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PubMed2002

Sarbanes-Oxley raises red flag for not-for-profits.

In the near future, not-for-profits likely will feel the effects of these Sarbanes-Oxley directives: Establish audit committees with independent membership (precluding senior managers from being members) and make corresponding changes to corporate bylaws; Meet a higher standard for financial reporting, including increased disclosure and system certification representations as part of annual audits; Adopt a code of ethics for senior financial officers; Avoid senior executive compensation packages involving personal loans from the corporation; Ensure that board members are appropriately qualified and free of conflicts of interest.l

Accounting↗
PubMed1994

Epidemiology of failed tobacco control legislation.

OBJECTIVE: To evaluate the influence of tobacco industry campaign donations, district location, and political party affiliation on tobacco control legislation among members of the US Congress. DESIGN: Data were obtained from the Federal Election Commission on money contributed by the 10 leading tobacco political action committees and by tobacco industry-aligned individuals to members of the US House of Representatives (1991-1992) and Senate (1987-1992). Logistic regression analyses were performed using recorded votes and cosponsorship activities concerning tobacco control legislation during the 102nd and 103rd Congresses and membership on the House Congressional Task Force on Tobacco and Health as the dependent variables and tobacco money received, party, district location, and caucus or committee membership as the independent variables. SETTING: United States Congress in 1991 and 1992. INTERVENTIONS: None. MAIN OUTCOME MEASURE: Support for federal tobacco control legislation. RESULTS: The tobacco industry donated approximately $2.4 million to members of Congress from January 1991 through December 1992. House members received an average of $2943 (1991-1992) and senators received an average of $11,593 (1987-1992). The more tobacco money a member received, the less likely the member was to support tobacco control legislation. In the Senate, on a vote to end the taxpayer subsidy of tobacco products in military stores, the odds ratio that senators in the top quartile of tobacco money recipients did not support the measure vs senators in the lowest quartile of tobacco money recipients was 42.2 (95% confidence interval, 4.1 to 430.0; P < .001). In the House, on a vote to end a $3.5 million subsidy to promote American tobacco abroad, the odds that House members in the top third of tobacco money recipients would oppose the legislation were 14.4 times greater (95% confidence interval, 5.5 to 39.0; P < .001) than for House members in the lowest third of tobacco money recipients. Receiving more tobacco money, being a member of the Republican party, and representing a tobacco-producing state were all associated with decreased support for tobacco control issues. The amount of tobacco money received was the variable most strongly and consistently associated with a lack of support for tobacco control legislation, even when we controlled for additional factors such as district location and party. CONCLUSION: Tobacco industry contributions to members of the US Congress strongly influence the federal tobacco policy process. Unless this influence is diminished through a combination of members refusing tobacco money and campaign finance reform, this process of contributing to death by thwarting tobacco control will continue to claim hundreds of thousands of lives a year.

Fund Raising↗
PubMed2004

Practice guidelines for the renal biopsy.

Biopsy of the kidney should never be undertaken without careful consideration of the risks vs benefits. Given the importance of a correct diagnosis in the treatment and prognosis of renal disease, the pathological evaluation should use all available modalities. Native kidney biopsies require examination by light microscopy, immunohistochemistry and electron microscopy. The processing of the renal biopsy is complex and requires the support of a fully equipped anatomic pathology laboratory. Technical expertise is required to process the small fragments of tissue and to produce sections of highest quality. The correct diagnosis requires a well-trained renal pathologist with thorough knowledge of not only renal pathology but also renal medicine in order to correlate intricate tissue-derived information with detailed clinical data. In view of the importance and consequences of the pathologic diagnosis, the Renal Pathology Society appointed an Ad Hoc Committee on Practice Guidelines, to define the essential ingredients necessary to provide quality renal pathology diagnoses. This document incorporates the consensus opinions of the committee and the RPS membership at large.

Biopsy↗
PubMed1990

Reviewing the reviewers: a survey of institutional ethics committees in Australia.

Completed questionnaires were received from 89 (88%) of the 101 Australian institutions identified as having an ethics committee which reviewed research on human subjects. The majority (75%) of committees complied with national requirements to include a layman, a laywoman, a minister of religion, a lawyer and a medical graduate with research experience in their membership. On average, the committees considered 41 research protocols in the year from mid 1987 to mid 1988. The proposed projects were from the medical sciences, including health services and epidemiology research (80% of projects), and the behavioural and social sciences (20% of projects). Less than half the committees monitored research projects in progress as a general practice. Most of the monitoring that was conducted was based on a report from the researcher on the progress of the study. Although monitoring, frequency of meetings, selection of committee members, member involvement in the review of their own protocols and provisions for expedited review gave cause for concern, most committees were found to follow the national guide-lines.

Australia↗
PubMed1981

Pharmacist involvement in institutional review of clinical trials.

The establishment of an institutional review committee (IRC) for investigational clinical trials in a large community hospital is reported. After the need for an IRC was identified, the pharmacy and therapeutics committee charged the director of pharmacy with drafting a protocol for establishing an IRC. Following a literature review, guidelines were written for the IRC in the form of a committee manual. These guidelines were approved, and composition of the nine-member committee was set as follows: three members of the trustee medical education and research committee, three members of the medical staff, one member each of the clergy staff and the pharmacy staff, and one nonaffiliated community representative. The IRC reviews, approves or denies, and supervises all proposed clinical investigations. Risk/benefit ratios, purpose, recruitment and selection procedures, financial support, and informed consent documents of the proposed study are among the factors considered in the approval process. Guidelines for written policies and procedures governing IRC structure and activities are presented. The involvement of the pharmacist in the establishment and subsequent functions of the committee is described. IRC membership is an opportunity for the pharmacist to work with other professionals in protecting the rights and welfare of human research subjects.

Clinical Trials as Topic↗
PubMed1987

[The Veterinary Drug Act and rational pharmacotherapy. Various marginal notes on the registration and channeling of veterinary drugs].

A short introductory note is followed by a more detailed discussion of a number of aspects of the administration of the Veterinary Medicinal Products Act. Among other things, attention is paid to the following subjects: the Registration of Veterinary Drugs Committee (RVDC) and its working parties (no participation of specialists from the Faculty of Veterinary Medicine, no varied membership of the Veterinary Drugs Committee), the veterinary use of drugs registered for human use (supplementary registration), the position of particular species of animals (supplementary registration), the records (no environmental requirements, absence of clear directions for the toxicological evaluation of veterinary-drug metabolites, risks of the number of veterinary drugs available being reduced) and the criteria of directing veterinary drugs into specific channels ('veterinarians only' system, role of pharmaceutical chemists). It would also appear to be advisable that the Committee specify within a short time which antibiotics are not eligible for veterinary use. This also holds good for substances such as mutagenic and carcinogenic compounds showing doubtful toxicological characteristics.

Animals↗
PubMed2005

Global gene mining and the pharmaceutical industry.

Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samples are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society of Human Genetics preparing background paper on 'Polymorphic sequence variants in medicine: Technical, social, legal and ethical issues. Pharmacogenetics as an example'. Within the European project Privacy in Research Ethics and Law (PRIVIREAL), recommendations for common European guidelines for membership in research ethical committees have been discussed, balancing the interests and assuring independence and legal competence. Good decision making, assuring legality of protocols and assessment of data protection is suggested to be part of any evaluation of protocols.

Drug Industry↗
PubMed2006

SRTR center-specific reporting tools: Posttransplant outcomes.

Measuring and monitoring performance--be it waiting list and posttransplant outcomes by a transplant center, or organ donation success by an organ procurement organization and its partnering hospitals--is an important component of ensuring good care for people with end-stage organ failure. Many parties have an interest in examining these outcomes, from patients and their families to payers such as insurance companies or the Centers for Medicare and Medicaid Services; from primary caregivers providing patient counseling to government agencies charged with protecting patients. The Scientific Registry of Transplant Recipients produces regular, public reports on the performance of transplant centers and organ procurement organizations. This article explains the statistical tools used to prepare these reports, with a focus on graft survival and patient survival rates of transplant centers--especially the methods used to fairly and usefully compare outcomes of centers that serve different populations. The article concludes with a practical application of these statistics--their use in screening transplant center performance to identify centers that may need remedial action by the OPTN/UNOS Membership and Professional Standards Committee.

Adolescent↗
PubMed2005

Preliminary identification of core domains for outcome studies in psoriatic arthritis using Delphi methods.

OBJECTIVE: To develop a consensus based set of core domains for outcome studies in psoriatic arthritis. METHODS: A list of 26 potential domains was prepared through literature review and email discussions amongst the GRAPPA steering committee members and scored by rheumatologists identified through membership of the CASPAR study and the steering committee. Each participant was emailed an up to date review of outcome measures in psoriatic arthritis and asked to distribute 100 points amongst each potential domain. In two subsequent rounds the group median, interquartile range, and earlier responses were emailed to each respondent to provide an opportunity to revise their scoring. RESULTS: Thirty two participants responded to the first round, of whom 30 responded to the third round. For DC-ART, the highest scoring domains were actively inflamed joint count, radiological damage score, patient global assessment, pain, physical function, acute phase response, and quality of life (scores 7 to 12). For SMARD, the highest scoring domains were pain, patient global assessment, physical function, quality of life, and active joint count (scores 10 to 18). For clinical record keeping, three domains scored highly at 10 (pain, patient global assessment, and active joint count). For rehabilitation, the highest scoring domains were physical function, quality of life, pain, patient global assessment, work limitations, and work incapacity (scores 10 to 15). CONCLUSION: Amongst rheumatologists with an interest in psoriatic arthritis, a reduced list of potential standard outcome domains have been defined by Delphi consensus methods.

Arthritis, Psoriatic↗
PubMed1994

Inappropriate and appropriate selection of 'peers' in grant review.

OBJECTIVE: To assess the members of the California Tobacco Related Diseases Research Program Behavioral and Public Health Research on Tobacco Study Section and those of the Agency for Health Care Policy and Research (AHCPR) Dissemination Study Section as "peers" to review tobacco policy research. Both study sections reviewed a similar grant application on tobacco policy research written by one of us (S.A.G.). DESIGN: Search of MEDLINE for 1989 through 1993 with the keyword tobacco for Tobacco Related Diseases Research Program and AHCPR reviewers. As a control, the National Institutes of Health Cardiovascular Study Section, which reviewed a ventricular function grant submitted by the same author with the keyword heart, was analyzed. SETTING: Not applicable. PATIENTS OR OTHER PARTICIPANTS: Study section members. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Publications by study section members in areas germane to the proposal being reviewed. RESULTS: Six (33%) of 18 Tobacco Related Diseases Research Program reviewers had no "tobacco" publications (median, two publications; interquartile range, zero to four). The members' "tobacco" publications concentrated on well-controlled experimental interventions on smoking cessation and prevention strategies, not tobacco policy. Only one member had primary expertise in tobacco policy research. None of the AHCPR reviewers had "tobacco" publications. All 31 (100%) of the National Institutes of Health reviewers had "heart" publications (median, nine publications; interquartile range, seven to 19). Five members had a primary interest in the subject of the National Heart, Lung, and Blood Institute application. CONCLUSIONS: Study section members' professional interests play a critical role in the level of interest and enthusiasm they will have for a proposal, which affects the priority score. In contrast to the study section that reviewed the heart grant, the study sections that reviewed the tobacco control grant were not "peers." The membership of these review committees has effectively precluded research on tobacco control policy.

Peer Review, Research↗
PubMed1995

Furore over language, shortage of women leaders signs of need for change at CMA, committee says.

Negative comments made recently about use of the term "chair" instead of "chairman," and the continuing shortage of women at decision-making levels of organized medicine are ample evidence that the work of the CMA's Gender Issues Committee (GIC) is not done, says the committee chair, Dr. May Cohen. At its fall meeting, the GIC said the CMA should actively promote greater representation by women physicians on its political and expert committees; a target of at least 25% membership within the next 2 to 5 years was suggested. The committee discussed other measures the CMA should consider in its attempts to become more representative of Canada's physician population.

Canada↗
PubMed1994

Experiences with committees dealing with the issues of ethics.

Ethics committees have been active in Germany for 15 years now. Since 1983, such committees, which were established under public law with medical schools, medical associations and representatives of the Federal Health Office among their members, have established a working group with a growing membership of currently some 45 committees. The group's functions include the exchange of experience, the discussion of relevant ethical issues as well as the harmonization and standardization of their internal procedures. In addition, it serves as a point of contact for members of Parliament. Government and journalists. Since 1990, the group has published four yearbooks under the title of 'Medizin-Ethik' [1]. Germany's ethics committees are bodies serving no other purpose than that of biomedical research on human beings (scientific experiments, diagnostic and therapeutic methods, clinical trials involving drugs). They are intended to protect test persons and patients against acts which must not be permitted for ethical and/or legal reasons. Ethics committees fulfil the task of counselling the medically responsible researcher and of examining in advance whether relevant scientific, legal, medical and ethical standards will be met by the biomedical project envisaging scientific research on human beings and whether such a project will not violate accepted values. The ethical and legal standards to be adhered to in this connection have been laid down in the declaration issued by the World Medical Association in Helsinki/Tokyo/Venice/Hong Kong, they have been codified in human rights declarations and in a great number of national legal provisions and have been included in scientific standards.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗
PubMed1994

Product standards committees today and tomorrow.

The results of a survey of product standards committees conducted by the JOURNAL OF HEALTHCARE MATERIEL MANAGEMENT show that most hospitals have such a committee, chaired by the materiel manager. Despite the fact that respondents named 49 different disciplines as possible members of the committees and 100% attendance is experienced less than a quarter of the time, most respondents said they had the right number of people on their committee and that the committee was effective or very effective. With more facility affiliations in the offing, purchasing decisions will be made at a corporate level. To be viable in the future, the products committee will have to transform itself into a utilization review and cost oversight committee, and drastically reduce its membership.

Canada↗
PubMed1997

Institutional animal care and use committees: a flawed paradigm or work in progress?

In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership lacks the expertise in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and (c) the committee's operational base of authority is alien to academic culture and violates essential aspects of academic freedom. In addition, he found that the system is burdensome, requiring enormous expenditures of time and money that inappropriately diverts resources away from the business of scientific discovery. We dispute several aspects of Steneck's historical account and the coherence of his proposals. We believe his proposals, if followed, would be a step back into a failed past.

Animal Care Committees↗
PubMed2005

A network analysis of committees in the U.S. House of Representatives.

Network theory provides a powerful tool for the representation and analysis of complex systems of interacting agents. Here, we investigate the U.S. House of Representatives network of committees and subcommittees, with committees connected according to "interlocks," or common membership. Analysis of this network reveals clearly the strong links between different committees, as well as the intrinsic hierarchical structure within the House as a whole. We show that network theory, combined with the analysis of roll-call votes using singular value decomposition, successfully uncovers political and organizational correlations between committees in the House without the need to incorporate other political information.

Journal Article↗
PubMed1988

Survey on curriculum committees at U.S. and Canadian medical schools.

A 27-item questionnaire was sent to 144 U.S. and Canadian medical schools to identify prevailing patterns in the organization, philosophy, and function of curriculum committees. Overall, 76 percent responded, with 67 percent of the respondents being school administrators and 33 percent being faculty members. Fifty-one percent rated their school's committee as exerting a significant impact on the educational program over the previous five years. Fifty-six percent of the committees had a routine procedure for course review and used data from multiple sources when conducting curriculum evaluations. The committees that annually received a specific assignment from the dean were the most likely (91 percent) to be rated as having a significant impact, followed by committees that conducted frequent course reviews (66 percent). Thirty-eight percent of the committees were primarily faculty oriented, 29 percent were decidedly administrative in composition, and the remaining committees exhibited a mixture of membership.

Administrative Personnel↗