Government encouragement of free markets is a highly effective means of fostering pharmaceutical innovation; the NIH, by including “free-market provisions” in its licensing agreements that discourage anti-competitive and research-impeding behavior, can do a great deal to support this goal even without legislative overhaul.

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari’s theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit “public option” for pharmaceutical development.

Previous research has found that funding disparities are driven by applications’ final impact scores and that only a portion of the black/white funding gap can be explained by bibliometrics and topic choice. Using National Institutes of Health R01 applications for council years 2014–2016, we examine assigned reviewers’ preliminary overall impact and criterion scores to evaluate whether racial disparities in impact scores can be explained by application and applicant characteristics. We hypothesize that differences in commensuration—the process of combining criterion scores into (...) overall impact scores—disadvantage black applicants. Using multilevel models and matching on key variables including career stage, gender, and area of science, we find little evidence for racial disparities emerging in the process of combining preliminary criterion scores into preliminary overall impact scores. Instead, preliminary criterion scores fully account for racial disparities—yet do not explain all of the variability—in preliminary overall impact scores. (shrink)

The report by Barbara Bierer and Mark Barnes highlights the complexities experienced by institutions that conduct Public Health Service‐funded research involving human subjects and that need to negotiate the requirements of two sets of federal regulations: 45 C.F.R. 46, covering protections for human research subjects, and 42 C.F.R. 93, the PHS policies on research misconduct. As the nation's single largest sponsor of biomedical and behavioral research, the National Institutes of Health seeks to exemplify and promote human research protections and the (...) highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. The NIH is committed to protecting the rights and welfare of research participants and to upholding integrity standards for research supported with public funds. However, human subjects protections must always take priority. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 The subject was the future (...) of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s... (shrink)

Theory suggests that individuals with social anxiety manifest unique patterns of cognition with less efficient fluid cognition and unperturbed crystallized cognition; however, empirical support for these ideas remains inconclusive. The heterogeneity of past findings may reflect unreliability in cognitive assessments or the influence of confounding variables. The present study examined the relations among social anxiety and performance on the reliable, newly established NIH Toolbox Cognition Battery. Results indicate that high socially anxious adults performed as well as low anxious participants on (...) all measures of fluid cognition. However, high socially anxious adults demonstrated enhanced crystallized cognitive abilities relative to a low socially anxious comparison group. (shrink)

Kesselheim proposes doubling the NIH’s budget to promote clinically meaningful pharmaceutical innovation. Since the effects of a previous doubling (from 1998-2003) were mixed, I argue that policymakers should couple future budget growth with investments in experimentation and evaluation.

Concern over research integrity at the NIH led to the adoption of strict conflict of interest rules in 2005. An outcry from NIH scientists followed. This paper analyzes the legal and ethical issues raised by the new rules, and suggests potential areas for modification.

v. 1. Indijska filozofija i odabrani tekstovi -- v. 2. Iran, Islam, Kina, Japan i odabrani tekstovi.

The NIH-Moderna mRNA COVID-19 vaccine’s steep price increase raises concerns that this will be the new anchor for continued price hikes and underscores the need for upstream government intervention to enable greater accountability and stewardship of public biomedical research investment.

In lieu of an abstract, here is a brief excerpt of the content:The Blossoming of Bioethics at NIHEzekiel J. Emanuel (bio)The establishment of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center of the National Institutes of Health (NIH) has coincided with a burgeoning of interest and activity related to bioethical issues at NIH. The department has precipitated a reexamination and revitalization of existing bioethics activities in the Clinical Center and has launched new programs especially in the (...) areas of education and research. In addition, the department contributes to the work of others throughout NIH who address bioethical issues.The Organizational Location of the Department of Clinical BioethicsBefore describing the history and current activities of the Department of Clinical Bioethics, I will say something about it administrative location. Comprehension of the department’s organizational location is essential to understanding its history, role, and function. Prior to interviewing for the position of chair of the department, I did not—and, if truth be told, still do not fully—understand the details of the organizational structure of NIH. I therefore assume that many other bioethicists outside of the Institutes, especially those who do not regularly receive NIH funding, may not fully grasp its organizational intricacies.The Department of Clinical Bioethics is a department within the Warren G. Magnuson Clinical Center, which is NIH’s “hospital.” Hospital is in quotes because all of the patients at the Clinical Center must be enrolled in a research protocol and, therefore, are research subjects. The Clinical Center is where NIH’s clinical researchers admit their research subjects or see them in the out-patient setting. The Department of Clinical Bioethics reports directly to the Director of the Clinical Center, John I. Gallin, M.D., and receives its finances, space, and other resources from the Clinical Center.In this way, the department is part of NIH’s intramural (“inside”) program. People employed by NIH conduct intramural research, training, and other initiatives. The extramural program, which receives approximately 87 percent of NIH’s budget, funds research at institutions outside NIH. The extramural program awards grants and contracts for research, training, and conferences conducted [End Page 455] by investigators who are not affiliated with NIH. The National Human Genome Research Institute’s ELSI (Ethical, Legal, and Social Implications) program, for example, is part of NIH’s extramural program. As part of the NIH intramural program, the Department of Clinical Bioethics is not empowered to fund independent initiatives of people outside of NIH through grants and contracts. However, the department can collaborate with bioethicists and others on research, educational, and other programs outside of NIH and has some funds to support these collaborations.In addition, it is important for bioethicists to understand that NIH is a collection of 24 institutes and centers. Although there is coordination and collaboration between the institutes and centers, each is funded separately, and each has its own scope, programs, administrative structures, research agendas, training priorities, boards of advisors, and so forth. In this sense, NIH is more like a university that has many distinct schools, each with its own dean, faculty, budget, and fund raising office, than one that is tightly integrated and centrally-administered. Within NIH’s diffuse administrative structure, the Department of Clinical Bioethics is located within one of the centers (the Clinical Center) and has defined authority and responsibility only for bioethics within that center; in addition, because the Clinical Center’s mission is to support clinical research at other institutes, the department’ mission includes supporting the work of those institutes as well. Intellectual exchanges and relationships with other institutes and centers are neither pre-ordained nor administratively established; such relationships must be developed case-by-case, topic-by-topic, and initiative-by-initiative.The History and the Development of the Department of Clinical BioethicsThe Department of Clinical Bioethics was launched in late 1996. Although the department’s creation marked a major commitment to bioethics by the Clinical Center, and especially by its director, Dr. Gallin, it was formed on a pre-existing foundation of bioethics activities at NIH. 1In 1977, John Fletcher, Ph.D., was appointed by then Director Mortimer Lipsett as the bioethicist at the Clinical Center; his official title was Assistant for Bioethics... (shrink)

A veritable cookbook for individuals or corporations seeking funding from the federal government, The Complete Writing Guide to NIH Behavioral Science Grants contains the latest in technical information on NIH grants, including the new electronic submission process. Some of the most successful grant writers in history have contributed to this volume, offering key strategies as well as tips and suggestions in areas that are normally hard to find in grant writing guides, such as budgeting, human subjects, and power analysis. A (...) "who's who" among grant reviewers, this guidebook provides "inside" information as to why some grants are scored well while others flounder during review. A must-read for both entry level grant writers making headway in the complex NIH grant system for the first time as well as more seasoned investigators who can't seem to break the barrier to funded research grants, Drs. Scheier and Dewey's comprehensive volume provides simple and clear explanations into the reasons why some grants get funded, and a step-by-step guide to writing those grants. (shrink)

Many assumed that the Obama administration would usher in a sea change from the previous administration by expanding NIH support for human embryonic stem cell (hESC) research and reducing the patchwork of state and federal regulations that currently governs it. This article examines the extent to which NIH’s new Guidelines are likely to accomplish these goals.

al-Kitāb al-awwal. al-Qawāʻid al-Badrīyah fī ʻaqāʼid al-barīyah -- al-kitāb al-thānī. Masālik al-naẓar fī masālik al-bashar -- al-kitāb al-thālith. Taʻjīz al-mustaʻjaz.

: Some industry relationships are a good idea, and that makes banning the dangerous ones difficult.