Initial Review Group Research Articles

DEVELOPMENT OF PISA TYPES OF QUESTIONS AND ACTIVITIES CONTENT SHAPE AND SPACE CONTEXT PANDEMIC PERIOD

This research belongs to the type of development research, which consists of the main stages, including preliminary design and formative evaluation. This study aims to obtain valid and practical PISA-type development questions consisting of initial design, self-evaluation, expert review, one-to-one, and small group. The emergence of this research is due to the low mathematical literacy of students in Indonesia. This study took a particular research subject for grade IX junior high school students in Palembang City. From this study, the results obtained include the development of PISA-type questions and activities using the context of social distancing during the pandemic.

National Heart, Lung, and Blood Institute

I am pleased to provide an update on the policies and programs of the National Heart, Lung, and Blood Institute (NHLBI). This is an exciting time of many transitions for the federal government as a whole and the National Institutes of Health (NIH) in particular. As these changes take form, I want to assure you of our unwavering commitment to support our community of heart, lung, and blood investigators and to the goals articulated in the NHLBI Strategic Plan. My goal in the present article is to discuss the NHLBI budget for the 2009 fiscal year (FY) (October 1, 2008, to September 30, 2009, FY 2009) and to describe new policies that we are implementing for early stage investigators and for revised grant applications. The NIH is operating under a continuing resolution (CR),1 which means that Congress has not provided the NIH with an appropriation for FY 2009. This requires us to operate at the same level of funding as we had in FY 2008. Because we are obligated to provide FY 2009 cost of living increases, the actual purchasing power of the FY 2008 appropriation is reduced in FY 2009. The CR authorizes us to fund noncompeting research grants at 90% of the previously committed levels until a FY 2009 appropriation is made. The CR expires March 6, 2009, but we must be prepared for the possibility that the CR amount will become the FY 2009 appropriation. Accordingly, the NHLBI is currently operating with a CR budget of $2.922 billion. Similar to FY 2008, noncompeting awards will be provided a 1% inflation rate. Detailed information can be found in the NHLBI FY 2009 Funding and Operating Guidelines.2 We …

Can Underpowered Clinical Trials Be Justified?

As a physician-investigator, I have participated as an ad hoc reviewer for a number of years in the National Institutes of Health (NIH) Clinical Oncology Study Section, one of many chartered Initial Review Groups that reviews applications to fund cancer clinical trials and studies of biological materials derived from cooperative group clinical trials. This group is unique because of its charge and the members who comprise its body of reviewers. Every proposal is reviewed by at least three clinical investigators (usually physicians) with backgrounds in radiation oncology, medical or pediatric oncology, pathology, and a variety of other biomedical science disciplines. Additionally, a biostatician reviews each proposal to determine the validity of the method of design and of the data analysis plan. Even when a study is sufficiently important to conduct and its hypothesis is sound, one might expect that a review committee would disapprove a study that is poorly designed and that will not produce statistically significant results. All too often, however, protocols that are creative and important but flawed methodologically receive a positive review for a variety of reasons: the study is a great idea, it's a truly innovative approach, or the disease under study is terrible and without any effective treatment, so anything in this area would help. Yet is it ethical to conduct methodologically flawed clinical trials? More specifically, can we justify conducting studies with few participants, known as underpowered clinical trials, if these trials are unlikely to produce statistically significant results?

The New NIH Loan Repayment Program for Pediatric Research and for Clinical Research

In 2000, the United States Congress enacted an eagerly anticipated program to encourage physicians to pursue careers in research by providing educational loan repayments. This program was designed to help alleviate the financial burden associated with pursuing an academic career. Physicians pursuing pediatric research and clinical research who compete successfully in this program may receive up to $35,000 each year toward repayment of their educational loan indebtedness, plus 39% of that amount to cover the tax consequences of this additional income. An aggressive lobbying effort by the pediatric academic community in the last few years culminated in success on October 17, 2000, when Congress passed the Children's Health Act, which contains a provision authorizing the Secretary of the Department of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish a loan repayment program for health professionals conducting pediatric research. In this program, the NIH enters into a contract with a qualified health professional who agrees to conduct pediatric research for at least 2 years in return for the educational loan repayment. If performance is satisfactory, the contract may be extended until most of the educational loans are repaid. After passage of this groundbreaking pediatric research loan repayment program, Congress moved quickly to pass, on November 13, similar legislation authorizing such a program for clinical research in general, not limited to pediatrics. The NIH moved quickly to plan and implement this new authority, building on experience gained in similar loan repayment programs that have existed for several years in the NIH intramural research program. A planning committee produced a proposal for joint implementation of the two programs that was reviewed and cleared to proceed by the Office of Management and Budget (OMB). The program was formally published and announced in the Federal Register (2001;66(173):46643–7) on September 16, 2001, and the acting director of the NIH announced that funds would be provided in fiscal year 2002 to make contractual arrangements with approximately 250 individuals to begin the program. The NIH will select the recipients of these contracts on a competitive peer-reviewed basis, to assure that loan repayments serve the intended purpose of recruiting and retaining high-quality health professionals (mostly physicians) in careers in biomedical research, especially clinical investigation. Applicants must be U.S. citizens, nationals, or permanent residents with doctorate degrees. They must be currently supported by an NIH grant (F32 or T32 training grant; a K series career development award; a first-time RO1, RO3, or R21 research grant; a UO1 cooperative agreement grant; or a first-time director of a subproject of a PO1 or U series grant). Their total educational debt must exceed 20 percent of their annual income. Finally, they must be engaged in pediatric research or clinical research. The NIH expects application forms approved by the OMB to be available around December 1. Forms may be obtained from the Office of Loan Repayment and Scholarship, NIH, 2 Center Drive, Room 2E30, Bethesda, MD 20892-0230, U.S.A., or by e-mail request ([email protected]). Applications will include a personal statement about research career goals, a description of the current research that qualifies the applicant, a research training plan (if applicable), recommendations from three individuals, and a supporting statement from the sponsoring institution. Information on loan indebtedness must also be provided. In the first year of the program, applications will be assigned to the Institute funding the grant that qualifies the applicant for the program. Institute Initial Review Groups (IRG) will provide peer review. The Institute will make funding decisions based on the evaluation of the IRG and on program need and balance. Successful applicants will be offered 2-year contracts, indicating the amount of the loan that will be repaid quarterly by the NIH to the lending institution, in return for a commitment by the applicant to continue to engage in pediatric or clinical research during that time. Performance will be closely monitored, and if research activity ends, the loan repayment will terminate. This program represents a commitment by the U.S. government to increase the number and quality of health professionals engaged in pediatric or clinical research by reducing the often-cited barrier of educational loan debt as a factor that forces young clinicians into clinical practice. The NIH is eager to launch and extend this program, and encourages applications from highly qualified individuals for whom this program can become the means to a career in research.

Avoiding gender and minority barriers to NIH funding.

To inform investigators of the National Institutes of Health (NIH) guidelines for the inclusion of women and minorities as subjects in clinical research and provide tips on avoiding barriers to federal funding. Information about gender and minority barriers to funding was obtained by reviewing NIH policies, information submitted by applicants, and comments provided by NIH reviewers. A brief history of the goals of U.S. federal legislation to increase opportunities for obtaining information to help enhance health and disease treatment for all Americans and to detect and account for ethnic and gender differences is described. Examples were derived from NIH Summary Statement comments of initial review groups. Applications submitted to NIH are being barred from initial funding, even with excellent priority scores, if the plan for inclusion of women and minorities is judged to be scientifically unacceptable by the initial review group. This situation is correctable and avoidable.

Toward greater public health relevance for psychotherapeutic intervention research: An NIMH workshop report.

A multidisciplinary group of experts was convened by the National Institute of Mental Health (NIMH) to discuss new opportunities in psychotherapy research. Participants agreed that more research is needed to assess stakeholders’ needs, to better understand techniques commonly used in clinical practice, and to test efficacious treatments in community settings. These steps will require increased collaboration across different disciplines, development of new research methods, and a willingness for investigators to ask novel research questions. Participants outlined obstacles to conducting public health-oriented research such as the current dearth of supportive infrastructure (e.g., lack of training opportunities for new investigators), concerns about how applications for conducting new or hybrid methodologies will fare when evaluated by NIMH initial review groups, and the obvious differences in terminology used by relevant stakeholders.

The National Cance Advisory Board

The National Cance Advisory Board

An Analysis of Applications Reviewed for NIMH Grant Support for Training for Leadership in Public Psychiatry for FY 1984

The authors undertook a study of the 1984 public psychiatry training grant applications that were submitted for review by a National Institute of Mental Health (NIMH) Initial Review Group (IRG) consisting of 12 psychiatrists in March, 1984. The programs recommended for approval and disapproval were analyzed to determine which characteristics in the opinion of the reviewers constituted a well organized and sound training program in public psychiatry worthy of NIMH grant support. Nine factors were found to be associated with the programs recommended for approval.

The biologic forms of malignant melanoma

Biology, the science of life, encompasses the stud'), of the strttcture, flmction, growth, origin, evolution, and distribution of living organisms and life processes. A disease entity is a life process, albeit an abnornml one, and its stud)' should include origin, evolution, growth, distribution, structure, and function, along with other appropriate investigations, from the molecular to the clinical level. The biologic study of a disease should distinguish one disease form from another if those disease forms are, in fact, entities. Biologic studies of malignant melanoma indicate that there are different forms of the disease. This communication is concerned with some of the attributes that distinguish the four common melanomas: lentigo maligna melanoma, acral lentiginous melanoma, nodula r melanoma, and superficial spreading melanoma. Mucosal lentiginous is similar to acral lentiginous melanoma, and, except for location, the mucosal and acral melanomas are indistinguishable. were evaluated by 44 attributes, including biologic form of the disease; the patient's age, sex, and race; and the location, thickness, and level of invasion. The data set of 340 cases is called the comprehensive review group and that of 1,042 cases tile initial review group. The initial review group has been reduced to 921 cases, for reasons relevant to this paper. One hundred fourteen cases (10.9 per cent) could not be classified as to biologic type on initial pathology review because the biopsy material and completely excised lesion had not been concurrently reviewed and tile findings integrated. Seven other cases in which no demonst rable pr imary lesion was found were eliminated from this study of primary melanomas. In contrast, in the comprehensive review group only nine of 340 cases (2.6%) were unclassified. Detailed study of representative histologic features is required for proper classification of melanomas. The final data set, combining the comprehensive and initial review groups, consists of 1,261 cases (chart I).

Ten fatal mistakes in grant writing.

I have just stepped down as the Chair of the National Institute on Drug Abuse (NIDA) Initial Review Group for Epidemiology, Prevention, and Services Research. The massive title means only that I chaired the meetings of the group of scientists who reviewed the grant proposals that many psychologists and other scientists submitted: grants to study epidemiological, social, psychological, or treatment aspects of drug abuse. Our primary task was to decide whether the research had scientific merit. If, in our judgment, the proposed study was good science, we then assigned a priority score to the grant: a score showing how much we thought the research would contribute to scientific knowledge about drug abuse. Those ratings were extremely important; they almost always determined whether a proposal could eventually be funded. While I was on the committee, not one single grant that the committee rejected was funded. Furthermore, more than 90% of the time, the proposals that were funded were selected from those that had the best priority numbers. I do not want to discuss how to prepare a good grant proposal or even list all of the little things that can go wrong. There are excellent materials available elsewhere on how to write a grant (Gordon, 1978; Holtz, 1979; Lindholm, Marin, & Lopez, 1982). After participating in this review process for several years, however, I decided that there were a few very basic mistakes that people made, mistakes that almost always led to rejection of their proposals. I saw these same fatal flaws time and again at NIDA, and also when serving as a special reviewer for other agencies. Avoiding these errors might keep one from wasting a lot of time and effort in preparing a proposal that would have almost no chance of being funded.

The Application Processes at the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism

NIDA and NIAAA support individual and institutional research efforts through several different kinds of grants. Those most commonly awarded include: Individual Research Grants; Individual postdoctoral National Research Service Awards; Institutional National Research Service Awards; Research Center Development Awards; and New Investigator Research Awards. Grants are also made for research demonstration and dissemination projects, for program projects, and for conferences. Grant applications are submitted to the Division of Research Grants at NIH, then assigned to the appropriate Institute by the ADAMHA Grants Review and Referral Office. Each application reveives two sequential levels of review. The first level involves panels of experts, known as Scientific Review Groups or Initial Review Groups, who evaluate the scientific and technical merit of each grant proposal. The second level of review is by NIDA's or NIAAA's National Advisory Council, who look also at the applications's relevance to the Institute's programs and priorities. Overall, applications are evaluated on the basis of: scientific significance and originality; appropriateness and adequacy of the research approach and methodologt; qualifications and experience of the researchers; availability of resources; and reasonable nature of project's budget and time frame. After an application has been approved through the dual review process, it is considered for funding. An application that has been approved is not automatically funded; this depends on the award criteria of each program and on total funds available. If an application has been approved and a decision to fund it made, an award statement is issued by the Institute's Grants Management Office.