Enhancing the Vitality of the National Institutes of Health Organizational Change to Meet New Challenges (2003) / Chapter Skim
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4. The Organizational Structure of the National Institutes of Health
4. The Organizational Structure of the National Institutes of Health
Pages 67-82
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From page 67... ...
, have suggested consolidating all existing institutes into five or six larger institutes of about equal size, whose leaders would report to the NIH director. Such a solution might well simplify some aspects of NIH management and some have suggested it might improve the overall effectiveness of the research portfolio.
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From page 68... ...
had been elevated to "bureaus," giving their directors more authority and the flexibility to create separate divisions to house major subunits of these institutes (NIH, 19761.1 These changes were to accommodate health advocates' concerns, but pressures from 1As a result of the War on Cancer Act of 1971, NCI was elevated to a bureau with a greatly expanded budget and special authorities. NHLBI also became a bureau after the National Heart, Blood Vessel, Lung, and Blood Act of 1972 expanded its programs and budget; Congress added blood to the name of the institute in 1976.
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From page 69... ...
add to administrative costs without ensuring increased appropriations." Because there might be circumstances in which organizational change would be necessary and it would be important to recognize such circumstances, the 1984 committee recommended that there be a formal process to assess proposed major organizational changes in NIH, and it articulated five criteria for evaluating organizational proposals: "The activity of a new institute or other organizational entity must be compatible with the research and research-training mission of NIH. If a major emphasis of the proposed new entity is in regulation, the delivery of services, or other non-research activities, it is not appropriate for incorporation in NIH.
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From page 70... ...
For a proposed addition, the likelihood of available resources to support it should also be assessed and the burden of proof should reside clearly with those seeking to add an organizational element. To initiate the process, the director should consult with the Advisory Committee to the Director and should a consensus develop on the value of further exploration, the NIH director should appoint an ad hoc investigative committee, ensuring that the appropriate array of technical expertise to evaluate a particular proposal is present and that the committee has appropriate representation of the extramural scientific and voluntary health advocacy communities.
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From page 71... ...
Two particular options were raised during Committee discussions as candidates for merging: the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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From page 72... ...
304, the Drug Abuse Education, Prevention, and Treatment Act of 2001, as reported by the Senate Judiciary Committee on November 29, 2001, contained a provision that called for a study of a merger of NIDA and NIAAA by the National Academies. Although the bill was enacted as PL 107-273 in November 2002, the provision relating to the study was no longer included.
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From page 73... ...
The Organizational Structure of the National Institutes of Health substance. And the exclusive focus of the two institutes on specific substances has meant that some addictions, e.g., gambling and food addictions, have received .
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From page 74... ...
As described in Chapter 3, the challenge for clinical research is that most common diseases are complex, multietiologic disorders in which a multiplicity of genetic and other factors interact with each other. As a result, clinical research is faced with the complex challenge of identifying the resources, intellectual capital, and large cohorts of patients with appropriate phenotypes for studies.
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From page 75... ...
For example, it has established and expanded a series of special training programs for clinical researchers collectively known as K awards. And recognizing that loans accumulated during college and medical school greatly burden young physicians and influence their choices of career paths, NIH has responded by creating competitive loan-repayment programs that offer up to $35,000 per year for 2 years to health professionals pursuing careers in various aspects of clinical research.
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From page 76... ...
characterizing the current state of clinical research as "increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants." The challenging and expensive enterprise of clinical research requires mastery of a broad array of skills in clinical medical fields; the application of biostatistics to clinical trial design and analysis; adherence to the principles, precedents, and procedures of bioethics; the organization and oversight of complex projects; and the communication of complex ideas to potential trial participants and peers.
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From page 77... ...
· Developing with the Department of Health and Human Services' Office for Human Research Protections a national approach to standardizing and harmonizing regulations for protecting research subjects and improving standards of privacy protection. · Supporting the development of integrated, interoperable data networks, medical record systems, and related research under a common national health information infrastructure with standards to facilitate collection and sharing of clinical research information.
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From page 78... ...
A concerted, proactive effort requires that someone in a leadership position with the attention of the NIH director and the authority to assess and coordinate efforts across NIH systematically and routinely evaluate NIH's clinical research programs in toto. Those strategic initiatives should be aimed at facilitating the widespread incorporation of new concepts and technologies in molecular genetics, cell biology, imaging, computational biology, and information sciences into clinical research practice.
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From page 79... ...
The Committee decided that the best option is to build the new NCCRRR on the NCRR, adding to its responsibility for the GCRCs and the K awards for training and career development the oversight of the Clinical Center and coordination of clinical activities for which other ICs are responsible. If staff responsible for these critical aspects of NIH's clinical research and training portfolio report to a central office, there would be greater opportunity to enhance data sharing among clinical investigators, clarify, solidify, and standardize relevant policies, and identify and pool resources for high-cost, essential core infrastructure needs.
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From page 80... ...
Although planning at the Clinical Center emphasizes flexible cross-Is intramural use of the facility, it is envisioned that the new entity would assume a much stronger leadership role for the entire intramural and extramural NIH clinical research enterprise and work in close partnership with the academic community and the private sector. For example, the new Center could enhance and improve relations and ongoing discussions with clinical research organizations outside NIH, such as the Office for Human Research Protections, the Food and Drug Administration, CDC, AHRQ, and the pharmaceutical and biotechnology industries.
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From page 81... ...
The Organizational Structure of the National Institutes of Health believes that Congress should consider amending the authorizing legislation for NIH to require that either on receiving a congressional request or at the NIH director's discretion in responding to public requests for a structural change, the director should initiate a public process to evaluate the scientific, medical, financial, and public costs of the proposed change. Some ICs have overlapping missions and substantive foci and would work together more effectively than apart, and the Committee recommends the immediate initiation of two careful studies using the recommended process to evaluate these mergers.
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From page 82... ...
The public process for evaluating proposals to create organizational units described in Chapter 4 should also be applied to programmatic offices in the OD. Finally, to enhance the quality and innovative nature of NIH's portfolio, the Committee proposes a variety of adjustments in intramural research ant!
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