Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “NIH Guidelines”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 55 records · Page 3Linked to original sources
PubMed2003

The National Institutes of Health system for enhancing the science, safety, and ethics of recombinant DNA research.

Oversight of recombinant DNA research by the National Institutes of Health (NIH) is predicated on ethical and scientific responsibilities that are akin, in many ways, to those that pertain to the oversight of animal research. The NIH system of oversight, which originated more than 25 years ago, is managed by the NIH Office of Biotechnology Activities (OBA), which uses various tools to fulfill its oversight responsibilities. These tools include the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) and the Recombinant DNA Advisory Committee. The OBA also undertakes special initiatives to promote the analysis and dissemination of information key to our understanding of recombinant DNA, and in particular, human gene transfer research. These initiatives include a new query-capable database, an analytical board of scientific and medical experts, and conferences and symposia on timely scientific, safety, and policy issues. Veterinary scientists can play an important role in the oversight of recombinant DNA research and in enhancing our understanding of the many safety and scientific dimensions of the field. These roles include developing appropriate animal models, reporting key safety data, enhancing institutional biosafety review, and promoting compliance with the NIH Guidelines.

Animal Welfare↗
PubMedDate not supplied

Development of the National Institutes of Health Guidelines for Recombinant DNA Research.

Recombinant DNA is a technique of major importance in basic biomedical research and, increasingly, in industrial applications. Although the risks of this research remain hypothetical, scientists working in the field have spearheaded discussions of safety. The original National Institutes of Health (NIH) Guidelines for Recombinant DNA Research were issued in June 1976. They assigned each type of recombinant DNA experiment a specific level of "physical containment" and of "biological containment." Responsibility for overseeing the application of the guidelines belongs to the NIH Recombinant DNA Advisory Committee (RAC)--composed of scientists and laymen, including non-voting representatives from many Federal agencies--and local institutional biosafety committees at each university where recombinant DNA research is conducted. The NIH guidelines were subsequently adopted by other Federal agencies, but congressional proposals aimed at extending the guidelines to private industry did not result in national legislation. Some States and localities regulate recombinant DNA research, however, and many private companies have voluntarily submitted information on their recombinant DNA work for RAC and NIH approval. The NIH guidelines underwent a major revision in December 1978 and have been revised approximately every 3 months since then. NIH supports experiments to assess recombinant DNA risks and publishes and updates a plan for a risk assessment program.

Containment of Biohazards↗
PubMedDate not supplied

Clinical management of primary hyperparathyroidism and thresholds for surgical referral: a national study examining concordance between practice patterns and consensus panel recommendations.

OBJECTIVE: To determine whether 1990 guidelines established by the National Institutes of Health (NIH) for the optimal management (surgical versus nonsurgical) of patients with asymptomatic primary hyperparathyroidism (PHPT) are known and followed by endocrinologists. METHODS: We surveyed endocrinologists in the United States who were randomly selected in 1998 from two endocrine societies. Endocrinologists were asked about management of asymptomatic patients with PHPT, awareness of NIH recommendations, practice demographics, and annual PHPT case volume. We classified endocrinologists into either low-volume (<12 cases of PHPT per year) or high-volume (> or = 12 cases per year) physicians. RESULTS: Of 374 eligible physicians, 146 (39%) responded to our survey. In comparison with nonrespondents, respondents were of similar age, sex, years in practice, and geographic location profiles; this finding suggested minimal nonresponse bias. More high-volume physicians than low-volume physicians were aware of the NIH guidelines (75% versus 50%; P<0.01). Management of asymptomatic patients was similar between volume groups; overall, 39% of patients were referred for surgical treatment. Nevertheless, considerable variation in management existed; 7% of all physicians referred > or = 90% of their asymptomatic patients for surgical treatment, whereas 31% referred < or = 10%. Adherence to monitoring guidelines for nonsurgically managed patients ranged widely, depending on the specific recommendation (from 6% of physicians obtaining creatinine clearance assessments every 6 months to 78% of physicians ordering serum calcium measurements every 6 months). Surgical referral practices also varied substantially, with 25% of all physicians referring a 40-year-old patient with PHPT when hypercalcemia was mild (< or = 1 mg/dL above normal), 39% when hypercalcemia was moderate, and 31% when hypercalcemia was severe (>1.5 mg/dL above normal). Of the responding physicians, 4% reported that hypercalcemia alone was not sufficient justification to refer a patient for surgical intervention. Higher PHPT case volume was not associated with differences in surgical referral. CONCLUSION: Suboptimal awareness of the 1990 NIH panel recommendations and the substantial variation in clinical management of PHPT indicate that newer NIH guidelines developed in 2002 must be more widely disseminated and strongly recommended if practice patterns are to be influenced and clinical outcomes improved.

Adult↗
PubMed1998

Antenatal corticosteroids for the prevention of neonatal respiratory distress in a predominantly rural state Medicaid population.

OBJECTIVE: To examine the use of prenatal intramuscular steroids in a community setting as outlined in National Institutes of Health (NIH) guidelines to reduce respiratory distress syndrome in premature infants. METHODS: We performed a complete chart review for 1 year of deliveries to Medicaid mothers at 25-34 weeks' gestation at all obstetric units in Arkansas, analyzing time of arrival to the hospital, time of delivery, and dosage, and route of steroid administration to compare processes between community and teaching center sites, and general performance with NIH guidelines. RESULTS: Of 191 deliveries at 25-34 weeks' gestation, 63.4% of mothers received at least one dose of corticosteroids before delivery. Only 124 (65%) of these mothers presented to the hospital more than 4 hours before delivery and 87% of these mothers received at least one dose of corticosteroids before delivery. Ninety percent of women who were transferred after presenting in labor and 94.9% of women who delivered at the tertiary care referral center received corticosteroids. There was no statistically significant difference in corticosteroid administration rates for women with or without preterm premature rupture of membranes. Many women received corticosteroids at dosages and intervals disparate with NIH guidelines. CONCLUSION: Obstetric providers in Arkansas administered antenatal steroids to Medicaid women in preterm labor at a rate higher than stated in previous literature. Delivery at a nonreferral center or within 4 hours of arrival to the hospital were associated with reduced antenatal corticosteroid administration. Improved performance efforts should target institutional usage and behavior of mothers at risk for premature delivery.

Adrenal Cortex Hormones↗
PubMed1990

Department of Health and Human Services. Recombinant DNA research; proposed actions under the guidelines.

This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on October 16, 1990. After consideration of these proposals and comments by the RAC, the Director of the National Institutes of Health will issue decisions in accordance with "NIH Guidelines".

Containment of Biohazards↗
PubMed1990

Department of Health and Human Services, National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines.

This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on February 4, 1991. After consideration of these proposals and comments by the RAC, the Director of the National Institutes of Health will issue decisions in accordance with the NIH Guidelines.

Clinical Protocols↗
PubMed1990

Department of Health and Human Services, National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines.

This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on October 16, 1990. After consideration of these proposals and comments by the RAC, the Director of the National Institutes of Health will issue decisions in accordance with the NIH Guidelines.

Animals↗
PubMed1987

Recombinant DNA research; proposed actions under guidelines. National Institutes of Health.

This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on September 21, 1987. After consideration of these proposals and comments by the RAC, the Director of the National Institutes of Health will issue a decision on these proposals in accord with the NIH Guidelines.

Containment of Biohazards↗
PubMed1989

Recombinant DNA research; proposed actions under guidelines. National Institutes of Health, PHS, DHHS.

This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on October 6, 1989. After consideration of these proposals and comments by the RAC, the Acting Director of the National Institutes of Health will issue decisions in accordance with the NIH Guidelines.

DNA, Recombinant↗
PubMed1994

An evaluation of antihypertensive prescribing practices.

We evaluated the management of patients with hypertension (including drug prescribing) by US physicians, compared their prescribing to National Institutes of Health (NIH) guidelines, and compared the pharmacoeconomics of the prescribed antihypertensive drugs. A 1991 national US database, using physician-patient encounter forms, was our data source. Results showed that physicians generally met the NIH guidelines regarding diagnostic/screening services, patient counselling/education, antihypertensive drug prescribing and follow-up. Two areas should be the foci of continuing medical education for US physicians. Firstly, physicians need to be reminded that centrally acting alpha 2-agonists are optimally used as supplemental antihypertensive drugs rather than as initial agents, which is how some physicians utilised them. Secondly, if once-daily administration is used to promote patient compliance, physicians should be aware that, of the frequently prescribed first-line antihypertensive drugs, hydrochlorothiazide, chlorthalidone and atenolol presently have substantially less expensive once-daily dosage forms than other diuretics or beta-blockers, calcium antagonists or ACE inhibitors.

Antihypertensive Agents↗
PubMed2004

The yellow zone in asthma treatment: is it a gray zone?

OBJECTIVE: To review the available literature on methods of preventing and minimizing exacerbations and to target problems for improvement. DATA SOURCES: PubMed and Cochrane Review searches of the English-language literature using the following key yellow zone terms: asthma exacerbation, self-management plans, inhaled corticosteroids, and acute management of asthma exacerbations. STUDY SELECTION: Articles relevant to our yellow zone intervention inquiry. RESULTS: The National Institutes of Health (NIH) guidelines advocate that physicians give patients written action plans with instructions on managing home (yellow zone) exacerbations. However, the criteria used to identify the yellow zone are ambiguous and often confusing to patients and physicians. In addition, apart from a passing mention that doubling doses of inhaled corticosteroids may be an option in asthma step-up care, the guidelines contain no recommendations for yellow zone treatment strategies. This deficiency is directly related to the paucity of organized evidence on the efficacy of the various pharmacological interventions that can be used during an exacerbation. CONCLUSIONS: Translating the NIH guidelines into realistic clinical practice requires a clearer and more patient-friendly definition of the yellow zone, and this improved definition will facilitate the prescription of effective interventions in the management of yellow zone exacerbations.

Administration, Inhalation↗