industry may 

have limited interest in providing support 

for scientific studies for broader-scale use 

of these products. Conducting such studies, 

while scientifically important, may be 

extremely costly, as many of these products 

have been associated with expensive research 

and development costs. To recoup these 

investments these products have been priced 

accordingly. 

– Because of the pivotal roles played by the 

pharma and biotechnology technology 

industries in the evolution of American 

medicine, the opportunities for collaborative 

research and development between NIH 

scientists and scientists in these industries 

are substantial. NIH needs to develop streamlined mechanisms to facilitate these important interactions. 

■ Changes in governmental regulatory requirements and governmental oversight are driving 

change in medical practice and clinical research. 

The impact of increased regulatory requirements on NIH, on the hospital and its operation, and on the clinical research process cannot 

be overemphasized. The President reiterated an 

interest in downsizing and outsourcing and 

has also issued five major goals for reforming 

governmental management practices, including goals relating to: 

– Budget and Performance Integration 

– Strategic Management of Human Capital, 

including Administrative Restructuring and 

Streamlining 

– Competitive Sourcing (A-76) 

– Improving Financial Performance 

– Expanding Electronic Government. 

Each of these goals is discussed in more detail in 

the text. 

■ Changes at NIH are also influencing the 

manner in which the Clinical Center operates. 

– To address the needs of the Clinical Center’s 

failing physical plant, a new Clinical Research 

Center opened in 2005. 

– The organization and administration of 

patient care in the new facility has been 

modified from Institute oriented to program 

oriented, necessitating a change in culture and 

a change in the processes used to provide care. 

– The new building has also served as a stimulus for the Institutes to improve and expand 

their clinical research programs. Several 

institutes initiated new programs and/or 

recruited new clinical investigators to buttress their clinical research activities. These 

program modifications require careful assessment by CC administrators and department 

managers to assure the provision of seamless 

clinical research support. 

– Toward the end of the 1990s, several Institutes developed new initiatives that involve 

‘off-site’ activities, and have requested CC 

support for these activities. These programs 

range from ‘outreach’ efforts to underserved 

communities to telemedicine projects. This 

trend toward developing outreach programs 

designed to offer clinical research opportunities to underserved populations has continued through 2007. NIAID and NIAMS have 

organized highly successful HIV and rheumatology clinics in the Cardozo community to 

reach out to the urban Hispanic population 

in Washington, D.C. In the last three years, 

both NCI and NHLBI have established 

presences in this clinic. The Clinical Center 

has developed strategies to address the many 

significant regulatory, economic, and logistical issues that arise from these initiatives in 

order to maintain the highest possible standard of care for the services it provides. 

– The years 1995-2002 witnessed a doubling of 

the NIH budget. During the time that the 

NIH budget increased by 105 percent, the 

Executive Summary 5 
Clinical Center’s budget increased by 37.8 

percent. Examining these data using constant 

(FY 1994) dollars, the IC’s intramural budget increased by 48 percent from FY 1994 to 

2007, whereas the Clinical Center’s budget 

increased 3.6 percent (see figure, below). 

Percent Change in Intramural


Research and CC


FYs 1994–2007


(In Constant Dollars) 

60.0% 

50.0% 

40.0% 

30.0% 

20.0% 

10.0% 

0.0% 

47.8% 

3.6% 

FY94 vs. FY07 

Intra. Research CC Oper. Level 

Since 2002, the Clinical Center’s budget has 

remained essentially flat. The fact that certain hospital costs continued to escalate (pharmaceutical 

products, personnel costs, medical soft goods, etc.), 

demanded cost-consciousness, cost-effectiveness, 

efficiency and creativity from Clinical Center managers. In an attempt to maintain a constant, highquality level of services provided and to attempt to 

meet the needs of new initiatives, the Clinical 

Center has shifted some of the costs associated with 

research services from its budget to those of the 

institutes. These cost shifts have been unpopular 

with the ICs and have resulted in a rethinking of 

the manner in which the Clinical Center is funded 

(i.e., the so-called “school tax”). 

■ As technology advances, institutes are increasingly requesting more, and more sophisticated 

(and, therefore, often expensive), clinical 

research support. 

■ To address another perceived organizational 

weakness, the Clinical Center has replaced its 

medical information system. The new information system affords the organization the 

opportunity to develop better departmental, 

financial, and back-end (i.e., Institute) clinical 

research support than the previous system. 

■ The NIH Director has identified a clear need 

for strategic planning for the Nation’s overall 

clinical research enterprise and has embarked 

on a path designed to lay out a ‘road map’ for 

the continued success of clinical research, both 

in the NIH intramural program, as well as 

throughout the United States. The importance 

of the Director’s Road Map is that it should 

define the future path for clinical biomedical 

research, both in the short and long runs. A 

crucial aspect of this initiative for the Clinical 

Center is that the initiative will help define the 

Clinical Center’s future role and its relationship 

to clinical research programs in the extramural 

clinical research environment. 

■ As part of the restructuring for the Road Map, 

the NIH Director restructured the oversight of 

central services on the NIH campus. The major 

new advisory bodies for the Director that have 

an oversight function for the CC are the 

Intramural Working Group, and its subgroups, 

the Facilities Working Group and the Financial 

Working Group. Both the Institute Directors 

and the Scientific Directors continue to provide input to the NIH Director about central 

services, as well. In addition, the NIH Director broadened the scope of the CC’s Board of 

Governors to make this group advisory to the 

NIH Director about clinical research in 

general, including clinical research in the CC. 

The NIH Director renamed this group, “The 

Advisory Board for Clinical Research.” These 

changes in oversight have resulted in additional 

scrutiny of the CC and its operations. 

■ During the past three years, scientists at NIH 

have been the subject of several ethics investigations. A small number of individuals were 

found to have been noncompliant with Federal 

ethics rules. To address these deficiencies and 

Congressional concerns, NIH developed a new 

set of guidelines, policies, and review processes. 

New policies have eliminated employees’ ability 

to consult for remuneration with commercial 

entities and dictate more stringent rules on 

financial holdings for senior employees. 

Employees may still establish official duty 

collaborations with industry and have been 

encouraged to do so. 

■ The gap between salaries NIH is authorized 

pay and salaries earned by physicians at academic centers has continued to widen, making 

it difficult to recruit for scarce and/or highly 

paid specialties and subspecialties. Coupled 

6 2008 Environmental Assessment 
with the restrictions on outside activities 

described above, recruiting and retention have 

become quite difficult. To counter this trend, 

NIH has developed new salary limits for Title 

42, and is beginning to implement a modified 

Title 38 appointment mechanism that includes 

a salary structure that is much more competitive with academic centers. 

■ NIH is phasing out the extramural General 

Clinical Research Center awards and program 

and is replacing this structure with a series of 

Clinical and Translational Science Awards 

(CTSAs). Centers receiving these new awards 

will, of necessity, be much more integrated than 

in the previous program and, as a result, will 

offer unprecedented opportunities for the 

Clinical Center, as well as for intramural investigators, to partner or participate in their 

activities. The Clinical Center has already 

begun a series of successful interactions and 

collaborations with the CTSA network. 

Examples of successful interactions between 

the Clinical Center and CTSA sites include: 

– Clinical Research Subject Survey. The Clinical 

Center developed a clinical research subject 

survey to assess the satisfaction of participants with clinical research projects and 

processes. This survey is being adapted by 

investigators at the CTSA at Rockefeller 

University and will be tested broadly across 

the CTSA network. 

– Informatics. The Clinical Center, in partnership with intramural institute based investigators, created a new informatics tool called 

ProtoType, a protocol authoring tool that 

provides a structure for writing protocols and 

includes IRB recommended language cassettes and important teaching tools. In addition, ProtoType provides ability to rapidly 

implement centrally new policy or regulatory 

requirements. ProtoType is designed to be 

much more than a protocol authoring tool 

and has the potential to submit protocol 

information to clinicaltrials.gov, map protocols for resource projections, and send alerts 

to Principal Investigators for noncompliance 

of protocol intentions and assisted preparation of Adverse Event Reports. The 

Clinical Center shared ProtoType with the 

Rockefeller University investigators early in 

its development and Rockefeller University 

investigators provided valuable feedback to 

its development. The Clinical Center looks 

forward to sharing this new technology with 

the CTSA network. 

– Data Repository. The NIH intramural program recently launched the second phase of 

the Clinical Research Information System 

(CRIS) completed a few years ago. The initiative, called CRIS II, is being led by the 

Clinical Center in partnership with the 

NIH intramural programs. The major goal 

of CRIS II is to build a data repository to 

coordinate hospital-based information with 

bench information generated by the institutes. We are planning to construct the new 

intramural data repository in partnership 

with the CTSA network. 

– Clinical Research Nursing. The Nursing 

Department in the Clinical Center has partnered with nursing leadership at the 

Rockefeller University as well as nurses from 

other CTSA programs to define the specialty 

of clinical research nursing. A new network of 

Clinical Research nurses is being established 

that will unify this new career path in nursing, establish training modules for research 

nurses and identify requirements to be a clinical research nurse. 

– Training. The NIH Clinical Center, together 

with IC-based investigators, has developed a 

core curriculum in clinical research with three 

core courses: an introductory course on the 

Principles and Practice of Clinical Research, 

Clinical Pharmacology and Clinical Bioethics 

(described in more detail below). 

– Bench-to-bedside awards. The Clinical Center 

has sponsored intramural bench to bedside 

awards for the past nine years designed to 

promote interaction between basic and clinical scientists. This highly successful program 

has sponsored 119 awards at $100K/year for 

two years at a total investment of over $20M. 

For the past two years the awards have 

included partnerships between intramural 

and extramural investigators where intramural scientists invite extramural partners, 

including partnerships with intramural and 

CTSA scientists. The future plan is to expand 

these awards and allow extramural investigators to identify intramural partners. 

Executive Summary 7 
■ Partially due to the limited funding for all of 

NIH, the census of the Clinical Center has 

dropped over the past few years. The Clinical 

Center Director, working with IC and NIH 

leadership has developed innovative strategies 

for forming partnerships with extramural 

investigators. For example, the highly successful 

intramural program for novel ‘bench-to-bedside’ awards has been expanded to include 

extramural investigators who are interested in 

partnering with intramural scientists in the 

conduct of a project. Although additional 

strategies may require legislation for implementation, the Clinical Center continues to 

pursue these in order to maximize the use of 

its unique resources. 

Thus, over the past eleven years, several factors, 

taken together, have resulted in a substantial 

change in the culture of the NIH intramural 

community. These factors and the resulting 

change in the internal environment are enumerated in this document. 

This report assesses these opportunities and threats 

in detail in the context of the identified strengths 

and weaknesses inherent in the Clinical Center. 

8 2008 Environmental Assessment 
Introduction


The Clinical Center finds itself poised for 

more change in an increasingly complex healthcare environment. A clear understanding of this 

complicated environment, including a detailed 

assessment of the organization’s strengths, weaknesses, opportunities, and factors from the internal 

and external environments that pose a threat to 

the organization is essential for the Clinical Center 

to succeed in the next decade and beyond. To 

be successful, the Clinical Center must be able to 

identify its internal strengths and capabilities and 

be able to position itself to meet the challenges 

posed by the dramatic changes in healthcare and 

in the healthcare industry in the United States. 

The process of self-assessment and improvement 

is a continuous cycle. In 1995, the Clinical Center 

was provided with a unique opportunity to conduct a thorough environmental assessment as a 

result of a mandate from the DHHS Secretary. 

This review ultimately provided the Clinical 

Center with an opportunity to review the best 

practices of 30 facilities throughout the country, 

with an eye toward adopting as many of these 

best practices as were relevant to the Clinical 

Center’s environment1. In the eleven years that 

have intervened since this document was initially 

drafted, the Clinical Center has sought additional 

input from: 1) its major customers, the NIH 

Institutes (through our governance structure, 

through annual planning meetings with each of 

the institutes, as well as through ongoing dialogue 

with the Clinical, Scientific and Institute Directors); 2) a second set of major customers – our 

clinical research subjects – through ongoing patient 

perception surveys as well as through regular 

meetings with the Clinical Center Director’s Patient 

Advisory Group; 3) the extramural academic 

community (through ongoing reviews by the 

Clinical Center Board of Scientific Counselors 

and through the Operational reviews of the CC 

Departments); and through separate meetings 

convened with outside experts to chart the future 

courses of the Clinical Center’s Bioethics Program, 

Imaging Sciences Program, Laboratory Medicine 

Department, and the Pain and Palliative Care 

Service; 4) Industry, insurers, and managed care 

representatives (in meetings designed to address 

patient recruitment and third party payment 

issues); 5) Healthcare executives and experienced 

healthcare administrators (through meetings of 

the Clinical Center’s Board of Governors); and 

6) Intramural and extramural experts in hospital 

operations, in the conduct of operational reviews 

of Clinical Center departments. The advice and 

counsel of these intramural and extramural advisors 

provide the backbone for the Clinical Center’s 2007 

environmental assessment. The previous edition 

of this document was written in 2004. In the 

intervening years, a number of factors in both the 

internal and external environments have changed 

substantially, prompting this revision. 

The Clinical Center’s environmental assessment 

is divided into three segments: 1) Clinical Center 

strengths; 2) organizational weaknesses; and 3) 

external trends and factors influencing change: 

a) in healthcare, b) in clinical research in general, 

and c) in clinical research at the Clinical Center, 

including an emphasis on opportunities that present 

themselves to the Clinical Center in the context of 

these other findings. 

Introduction 9 
Clinical Center Strengths


The Clinical Center serves as focal point for 

clinical research in, and is an integral component 

of, the NIH biomedical research community. As a 

national resource, the Clinical Center provides the 

patient care, services and environment needed to 

initiate and support the highest quality conduct 

of, and training in, clinical research. The Clinical 

Center provides a unique venue and opportunity 

in which to conduct studies that bridge the gap 

between basic science and clinical application at the 

patient’s bedside. In 1994, a panel of extramural 

advisors convened at the request of the Director 

of NIH to assess the status of the intramural 

research program noted that the Clinical Center 

has been, “. . . a unique and invaluable resource for 

the direct clinical application of new knowledge 

derived from basic research”. In the conclusion of 

their report, these external advisors noted, 

“Upon analysis of the programs of the Clinical Center 

facility, the External Advisory Committee is strongly 

of the opinion that the Clinical Center is essential to 

the intramural research program. The committee 

recognizes that a crucial asset of the Clinical Center 

complex is the flexibility it offers to respond to new 

opportunities and needs by rapid redirection of 

resources, such as with research on human immunodeficiency virus, breast cancer, and prostate cancer. 

Because the Clinical Center is not obligated to provide 

all types of clinical services, it can more readily redirect 

resources to new, innovative areas of research. In addition, the existence of a high caliber staff, on-site, with 

expertise in clinical research, allows for the rapid 

implementation of new initiatives.2 

The Committee also recognizes that the Clinical 

Center, with its appropriate facilities and support 

staff, allows scientists to conduct long-term clinical 

studies of individual patients and large families that 

would be difficult, if not impossible, to do in the extramural community because of the lack of sufficient 

and long-term funding. It also provides an excellent 

setting for the training of clinical investigators.” 3 

In the late 1990s, the NIH leadership invested 

heavily in the revitalization of the Clinical Center.

4 

This revitalization has helped position the Clinical 

Center to meet the expanding clinical research 

agendas of the institutes for the foreseeable future. 

The opening of the new Clinical Research Center 

in 2005 provides and even more effective bridge to 

the future of clinical research. In the 50 years since 

the Clinical Center opened its doors to the public, 

the Clinical Center and its staff have contributed 

significantly to biomedical science and translational 

research—moving discoveries in the basic sciences 

into clinical medicine. In the process of providing 

the infrastructure and research support for 

Institute/Center (IC) scientists during this period, 

the Clinical Center and its staff have developed 

many unique organizational strengths. Among 

them are the following: 

■ The Clinical Center is the clinical research 

hospital supporting the intramural program 

of the National Institutes of Health. 

The National Institutes of Health is among the 

most respected scientific organizations in the 

world. The NIH intramural program has received 

consistent intellectual and scientific support from 

the academic scientific community as well as steady 

economic support from the government of the 

United States. As the clinical research arm of the 

intramural component of the NIH, the Clinical 

Center is not subject to the extremes of funding 

crises prevalent in the extramural community. For 

this reason, some types of studies (particularly those 

relating to natural history and disease pathogenesis, 

as well as studies of orphan diseases) can be conducted almost nowhere else but, and nowhere as 

well as, at the Clinical Center. At a time in which 

funding for the NIH is increasing at a substantially 

lower rate then during the past seven years, the 

Clinical Center must exhibit careful stewardship 

of its resources. 

10 2008 Environmental Assessment 
■ The Clinical Center has a critical mass 

of world-class scientists and clinical 

investigators working closely together. 

Perhaps no other center in the world has the collaborative mix of basic scientists and clinical researchers 

found in the NIH intramural program. This blend 

of basic and clinical science has provided a critical 

mass of scientific ferment that has produced striking 

accomplishments in clinical research over the first 

50 years of the Clinical Center’s existence. The fact 

that the basic and clinical scientists work in close 

proximity produces a cross-fertilization of ideas 

that is unique in the academic medical community. 

The quality of the basic and clinical scientists 

cannot be overemphasized; many of the NIH intramural investigators are recognized as international 

authorities in their fields. 

■ The support staff and research infrastructure 

in the Clinical Center is uniquely tailored to 

support excellence in clinical research. 

Unlike most academic medical centers, Clinical 

Center support staff and service personnel have 

been recruited to support a clinical research, rather 

than a purely patient care, mission. The service and 

support staff at the Clinical Center provide unrivaled support for clinical research. Many of the 

services provided by Clinical Center Departments 

would likely not be found in most academic 

institutions and have been developed entirely to 

support the clinical research enterprise. The Clinical 

Center staff also provide state-of-the-art clinical 

diagnostic support services. Support staff and 

service personnel often function as collaborators 

in research studies and have made numerous substantive scientific contributions. At all levels of the 

organization, alignment with the research mission 

is a highly visible goal. 

■ The Clinical Center focuses on a specialized 

research portfolio. 

As noted above, unlike most academic medical 

centers, studies conducted at the Clinical Center 

much more frequently evaluate the natural history 

or pathogenesis of disease states. Clinical trials at the 

Clinical Center are primarily Phase I and Phase II 

trials, as compared with most extramural centers, 

which focus primarily on Phase III and Phase IV 

studies. The Clinical Center offers a superb venue 

in which to conduct translational or ‘proof of 

concept’/‘proof of principle’ studies. Additionally, 

scientists working at the Clinical Center have 

assembled cohorts of patients who have rare or 

orphan diseases. For patients who have certain of 

these orphan diseases, the Clinical Center may be 

the only place where meaningful clinical research 

studies of their diseases are carried out. The study 

of rare and orphan diseases has resulted in innumerable contributions to the understanding of basic 

human physiology, pathology, psychology, genetics 

and immunology. 

■ The Clinical Center provides quality patient 

care to its clinical research subjects. 

The Clinical Center’s staff is committed to the 

clinical research mission. To provide optimal support for clinical science, the Clinical Center’s highly 

skilled service and support staff have consistently 

provided excellent care to the subjects of clinical 

research protocols. The subjects of clinical research 

studies have a different relationship to the Clinical 

Center than the relationship patients have with 

academic medical centers to which they are admitted. The subjects of these studies are partners in 

the research carried out at the Clinical Center. 

For this reason, the importance of providing excellence in patient care cannot be overemphasized. 

The highest quality patient care remains a major 

objective for Clinical Center staff, an objective 

that has been reached consistently during its first 

five decades of existence, and a goal toward which 

Clinical Center administration and staff continuously strive. Over the past ten years, the Clinical 

Center has made a substantial investment to find 

out how our patients view the services provided 

by Clinical Center staff as well as how they view 

our clinical research processes. Excellence in 

patientcare and clinical research support are evermoving targets. 

■ The culture of the Clinical Center is 

science-driven. 

The principles of performance improvement are 

based on the principles of epidemiology. The culture and mission of the Clinical Center are grounded entirely in science. Clinical Center scientists and 

managers are familiar with the epidemiologic orientation of performance improvement. Scientists and 

staff are accustomed to using epidemiologic principles to analyze data and to make decisions. For this 

reason, Clinical Center staff are well positioned to 

collect and analyze managerial data and to integrate 

the results of data analysis into decisions affecting 

the manner in which the work of the organization 

is conducted. The entire organization has been 

Clinical Center Strengths 11 
trained in the epidemiologic principles of performance improvement and both managers and 

line employees use these principles. The sciencebased culture of the Clinical Center positions the 

Clinical Center extremely well to use these principles scientifically to: 1) collect data for performance 

measurement; 2) analyze the data to address identified problems; 3) propose interventions based on 

solid, scientifically obtained data; and 4) assess the 

usefulness of these interventions. 

In the intervening eleven years since the initial draft 

of this document was published, many of the 

Institutes have initiated major external reviews of 

their intramural clinical programs. A major report 

has recently been issued by the National Academy 

of Sciences’ Institute of Medicine addressing issues 

relating to the overall governance of NIH and 

underscoring the importance of clinical research 

in the biomedical research enterprise.5 In 2003, the 

Director of NIH convened an advisory panel, 

the Blue Ribbon Panel on Intramural Clinical 

Research, to address issues of substance for the 

Intramural research program. In addition, the NIH 

Director has embarked on a journey designed to 

lay out a ‘road map’ for the continued success of 

clinical research in the United States. The importance of the Director’s Road Map is that it should 

help define the future path for clinical biomedical research in our country, both in the short and 

long term.6 These and other initiatives suggest 

that, across the campus, interest in quality clinical 

research is continuing to increase. In addition, the 

opening of the new Clinical Research Center, the 

procurement and implementation of the new 

Clinical Research Information System, the increased 

emphasis on cross-disciplinary molecular projects, 

the partnerships with extramural scientists in the 

expanded bench-to-bedside program, and the 

changing intramural environment have spawned 

a new level of collaboration and customer orientation among Clinical Center leadership. 

■ The unique clinical research mission of the 

Clinical Center allows it organizational and 

scientific flexibility that most institutions 

do not have. 

Because the primary mission of the Clinical Center 

is clinical research, the institution does not make 

commitments, either to its research subjects or to 

the community, to provide comprehensive healthcare services. Since the Clinical Center does not 

have to commit resources and personnel to an 

Emergency Room or to general acute care, it can 

focus its efforts on specific areas of clinical science. 

For this reason the IC-driven science conducted in 

the Clinical Center can respond quickly, both to 

emerging problems for which an immediate 

change in the national research agenda is needed, 

as well as to scientific opportunities when they 

arise. For example, the Clinical Center responded 

quickly to study: 1) AIDS and HIV infection 

when the disease first surfaced in society; 2) multiply-drug-resistant tuberculosis when this problem 

first became apparent; 3) the chemotherapy of 

ovarian cancer when Taxol became available; 4) an 

innovative solid organ transplantation program; 

5) protocols to study the pathogenesis and therapy 

of the Severe Acute Respiratory Syndrome (SARS); 

6) protocols to study patients with pandemic 

influenza; and 7) protocols designed to study the 

perplexing problem of obesity in the United States. 

■ The Clinical Center provides access to 

expensive state-of-the-art technologies 

that are not readily available in many 

other centers. 

Since the Clinical Center and the NIH intramural 

programs are charged with advancing the frontiers 

of science, the Clinical Center often either develops, 

or is among the first to acquire, new technologies 

that facilitate the conduct of clinical research. 

Scientists working in the NIH Intramural program have access to a new state-of-the-art clinical 

information system, numerous molecular diagnostic techniques, Positron Emission Tomography 

(PET) scanners, three cyclotrons, several magnetic 

resonance imaging machines (including 3, 4, and 

7 Tesla experimental machines), unique cellprocessing facilities, creative functional outcomes 

measures in our Rehabilitation Medicine Department, and a variety of other cutting-edge technologies. In addition, scientists working for, and at, 

the Clinical Center have the opportunity to forge 

cooperative research and development agreements 

(CRADAs) with industry scientists who have developed cutting-edge technologies. In fact, the Clinical 

Center often provides a near-ideal venue in which to 

test such technologies. 

12 2008 Environmental Assessment 
Clinical Center Weaknesses 


As a result of both evaluations by external 

advisors as well as self-assessment, the Clinical 

Center initially identified several issues that might 

be considered programmatic or systemic weaknesses. 

■ Existing Clinical Center governance 

mechanisms are complex. 

Historically, governance of the Clinical Center 

was unclear, with multiple committees providing 

oversight. The old structure lacked clarity in how 

decisions were made. The net effect of the indistinct 

lines of authority is that the Clinical Center lacked 

the means to manage its business efficiently. 

NIH has continued to wrestle with the development of clear, effective governance for the Clinical 

Center. In 1996, the Clinical Center appointed and 

convened a new Board of Governors. The Board of 

Governors developed and approved a streamlined 

organizational reporting system for the Clinical 

Center. As a result of the introduction of this new 

governance system, Institute stakeholders felt 

somewhat disenfranchised and appealed to the 

Director of NIH. The Director, NIH appointed 

an advisory board, initially called the Clinical 

Center Advisory Council, that permitted the major 

stakeholders to address Clinical Center issues that 

are important to the Institutes and to provide 

advice and counsel to the Director of the Clinical 

Center. In FY 2000, the Acting Director of NIH 

reconstituted this council as the Clinical Center 

Research Steering Committee (CCRSC). In 2003, 

the National Academy of Sciences’ Institute of 

Medicine issued a report calling for reorganization 

of some aspects of the NIH intramural program. 

The report also underscored the importance of 

maintaining a robust clinical research infrastructure 

in the United States. In 2003, the NIH Director 

convened another advisory panel, the Blue Ribbon 

Panel on Intramural Clinical Research. This panel is 

charged with assessing the state of the intramural 

research program and will also evaluate governance 

structures for the Clinical Center. In response to 

these recommendations, the NIH Director made 

additional modifications of the oversight structure 

for the CC. The NIH Director subsequently broadened the scope of the Clinical Center Advisory 

Committee and reconstituted it as the Advisory 

Board for Clinical Research. This committee continues to provide a venue in which the Institutes 

can contribute to the governance of the Clinical 

Center, particularly with respect to issues relating to 

the science agenda. As noted above, as part of the 

NIH Director’s restructuring related to his Road 

Map initiative, new oversight committees – the 

Intramural Working Group, the Facilities Working 

Group, and the Financial Working Group – were 

convened within the past three years. 

Over the past eleven years, the Clinical Center 

Director has sought advice from other important 

stakeholders, including Clinical Center clinical 

research subjects and clinical research principal 

investigators. The Clinical Center Director maintains a Patient Advisory Group that has provided 

and continues to provide advice to the Director 

from the unique perspective of clinical research 

subject-participants. Thus, because of the multiplicity and complexity of its myriad stakeholders, 

the governance structure for the Clinical Center 

remains complex. 

■ Historically, the Clinical Center was subject 

to bureaucratic inflexibility in personnel, 

procurement, and fiscal management; 

acquisition in 2001 of new Title 42 personnel 

authorities and other delegations of authority 

have provided some relief. 

As a center in the National Institutes of Health, the 

Clinical Center reports to the agency, to the Public 

Health Service, and to the Department of Health 

and Human Services. Its activities are subject to 

agency rules, regulations and policies; PHS rules, 

regulations and policies; DHHS rules, regulations 

and policies; rules, regulations and policies of the 

Office of Management and Budget, the Office of 

Clinical Center Weaknesses 13 
Personnel Management, and the General Services 

Administration; and all other applicable Federal 

rules, regulations and policies, as well as applicable 

Federal statutes. As a result of this extensive bureaucracy, “The Clinical Center faces a series of very 

serious barriers to managerial efficiency in areas 

such as personnel, purchasing, and contracting...7 

...The Clinical Center needs a great deal of flexibility to operate productively.”8 The Report of the 

DHHS Secretary’s external review committee in 

1996 noted that, “whereas the government’s personnel system is structured to provide fair, consistent 

rules for employees and managers, it undermines 

the Clinical Center’s efficient operation.”9 With 

respect to fiscal issues, the report states, “As is the 

case with all government operations, the Clinical 

Center must spend its entire budget within the fiscal year; no carryover is allowed9

. . . The Clinical 

Center should have a means of retaining reserves 

from year to year.”10 The report also notes that the 

NIH’s existing budget process for the Clinical 

Center “...makes future Clinical Center funding 

far more unstable than funding of NIH as a 

whole.”11 These points were valid in 1996 and 

remain so in 2007. 

Since the initial draft of this document was 

written, the Clinical Center has worked with the 

Director, NIH and the Directors of the Institutes 

to try to streamline the Clinical Center’s funding 

stream. The prior funding mechanism rewarded 

“non-use” of the Clinical Center. A new funding 

mechanism has been designed, patterned after the 

concept of a “school tax.” Because Institute charges 

are not linked to use in this new funding model, 

it has stimulated use of the Clinical Center and 

will provide far more stable funding than the old 

funding mechanism. This new mechanism was put 

in place in the FY 2000 budget cycle. Appropriations language was written for the FY 1997 budget 

cycle to allow the Clinical Center to carry over 

some funds; this language has again been approved 

for the present fiscal year. These carryover funds 

provide an important source of revenue support 

for new clinical research initiatives of the Institutes. 

The Clinical Center has also attempted to address 

the issue of inadequate cost accounting. Initially, the 

Clinical Center hired a consultant to provide advice 

about the establishment of an activity-based costing 

system. The recommendations of the consultant 

were adopted and the Clinical Center has implemented this system. Through its more precise 

detailing of costs and activities, this activity-based 

costing system has proved to be of substantial 

utility to the Clinical Center’s administration, as 

well as to its major customers and stakeholders. 

In response to the Institutes’ requests for more 

precision, the Clinical Center has again turned to 

consultants, this time from Price-Waterhouse 

Coopers, who have conducted an in-depth analysis 

of our current state and have made recommendations concerning the implementation of financial 

systems and a data transformation initiative that 

will yield more precision with respect to the costs 

associated with goods and services provided to 

patients participating in clinical research protocols 

in the Clinical Center. 

Performance measurement continues as a major 

organizational focus. During the past ten years the 

Clinical Center has collected and continued to 

refine organization-wide activity data that are used 

by the Director to assess overall performance. In 

addition, Clinical Center departments collect data 

relevant to the performance of their individual 

departmental operations. The goal of measuring 

performance is to track departmental and organizational progress toward our strategic goals. Thus, an 

important aspect of the performance measurement 

system is making certain that the outcomes and 

processes being measured are relevant to our key initiatives and strategic goals and that the measurement of these structures, processes and outcomes 

allow the Clinical Center to track progress toward 

these organizational goals. The performance measurement initiative is relevant to both the operations 

of the Clinical Center as well as to clinical care 

provided in our facility. 

In the years since the initial draft of this document 

was written, NIH has also received several delegations of authority from the Secretary, Department 

of Health and Human Services (e.g., Title 42 f 

personnel authority; Title 42 g personnel authority, 

and Title 38 personnel authority modifications). 

Use of these delegations has helped to address some 

of the problems relating to inflexibility in personnel 

and procurement systems. 

Eight years ago the Clinical Center’s Office of 

Human Resources Management developed (and 

had approved by the DHHS Secretary) a program 

to be able to use a new personnel authority, 

Title 42, to appoint clinical research support staff. 

This project – that uses personnel procedures substantially different from traditional governmental 

personnel systems – has met with measurable 

success and demonstrates an increase in efficiency 

of responsiveness and decreased vacancy rates in 

relevant departments. 

14 2008 Environmental Assessment 
In the past three years, the Clinical Center has 

developed a ‘managing performance’ initiative. The 

goal of this initiative is to encourage Department 

Heads and Supervisors to get the most from their 

employees, to make certain that Clinical Center 

employees work to their potentials and to make 

certain that our Departments have the right people 

on the job. The Clinical Center hired an attorney 

who has extensive governmental personnel experience to oversee the project and to provide support 

to the Department Heads. This initiative has had 

a significant salutary impact on the overall quality 

of the Clinical Center’s workforce, has provided us 

with the opportunity to retrain some staff for positions for which they are more qualified, as well as 

the opportunity to separate staff who are not productive and consistently under-perform. During a 

time of severe financial constraint this initiative 

has provided the organization with flexibility far 

beyond what has traditionally been available. 

■ Many intramural and extramural scientists 

believe that clinical research is not valued 

as highly as is basic science. 

Clinical researchers nationwide have long held the 

perception that NIH relatively undervalued their 

work. In 1979, James Wyngaarden, then the 

Director of NIH, referred to the clinical researcher 

as an “endangered species”. In response to the concerns of both intramural and extramural scientists 

concerning the standing of clinical research, the 

then Director of NIH convened a panel of experts 

charged with reviewing the status of clinical research 

in the United States and making recommendations 

to the NIH Director on how he might ensure 

effective continuance of clinical research in the 

United States. Dr. David Nathan, president of the 

Dana Farber Cancer Institute, chaired the committee. 

The leadership of the Clinical Center took the 

panel’s recommendations seriously and developed 

substantive responses to many of them. The Clinical 

Center’s Director has developed an introductory 

course on the principles and practice of clinical 

research that has trained more than 2,900 students 

and has also edited and published a textbook (now 

in its second edition) that accompanies the course. 

A Clinical Research Training Program for medical 

students, including mentoring by some of NIH’s 

most accomplished clinical researchers has been 

successfully implemented. A collaborative Masters’ 

Degree program (now with several graduates) in 

clinical research has been developed with Duke 

University. A required course on clinical research 

for all principal investigators has been established 

and is now available on the World Wide Web. A 

clinical pharmacology course has been developed 

and implemented (complete with an accompanying 

textbook) and a Bioethics Course has been developed and implemented. Intramural programs have 

reviewed and revitalized their clinical research 

programs. Both NIH and the Clinical Center 

have engaged in dialogues with the insurance and 

managed care industry. In late 2001, the NIH 

Intramural Program invited the Association for 

the Accreditation of Human Research Protection 

Programs (AAHRPP) to visit the campus to pilot 

its new accreditation program process. The NIH 

Intramural Program is now gearing up to apply for 

accreditation of its clinical research program 

through AAHRPP. 

■ Because the Clinical Center’s physical plant 

urgently needed renewal, the U.S. Congress 

provided funding for the construction of a 

new facility, the Mark O. Hatfield Clinical 

Research Center. 

A 1995/1996 external review noted that, “The 

Clinical Center’s 48-year-old physical plant is 

increasingly inadequate for the conduct of clinical 

research; it requires replacement.”12 A Congressionally 

mandated external review of the NIH intramural 

program conducted by an advisory committee to 

the NIH Director’s Advisory Committee also concluded, “In recent years, it has become clear that the 

infrastructure of the Clinical Center is deteriorating 13 

...The External Advisory Committee agrees with 

the need for renewal of the Clinical Center.”14 

For these reasons, NIH, the Department of Health 

and Human Services, and the Congress approved 

the concept of building a new Clinical Research 

Center, an architect was selected, a private developer hired, and construction completed in 2004. 

Patients were moved into the new hospital in April 

of 2005. To increase customer input in the governance of the new hospital, teams of “Partners” (i.e., 

institute staff and Clinical Center staff who share 

space and resources in the new building) were 

convened. The transition from the Magnuson 

building into the new CRC occurred seamlessly. 

■ Clinical researchers identified a need for 

restructuring the processes involved in 

outpatient surgery and outpatient care. 

In 2002, surgeons from several ICs identified a 

need for updating and streamlining outpatient/ 

ambulatory surgery processes in the Clinical Center. 

Clinical Center Weaknesses 15 
In a survey of employees conducted in 2002, 

Clinical Center staff also identified ambulatory 

surgical care as an area in need of process improvement. In 2003, a white paper on the state of surgery 

written by the members of the Surgical Advisory 

Committee in the CC identified the same problem 

with outpatient/ambulatory procedures. In 2004, 

the Clinical Center embarked on a major process 

redesign initiative (discussed below). One of the 

three major processes selected for redesign was outpatient/ambulatory surgery. The process redesign 

team has already presented options for streamlining 

and improving the ambulatory surgery to the 

Clinical Center Director. This project, which will 

require substantial renovation of areas immediately 

proximate to the operating suite, is scheduled for 

FY 2008. 

■ Although the Clinical Center lacked a 

strategic plan in 1995; it now has a 

vibrant plan that is updated annually. 

Although a strategic plan was drafted in 1990, this 

plan was never implemented. The plan was never 

used for conjoint planning with the ICs, nor was it 

used to facilitate decision-making. An external 

review conducted in 1994 stated, “The Clinical 

Center lacks a strategic plan describing how it will 

respond to long-range Institute needs, extramural 

pressures to reduce costs, and competition to alternatives to intramural research. Without such a plan, 

decisions that have long-lasting consequences or 

require long lead-times, will be untimely, if they 

are made at all.”13 

After obtaining input from major internal (e.g., 

Clinical Center Department Heads) and external 

(e.g., IC Directors, IC Scientific and Clinical 

Directors) customers, the Clinical Center developed a strategic plan. The plan was presented to, 

and approved by, the Clinical Center Board of 

Governors. The strategic and operating plan is 

used to provide information and context for the 

Advisory Board for Clinical Research as well as for 

the Clinical Center’s myriad other customers and 

stakeholders. This strategic plan has been in place 

and functioning well as a template for progress over 

the past eleven years. The strategic plan is revised 

annually to make certain it accurately reflects our 

direction and is responsive to the needs of our 

customers and stakeholders. The Clinical Center 

views its strategic plan as a dynamic document – 

projects are continuously being evaluated, revised 

and improved. 

In addition, the Clinical Center drafted its first 

annual operating plan in 1999 for FY 2000; this 

process was refined annually, beginning in FY 2000. 

An FY 2008 plan is being created as this document 

is being constructed. These documents delineate 

organizational priorities for the upcoming fiscal 

year, provide alignment of the short-term organizational priorities with long-term goals, provide a 

structure to help in decision-making during the 

fiscal year, and provide a new framework for managerial accountability. 

■ Clinical Center Information Systems 

do not adequately support managerial 

and financial data. 

The Clinical Center has long been a world leader 

in the field of “computerizing clinical data;”15 however, the Clinical Center’s information systems 

fall short in providing managerial and financial 

data required by IC and Clinical Center managers. 

One set of external consultants concluded in 1995 

that “...the data provided are retrospective and 

difficult to use in operational decisions... The 

architecture of the computer system is outmoded 

and cannot effectively integrate data between and 

among departments.”16 

In the past eleven years, several projects have been 

initiated to improve the quality and availability of 

financial and resource utilization information for 

better management of Clinical Center operations. 

In 2003, the Clinical Center recruited its second 

Chief Financial Officer who now provides overall direction for financial and resource utilization, 

setting the standards and defining the requirements. 

In 2005 the Clinical Center launched a new 

Clinical Research Information System. Considering 

the complexity of replacing an information system that was pathbreaking when it was initially 

implemented in the 1970s, the activation of the 

new system proceeded extremely smoothly. In 2006, 

a new Chief Information Officer was appointed 

and the Clinical Center is currently recruiting a 

new Chief for a new laboratory, the Laboratory of 

Informatics Development who will oversee the 

design and implementation of CRIS II – a project 

that will include a large data repository for IC and 

CC scientists. In addition, as noted above, the CC 

Budget office implemented and refined an activitybased costing system that provided markedly 

improved resource utilization data to IC customers. 

In addition, the Chief Financial officer and her 

team, with the assistance of contractors from 

16 2008 Environmental Assessment 
Price-Waterhouse Coopers have undertaken a major 

data transformation initiative that is evaluating 

other approaches to providing even more granular 

data to our customers and stakeholders. These 

projects provide the infrastructure for further 

progress in financial accountability and responsiveness to our customers’ and stakeholders’ needs for 

more accurate financial and planning information. 

■ Clinical Center successes are not adequately 

communicated to the public, to referring 

physicians, and to the insurance and 

managed care industries. 

In 1996, the DHHS Secretary’s Options Team 

report concluded that, “The outstanding work of 

the Clinical Center is not being communicated 

to those outside NIH in an effective manner. The 

public, insurers, and referring physicians must be 

informed about the ways that the Clinical Center 

promotes the highest standards for conducting 

research and training researchers.”15 

To address problems previously identified by focus 

groups and by external consultants, the Clinical 

Center has developed a marketing strategy, which 

includes letting a substantial contract to develop 

a public relations/marketing initiative and the 

creation of the Office of Patient Recruitment 

and Public Liaison, which in 2007 merged with 

Communications to form the new Office of 

Communications, Patient Recruitment and Public 

Liaison. The Clinical Center Board of Governors 

endorsed the patient recruitment project as part 

of the long-range goals included in the strategic plan. The three major communications goals 

of this new Office are: 

–	 To increase the visibility of the Clinical Center 

as a national center for clinical research 

–	 To increase recognition of the Clinical Center 

as a national center for the training of clinical 

investigators; 

–	 To educate the public about clinical research. 

■ Through 2007, patient recruitment efforts 

still are not optimal. 

For a variety of reasons, through 2007, patient 

accrual remained problematic. Despite significant 

efforts by the researchers to recruit patients, some 

excellent and, in some instances, important studies 

languished for lack of patients. 

As noted above, the Office of Patient Recruitment 

and Public Liaison has, as its primary mission, the 

support of patient recruitment and referral efforts. 

The primary goal of the service is to increase the 

enrollment, including women and minorities, to 

clinical research studies in the Clinical Center. The 

development of a more uniform, trans-Institute 

patient travel reimbursement policy may provide 

additional recruitment incentive. 

As a result of the events of 9/11/2001, DHHS 

mandated that the NIH campus be maintained 

under an increased level of security, mandating 

that the campus be completely encircled by a fence 

with security personnel supervising entry onto the 

campus at each gated entrance. The screening 

process is detailed, involving visual inspection of 

vehicles and personal searches of individuals coming onto campus. Patients and visitors have found 

these increased security measures to be intrusive 

and oppressive and have complained often about 

the inconvenience, delay, and intrusiveness of the 

security screening. Many staff believe that implementing these DHHS-mandated procedures has 

had an adverse impact of patient recruitment. In 

an attempt to address patient and visitor concerns, 

the Clinical Center’s Director advocated for, and 

was ultimately successful in obtaining, a dedicated 

gate entrances for patients and their families. This 

gate, which is manned by security personnel, as 

well as staff from the Clinical Center’s Hospitality 

Service, has streamlined the process for campus 

entry for patients and their visitors. Some programs 

(e.g., the NIAID Vaccine Research Center normal 

volunteer program) believe that even this new 

streamlined process is a barrier to recruiting normal volunteers. For certain programs (e.g., the 

NIMH Autism program, the NIAID Vaccine 

Research Center, and the National Institute on 

Alcohol Abuse and Alcoholism, off-campus screening sites are being considered. The Clinical Center 

is supporting these programs through staff consultation about: facilities preparation and management, 

centralized scheduling, information technology, 

medical records, specimen handling and processing. 

■ Although not offering “full services” was 

perceived as an organizational strength 

because it permits organizational efficiency 

and flexibility, not offering complete, integrated 

medical and surgical services is viewed as an 

institutional weakness by some customers. 

Clinical Center Weaknesses 17 
The fact that the Clinical Center does not provide 

full services is perceived by some Clinical Center 

and IC staff as a disadvantage for several reasons. 

For some physician research trainees, the fact that 

the Clinical Center does not offer “full-services” 

limits the desirability of the Clinical Center as a 

training site. In addition, some institutes perceive 

that this ‘less-than-full-service’ status limits their 

research opportunities. For example, not having an 

emergency room makes studies of myocardial 

infarction and/or brain attack difficult, if not 

impossible. Not offering these services necessitates 

developing procedures to acquire some types of 

support from local academic or community physicians. Response times for outside consultants are 

occasionally less than optimal. Additionally, their 

investment in, and commitment to, the Clinical 

Center patient population is almost invariably 

less than that of the NIH investigators. Because 

the Clinical Center does not see a full spectrum 

of illness, maintaining clinical competencies and 

training staff is difficult and often requires relationships with extramural institutions. To address these 

issues, the ICs and the Clinical Center have forged 

alliances with extramural institutions. Some examples of these alliances include: 

–	 Partnerships with Johns Hopkins University 

and the National Rehabilitation Hospital that 

will facilitate clinical training for fellows and 

junior staff and will afford senior staff the 

opportunity to maintain clinical skills; 

–	 A partnership with Johns Hopkins and 

Suburban Hospital that will facilitate the 

conduct of studies of acute medical problems 

(e.g., brain attack, myocardial ischemia) that 

heretofore have been impossible at the Clinical 

Center, primarily because of the absence of an 

Emergency Room; this program opened officially in May 1999; 

–	 A partnership with Duke University to facilitate 

advanced training in clinical research, including 

the opportunity to receive an advanced degree 

in Clinical Research; 

–	 A variety of partnerships with local institutions 

(e.g., Washington Hospital Center, Johns 

Hopkins, Georgetown, and others) to provide 

Clinical Center staff with opportunities to 

maintain clinical competencies. 

These extramural affiliations should strengthen 

training opportunities. Currently, the overwhelming majority of consulting services are provided 

by IC staff; traditionally, these consulting services 

have been managed by ICs maintaining clinical 

research interests in those fields. No formal system 

of accountability or responsibility exists for the 

consultation services. For this reason, not all ICs 

have emphasized the importance of responsiveness 

in clinical consultation, nor do their clinical services put forth the effort to maintain their clinical 

expertise. In mid-1997, the Medical Executive 

Committee formed a subcommittee to address 

the perceived problems with consultative services. 

The first steps in addressing the issue were: 1) to 

obtain Institute agreement about the “ownership,” 

or responsibility for, the various consultative 

services present in the Clinical Center; and 2) to 

develop a system, based in the Clinical Center’s 

Medical Information System, to collect information from both consultants and those requesting 

consultations about the timeliness, appropriateness 

and the quality of consultations provided by consultative services. The overall goal of the Medical 

Executive Committee’s subcommittee is to increase 

the quality of care provided to clinical research 

subjects at the Clinical Center. 

The Clinical Center has also made a substantial 

commitment to increase the quality and availability 

of clinical research training over the past four 

years, as described above. The CC established its 

Office of Clinical Research Training and Medical 

Education in May 2003. This office is responsible 

for the development, administration and evaluation 

of clinical research training and medical education initiatives that contribute to the professional 

growth and development of NIH clinician-scientists 

and other health care professionals. In the fall of 

2007, the office expanded to include a number of 

trans-NIH educational initiatives that were moved 

from the NIH Office of Intramural Training and 

Education. The current inventory of courses and 

programs includes: 

–	 “Introduction to the Principles and Practice of 

Clinical Research” – was established in 1995, 

provides formal training on how to conduct 

clinical research effectively. To date, 6,330 

students have registered for the course, and 

2,349 certificates have been awarded. From 

1997-2007, the course was teleconferenced to 

22 domestic and five international locations. 

A second edition of the course textbook 

was published in April 2007 by Academic 

Press/Elsevier. 

18 2008 Environmental Assessment 
–	 “Principles of Clinical Pharmacology” course – 

is designed to meet the needs of researchers who 

have an interest in the clinical pharmacologic 

aspects of contemporary drug development 

and utilization. The course was established in 

1998. Since then, 3,912 students have enrolled. 

A second edition of the course textbook was 

published in September 2006 by Academic 

Press/Elsevier. 

–	 “Ethical and Regulatory Aspects of Clinical 

Research” – this course is taught annually by 

the Clinical Center’s Bioethics Department. It 

was implemented in 1999 and offers formal 

education and training in the ethical conduct 

of clinical research. To date, 2,865 students 

have enrolled. The accompanying textbook, 

Ethical and Regulatory Aspects of Clinical 

Research: Readings and Commentary, was published by Johns Hopkins University Press. 

–	 The NIH-Duke Training Program in Clinical 

Research was introduced - 1998 and provides 

an opportunity for NIH physicians and dentists to receive a Master of Health Sciences 

in Clinical Research from Duke University 

School of Medicine. This program, offered via 

videoconferencing, provides formal courses in 

research design, research management and statistical analysis. For 2007-2008, six students 

enrolled into the program. To date, 132 students representing a cross-section of NIH 

Institutes and Cente-rs have been admitted and 

54 have received degrees. 

–	 The Clinical Research Curriculum Certificate 

program was established in 2004 and is intended for physicians, dentists, and allied health 

care professionals fully engaged in or intending 

to become engaged in clinical or translational 

investigation (see http://intranet.cc.nih.gov/ 

clinicalresearchtraining/curriculumcert.shtml). 

Individuals who complete the mandatory components of the program are awarded a certificate 

by the NIH Clinical Center. As of September 4, 

2007, 50 certificates have been issued. 

–	 The Clinical Research Training Program 

(CRTP) is a public-private partnership supported jointly by the NIH and a grant to the 

Foundation for NIH from Pfizer Inc. The 

CRTP was established in 1997 to train medical 

and dental students in clinical or translational 

research after completion of their clinical rotations. Students are assigned a tutor, in their 

field of interest, who guides them in choosing a 

mentor for their research project. In fiscal year 

2004, NIH Roadmap funds were earmarked 

to support an expansion of the program allowing for a doubling from 15 to 30 students 

per year. 

In an effort to improve the clinical services provided to clinical research subjects, the Clinical 

Center has launched several new clinical initiatives 

in the past decade, including the establishment 

of a multidisciplinary Pain and Palliative Care 

team, a General Internal Medicine Service (that 

has now grown to include two physicians and 

two Nurse Practitioners), as well as a General 

Pediatrics Service (that includes two physicians 

and a nurse practitioner) to provide general pediatrics consultative support. 

■ The Clinical Center has not routinely sought 

customer input about its services. 

As a service organization, customer input is crucial 

to the smooth functioning of the hospital. In 1997, 

the CC sought and received a generic clearance 

from the Office of Management and Budget to 

be allowed to conduct surveys of its customers 

and other partners. We have recently submitted 

our fourth request for a generic clearance to conduct such surveys. The CC initially partnered 

with the Harvard-based Picker Institute for its 

initial patient survey. Results from the survey identified areas that needed attention in the organization, but also established new quality benchmarks 

for the Picker group in terms of overall perceptions of quality. Picker was sold to the National 

Research Corporation (NRC) in 2001; however, 

the Picker ‘perception’ surveys have become the 

centerpiece of the NRC portfolio, so the Clinical 

Center has been able to maintain continuity in its 

customer perception program. In 2002, we conducted simultaneous employee and patient surveys 

centered on the Picker dimensions of care. The 

survey demonstrated improvement in the area of 

customer service following the customer service 

training initiative and also identified some areas 

ripe for improvement, including coordination of 

care, the ambulatory surgery program and process 

and the informed consent process. The results 

from these conjoint surveys have been used to 

identify areas needing organizational improvement. 

Clinical Center Weaknesses 19 
One minor example of the outcomes of these surveys is the development of a patient smoking area 

for patients coming to the CC. The need for this 

area was identified, at least in part through these 

surveys, and is now functional. These data led to the 

launch of major improvement initiatives in three 

areas – coordination of care, informed consent and 

ambulatory surgery. These three important organizational processes have been completely renovated 

through a major process redesign initiative led by 

the Associate Director for Nursing. In 2007, the 

Clinical Center began conducting continuous 

surveys of inpatients and outpatients. In addition, 

we surveyed perceptions of both our patients and 

our IC customers and stakeholders as part of each 

of the operational reviews conducted to date 

(Imaging Sciences, Nursing, Transfusion Medicine, 

Spiritual Ministry and Laboratory Medicine). 

Assuming that our generic clearance request from 

OMB is again approved, in 2007-2008 we will also 

survey patients about the comparative ‘built environments’ of the old and new hospitals, physicians 

who refer patients to the CC, and pediatric patients 

and their parents. 

The CC Director established a Patient Advisory 

Group in 1998. This group is composed of current 

and former patients and provides the Director with 

the patients’ perspectives about service quality in 

our hospital. This group has also helped identify 

issues that have become the focus of performance 

improvement activities (see customer service initiative, below). In part to improve our interface with 

the public, and to improve our outreach to minority and underserved communities, the CC established the Patient Recruitment and Public Liaison 

Center. This new center has had a substantial 

salutary effect on community relations since its 

inception six years ago. 

■ Historically (pre-1994), customer service 

was not an identified institutional priority. 

The Clinical Center Director’s Patient Advisory 

Group identified a need for organizational improvement in the area of basic courtesy and customer 

service. In response to this identified need, the 

Clinical Center embarked on a major customer 

service initiative. An external contractor was hired 

to assist with the training of staff throughout the 

organization – focusing particularly those at major 

customer/stakeholder interfaces. This program 

was received with a great deal of enthusiasm by 

Clinical Center staff. As noted above, results from 

patient surveys suggests that this initiative has had 

a beneficial effect from our patients’ perspectives. 

■ The Clinical Center has substantial 

opportunities to increase its attention to 

workforce diversity and healthcare disparities. 

Over the past five years, both NIH and the Clinical 

Center have also become increasingly aware of an 

organizational need to honor cultural diversity and 

to develop policies of inclusiveness for our workforce and in our everyday practices. The prior 

NIH Acting Director identified health disparities 

as a major NIH priority. The Clinical Center has 

successfully competed for funds from the NIH 

Center for Minority Health to facilitate recruitment of minorities into clinical studies. In addition, 

the Clinical Center is embarking on a major diversity awareness program and has redoubled its efforts 

to recruit minority staff. As part of this effort the 

CC has established a summer student training 

program that focuses on the recruitment of minority students. The challenge of recruiting talented 

women and minorities to the Clinical Center cannot be overemphasized. The NIH salary structure 

often lags behind competing academic centers, 

and is rarely competitive with industry. Talented 

women and minority candidates are consistently 

highly recruited. NIH has established the Office 

of Minority Health and a trans-NIH Working 

Group on Women in Biomedical Careers with an 

eye toward increasing our recruitment efficacy in 

this highly competitive field. One problem identified by the NIH Working Group on Women in 

Biomedical Careers relates to the challenge of retention – i.e., keeping talented women and minorities 

in the field of clinical research when salaries are not 

competitive and when other personal and family 

related issues place demands on the investigator’s 

time. Ideally, such individuals can be nurtured into 

positions of leadership, despite these obstacles. 

■ The Clinical Center had difficulty reconciling 

competing Institute demands within a 

defined budget and has no clear cut 

mechanisms for making decisions 

that benefit the entire organization 

(as opposed to individual customers). 

Whereas the Clinical Center, as a service organization, needs to be responsive to the program needs 

of its IC customers, the Clinical Center should 

not be involved in setting the clinical research 

agenda. Each IC sets its own scientific agenda. 

20 2008 Environmental Assessment 
The NIH Director convened a mini-retreat in 

2007 to address institutional issues relating to the 

identification of NIH institutional priorities for 

clinical research. As one result of the retreat, the 

NIH Director charged the entire organization 

with identifying crosscutting projects (i.e., analogous to the “Manhattan Project”) that will involve 

multiple Institutes. In addition, the Advisory Board 

for Clinical Research provides the Clinical Center 

Director with advice about intramural clinical 

research priority setting. Other recommendations 

from this retreat include: 

–	 Increasing the number of tenure-track clinical 

investigators; such an increase could be facilitated by centralized recruitment strategies 

and pooling of IC resources with a goal of first 

getting the best recruits, and then allowing 

them to later align themselves with ICs. 

–	 Re-opening fascinating, difficult clinical challenge or “fascinoma” clinics that had been 

used in the past to evaluate patients who are 

diagnostic conundrums and present broad, 

clinical challenges. 

–	 Making the CRC available to extramural 

research and industry provides expanding 

opportunities in areas of drug and technology 

development and access to a larger cohort of 

patients (discussed below). 

■ The Clinical Center and the Institutes have 

variable infrastructures to support their 

independent investigators and to support 

the processes of clinical research. 

The CC Director, working with the Clinical 

Center’s Medical Executive Committee, developed 

a set of Standards for Clinical Research that represent the minimum infrastructural standards that 

all NIH clinical research programs should have in 

place to assure appropriate investigator support, 

as well as the safe conduct of clinical research. 

Beginning in 2003, the Medical Executive commissioned reviews of each institute’s clinical 

research programs, based on these standards. The 

findings from these reviews, which are conducted 

by NIH peers, are being prospectively presented 

during executive sessions of the Medical Executive 

Committee meetings. The reviews afforded the 

individual IC clinical research programs the 

opportunity: 1) to see how other programs were 

approaching the new standards; 2) to identify 

‘best-practices’ among the ICs; and 3) to benchmark 

their own programs against the other programs 

on the NIH campus. These reviews will likely 

be invaluable when NIH applies for accreditation 

of its intramural clinical research program to one 

of the two oversight organizations that currently 

provide accreditation of clinical research/human 

subjects protection programs. 

Another feature of the variable research support 

infrastructure across institutes is the variety and 

sophistication of information systems to support 

protocol data management, patient recruitment and 

accrual statistics and IRB management. This disparity was noted during the development of the 

clinical research data repository business case and 

continues to be driver in the requirements for the 

planned system. 

■ Outpatient surgery and ambulatory care 

facilities are in need of redesign. 

With significant input from customers and stakeholders the CC has designed, and is in the process 

of renovating, our outpatient surgery venue. This 

project, which should result in a much more 

efficient patient flow and is much more ‘patientfriendly’ should be completed in 2008. Additionally, in 2003 stakeholders from several institutes 

noted that the Clinical Center’s ambulatory care 

clinic facilities were in need of restructuring and 

redesign. Clinicians raised questions about the 

optimal use of clinic space and clinic facilities. 

In addition, they identified unmet clinical needs 

(e.g., space to have private discussions with patients 

about treatment or protocol options, about prognoses). The Clinical Center Director’s Patient 

Advisory Group has expressed similar concerns. 

For these reasons, the Clinical Center assembled a 

team of stakeholders to assess possible restructuring 

of its outpatient services. The redesign and renovation of these areas is already underway and the 

round-robin process of redesign and renovation 

will continue for the next four years. 

■ The very constrained budgets of 2002 through 

2008 required the development of new strategies 

to gain operational efficiencies. 

To assure efficient operations of our Departments, 

the CC has developed a process for systematically 

reviewing the operations of our departments. These 

operational reviews involve both extramural experts 

in the field, as well as intramural stakeholders. In 

addition, to provide ICs with better financial 

data, we have launched a Data Transformation 

Clinical Center Weaknesses 21 
Initiative that is designed to provide more precise 

data about the costs associated with CC services. 

To date, we have conducted operational reviews of 

the Imaging Sciences Program, Nursing and Patient 

Care Services, the Department of Transfusion 

Medicine, and the Spiritual Ministry Department. 

The Department of Laboratory Medicine will be 

reviewed in September 2007. These reviews have 

resulted in a series of suggestions that have generated action plans from the departments that were 

reviewed that have already produced increased 

operating efficiencies. 

In addition, the CC has developed strategies to 

share some costs with Institutes for services that are 

primarily performed to support IC program 

research (e.g., research PET scanning, certain 

Transfusion Medicine Department products designated for research use, licensed pharmaceutical 

products being evaluated for ‘off-label’ indications). 

Whereas this strategy should help the CC manage 

financially during these very constrained times, 

senior leadership has concern that continued 

implementation of such cost-sharing strategies has 

the potential to suppress new ideas and perhaps 

negatively affect the organization. 

Finally, the Clinical Center’s Advisory Board for 

Clinical Research has provided oversight for a 

series of operational reviews of Clinical Center 

Departments and has made numerous suggestions 

to improve operating efficiency. This Board is 

comprised of internal customers and extramural 

experts in healthcare and hospital operations. Their 

advice has been extremely valuable in streamlining 

Clinical Center operations. 

■ After a peak during the budget doubling 

years (and immediately prior to opening the 

new CRC), the inpatient census has fallen, 

leaving the CC with unused capacity. 

To address the issue of unused capacity, the CC 

Director developed a highly successful program 

for competitive “Bench-to-Bedside” awards to stimulate creative translational work on the NIH 

campus. This initiative has been expanded to 

make it available to extramural investigators who 

wish to partner with intramural scientists in a translational research project. In addition, the Director 

of the Clinical Center has entered a dialogue with 

the NIH administration and IC leadership about 

making more of the Clinical Center’s unique 

clinical research infrastructure available to extramural scientists. Examples of unique infrastructural 

resources that may be used to attract extramural 

investigators includes (but is not limited to: sophisticated functional imaging studies, including 

MRI, MRA and PET scanning; intricate cell 

processing capabilities; molecular diagnostic 

studies; tailored functional outcome studies, and 

many others. Making these resources available to 

extramural investigators (and perhaps even to 

industry scientists) would likely significantly expand 

drug and technology development opportunities. 

Some barriers would have to be overcome to accomplish this, including managing shared resources, 

the potential for intramural and extramural funds 

to be used for the same project, and the management of intellectual property. Additional strategies 

that have been suggested as likely expanding and 

stimulating capacity within the intramural clinical 

research program include: 1) increasing the number 

of tenure-track clinical investigators; 2) centralizing recruitment for clinical investigators to take 

advantage of trans-institute opportunities; 3) develop clinical research “Manhattan Projects” that 

involve several ICs; 4) open “diagnostic dilemma” 

or “fascinoma” clinics; and 5) encouraging ICtenured and tenure-track investigators to write 

clinical research protocols. 

■ Institute protocols increasingly require 

sophisticated and costly genetic tests that 

are not available through CC laboratories. 

The Clinical Center is working with the leadership of the NHGRI to develop a strategy to meet 

investigators’ needs for genetic tests. The CC has 

surveyed investigators twice during the past year 

to attempt to learn more about their needs. The 

basic strategy that has been developed to address 

this critical need is writing a series of contracts 

(hopefully including substantial volume discounts). 

Such an approach would provide a mechanism to 

meet investigators’ increasing needs in this area, 

while simultaneously saving resources A spirited 

discussion of these needs was held at the Medical 

Executive Committee meeting to identify potential 

strategies for funding the necessary contracts. As a 

first pass, the MEC suggested that the CC be 

responsible for paying for all genetic testing that 

have FDA-approved indications for diagnosis. 

■ Despite the opening of the new CRC, several 

facilities-related issues present significant 

barriers to progress. 

As a result of an unannounced Joint Commission 

visit, several deficiencies in ongoing required pre22 2008 Environmental Assessment 
ventive maintenance and ongoing repair activities 

in both the Hatfield and the Magnuson buildings, 

as were problems addressing life-safety regulatory 

requirements for construction and renovation in 

the hospital (e.g., the construction/renovation 

permitting process, the development of, and training staff in interim life-safety measures, among 

others). These problems are compounded by the 

fact that many of the positions in the Office of 

Research Facilities (ORF) are currently being 

studied in the A-76 process for potential outsourcing. As a result they have had many of their staff 

leave and are unable to replace them until the study 

is complete. The Director of the Clinical Center 

established a working group, including the Director 

and Deputy Directors of the CC and ORF, as well 

as other involved customers and stakeholders in lifesafety processes in the CC. A new position was 

established by ORF that reports directly to both the 

CC Director and the Director, ORF. This group 

meets regularly and is systematically addressing the 

relevant construction, renovation, maintenance, 

engineering and life-safety issues to maintain compliance with regulatory standards. 

A third facilities-related issue concerns inadequate 

infrastructure (power, air handling and chilled 

water) in the ACRF and adjacent areas that were 

constructed in the late 1970s. Several devastating 

floods have occurred in these areas over the past five 

years, due to malfunctioning equipment, broken 

pipes, etc. The Clinical Center’s Operating Rooms, 

the Department of Transfusion Medicine’s Cell 

Processing Section, the Department of Laboratory 

Medicine, and our Imaging Sciences Program are all 

housed in this area. Since these are all technologically and equipment-intense, and since many of the 

programs (because of increasing demand for these 

kinds of studies) are rapidly expanding, addressing 

the infrastructure shortfall is a major institutional 

priority. The Director, ORF has made a commitment of additional funds for FY 2008 to begin 

addressing these issues as his highest priority. 

■ Changes in the ethics rules concerning 

stock holdings, consultation for industry, 

and other compensated-outside activities 

have had an adverse impact on recruitment, 

retention and morale. 

During the past three years, scientists at NIH 

have been subjects of several ethics investigations. 

A small number of individuals were found to have 

been noncompliant with Federal ethics rules. 

NIH developed a new set of guidelines, policies, 

and review processes. New policies have eliminated 

employees’ ability to consult for remuneration with 

commercial entities and dictate more stringent rules 

on financial holdings for senior employees. These 

new restrictive policies have had an adverse impact 

on recruitment, retention and morale on campus. 

The Director, NIH is working diligently to improve 

both the perceptions of NIH held by Congress and 

other important stakeholders as well as the morale 

of NIH staff. 

Clinical Center Weaknesses 23 
Factors in the External and Internal Environments 

Influencing Change in Healthcare Delivery and 

Clinical Research


Assessing the external and internal environments will afford the Clinical Center the opportunity to address several important questions, 

the answers to which will help shape the Clinical 

Center’s vision for the future. Among these important questions are the following: 

■ What external forces or trends are influencing the Clinical Center environment? 

■ How are these forces or trends currently 

influencing the Clinical Center, and how will 

they likely influence the manner in which 

the Clinical Center operates in the future? 

■ How is the Clinical Center positioned to 

manage these trends? 

These external and internal influences and trends 

will undoubtedly present the Clinical Center 

with both opportunities and challenges. Thus, 

the analysis of these factors will include both 

“Clinical Center opportunities” and “Clinical 

Center challenges for the future.” Certain of these 

external factors simultaneously present opportunities and threats. 

Clinical Center staff have visited many centers 

across the country that are viewed as “best-in-class”. 

In discussions with the leaders of these organizations, many factors driving change in the healthcare 

and clinical research environments were identified. 

These factors can be divided into “challenges and 

opportunities” and can be loosely grouped into 

several general categories. 

■ Changes in, or influenced by, societal values; 

■ Changes influenced by cost considerations; 

■ Process changes in healthcare driven by increasing competition, such as the rise of 

managed care; 

■ Changes influenced by shifts in population 

and population demographics; 

■ Changes in the practice and delivery of medicine; 

■ Changes in practice driven by technological 

advances; 

■ Changes influenced by governmental initiatives; 

■ Changes mandated by agency priorities and 

initiatives. 

As a result of the dramatic changes taking place in 

science, medicine, and the healthcare industry, the 

Clinical Center faces the following opportunities, 

challenges, and potential threats. 

Societal- and Value-Based Factors 

The dramatic changes in the political climate, including the wars in Iraq and Afghanistan, the aftermath 

of the heretofore unthinkable acts of September 11, 

2001 and the continued threat of additional acts of 

terrorism have mandated increased attention to emergency preparedness in our institution, have required 

diversion of resources to NIH safety and preparedness 

activities, have resulted in requests for scientific and 

intellectual support for the revitalization of the healthcare infrastructure in these war-torn countries, and 

have fundamentally altered the day-to-day workplace 

lives for individuals working on the NIH campus. 

Terrorist acts directed against the United States have 

increased steadily over the past years. The potential 

for additional acts of terror, including bioterrorism, seems likely, if not inevitable. The events of 

September 11, 2001 had a profound and lasting 

impact on the United States. These events forced 

a rethinking of how we, as Americans, conduct 

virtually every aspect of our lives. The need to focus 

resources on national defense and public safety 

also have mandated substantial changes in our 

internal environment. The perimeter of the NIH 

campus is now fenced and campus entry points 

are staffed with security screeners. If one wishes to 

park in a below-building garage, the security staff 

swab the vehicle for explosives before permitting 

its entry into the underground garage. 

24 2008 Environmental Assessment 
The Clinical Center has responded to these new 

circumstances: by revising and broadening its 

disaster plan; by preparing and distributing an 

emergency management flip chart throughout the 

Clinical Center complex (to make key information 

readily available to all its staff); by working with 

the NIH Continuity of Operation Planning 

Group, by participating in pandemic influenza 

planning, and by entering into an emergency preparedness partnership. 

To address the complex issues relating to hospital 

and community emergency preparedness in the 

21st century the Clinical Center, the Suburban 

Hospital Healthcare System, and the National 

Naval Medical Center formed an emergency preparedness partnership – the Bethesda Hospital 

Emergency Preparedness Partnership. This partnership, composed of three diverse organizations 

that have strikingly complementary resources, has 

made it possible for the Clinical Center to plan 

for possible emergency situations in an unprecedented fashion. 

The DHHS Secretary contributed a 250-bed 

contingency station field hospital to be embedded 

at the CC for partnership surge capacity and the 

Department of Defense provided $5M in earmarked funding for the Partnership. These resources 

have been used to procure equipment and supplies, 

to support drills that are run jointly among the 

three partners, and to assist with ongoing strategic 

planning and preparedness assessments. These 

funds also will be used to test novel technologies 

in emergency situations. In addition, the partnership conducted a feasibility study of constructing 

either bridges or tunnels from NIH to the other 

partners. The Bethesda Hospital Emergency Preparedness Partnership has run several, highly 

successful complex drills that involve the staff 

from all three facilities. 

The Bethesda Hospital Emergency Preparedness 

Partnership has also developed close working 

relationships with other Montgomery County 

hospitals, and the Montgomery County Collaborative Task Force (for emergency preparedness) 

as well as with the Capitol Area Emergency 

Preparedness Planning team. This, the Clinical 

Center and the NIH in general are much better 

prepared to deal with emergency situations than 

at any time in the past. 

The impact of the dramatic changes on the NIH 

workforce brought about by the September 11, 

2001 disasters and their sequelae cannot be underestimated. Staff continue to be faced, on a day-today basis, with substantial uncertainty. 

The emergence of new infectious diseases, the 

resurgence of other infections, and the potential for the 

use of highly pathogenic infectious agents as weapons 

of bioterrorism presents substantial threats to the public 

health and are associated with the urgent need to 

be prepared to address and answer relevant scientific 

questions that may make it possible to mitigate the 

damage produced by these infectious diseases. 

The past several years have seen the emergence of 

several new, primarily zoonotic infections, the 

resurgence of others, and the fear that some exotic 

infections might be used as agents of bioterrorism. 

The spread of West Nile Virus from the Middle East 

to the North American continent, the emergence 

of hantavirus infections in the U.S. Southwest, 

the worldwide epidemic of the Severe Acute 

Respiratory Syndrome (SARS), and the importation of Monkeypox to the United States are examples of zoonotic infections associated with new and 

substantial public health risks for U.S. citizens. The 

resurgence of tuberculosis and the ever-present 

threat of pandemic influenza are examples of 

infectious diseases that can resurface at any time 

to present significant public health risks. The mailborne epidemic of anthrax that occurred in 2001 

and the sufficient concern in the U.S. Federal 

Government that the agent of smallpox could be 

used as an agent of bioterrorism that prompted a 

nationwide immunization program are examples 

of the existing bioterrorism threat. Finally, the 

specter of pandemic influenza continues to loom 

over the entire globe as a result of an almost 

unprecedented epidemic of avian influenza and 

the real possibility that the avian virus might make 

the jump to become an aggressive, transmissible 

human pathogen. Emerging infectious diseases, 

resurgent infections, and biological agents associated with risks as agents of terrorism are all associated 

with a plethora of unanswered scientific question. 

The Clinical Center provides an ideal venue in 

which to address some of these questions, and over 

the past three years, the Clinical Center has seen the 

development of clinical protocols that address some 

of these issues concerning: West Nile Virus, SARS, 

multiply-drug-resistant tuberculosis, pandemic 

influenza, anthrax and smallpox immunization. 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 25 
With its solid core of basic scientists and nearly 

ideal translational research environment, the Clinical Center is strategically situated both to be able to 

respond to these public health emergencies when 

they arise as well as to be able answer some of the 

very perplexing scientific questions. For example, 

the Clinical Center Department of Laboratory 

medicine Microbiology Service played a pivotal role 

in interpreting cultures from potentially exposed 

individuals during the mail-borne anthrax epidemic, processing thousands of cultures. The presence 

of patients who have these infections present formidable challenges to the NIH workforce and the 

threat of the emergence of these diseases – either 

through a natural epidemic or as a result of an act of 

bioterrorism – is another source of anxiety for both 

the NIH staff and the surrounding community. 

Declining funds for biomedical research also has added 

a degree of instability to the NIH environment. 

The U.S and international economies have been 

struggling during the past seven years. The economic downturn has resulted in restructuring of 

Federal, State and local governmental budgets. 

Corporations have cut back research and development efforts and many small biotech companies 

have gone bankrupt. With increasing financial 

support required to maintain the war effort in 

Afghanistan and Iraq, the additional requirement 

of substantial funds intended to assist with the 

revitalization of those countries, and the substantial 

investment in homeland security, the budgets for 

Federal Agencies will likely continue to be impacted 

significantly. The fact that the cycle of doubling 

the NIH budget was completed in 2002 resulted 

in substantially leaner budget years for NIH over 

the next few years. 

U.S. society has steadily increased its perceptions of 

social responsibility. 

Society has become more attuned to social responsibility for healthcare delivery since the 1960s. 

Interest in, and expenditures for, medical care for 

the elderly and the socially disadvantaged has 

increased dramatically during the past 30 years. 

The costs associated with providing care to elderly 

and indigent patients have begun to stress the 

healthcare delivery system. The increased social 

awareness has led to an increased appreciation of 

the role of alcohol and substance abuse in society, 

has shed light on the unique health problems 

associated with aging, and has clearly contributed 

to the founding of the National Institute on Aging, 

the National Institute on Alcohol and Alcohol 

Abuse, and the National Institute on Drug Abuse. 

This trend toward increasing social responsibility 

provides NIH and the Clinical Center with an 

opportunity to create and conduct landmark studies in these important areas. Conversely, because 

of increasing social responsibility, some in U.S. 

society would prefer to divert research dollars to 

support current costs of medical care. Such an 

approach is particularly understandable in the shortterm, but may be more costly in the long run. 

Americans increasingly value the “Quality of Life.” 

In the past twenty-five years, society’s focus has 

subtly shifted from “staying alive” to the “quality of 

life.” As Americans have become much more 

conscious of “quality of life” as an endpoint or outcome, American medicine has, of necessity, been 

forced to accommodate these changes in values. 

As American society has turned attention to this 

issue, Congress has also developed an interest in 

“quality of life” concepts. This shift in societal 

focus provides the intramural program and the 

Clinical Center with the opportunity to include 

objective and subjective measures of the functional 

outcomes that contribute directly to the “quality 

of life” as outcomes of clinical research projects. 

Particularly in oncologic studies, patients’ values 

and individual, unique measures of “quality of 

life” may influence their choices of therapy. 

Clinical Center Departments such as Rehabilitation Medicine, Pharmacy, and Critical Care 

Medicine have unique opportunities to contribute 

to Clinical Center studies in this area. Although not 

traditional ‘clinical care,’ this unique ‘clinical 

research support’ is an important component of 

the support provided by certain of the Clinical 

Center Departments. Ignoring this important 

trend in its clinical studies could place the Clinical 

Center at a disadvantage in the eyes of its societal 

customers. Since the drafting of the initial Clinical 

Center Environmental Assessment, public interest 

in “quality of life” issues has not waned; if anything, 

interest has intensified. Healthcare institutions 

have developed strategies to begin to measure 

changes in the “quality of life” that are effected by 

various therapeutic alternatives. These measurement 

strategies are a direct outgrowth of the persistent 

public interest in “quality of life” issues. 

26 2008 Environmental Assessment 
Wellness and prevention strategies are increasingly valued. 

In the past three decades, the U.S. society has 

increasingly focused attention on nutrition, diet, 

exercise, and avoidance/cessation of smoking and 

alcohol consumption. This focus on health and 

wellness again provides the NIH intramural 

program with clear opportunities to study basic 

mechanisms of health and the pathogenesis of 

disease states relating to this societal focus. 

In response to society’s interest, NIH has increased 

its investment in wellness and prevention activities. 

The external focus on “prevention” and “wellness” 

has continued to intensify over the past sixty 

months. Prevention activities are, in general, among 

the most cost-effective interventional strategies. 

For these reasons, this trend is likely to continue 

for the foreseeable future. 

One area where the focus on “quality of life” issues 

has not impacted American society is the remarkable, continuing problem of obesity in our society. 

Under the prevention and ‘wellness’ umbrella, 

DHHS leadership launched a major initiative to 

combat obesity in the United States. Several NIH 

Institutes are currently collaborating in a transinstitute NIH initiative that is designed to complement DHHS efforts. NIH responded by creating 

a new unit in the CRC dedicated to metabolic 

studies and the installation of two metabolic 

chambers to measure caloric intake and output with 

precision. This new unit was opened in 2007 and 

the metabolic chambers are in the process of being 

fully commissioned as this document is being 

written. These chambers provide another unique 

tool for investigators interested in perplexing problems related to metabolism – whether related to 

obesity or the wasting syndromes associated with 

oncologic chemotherapy and/or HIV infection. 

Technology in medicine is advancing almost exponentially; technologic advances are highly publicized; 

thus, these advances become “desired”. 

Medical technology blossomed in the 1990s. In 

the past forty years the tools of medicine have 

changed more than in the past five hundred years. 

NIH contributes to this rapidly advancing field, 

and, as a result, often has unique opportunities to 

use these technologies as they are being introduced 

into society to investigate the frontiers of medicine. 

Since the Clinical Center is ideally positioned to 

adapt swiftly to the development of new technologies, such rapidly advancing technologies provide 

the Clinical Center with unique opportunities to 

enhance its national and international reputation 

as a creative, innovative institution. Such new 

technologies often have direct impact on cost. 

Occasionally the required capital expenditures for 

new equipment are quite large and some technologically advanced procedures are labor intensive. 

These changes tend to increase the costs of care. In 

other instances, introduction of new technologies 

have been associated with less invasive procedures 

and decreased length of hospital stays (e.g., laparoscopic cholecystectomy), thereby decreasing the net 

costs of care, despite the outlay for the necessary 

capital equipment. 

The delineation of the human genome has resulted 

in a proliferation of studies in the field of genomics 

and proteomics that will likely quickly move science 

to more sophisticated, gene-based studies and, 

likely to a younger patient population. The focus 

on genomics and proteomics will also likely (at 

least ultimately) favor prevention studies. 

A general trend in the Clinical Center over the past 

several years is toward increased intensity/acuity of 

services per patient visit (i.e., more and more 

sophisticated imaging studies, more molecular tests 

per patient visit, more sophisticated cellular therapies, increasing numbers of serial studies, etc.) 

Many such studies are outside the bounds of what 

would traditionally be characterized as ‘standard 

care’ but easily fit under the rubric of ‘clinical 

research support’. 

Over the past ten years, the Clinical Center has 

continued to invest in new technologies, trying to 

position itself in the forefront of academic institutions in this arena. Clinical Center initiatives in this 

area include: the procurement, installation and 

activation of a new clinical research information 

system, the creation (in collaboration with private 

industry) of a new, state-of-the-art cell processing 

facility, new Positron Emission Tomography/CT 

imaging technologies, new computer tomography 

scanners, the purchase of upgraded magnetic resonance imaging capacity, the purchase of new stereotactic neurosurgical equipment, the purchase of a 

robotic surgical apparatus, additional emphasis on 

molecular diagnostics in Laboratory Medicine and 

Transfusion Medicine, the creation of an imaging 

center, in collaboration with NHLBI, NINDS and 

Suburban Hospital specifically designed to study 

acute cardiac and neurological vascular events in 

the Suburban Hospital Emergency Room, the 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 27 
purchase of an additional magnetic resonance 

imaging device and renovation of a part of the CCs 

operating suite to support a new intraoperative 

imaging program (particularly of use to the NCI 

Radiation Oncology Program and the NINDS 

Neurosurgery Program), and the renovation of the 

Imaging Sciences Radiology suite to support much 

of this new technology. 

Some sectors of the U.S. population have become 

highly suspicious of “clinical research”. 

As a result of adverse publicity arising from certain 

infamous clinical studies (e.g., the Tuskeegee study, 

the Willowbrook studies), some segments of the 

U.S. population have developed a substantial 

mistrust of the entire clinical research enterprise. 

Developing programs that reach out to these segments of society with sensitivity could enhance the 

Clinical Center’s reputation and result in a renewed 

patient-recruitment base. Congress and DHHS 

view ineffective recruitment of women, minorities, 

and underserved populations as problematic. 

Recent adverse publicity associated with the 

cloning of farm animals and the proposal to clone 

humans may present additional problems with 

certain aspects of the public’s perception of biomedical research. 

Clinical Center leadership has attempted to reach 

out to several minority communities who have not 

been traditionally invested in the clinical research 

process. For example, the Clinical Center’s Office of 

Patient Recruitment and Public Liaison has interacted with the local Hispanic community, and the 

Director of the Clinical Center made a presentation 

to the Annual Meeting of the National Medical 

Association. The Office of Patient Recruitment and 

Public Liaison also produced a video to assist in the 

recruitment of minorities to clinical research studies. In addition, the Clinical Center created a home 

page on the World Wide Web that includes a 

description of all active clinical research protocols 

at the Clinical Center. The Clinical Center also 

has established a Bioethics Department, which has 

positioned the organization to address the complex 

issues associated with cultural biases toward participation in clinical research. 

Population- and Clinical Research Subject-Based 

External Factors 

Patients and clinical research subjects are becoming 

increasingly sophisticated healthcare consumers. 

Consumerism is a relatively new phenomenon in 

U.S. healthcare. Because of the free availability of 

data, individuals have access to much more information about medicine and healthcare. As a result 

of the increasing publicity associated with iatrogenic 

and nosocomial medical misadventures, and as a 

result of the increasing media coverage of progress 

and problems in healthcare, the special standing of 

physicians in the community – the mystique of the 

white coat – has essentially disappeared. As healthcare costs have escalated, to try to maintain profit 

margins, insurance companies have increased 

copayment rates, and patients are now paying an 

increasing fraction of healthcare costs out of their 

pockets. For this reason the healthcare customer 

has become much more interested in cost and 

quality comparisons when procuring healthcare 

services. Since the Clinical Center delivers high 

quality healthcare without charge to the participants in its clinical studies, as healthcare customers 

focus more intensely on cost and quality, the 

Clinical Center should have an opportunity to 

recruit study subjects more effectively by appealing to both patients and providers. In addition, 

as the focus on cost and quality increases, the 

Clinical Center should have the opportunity to 

become better recognized as an outstanding clinical 

research facility. 

In the eleven years since the strategic plan was 

initially drafted, consumerism in healthcare in the 

United States has continued to increase. Numerous 

healthcare organizations have organized themselves 

along medical “product lines,” and public advertising of these product lines (e.g., imaging services, 

management of coronary artery disease) has 

increased. Consumers of healthcare in the United 

States in 2007 are focusing on several issues, among 

them: 1) ready access to healthcare and to their 

healthcare providers; 2) clear communication with 

their providers; 3) provider responsiveness to 

questions and problems; 4) patient safety; and 

5) the level of customer service available from 

their providers. 

With respect to the safety of patients participating 

in the clinical research studies at the Clinical Center, 

the Clinical Center has been proactive in the development of novel approaches to mitigate risk in 

our environment. We developed an electronic 

Occurrence Reporting System (ORS) that provides immediate responsiveness about events 

occurring in our institution and that allows CC 

28 2008 Environmental Assessment 
staff to evaluate more than 5,000 occurrences 

annually. These data are used to assess for trends, 

clusters, and potential sentinel events. We have 

been able to use these epidemiological data to 

make process improvements in a variety of patient 

care processes. When sentinel events occur, we 

routinely conducted detailed root cause analyses 

of these events, with an eye toward improving 

our patient care processes to mitigate risks for 

adverse events. Finally, the CC is interested in using 

technology to mitigate risk. We have run two pilot 

tests of biometrics equipment to assess their potential utility as a patient safety device. In addition, in 

FY 2008 we will submit an exhaustive Request for 

Proposals (RFP) for the broad-scale implementation 

of bar-coding technology in several clinical and 

patient-care processes. 

Scientific literacy is decreasing in the United States; 

science education in the United States is not keeping 

pace with Europe and Asia. 

At the same time that consumerism in healthcare is 

burgeoning, the quality and efficacy of science education in the United States is not keeping pace. 

Studies conducted by the Congressional Office of 

Technology Assessment, the National Science 

Foundation, and the American Association for the 

Advancement of Science in 2001 suggested that 

science education in the United States is lagging 

substantially behind that of Europe and the Far 

East. Comparing the results from 15 developed 

nations of international standardized tests, United 

States students placed last in biology, third from the 

last in chemistry, and fifth from last in physics. 

Further, the talent pool entering science occupations is also diminishing. For example, the percentage of National Merit Scholarship finalists 

entering careers in science, the health sciences, and 

engineering have been steadily decreasing. If the net 

impact of faltering science education in the United 

States is that science per se is valued less in U.S. 

society, the likelihood that biomedical science discoveries and science-based health interventions – 

the forte of the National Institutes of Health – will 

be undervalued or misunderstood is increasing. 

Societal demographics are changing. 

Data from the U.S. Office of Vital Statistics demonstrate that life expectancy is lengthening; therefore, 

the U.S. population is becoming older. Older 

patients require more healthcare and develop different medical problems. When coupled with the value 

shifts noted above, these demographic changes subtly modify the national research agenda. This modified agenda provides NIH scientists with scientific 

opportunities. In addition, the demographics of 

large metropolitan population centers are also 

changing. The percentage of minorities and underserved individuals in the populations of major 

U.S. cities continues to increase. As these populations continue to expand, the Clinical Center is 

faced with the challenge of developing effective 

communication strategies with these segments of 

society. Since healthcare delivery to these populations is currently suboptimal, the development of 

effective communication strategies might serve both 

the interests of these communities and the Clinical 

Center by offering access to a quality of healthcare 

otherwise not available, while simultaneously providing a source for patient recruitment. 

Society has become increasingly litigious; malpractice 

claims have increased dramatically; malpractice 

insurance rates have escalated almost exponentially. 

The costs associated with the unprecedented rise in 

the number and size of malpractice suits over the 

past three decades have contributed significantly to 

the escalation of healthcare costs in the United 

States. Although the Clinical Center has had few 

such claims, the Clinical Center is, by no means, 

immune to these actions. This trend presents a 

challenge to develop effective mechanisms for 

assuring quality, both in the studies conducted at 

the Clinical Center, as well as in the care provided 

to Clinical Center clinical research subjects. In 

addition, the challenge presented by an increasingly litigious society should galvanize the Clinical 

Center to seek “customer” input regarding the 

quality of services provided. 

“Alternative, complementary and integrative” 

medicine are assuming increasingly visible roles in 

U.S. medicine. 

The public has long been interested in alternative 

and complementary medicine. Whereas medicine 

and society unquestionably have a great deal to learn 

from “nontraditional” and “cultural” remedies and 

treatments, the term “alternative and complementary medicine” has often been used to shroud medical fraud. “Miracle cures” such as Krebiozen and 

Laetrile often turned out to be far less effective than 

they were originally touted. The increased societal 

interest in alternative and complementary medicine 

proffers the challenge to the intramural program at 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 29 
NIH to develop open lines of communication with 

its clinical research subjects and the public on these 

issues. Failing to give credence to the possibility that 

non-traditional remedies and treatments may have 

real value runs counter to the science-based culture 

of NIH. NIH as a truly unbiased, impartial community is ideally situated to address issues such as 

the safety and efficacy of nontraditional approaches 

to medical care. 

In the late 1990s, NIH has increased its emphasis 

on the evaluation of alternative and complementary medicine. A Center for Alternative and 

Complementary Medicine was created at NIH in 

1998. Funding for studies of these approaches was 

increased. Major clinical trials of alternative and 

complementary therapies funded by NIH are in 

progress. The emphasis on alternative and complementary medicine is also apparent in the Clinical 

Center, where for the past several years an external 

consultant skilled in acupuncture has been providing treatment to patients with chronic pain. In 

addition, senior Staff Clinicians from the Clinical 

Center Department of Rehabilitation Medicine 

have been trained to perform acupuncture and, the 

Clinical Center established a Pain and Palliative 

Care Service in 2001 that regularly uses a variety of 

complementary and alternative medicine strategies 

NIH is poised to study the efficacy of the complementary and alternative therapies reiki and “pet 

therapy” in Clinical Center clinical studies. 

Cost-Based External Factors 

Cost continues as a major driving force in the U.S. 

healthcare industry. 

In the past two decades, healthcare costs have 

escalated exponentially, primarily at consumers’ 

expense. The Federal government, as well as state 

and local governments, have become intensely 

interested in controlling costs. These interests have 

led to formal scrutiny of the systems and processes 

in medicine and in healthcare delivery. Cost considerations have had a profound impact on the 

healthcare industry in the United States, leading 

to: 1) increased reliance on the use of business 

management theory (e.g., CQI, reengineering, etc.) 

to attempt to generate efficiencies in the healthcare 

industry; 2) a careful assessment of the substantial 

variation in patterns of care of individual diseases or 

conditions; 3) a call for standardization of clinical 

practice across the country; 4) an increasing trend 

toward the systematization of medicine – evaluation 

of outcomes, standards of care, clinical guidelines/pathways/care maps; 5) a remarkable shift 

toward capitation, managed care, and verticallyintegrated healthcare systems; 6) a dramatic shift 

away from subspecialty medicine and an increased 

emphasis on primary care; 7) more reliance on 

“non-physician” primary-care and extended-care 

providers; 8) an aggressive trend toward early discharge and emphasis on outpatient medicine; 9) 

aggressive competition for healthcare customers; 

and 10) major centers aggressively streamlining, 

downsizing, cross-training, and seeking new, more 

efficient “models of care”. These trends have continued through 2007. 

Cost considerations have led to a rethinking of 

such pivotal issues as the basic processes and models 

of care delivery; the increasing reliance on “nonphysician” primary care providers; an increasing 

penetration of managed care into the healthcare 

marketplace; a dramatic increase in competition for 

patients, and a shift to outpatient, day-hospital 

and primary care medicine, among many others. 

Whereas the costs of care and payment for care are 

primary drivers for the healthcare industry, the 

regulatory environment and the human subjects 

protection rules are the primary drivers in the 

NIH/Clinical Center environment. The Clinical 

Center finds common ground with the healthcare 

industry in the need for us to maintain fiscal 

accountability to our customers and stakeholders. 

Several of the newer strategies and approaches have 

also become highly visible in the Clinical Center 

over the past five years, including increased use of 

physician extenders and a continued shift toward 

outpatient and day hospital studies. 

Spiraling costs associated with healthcare and 

clinical research also led to a downturn in clinical 

research investigators on the NIH campus. For 

example, in 1997 the campus had 360 investigators 

who were principal investigators on clinical research 

studies and 1,088 active clinical protocols. Today, 

the campus has witnessed a resurgence of interest in 

clinical research, fueled both by the NIH Director 

who has challenged the Institutes to produce 

cutting-edge translational research as well as by the 

construction of the new clinical research center. 

By the end of FY 2003, there were 449 active principal investigators on clinical research projects and 

1,239 active clinical research protocols, representing 

increases of 14 and 25 percent, respectively, when 

compared with 1997. By the end of FY 2006, there 

30 2008 Environmental Assessment 
were 547 active principal investigators on clinical 

research projects and 1,372 active clinical research 

protocols, representing increases of an additional 

22 and 11 percent, respectively, when compared 

with 2003. One concern, however, is that fewer 

tenured and tenure-track investigators are principal 

investigators on clinical protocols. In 2001, there 

were 192 tenured principal investigators on clinical studies; by 2007 this figure had dropped to 156 

(a decrease of 19 percent). Similarly in 2001, 48 

tenure-track investigators were principal investigators on clinical protocols and by 2006, this number 

had fallen to 18 (a reduction by nearly 63 percent). 

These data have prompted a major review of career 

paths for clinical investigators at NIH. 

The following external trends will also provide 

numerous opportunities and threats to the Clinical 

Center and to the NIH intramural program. 

■ Adoption of new business management principles will likely foster organizational efficiencies. 

Organizational efficiencies remain an institution-wide focus for the Clinical Center. Despite 

this emphasis on efficiency, the Clinical Center 

has, nonetheless, been able to support substantial growth in some areas (e.g., the development 

of the stem-cell/cell processing facility, creation 

of a new Clinical Bioethics Department, substantial investment in state-of-the-art imaging 

technology, and increased investment in information systems support, among others). 

■ Evaluation of protocol-based care in a manner 

analogous to “critical pathways” will likely 

facilitate the development of a meaningful 

protocol-based cost-accounting system, while 

simultaneously expediting staffing assignments 

and organizational planning. The Clinical 

Center has embarked on an initiative to develop a protocol-writing software package, 

called ProtoType, which should assist with the 

increasingly cumbersome process of protocol 

writing and implementation. This software 

program will also provide a template for 

evaluating the clinical quality of the care 

delivered in the context of the protocol, will 

provide significant standardization of language 

in consent documents, should help facilitate 

human subjects protection review, and should 

provide a template for assessing the extent to 

which patients are able to adhere to the protocol as it is written. Standardization of the 

manner in which protocols are written should 

also facilitate accreditation of the intramural 

clinical research program by AAHRPP. 

■ The shift to a capitated clinical environment in 

the external community provides both opportunities and threats. Managed care organizations may well be interested in referring 

patients who would require large financial 

expenditures for care; conversely, some managed care organizations believe they may be 

legally barred from referring patients. 

■ In 1995 and 1996, in response to continued 

interest from the Office of Management and 

Budget in having the Clinical Center bill third 

party payers for some aspects of the care provided at the Clinical Center, Clinical Center 

leadership developed a four-pronged approach, 

including: developing a legislative process 

under which the Clinical Center could be 

granted the authority to bill third party payers 

for care delivered to enrollees participating in 

clinical research; establishing a dialog with 

managed care representatives concerning their 

interest in, and willingness to, support clinical 

research at the Clinical Center; developing an 

infrastructure to track the costs of participating 

in clinical research; and prospectively collecting insurance information from Clinical Center 

patients to determine the fraction who have 

insurance coverage and the potential impact 

of asking clinical research subjects’ insurers to 

cover some of the costs of their care at the 

Clinical Center. 

■ In 1996, Congress provided language in the 

NIH Authorization that permitted the Clinical 

Center to collect from third party payers. In 

February and March, 1997, the Clinical Center 

held meetings with representatives from insurance companies, managed care organizations 

large, self-insured corporations and from the 

Health Care Financing Administration 

(HCFA) (now the Center for Medicare and 

Medicaid Services [CMS]) to discuss the potential for recovery of some of the costs of clinical 

research and to address the possibility of broadening the Clinical Center’s referral base to 

encompass patients from health maintenance 

organizations and large insurer networks. The 

meeting provided Clinical Center leadership a 

great deal of insight into the current status of 

the insurance/managed care industry. The 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 31 
Clinical Center also conducted a six-month 

study of the insurance status of patients participating in clinical research studies at the 

Clinical Center. The Clinical Center’s Board 

of Governors reviewed all of the information 

collected in this process, and, after careful consideration of the information recommended 

against the Clinical Center pursuing third party 

payment for clinical research performed at the 

Clinical Center. 

■ The shift toward primary care has resulted in 

fewer high-quality young physicians in the fellowship pools, and less interest in clinical and 

basic science among medical school graduates. 

Many fellowship-training programs are closing. 

These trends clearly will have an impact on the 

manner in which the Clinical Center provides 

care to its clinical research subjects, as well as on 

the ICs’ clinical and basic science training programs. The Clinical Center and the other intramural clinical training programs will have to 

compete with the major academic institutions 

for this smaller pool of highly qualified applicants. In addition, the American College of 

Graduate Medical Education requires broad 

clinical exposure in training programs, which 

is difficult, if not impossible to provide in a 

program solely based in the Clinical Center. 

The American College of Graduate Medical 

Education accreditation standards require that 

the Clinical Center identify creative solutions 

and new partners in its training programs. 

■ The trend toward the use of “non-physician” 

providers affords the Clinical Center an opportunity to evaluate the model of patient care 

currently in use and to consider the expanded, 

creative use of “non-physician” care providers 

in intramural clinical research. In addition, the 

creative use of such personnel has already 

helped address the problem generated by the 

ever-diminishing fellowship pools. 

■ The trend toward outpatient and day-hospital 

medicine, which is paralleled in the Clinical 

Center’s operating statistics, provides an opportunity for Clinical Center scientists to develop 

creative, less expensive and labor-intensive 

protocols that can be conducted in our day 

hospitals and outpatient clinics. A substantial 

number of even labor-intensive studies can be 

conducted in the ‘day-hospital’ environment 

These trends should be useful to Clinical 

Center and IC management in terms of reducing the costs of clinical research. 

■ Competition among healthcare delivery organizations for patients has become even more of a 

driving force in the healthcare environment in 

the past thirty months. The aggressive competition for patients and clinical research subjects 

provides both opportunities and challenges to 

the Clinical Center. The intense competition 

for patients will likely make recruiting patients 

for clinical studies more difficult. Competition 

has already had a profound impact on the academic medical community. Institutions which 

used to operate profitably and which used to 

have substantial excess revenues that could be 

used to help fund clinical research projects have 

had to scramble to remain solvent. High quality institutions continue to seek partnerships 

with the Clinical Center to facilitate their 

research and training agendas, to increase their 

visibility in certain markets, and as a marker of 

the prestige of the institution. The Clinical 

Center’s new extramural alliances (discussed 

above) should strengthen its and its partners’ 

competitive positions. 

■ The explosion in technology discussed above 

provides the Clinical Center with a unique 

opportunity to use these cutting-edge technologies to develop less expensive types of care. The 

Clinical Center is uniquely situated to address 

the challenge of developing medical technologies that reduce the costs of medical care. 

In the time that has elapsed since the initial drafting 

and subsequent revisions of this document, most of 

the issues described above related to healthcare costs 

have persisted, or changed only subtly. The subtle 

changes that have occurred will likely exert minimal 

influence on the extent to which cost considerations 

influence the Clinical Center environment. Despite 

these somewhat subtle changes, financial considerations continue to be the primary influence on 

change in healthcare in the United States. 

Medical-Practice-Based External Factors 

Medicine, the practice of medicine and the conduct 

of clinical research are changing rapidly; progress in 

biomedical research produces natural change in the 

research agenda. 

Medical progress also keeps sicker patients alive for 

much longer periods of time. As a result, such 

32 2008 Environmental Assessment 
patients often remain at-risk for disease- or therapyrelated, care-requiring complications for extended 

periods of time. Such complications are often 

expensive and labor-intense. Rapid progress does, 

however, present unique challenges to the management and leadership of the Clinical Center. Rapid 

progress precipitates abrupt shifts in the research 

agenda, and often necessitates fast procurement of 

expensive new equipment, reagents and pharmaceuticals. The Clinical Center is ideally situated 

to reprogram resources to address new scientific 

opportunities for translational research. For example, since the previous iteration of this document, 

the Clinical Center has worked with several ICs 

(e.g., NIAID, NINDS, NIDDK, NIMH, NIAMS) 

to design and implement either innovative new 

clinical research programs or significant expansions 

of existing programs. 

Effective planning is essential to keep an organization the size of the Clinical Center aligned with the 

NIH mission, the Clinical Center’s mission and 

vision, and the ICs’ rapidly changing research agendas. Management must remain attuned to the intramural and extramural research cultures, must be 

able to predict, or at least detect, where progress will 

occur, and position the organization to capitalize on 

the progress. When new technologies are identified, 

the Clinical Center must assess the intramural need, 

and, where appropriate, adopt the new technologies, and make them available to the intramural scientific community. The management of the Clinical 

Center has to maintain effective communication 

with IC leadership to stay aware of progress as it 

occurs. Further, the Clinical Center departmental 

leaders must be flexible enough to reprogram resources and embrace progress as it occurs. Only in 

this way will the Clinical Center be able to supply 

the quality of clinical research infrastructure 

necessary to accomplish its mission. In the period 

following the drafting of the original environmental 

assessment, the emphasis on molecular medicine, 

immunogenetics, and molecular techniques has 

continued to increase. In addition, the CC is piloting a project with four Institutes to attempt to assess 

the intensity of resource utilization by new protocols prospectively. The Protocol Resource Intensity 

Assessment (PRIA) project may ultimately help the 

CC inform ICs of protocols that are potentially 

resource intensive – prior to their implementation. 

The pilot for this project (which involves substantial collaboration from the IC partners) should be 

completed in 2008. 

The characterization of the human genome has 

spawned the fields of genomics and proteomics. 

These fields will likely help shape a substantial 

fraction of clinical research studies on our campus 

for the foreseeable future. Information systems 

technology is advancing almost exponentially and 

the explosion of this technology is fueling advances 

in many other biomedical research disciplines. 

The marked shift toward molecular medicine has 

engendered numerous additional changes in the 

complex Clinical Center environment. Molecular 

techniques have made it possible to identify patients 

who, either invariably or with a much higher frequency that the general population, will develop 

debilitating diseases. Remarkable opportunities for 

evaluating host responses to illness have recently 

become available through the use of computerized 

assessment of gene expression by microchip gene 

arrays. Scientists are just beginning to unmask the 

potential of this new technology. The development 

of molecular techniques has also raised complex 

questions requiring increased reliance on bioethicists in making decisions regarding genetic testing, 

genetic counseling, gene therapy, genetic experiments, and the management of results from genetic 

tests. Secondly, the move toward molecular medicine has fostered increased investment in the technology needed to conduct these experiments and 

in personnel expert in managing the extraordinary 

data sets engendered by this technology. Third, this 

trend has produced a change in the manner in 

which we interact with our patients. In the past, 

extended hospitalizations may have been needed to 

conduct a study. For some of these experiments, a 

single phlebotomy may be adequate. Consequently, 

the Clinical Center has observed a substantially 

decreased length of stay and less reliance on patient 

admissions to conduct these studies. Finally, the 

complexity and specialization inherent in molecular 

medicine has mandated increasing collaboration 

among scientific disciplines and has resulted in a 

clear trend toward more cross-Institute projects. 

All healthcare institutions are being asked to 

measure performance and to demonstrate performance improvement. 

Medicine has begun to focus on costly variation in 

practice as well as on the benefits of standardization 

of the processes of care. The past nine years have 

seen an increased focus on he industrial model of 

‘performance measurement’ and outcomes assessment in healthcare. The focus on performance 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 33 
measurement has emphasized the importance for 

organizations and for components of organizations 

to have clearly measurable outcomes and processes. 

In addition, regulatory agencies, such as the 

JCAHO require that healthcare institutions demonstrate performance improvement activities. 

Patient safety and human subjects protection in 

clinical research have become increasingly important. 

As a result of the Institute of Medicine’s report, 

“To Err Is Human,” the nation – both the lay public and the healthcare industry – has been made 

even more acutely aware of the importance of 

patient safety. The Clinical Center has invested 

substantial resources in a major Patient Safety 

initiative that focuses on the occurrence, epidemiology, surveillance for, and prevention of, medical 

errors. This new program has as its centerpiece a 

highly successful Occurrence Reporting System 

(ORS) that has been redesigned based on customer 

input and is now extensively used by Clinical 

Center staff. The patient safety initiative involves 

four major efforts, three of which are focused on 

determining the real numbers of errors that actually 

occur in the Clinical Center and attempts to assess 

to what extent events that occur do get reported 

in the Occurrence Reporting System. The fourth 

aspect of the initiative is designed to assess the 

utility of linking biometric identification techniques with two dimensional bar-coding to eliminate person-to-person and transcribing ‘hand-offs,’ 

thereby decreasing opportunities for errors. In addition, the JCAHO has developed mandatory annual 

patient safety goals for health care institutions wishing to be JCAHO accredited. In our first survey 

following the implementation of these goals, no 

deficiencies were identified. 

Similarly, misadventures and mistakes in clinical 

research have given rise to increased scrutiny of the 

research environment and have resulted in increased 

regulatory requirements for a prescribed infrastructure to be in place to facilitate the conduct of 

research. NIH has been at the vanguard of this 

issue; in FY 2001 the Medical Executive published 

a set of Standards for Clinical Research and a 

process has been put in place to assure each institute’s compliance with the standards. In addition, 

in late 2001, the NIH volunteered to have its 

clinical research program evaluated as a pilot for 

the Association for the Accreditation of Human 

Research Protection Programs (AAHRPP) that has 

developed an accreditation process for clinical 

research programs. The NIH intramural program 

plans on formally applying for AAHRPP accreditation in 2008. 

Another way in which the institution has responded 

to concerns about human subjects’ protection is to 

develop programs to train investigators in the principles and practice of, as well as the ethics of, clinical research. Our organization was among the first 

in the nation to require completion of a basic course 

in clinical research principles in order to be an 

approved investigator on a protocol. All NIH investigators also are required to take training in the ethical conduct of clinical research. In addition, several 

other clinical research training courses and programs (described in more detail above) address this 

identified need. 

The healthcare industry is also experiencing a national 

shortage of nurses, pharmacists, anesthesiologists, and 

medical and radiological technical staff. 

The past decade has seen a worsening of a preexisting problem – a national shortage of crucial patient 

care and clinical research support personnel. 

Substantial workforce shortages have developed in 

Nursing, Pharmacy, Anesthesia, Clinical and Imaging technical staff, and information technology 

personnel. In FY 2007, the Clinical Center is actually faring reasonably well in most of these areas 

(i.e., with less turnover and fewer unfilled positions 

compared with other institutions in our community). In FY 2007, we continue to experience 

challenges in recruiting specialty nurses and anesthesiologists and other medical subspecialties for 

which the current salary structure is not entirely 

competitive with the private and/or academic sectors. We were successful in recruiting our firstchoice candidate for the Chief of our Rehabilitation 

Medicine Department and major recruitments are 

ongoing for Chiefs of Imaging Sciences and the 

Pharmacy Department. 

All personnel shortages present potential threats to 

CC operations, should they become more severe, 

and should the CC be unable to use its unique and 

attractive work environment to overcome market 

pressures. Therefore, the CC is assuming a proactive 

stance, including using alternative personnel 

authorities to speed the hiring process, making use 

of all available mechanisms to create and maintain 

competitive salary and reward structures, and 

aggressively marketing CC job opportunities. 

34 2008 Environmental Assessment 
Information systems technology is changing the face 

of medicine. 

The role and importance of information systems 

management in medicine is changing dramatically. 

The Clinical Center is well-situated to take advantage of the remarkable opportunities presented by 

the ongoing revolution in information systems 

management. Teleconferencing and telemedicine 

are likely to be of great value in the recruitment 

and management of patients at sites far removed 

from the Clinical Center. In addition, the striking 

progress in information systems technology 

presents unique opportunities to: 1) improve the 

quality of care provided to Clinical Center research 

subjects; 2) improve the training of clinicians; 3) 

create substantial efficiencies in the manner in 

which clinical research subjects are managed in the 

institution (e.g., display of histological sections, 

radiographs, magnetic resonance and computed 

tomographic scans, etc.) electronically at the 

patient’s beside or in the investigator’s office, as soon 

as the studies have been interpreted); 4) develop 

streamlined techniques for protocol writing and 

monitoring; 5) use the substantial expertise in 

clinical information systems management that has 

been developed over the past twenty years to produce an integrated system that meets scientific, 

clinical, fiscal, and managerial needs; and 6) move 

toward a paperless, totally electronic medical 

record. The Clinical Center clearly needs to integrate its patient care information system with a 

“real-time,” effective managerial and fiscal system. 

In addition, the Clinical Center is faced with the 

challenge of integrating three different types of data 

essential for managerial efficiency: 1) clinical 

patient-care data; 2) financial accounting data; 

and 3) research laboratory data. The challenges 

associated with the rapidly accelerating field of 

medical information systems management are: 

1) staying abreast of the technology as it advances; 

2) assuring that components of the organization 

have adequate information systems support to 

conduct its business efficiently and effectively, while 

simultaneously assuring that these systems are 

comßpatible with each other; and 3) making certain 

that the organization is consistently investing an 

appropriate amount of its resources into research, 

development, and maintenance of information systems technology. The information systems expertise 

already present on the NIH campus, combined with 

the investigational mandate of NIH, provide an 

ideal milieu for the development of automated, 

clinically relevant healthcare systems. The procurement and implementation of the new Clinical 

Research Information System offered the Clinical 

Center the opportunity to integrate these different 

kinds of data to improve organizational management and efficiency as well as patient care quality. 

This past year, a pilot project incorporating 

electronic documentation by physicians and other 

licensed independent practitioners was launched 

successfully. We anticipate that this project will be 

fully implemented across all licensed independent 

practitioners in the CC by the end of FY 2008. The 

Clinical Center has now embarked on the next 

phase of the development of its Clinical Research 

Information System by launching the CRIS II project. CRIS II is designed to integrate scientific laboratory and clinical data. Another aim of the project 

is to link to a specimen biorepository that manages 

data on the NIH collection of human samples. 

In the past six years, the Clinical Center has 

increased its investment in information systems 

technology dramatically. During this time, the 

Clinical Center has effectively doubled the labor 

force working in the information systems area. 

The number of ongoing Clinical Center projects 

involving information systems improvements is 

substantial. In addition, plans for the new Clinical 

Research Center include state-of-the-art information systems management – for data management 

in both clinical research and clinical care. 

The Clinical Center reorganized its informatics 

operation two departments and hired a Chief 

Information Officer to meet organizational needs. 

The leadership of the Department of Clinical 

Research Informatics is charged with the oversight 

of the management of the new Clinical Research 

Information System. An integrated laboratory 

system that has an interface to the existing Medical Information System (for our Department of 

Laboratory Medicine, the Department of 

Transfusion Medicine, and the NCI Laboratory of 

Pathology was also brought on-line, as were a 

Radiology Information System/Picture Archiving 

and Communication System (RIS/PACS), and a 

Peri-Operative Information System (POIS). An 

improved Pharmacy information management 

system is currently being designed and will be 

implemented within the next year. 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 35 
An increasing fraction of CC patients find Clinical 

Center clinical research programs via the Internet. 

The National Library of Medicine has developed a 

website (http://www.clinicaltrials.gov) that provides 

regularly updated information about federally and 

privately supported clinical research. This unique 

website provides information about each trial’s 

purpose, who may participate, locations where the 

study is being conducted, and phone numbers 

where an interested individual may get additional 

details. The information provided on ClinicalTrials.gov 

should be used in conjunction with advice from 

health care professionals. The role of the Internet 

in informing patients about their diseases and 

treatments is increasing almost exponentially. 

Individual patients and support groups write 

daily ‘blogs’ that characterize their diseases, associated complications, and both traditional and 

novel therapies. In addition to information available through the National Library of Medicine 

website, www.ClinicalTrials.gov, the Clinical Center 

and NIH Institute websites also provide detailed 

information about the intramural clinical research 

program and the clinical studies that are available 

for participation. 

The public learns about medicine, medical progress, 

and medical misadventures from the lay press. 

The American public receives a great deal of its 

information about medicine, medical progress, and 

medical and clinical research-related misadventures 

from the lay press. The press frequently focuses 

on unique, “newsworthy” numerators, while not 

necessarily providing relevant denominators for 

perspective. Such stories may contribute to a 

general mistrust of medicine and, in the eyes of 

the American Association of Medical Colleges, have 

fostered a general decrease in public support for 

academic medicine. This increasing presence of the 

press presents a challenge for the Clinical Center. 

The organization must develop techniques for 

making certain that the breakthroughs and benefits 

of the clinical research conducted at the Clinical 

Center receive appropriate attention in the press. 

Medicine has traditionally avoided efforts intended to 

standardize its practice. 

The fact that medicine has attempted to maintain 

itself as an “art” rather than a science has led to wide 

variation in the ways in which physicians provide 

care for patients who have similar illnesses or 

similar disease presentations. Pioneering studies 

evaluating medical systems and processes have 

documented substantial variation in care delivered 

to patients with similar syndromes and similar 

severity. These studies and the burgeoning interest 

in “process improvement” have resulted in an 

increasing focus on the systems and processes of 

medicine. This focus has also produced a heightened level of interest in the design and conduct of 

behavioral, clinical effectiveness, and cost effectiveness studies. Driven by cost concerns, the “outcomes” of various care strategies have become 

increasingly important. Most “outcomes” analyses 

are based on scientifically sound epidemiologic 

principles. For this reason, the Clinical Center is 

strategically positioned to assess a variety of outcomes (e.g., physiologic, symptomatic, functional, 

perceptual, economic and societal) in its ongoing 

natural history and disease pathogenesis studies, as 

well as in clinical trials. Including assessment of 

these kinds of outcomes will help make the basic 

and translational science products of the Clinical 

Center’s work relevant to medicine today. 

As medicine moves toward both primary care and 

toward specialties and subspecialties associated with 

large salaries, interest in careers in clinical research 

is decreasing. 

One effect of the shift toward primary care and 

toward the high-paying specialties and subspecialties is that fewer high-quality young physicians are 

expressing interest in subspecialty training and in 

careers in basic or translational research. Thus, 

clinical programs find fewer qualified individuals 

in fellowship pools. Some training programs have 

closed; others have downsized significantly; others 

have moved to a purely clinical focus. Because of the 

continually decreasing candidate pool, attracting the 

best and the brightest at the postdoctoral fellow 

level from within the United States has become 

increasingly difficult for the intramural program. 

This problem is undoubtedly complex, involving 

heavy medical school debt burden, a move toward 

primary clinical care, and the incentive that academic centers have for keeping their best. With 

the costs of a medical education now easily exceeding $150,000, new graduates often simply cannot 

afford to take three to seven additional years’ training before they begin to repay their debts. This 

challenge provides the Clinical Center and the 

NIH intramural program with the opportunity to 

address some of the financial concerns of new graduates as an incentive to coming to the intramural 

36 2008 Environmental Assessment 
program. NIH has attempted to address this problem through the creation of three separate loan 

repayment programs (AIDS, General and Clinical 

Research). These programs have become valuable 

recruitment and retention tools. In addition, within 

the past year, NIH has developed the potential to 

pay for licensure for healthcare providers practicing 

in the Clinical Center. We anticipate that this new 

procedure will be implemented in FY 2008. 

A traditional strength of the intramural program has 

been that the international reputation of the NIH 

leads to international collaborations and attracts 

motivated and gifted postdoctoral fellows from the 

international scientific community. These fellows 

work in NIH programs, supporting the NIH 

mission. Their work at NIH, in turn, facilitates 

the development of their careers when they return 

to their respective countries. 

The shift toward primary care has also resulted in 

an overabundance of physicians in some specialties 

and subspecialties and a shortage in others. This 

relative surplus has resulted in fluctuations in 

academic salaries, particularly for some historically 

highly paid specialties, such as radiology (particularly interventional radiology), surgery (and 

surgical subspecialties), and anesthesiology. The 

fluctuations in anesthesiology salaries initially 

resulted in a surplus of qualified anesthesia 

personnel. In response to the surplus, the academic 

anesthesiology leadership downsized anesthesia 

training programs, resulting in a significant decrease 

in supply of new staff. Over time, this decreased 

supply has precipitated a crisis in the supply of 

qualified anesthesiologists. As noted above, many 

academic institutions, including the Clinical 

Center, have encountered significant difficulties in 

being able to pay competitive academic salaries and 

to hire personnel to provide first-rate anesthesia 

services. Historically, the Clinical Center’s Department of Anesthesia and Surgical Services was 

entirely service-based. By the end of 2002, the 

Clinical Center was beginning to have difficulty 

recruiting first-rate staff to its anesthesia program. 

Particularly because the program had been servicebased, the discrepancies in salary between our 

program and those of service-based anesthesiologists in the metropolitan Washington community 

were substantial. The Director, NIH recommended 

that the CC retain an external consultant to advise 

the Clinical Center’s Director about approaches to 

the shortage of qualified anesthesia staff. The 

consultant’s report, which was delivered to the 

Clinical Center Director in early 2003, recommended offering salaries competitive with at least 

the 50th percentile of salaries from the survey of 

anesthesia salaries conducted by the American 

Association of Medical Colleges. The report also 

recommended the establishment of a Department 

of Anesthesia and Surgical Services in the Clinical 

Center that was similar in scope and mission to 

other existing successful CC clinical departments, 

including the creation of a modest academic 

research program. In response to the consultant’s 

report, in FY 2003, the CC conducted a successful 

search for a new Chief of the restructured department and committed additional resources – 

including FTE, space and funding – to support 

the revitalized department. The Clinical Center’s 

approach was entirely consonant with the external 

consultant’s recommendations. The consultant’s 

report argued that offering a more academic program that would allow young anesthesiologists 

scientific opportunities unavailable at other academic institutions because of clinical service demands, 

(thereby taking advantage of the Clinical Center’s 

unique environment for clinical research). Although 

the progress has been “slow but steady,” the Chief 

of the Department of Anesthesia and Surgical 

Services continues to have success recruiting young 

anesthesia personnel who have interest in science. 

Contract expenditures will drop substantially in 

FY 2008. NIH has responded by approving salaries that are competitive with those reported by 

the AAMC. 

Government-Based External Factors 

The Federal Government has reiterated an interest in 

downsizing and outsourcing. In 2001, the President 

issued five major goals for reforming management 

in government. 

Each year, primarily as a consequence of the 

penetration of managed care in the healthcare marketplace, in order to compete, academic centers 

have fewer dollars available for clinical research. 

Similarly, Federal agencies are responding to five 

goals of the current administration. “Outsourcing,” 

administrative consolidation, and privatization are 

frequent considerations. Privatization represents one 

mechanism that can be used to make government 

smaller, more efficient, and more responsive to 

customers’ needs. Public/private partnerships have 

become increasingly common. 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 37 
During the 1990s, the Secretary, DHHS granted 

numerous delegations of authority for personnel, 

procurement, and logistics that have been frequently requested by the NIH community. Perhaps 

paramount among these delegations of authority 

were personnel/appointment mechanisms (e.g., 

Title 38, Title 42) that permitted the Clinical 

Center to pay highly competitive salaries to most 

physicians, nurses and allied health professionals 

that previously would have been impossible under 

standard Title 5, General Schedule pay authorities. 

The combination of fluctuating salaries for some 

medical specialties because of market pressure 

(discussed above) plus the remarkable flexibility of 

these new personnel authorities made it possible 

for the Clinical Center to assimilate contracts that 

were previously necessary to provide adequate 

medical coverage for Clinical Center patients. The 

Clinical Center has continued to seek additional 

organizational efficiencies. 

As noted above, the Bush Administration has 

reiterated an interest in government-wide management reforms and has established five major 

management reform goals: 

■ Budget and Performance Integration. The OMB 

vision is to provide a greater focus on organizational performance, by formally integrating 

performance/outcomes with budget decisions. 

The ultimate intent is to have agencies produce performance-based budgets. The linkage 

of performance/outcomes with budget was 

phased in, with OMB initially working with 

agencies to identify outcomes for a few programs, and to determine how effectiveness can 

be improved. 

■ Strategic Management of Human Capital. The 

President proposed to make the government 

more citizen-centered (i.e., ensuring as little 

distance as is possible between the citizens 

and decision-makers). Two approaches will be 

used to address this goal: ‘flattening’/streamlining (i.e., administrative restructuring) the 

federal hierarchy, (i.e., reducing the number of 

layers), and using workforce planning to help 

agencies redistribute higher-level positions to 

front-line, service delivery positions that interact with citizens. 

■ Competitive Sourcing. The President has proposed to increase competition for activities 

performed by the government as listed on 

agency FAIR Act inventories, beginning with a 

requirement in FY 2003 that agencies complete 

public-private or direct conversion competitions involving 10 percent of the FTE listed on 

their Federal Activities Inventory Reform Act 

inventories. NIH is not immune from these 

goals and the CC will be required to participate 

in these streamlining activities. Over the past 

eighteen months the senior leadership of NIH 

and the ICs have developed some strategic 

approaches to these streamlining activities 

(examples follow). 

– Improving Financial Performance. The primary goal of this initiative is to reduce 

erroneous payments. 

– Expanding Electronic Government: The 

President proposed a coordinated approach 

to E-government that crosses agency boundaries. Specifically, the administration wants 

to: 1) prioritize and manage e-government 

projects effectively by improving IT capital 

planning; 2) create a citizen-centered web 

presence and build e-government infrastructures that include e-procurement and 

e-grants; and 3) develop an E-government 

approach that is performance/outcomes oriented and contributes to the administrative 

restructuring initiative (and that includes 

specific goals). To accomplish this goal: 

1) agencies will be required to identify IT 

investments that can be redirected, restructured or consolidated; and 2) agencies should 

maximize the use of electronic means to 

deliver services and benefits in a citizencentric matter, while assuring both security 

and privacy. NIH is currently in the midst 

of a major initiative that is designed to 

centralize many information technology 

functions on the campus. 

Regulatory requirements are becoming more stringent 

and more burdensome. 

Requirements of organizations that regulate the 

conduct of patient care and clinical research in the 

Clinical Center have increased substantially over 

the past two decades, in many instances without 

clearly adding value. Some oversight and regulatory 

activities arise from within NIH (e.g., Office of 

Protection from Research Risks, Office of Human 

38 2008 Environmental Assessment 
Subjects Research, Recombinant DNA Advisory 

Committee, Office of Scientific Integrity, DHHS 

ethics regulations and reviews for clinical investigators’ personal financial holdings, among others); 

others arise from IC programs (e.g., Cancer 

Treatment Evaluation Program, NCI); others are 

Departmental- or Agency-based in origin (e.g., 

Inspector General, Food and Drug Administration); 

others arise from other Departments within the 

government (e.g., Nuclear Regulatory Commission, 

Occupational Safety and Health Administration), 

and still others arise out of a continuing need for 

external evaluation and accreditation of clinical 

activities (e.g., Joint Commission on Accreditation 

of Healthcare Organizations [JCAHO], College 

of American Pathologists [CAP], American 

Association of Blood Banks [AABB]), and oversight/accreditation of clinical research activities 

(the Association for the Accreditation of Human 

Research Protection Programs [AAHRPP] and 

the National Committee on Quality Assurance 

[NCQA]). The Clinical Center faces the challenge 

of meeting the increasing requirements of a burgeoning list of regulators with decreasing staff, 

decreasing resources, and a physical plant that is 

in dire need of revitalization. Simultaneously, the 

Clinical Center has the opportunity to consolidate 

certain of these activities (e.g., the AABB or CAP 

surveys now substitute for both certification by the 

Center for Medicare and Medicaid Services for the 

Clinical Laboratory Improvement Act of 1988 

[CLIA] and JCAHO surveys), and the requirements 

of some others provide justification for the creation 

of the new Clinical Research Center. The increasingly burdensome nature of regulatory requirements 

was identified as a major obstacle to the successful 

conduct of clinical research in a survey of NIH 

Principal Investigators in FY 2003. In order to 

attempt to address some of the bureaucratic barriers 

to establishing new clinical research protocols, the 

Clinical Center, working with several IC scientists, 

is developing a software program, called ProtoType, that is designed to assist with the increasingly 

cumbersome process of protocol authoring. In 

addition, the Deputy Director of the National 

Institute of Allergy and Infectious Diseases has 

launched a campus-wide initiative to attempt to 

streamline the bureaucracy inherent in the clinical 

research process. 

In light of the increasing activity in the area of 

molecular medicine and the virtual explosion of 

new laboratory tests that can be used for diagnosis 

and prognosis in medicine, the Clinical Center, 

and, in fact, the entire NIH has come under increasing pressure to have its laboratories comply with 

CLIA. The Clinical Center Director was given the 

task of ensuring that all Intramural laboratories 

performing laboratory tests linked to patient identifiers that may be used for patient care meet CLIA 

standards. At the request of the Clinical Center 

Director, the Chief of the Clinical Center’s 

Department of Laboratory Medicine established a 

highly successful program to facilitate NIH laboratories’ compliance with the CLIA regulations. To 

date, the Department of Laboratory Medicine has 

worked with 72 laboratories throughout the NIH 

and has assisted in the CLIA certification of 58 of 

them. Currently, 38 laboratories on campus maintain CLIA certification. 

Whereas the Clinical Center has been determined 

to be a ‘non-covered entity’ for the new Health 

Information Portability and Accountability Act 

(HIPAA), the overall impact of HIPAA compliance 

by NIH collaborators on the Intramural clinical 

research program remains to be determined. 

Although the existing Clinical Center Medical 

Information System cannot be reengineered to be 

compliant with the tenets of the HIPAA legislation, 

the Clinical Center’s Director has stated publicly 

that the new Clinical Research Information System 

will address the spirit of the HIPAA legislation. 

In addition to the regulatory requirements for the 

Agency, for clinical care, and for hospital management, NIH also faces increasing regulatory 

requirements for the conduct of clinical research. 

Regulatory requirements for human subjects 

protection, for radiation safety, for genetic therapy, 

for drugs and devices, for recombinant DNA, 

and for a variety of other issues have increased 

dramatically over the past several years, resulting 

in an increasing time from the development of 

a novel hypothesis to the implementation of a 

clinical research protocol. The Clinical Center is 

working diligently to try to streamline these 

processes as much as is possible. The CC Director 

has developed an electronic protocol-authoring 

tool (ProtoType) that should facilitate electronic 

submission and management of new protocols. 

In addition, the Deputy Director for Clinical 

Research of NIAID has assembled a campuswide team of stakeholders who are working systematically to address as many of these regulatory 

impediments as possible. 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 39 
Agency- (NIH-) Based External Factors 

As a result of a constellation of factors, the culture of 

the NIH Intramural program is changing. 

Several factors, taken together, have produced, and 

are continuing to produce, a substantial change in 

the environment and culture of the NIH Intramural 

program. Among these factors are the following: 

■ NIH and Institute administrators have made a 

major investment in scientific quality. Several 

Institutes have conducted detailed external 

reviews of their intramural programs in the past 

sixty months. In addition, an external panel 

convened by the NIH Director (i.e., the 

Marks/Cassel Committee) issued a detailed 

report in 1994 that provided clear recommendations to revitalize the intramural program.16 

■ NIH has developed and implemented new, more 

rigorous tenure-track and tenuring policies. 

■ The rigor of scientific reviews has been intensified. 

■ Both the current and immediately preceding 

NIH Director, have made major efforts to 

elevate the status of clinical research on the 

NIH campus. The net effect from these leadership efforts has been that several institutes 

have initiated new programs and/or recruited 

new clinical investigators to buttress their 

clinical research activities. The Clinical Center 

has developed a proactive strategy for managing new programs and significant program 

expansions that includes creation of a project 

team comprised of IC and Clinical Center 

stakeholders; scheduled meetings with this 

implementation team, creation of a project 

implementation plan, and ongoing follow-up 

with IC leadership and staff to assure smooth 

handoff and implementation. 

■ Successful conduct of clinical research is essential to biomedical progress. Nonetheless, the 

processes of clinical research are complex, 

labor-intensive and expensive. For these reasons, the NIH Director developed a ‘road map’ 

for the continued success of clinical research, 

both in the NIH intramural program, as well 

as throughout the United States. The NIH 

Director’s Road Map has helped plot the path 

for clinical biomedical research in the United 

States and will help define the precise roles that 

the NIH Intramural clinical research program 

and the NIH Clinical Center will play in 

clinical sciences in the decade to come. The 

road map also helps define the relationship of 

both the NIH Intramural clinical research 

program and the NIH Clinical Center to 

clinical research programs in the extramural 

clinical research environment. 

■ As technology advances, institutes are increasingly requesting more and more sophisticated 

clinical research support. During institute 

planning meetings for the past eight years, an 

increasing number of requests for clinical 

research support activities (as opposed to standard care support) have been received. The 

NIH Intramural Research Program needs to 

develop a process for deciding (in concert with 

its collegium of customers) which of the 

requests to implement, as well as how to present the increased costs associated with these 

projects to both internal and external customers. Such services (which are often both 

efficiently and effectively centralized) add 

substantially to the expense of running the 

Clinical Center. One example of such a service 

is the Clinical Center’s cell processing facility, 

which provides protocol-specific cellular therapy support for many specific IC protocols. 

■ The costs associated with conduct of biomedical research are escalating faster than inflation, 

necessitating that Institutes carefully evaluate 

costs and quality of proposed intramural 

projects with more rigor than has been done in 

the past and that the Clinical Center develop 

strategies for prospectively determining the 

likely costs associated with new scientific projects (the PRIA project described above is one 

such attempt). 

■ A variety of factors have conspired to produce 

an unprecedented level of trans-Institute collaboration and sharing of resources, among them: 

– Increased emphasis on clinical research and 

on research quality on the NIH campus; 

– Increasing costs of clinical research; 

– Increased reliance on molecular methods, 

genomics, proteomics, and specific expertise, 

not necessarily associated with an IC or a discipline, to conduct complex studies; 

40 2008 Environmental Assessment 
– Increased emphasis by Clinical Center and 

NIH leadership on planning; 

– Emphasis on the part of Clinical Center leadership on the inclusion of major customers, 

partners and stakeholders in the planning 

process; 

– Joint Clinical Center/IC appointments in 

Imaging Sciences, Bioethics and Clinical 

Pharmacology; 

– The construction of the new Clinical 

Research Center, which is not organized with 

dedicated “Institute-space,” has fostered collaboration among the “partners” who share 

‘program’ space and resources in the new 

building. 

– The NIH Director’s	 Road Map initiatives 

that require trans-institute collaboration. 

– The new recommendation to initiate transinstitute “Manhattan” -style translational 

projects. 

■ The Clinical Center now has six years’ experience using the ‘school tax’ funding stream. This 

approach to Clinical Center funding was established to bolster institutes’ clinical research programs and likely has contributed to expanded 

use of the Clinical Center. Institute pay a 

“school tax” based directly on the size of the 

Institute’s intramural appropriation to support 

the Clinical Center (without regard to the 

extent to which the Institute uses the facility). 

The disincentive to use the Clinical Center (in 

the previous funding scheme) has been replaced 

with an incentive to use it. This approach also 

solves the problem identified by the previous 

DHHS Secretary’s evaluation team of the interdependence of Institutes’ budgets under the 

prior funding structure. As noted above, faced 

with a flat budget for five years, the Clinical 

Center shifted some costs for certain researchrelated services to the ICs, resulting in a resurfacing of concerns about the appropriateness of 

the school-tax approach. As this document is 

being written, several possible modifications to 

the Clinical Center’s funding stream are under 

consideration by IC and NIH leadership. 

■ The Advisory Board for Clinical Research oversight of Clinical Center operations lessens the 

extent to which the Clinical Center must try 

to respond to the competing priorities of its 

Institute customers. This increased independence should permit the Clinical Center to 

become more efficient and to foster collaboration among the Institutes conducting research 

in the Clinical Center. 

■ Consonant with both the DHHS initiative to 

restructure and streamline administrative 

services as well as the President’s outsourcing 

initiative, the NIH leadership has imposed 

FTE ceiling reductions for all ICs. The Clinical 

Center’s ceiling has been reduced from an 

operational ceiling of 1975 in 2002 to 1857 

for 2007. The proposed ceiling for 2008 is 

1837; however, each IC will be allowed an 

FTE target of 102 percent (to account for 

vacancies), raising the functional CC ceiling 

to 1883. Thus, even though the functional 

ceiling has been raised, the CC budget will not 

be increased to accommodate additional personnel to fill these slots. At a time when clinical 

research programs are expanding and being 

reinvigorated, and at a time when the Clinical 

Center budget has been essentially flat, at 

best, these budget FTE constraints present 

an additional formidable challenge to CC 

leadership and will require creativity and 

stewardship of resources to meet these expanding service needs. 

The NIH budget receives intense scrutiny by Congress 

and the President. 

Twenty-five years ago the costs of clinical research 

were not a primary concern of the ICs conducting 

research in the Clinical Center. In the late 1980s 

and early 1990s, however, the increases in the costs 

of clinical research in the Clinical Center began to 

rise significantly faster than the overall intramural 

budget. Almost simultaneously, the ICs became 

aware of the substantial differences in the costs of 

clinical versus bench research. Some ICs began to 

divest themselves of their clinical research portfolios 

in order to cut costs. When the current Clinical 

Center Director was appointed, he made financial 

stewardship and increased financial accountability 

a primary goal for the organization. New planning 

mechanisms, new information systems, and new 

reports of utilization were developed to provide 

more and more accurate information to the 

Institutes. 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 41 
For the years 1995 to 2002, both the Congress and 

the President publicly stated a goal of doubling the 

NIH budget. Thus, NIH (and the Clinical Center) 

have received substantial budget increases for the 

past several years. The process of doubling the NIH 

budget was completed in 2002. Subsequent years’ 

funding was modest, by comparison and the 

Clinical Center’s budget was held flat by NIH 

for that period. Given that certain hospital costs 

(e.g., pharmaceutical inflation, personnel costs, 

inflation of costs associated with the purchase of 

hospital soft-goods) will continue to escalate at a 

rate that far exceeds intramural budget growth, 

Clinical Center leadership and managers need to 

manage our expenditures conservatively for the 

foreseeable future. 

The Clinical Center has taken several approaches to 

increasing its organizational efficiency, including the 

assimilation of expensive contracts, the institution 

of operational reviews for Clinical Center departments, and increasing reliance on the Advisory 

Board for Clinical Research, whose extramural 

members have substantial expertise in healthcare 

operations and financing twenty. The Board, which 

includes numerous healthcare executives from 

prestigious extramural academic centers, provides 

advice to the Director of the Clinical Center concerning Clinical Center operations. The modified 

governance structure and the Advisory Board for 

Clinical Research have provided Clinical Center 

leadership with the opportunity to manage the 

operations of the organization more efficiently than 

ever before. Nonetheless, the very tight financial 

times brought about by having essentially flat 

budgets for the past five years have prompted NIH 

and IC leadership to revisit the school tax and the 

Clinical Center’s funding stream. Other possible 

approaches to increasing revenue include: 

■ Third party recovery for aspects of care provided at the Clinical Center; 

■ Developing partnerships with industry (including cost recovery) to use Clinical Center excess 

capacity; 

■ Developing partnerships with extramural investigators (including cost recovery) to use Clinical 

Center excess capacity. 

Institute research agendas compete directly with each 

other; for NIH to improve overall corporate efficiency, 

collaboration among ICs is essential. 

Occasionally, IC research agendas compete directly 

with each other. Although NIH efforts have been 

expended over the past several years to attempt to 

facilitate trans-IC collaboration, because of the 

highly competitive nature of some areas of investigation, collaboration has sometimes been difficult 

to achieve. Because ICs compete for Clinical Center 

resources, while independently valuing widely disparate services, the Clinical Center is faced with the 

challenge of meeting these varied requirements 

while fostering collaboration and cooperation 

among IC scientists in a cost-competitive environment. In addition, the Clinical Center is faced with 

the challenge of integrating basic science and basic 

scientists into the clinical research agenda of the 

NIH intramural program. Because many basic 

scientists are unaware of the clinical opportunities 

and venues in which to apply basic science findings, 

the Clinical Center is faced with the challenge of 

improving the accessibility of the Clinical Center 

and its resources to basic scientists. 

As noted above, collaboration among Institutes has 

become increasingly important with the opening of 

the new Clinical Research Center. Institutes share 

space related to their clinical programs in the new 

CRC. Since the design of the new building is not 

“institute-based,” but rather based on clinical 

disciplines or programs of care. Institutes share 

space and resources in the new facility. The nature 

of modern molecular medicine calls for more 

cross-Institute collaboration. 

NIH has endorsed a change in governance for the 

Clinical Center. 

The creation of the Clinical Center’s Board of 

Governors (now the Advisory Board for Clinical 

Research) in 1996 provided the Clinical Center 

with the unique opportunity to be supervised 

through a governance structure that can prepare 

the organization to compete effectively in the 

clinical research arena for the foreseeable future. 

The new governance structure has permitted 

the following unique opportunities for Clinical 

Center management: 

42 2008 Environmental Assessment 
■ The opportunity to seek the expert advice 

concerning hospital operations and management from nationally recognized authorities in 

hospital and research management; 

■ The opportunity to manage the clinical 

research process more efficiently than under 

the prior system; 

■ The opportunity to facilitate change far more 

efficiently than under the prior system; 

■ The opportunity to seek and develop organizational flexibilities not possible under the existing system (e.g., delegations of authorities, 

generic clearance for surveys, etc.). 

The expanded role for the Advisory Board for 

Clinical Research mandates that this board include 

ongoing assessment of, and encouraging the further 

development of integration of the clinical research 

programs across the campus. The Board is also 

providing the NIH Director and the Clinical 

Center Director with advice about the creation of a 

meaningful interface between the NIH Intramural 

Research Program and the network of Clinical and 

Translational Science Award grantees. 

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 43 
44 2008 Environmental Assessment 
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Executive Summary 48 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

National Institutes of Health 

NIH Clinical Center 

For administrative use 

January 2008