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Results for “Office for Human Research Protection”

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At least 127 records · Page 7Linked to original sources
PubMed1999

Development of reactive topical skin protectants against sulfur mustard and nerve agents.

The potential for highly reactive nanoparticles (RNP) to absorb destructively, i.e. to neutralize highly toxic substances such as the warfare agents GA, GB, HD and VX, has been demonstrated in the laboratory. Reactive nanoparticles represent a new class of nanoscale particles of metals and metal oxides that differ from other nanoparticles in reactivity and crystalline morphology. The potential for incorporating RNP into a protective barrier skin cream also has been demonstrated. Preliminary studies indicate that RNP are physically and chemically compatible with a base cream provided by the Army Medical Research Office and, importantly, remain reactive with chemical agents while promising to be compatible with skin contact.

Administration, Topical↗
PubMedDate not supplied

Chemotherapy-handling practices of outpatient and office-based oncology nurses.

PURPOSE/OBJECTIVES: To determine the current patterns of use of personal protective equipment among oncology nurses while handling antineoplastic chemotherapeutic agents in outpatient and office-based settings. DESIGN: Descriptive-correlational, mailed survey. SETTING: National survey of oncology nurses. SAMPLE: 500 randomly selected members of the Oncology Nursing Society who identified their work settings as office, clinic, or outpatient private practice; 263 responded for an overall response rate of 53%. METHODS: Mailed, self-report survey based on the current Occupational Safety and Health Administration's (OSHA's) guidelines for the handling of hazardous drugs. MAIN RESEARCH VARIABLE: Chemotherapy-handling practices. FINDINGS: More than 94% of participants reported usually wearing gloves during chemotherapy handling; 55% reported using laboratory coats as protective garments. Usual use of face and respiratory protection was less than 6%. Chemotherapy was reported to be prepared in laminar air flow hoods in 99% of work settings. Only 46% of sites reportedly provided any type of medical monitoring. CONCLUSION: Use and availability of personal protective equipment when handling chemotherapy have increased, but medical monitoring of exposed employees still is neither widely practiced nor consistent with OSHA guidelines. IMPLICATIONS FOR NURSING: Safety concerns and potential adverse health effects associated with the occupational handling of chemotherapeutic agents have been reported. Historically, nurses' adherence to chemotherapy-handling guidelines has been poor. Results suggest that adherence is increasing; however, research is lacking regarding nurses' level of knowledge of and specific barriers to safe handling of chemotherapy.

Ambulatory Care↗
PubMed2001

Third-party rights and risks: a forum on informed consent of persons affected by the study of human subjects--conditions, experiences, and concerns in a Nordic country.

In Denmark, health research using personal information can be conducted only with permission from a regional scientific ethical committee and the national Data Protection Office. There are no rules applying to the rights and risks of third parties. In this article, the implications for third-party rights and risks of the type and level of involvement of the subjects are discussed from a Danish point of view. Particular emphasis is put on the current conditions, experiences, and concerns with regard to use of already registered personal information, which in the Nordic countries offers unique opportunities for large-scale, longitudinal, population-based studies also involving third parties. These opportunities have recently been challenged by a European Community Directive, with which all member states must comply, requiring informed consent on every transaction of personal data, but through a political process, it was possible to obtain a series of amendments allowing the special register-based research to continue. Crucial arguments favoring the amendments were that no damage has been observed so far and that such research has no interest in the individual data, only in the statistical distributions and associations. Finally, the article suggests that the rights and risks of third parties might be considered on the basis of use: third-party information provided by the subject only as a source of such information distinct from use of the information as an integral part of the subjects' information about themselves and their lives.

Denmark↗
PubMed2006

Research misconduct among clinical trial staff.

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations.

Clinical Trials as Topic↗
PubMed2003

Bicycle helmet assessment during well visits reveals severe shortcomings in condition and fit.

BACKGROUND: Improper bicycle helmet fit increases the risk of head injury. Information on the rate of proper use of bicycle helmets is lacking. Promotion of helmet use is recommended at well-child and adolescent visits. Actual helmet assessment during such visits has not been reported. OBJECTIVES: The primary goal of this study is to measure the proportion of children whose helmets are in proper condition and can be made to fit properly by the child and/or parent. The secondary goal is to begin to assess the value and practicality of helmet inspection during well-child and adolescent visits. METHODS: The study took place at a private pediatric office in Falmouth, Massachusetts, from June 1 through August 31, 2001. Eligible children and adolescents were those aged 4 to 18 years presenting for well examination, along with siblings present at the visit. Eligible families completed a questionnaire, then had a timed attempt to fit a helmet, followed by an assessment of helmet fit and condition against a predetermined standard. RESULTS: Eighty-four percent (395/473) of eligible families participated. A total of 479 participants were assessed. Eighty-eight percent of participants (419/478) owned a helmet. Reported helmet use "always" or "almost always" was 73% for bicycling (317/434), 69% for in-line skating (193/279), 58% for scootering (179/310), and 50% for skateboarding (79/158). Compared with younger children, teenagers were less likely to wear helmets for all activities. Complete pass rate for every aspect of condition and fit was 4% (20/478, 95% confidence interval: 3-6). The pass rate when the parent alone fit the helmet was 0% (0/52). Three individual aspects of fit were most problematic: 1) helmet 'resting position' too high on the forehead (pass rate 249/479; 52%), 2) improper strap position (pass rate 157/476; 33%), and 3) excessive movement of the helmet from front to back of the head (pass rate 247/479; 52%). Mean time for questionnaire completion was 4 (standard deviation: +/-1) minutes, and 7 (standard deviation: +/-3) minutes for helmet assessment. CONCLUSIONS: Ninety-six percent of children and adolescents wore helmets in inadequate condition and/or with inadequate fit. This occurred despite a high acceptance of helmet use by this population. Initial evidence suggests that helmet assessment during well visits may be practical and valuable.

Adolescent↗