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As nursing research becomes more common, so does the issue of whether or not patients should be involved and, if so, to what extent. This article examines how the data protection legislation helps to protect patients, and whether they have the capability to decide to participate, or not.
The growing number of large health data bases available represents a valuable resource for health care research. Many available data bases, however, have subtle and/or complex defects in their design as well as in the quality of the data themselves. The apparent ease and economy of using pre-collected data cannot eliminate the need for careful selection, examination, and analysis of these data. Existing documentation should be critically reviewed to assess the appropriateness of the data base for its intended use. Once in hand, the completeness and coding of the data should be examined in detail before attempting to test hypotheses. In conducting data analysis, the investigator must be aware of the potential problems related to the size of the data base, the unit of analysis, and the sampling strategy--particularly if sampling involved stratification or clustering. Awareness of the potential pitfalls inherent in the use of large health data bases can help prevent many problems and disappointments, as well as improve the validity and efficiency of statistical analysis.
In 2003, 2 new sets of rules and regulations affecting the conduct of clinical research involving children and adolescents went into effect: the revised American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct (APA, 2002; effective June 1, 2003) and the Privacy Rule (45 CFR Part 160 and A and E of Part 164; effective April; 14, 2003) of the Health Insurance Portability and Accountability Act (HIPAA: Public Law 104-191). This article highlights those APA ethical standards and HIPAA regulations relevant to clinical research involving children and adolescents and discusses how psychologists can apply these rules in ways that will ensure ethical and legal compliance.
BACKGROUND: The higher methodological complexity of either diagnostic or therapeutic procedures has raised concern about the ethical principles that should underlie the conduct of biomedical research involving humans. AIM: To evaluate ethical problems of research proposals submitted to an ethics committee. MATERIAL AND METHODS: All research proposals involving humans, submitted within a two years period to the ethics committee of the School of Medicine of the Catholic University, were retrospectively reviewed. "Ethical problem" was defined as any explicit disagreement with the ethical principles and guidelines for the protection of human subjects involved in biomedical research, according to the Helsinki declaration. RESULTS: In 20 of 44 reviewed projects, an ethical problem was identified. The most common problems were the absence or inadequacy of the informed consent, the justification of the use of placebo and problems related to the methodological aspects of the research, particularly the lack of an adequate control group when the potential benefits of a new drug were evaluated. CONCLUSIONS: According to the Nüremberg code, the Helsinki declaration and the International Principle of Ethics in Biomedical Research, we analyse ethical problems and suggest judgement elements for them.
The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.
The prominence of systematic reviews as bases for evidence-based practice is increasingly recognized and has significance for practice disciplines such as nursing. Synthesizing research findings is key to informing the clinical care of individuals burdened with health problems. A major issue in conducting such reviews involves developing reliable and valid coding procedures for extracting data from the research literature. A formalized process is described for developing coding instruments that have been used in five separate studies. Initial instrument development for a diabetes self-management education meta-analysis is described, followed by a discussion of adapting the instruments for subsequent meta-analytic studies of self-management interventions in diabetes care and of interventions to reduce caregiver burden of individuals with Alzheimer's disease dementia. Although time and effort are required for development of coding processes for research synthesis, these instrument development activities are one of the critical elements of producing reliable and clinically useful information.
This study was based on the investigators' earlier work on alcoholism and the family and involved a comprehensive assessment of sequential patterns associated with the marital interactions of alcoholic, depressed, and nondistressed men. A total of 131 couples were assessed in a laboratory-based discussion of personally relevant problems. Videotaped observations were conducted during drinking and nondrinking sessions and were subsequently coded according to the Marital Interaction Coding System. Depressed couples were most distinguishable in terms of unique antecedent-consequent patterns, whereas alcoholic and nondistressed control couples were similar to one another and different from depressed couples. Results are discussed in regard to the extant literature on interpersonal theories of depression and alcoholism and in regard to future research needs.
BACKGROUND: Since 1987, cancer centers and clinical cooperative groups serving as 'research bases' for the National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP) have been required to design and conduct cancer prevention and control (CP/C) clinical trials in addition to therapeutic trials. The study describes the structural and strategic adaptations that CCOP research bases have made to incorporate CP/C research into their scientific agendas and operations. METHODS: Approaches to CP/C research in four cooperative groups with different scientific agendas were investigated: the Eastern Cooperative Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, the North Central Cancer Treatment Group, and the Southwest Oncology Group. Sixty-five individual interviews with group leaders and investigators were conducted. Data were coded and thematically analyzed from transcribed interviews, observations of scientific sessions, and secondary documents. RESULTS: The cooperative groups have tailored CP/C research programs to fit the interests, skills, and practice settings of their investigators without making significant adaptations in administrative and statistical infrastructures. Ongoing challenges include finding ways to broaden the pool of investigators designing CP/C protocols, involve more nononcologists in protocol design, and secure more stable and adequate funding for CP/C research. CONCLUSION: The cooperative groups' experiences with CP/C research suggest that, with adequate resource investments, existing clinical research networks can expand into new areas of scientific investigation.
BACKGROUND: Variant Creutzfeldt-Jakob disease (vCJD) is a human prion disease caused by infection with the agent of bovine spongiform encephalopathy. After the recognition of vCJD in the UK in 1996, many nations implemented policies intended to reduce the hypothetical risk of transfusion transmission of vCJD. This was despite the fact that no cases of transfusion transmission had yet been identified. In December 2003, however, the first case of vCJD in a recipient of blood from a vCJD-infected donor was announced. The aim of this study is to ascertain and compare the factors that influenced the motivation for and the design of regulations to prevent transfusion transmission of vCJD in the UK and US prior to the recognition of this case. METHODS AND FINDINGS: A document search was conducted to identify US and UK governmental policy statements and guidance, transcripts (or minutes when transcripts were not available) of scientific advisory committee meetings, research articles, and editorials published in medical and scientific journals on the topic of vCJD and blood transfusion transmission between March 1996 and December 2003. In addition, 40 interviews were conducted with individuals familiar with the decision-making process and/or the science involved. All documents and transcripts were coded and analyzed according to the methods and principles of grounded theory. Data showed that while resulting policies were based on the available science, social and historical factors played a major role in the motivation for and the design of regulations to protect against transfusion transmission of vCJD. First, recent experience with and collective guilt resulting from the transfusion-transmitted epidemics of HIV/AIDS in both countries served as a major, historically specific impetus for such policies. This history was brought to bear both by hemophilia activists and those charged with regulating blood products in the US and UK. Second, local specificities, such as the recall of blood products for possible vCJD contamination in the UK, contributed to a greater sense of urgency and a speedier implementation of regulations in that country. Third, while the results of scientific studies played a prominent role in the construction of regulations in both nations, this role was shaped by existing social and professional networks. In the UK, early focus on a European study implicating B-lymphocytes as the carrier of prion infectivity in blood led to the introduction of a policy that requires universal leukoreduction of blood components. In the US, early focus on an American study highlighting the ability of plasma to serve as a reservoir of prion infectivity led the FDA and its advisory panel to eschew similar measures. CONCLUSIONS: The results of this study yield three important theoretical insights that pertain to the global management of emerging infectious diseases. First, because the perception and management of disease may be shaped by previous experience with disease, especially catastrophic experience, there is always the possibility for over-management of some possible routes of transmission and relative neglect of others. Second, local specificities within a given nation may influence the temporality of decision making, which in turn may influence the choice of disease management policies. Third, a preference for science-based risk management among nations will not necessarily lead to homogeneous policies. This is because the exposure to and interpretation of scientific results depends on the existing social and professional networks within a given nation. Together, these theoretical insights provide a framework for analyzing and anticipating potential conflicts in the international management of emerging infectious diseases. In addition, this study illustrates the utility of qualitative methods in investigating research questions that are difficult to assess through quantitative means.
Microsatellite analysis of chromosomes carrying particular cystic fibrosis mutations has shown different haplotypes in four cases: R334W, R347P, R1162X, and 3849 + 10kbC-->T. To investigate the possibility of recurrence of these mutations, analysis of intra- and extragenic markers flanking these mutations has been performed. Recurrence is the most plausible explanation, as it becomes necessary to postulate either double recombinations or single recombinations in conjunction with slippage at one or more microsatellite loci, to explain the combination of mutations and microsatellites if the mutations arose only once. Also in support of recurrence, mutations R334W, R347P, R1162X, and 3849 + 10kbC-->T involve CpG dinucleotides, which are known to have an increased mutation rate. Although only 15.7% of point mutations in the coding sequence of CFTR have occurred at CpG dinucleotides, approximately half of these CpG sites have mutated at least once. Specific nucleotide positions of the coding region of CFTR, distinct from CpG sequences, also seem to have a higher mutation rate, and so it is possible that the mutations observed are recurrent. G-->A transitions are the most common change found in those positions involved in more than one mutational event in CFTR.
WITH THE PROGRESS MADE IN KNOWLEDGE AND TECHNIQUES: Therapeutic efficacy has advanced. However, interrogations concerning the control of the power that is conferred and the new obligations towards patients that stem from this progress have emerged and, further to the sinister ethical deviations in medical research and testing, and the supreme temptation that is represented by the money involved, questioning has increased. THE NUREMBERG CODE: Promulgated in December 1947, is the founder text of modern biomedical ethics. Subsequently completed by numerous other international conventions, it established the principle of voluntary, informed consent, therefore confirming the autonomy of the patient and the respect that is due from the physicians. However, questions arise not only regarding the foetus and embryo, but also regarding those reaching the end of their lives. CONCERNING EMBRYOS: No contradiction is apparent between the singularity of the human embryo and the use of embryos destined to be destroyed in highly scientific and moral quality research projects. With regard to the development of methods for producing cloned human embryos, it appears to be associated with greater risks than establishing urgent and necessary steps towards fulfilling the promises of regenerating medicine. Last but not least, deviations in reproductive biology and clinical trials conducted in this field, with relentless procreation and "human studies", must be denounced. AT THE OTHER END OF LIFE: It is worrying to note the apparent facility with which our societies consider that old age is an indignity. To call knowledge a 'power' is to consider that such power can be used not only to relieve suffering but also to manipulate others. The humanistic finality of an intention is not sufficient to guarantee neither its benignity nor its morality.
All international codes of research ethics and virtually all national legislation and regulation in the field of research involving human subjects project an attitude of protectionism. Written with the aim of avoiding a repetition of atrocities like those committed by the Nazi physician-researchers, calamities like the thalidomide experience, or ethical violations like those of the Tuskegee syphilis study, their dominant concerns are the protection of individuals from injury and from exploitation. In recent years, however, society's perception of clinical research has shifted dramatically. Now, largely as a consequence of the efforts of the AIDS activists, clinical research is widely perceived as benign and beneficial. Although this shift in attitude has resulted in some important improvements in research policies and practices, this new perception is just as wrong-headed as was the earlier excessive protectionism. It is necessary to maintain a balanced perspective; our policies should encourage the conduct of ethical research while maintaining the vigilance necessary to safeguard the rights and welfare of the subjects.
Carotid artery disease is an important factor in the aetiology of stroke and cerebrovascular insufficiency. Angiography remains the definitive technique for the investigation of the carotid arteries, but the risk and expense involved has stimulated research into suitable non-invasive techniques. A comparison between a velocity-sensitive, colour-coded Doppler principle ultrasound flowmeter (Echoflow) and conventional angiography was conducted on 52 patients (101 arteries) investigated at Royal Perth Hospital over a 16-month period. An acceptable correlation was found in 78% of cases. Echoflow scanning proved to be particularly accurate in assessing normal arteries. Our results support the use of Echoflow as a first line of investigation, and in aiding the selection of cases requiring further study, although we caution against routine angiography in all patients with positive Echoflow scan results.
There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research.
BACKGROUND AND OBJECTIVES: Federal regulations require that research subjects provide informed consent for their participation in biomedical research. Before giving consent, subjects are presented with information about study procedures, risks, benefits, and alternatives. Although investigators have assessed subjects' retention of consent material, little is known about how participants view methodologic dimensions of biomedical research, such as placebos and randomization, or the distinction between medical treatment in a research protocol versus personal health care. These issues were examined with a qualitative interview study. METHODS: Research interviews were conducted with 14 subjects who had recently completed their participation in one of two drug trial studies. The interviews were tape-recorded and transcribed. The transcripts were analyzed and coded for thematic content. RESULTS: Participants showed a thorough understanding of important study elements, such as randomization and placebos. They described primarily altruistic motives for participating in the drug trial. There was evidence that subjects might not make a clear distinction between personal medical care and treatment in a research protocol. CONCLUSIONS: Participants viewed their involvement in research very positively. They understood most important methodologic dimensions. The findings, however, suggest that the consent process should include greater attention to the distinction between research and clinical practice.
Most of the mitochondrial proteins are synthesized in the cytoplasm as precursors which are then translocated into the organelle. These precursors have a NH2-terminal extension which functions as a mitochondrial targeting signal. The import process through mitochondrial membranes is voltage-dependent; its mechanism is still unknown. Translocation has been proposed to occur through specific channels, thus, indicating the interest of the study of mitochondrial ionic channels. Two anion channels with different electrical characteristics have been described in the outer and the inner membranes. Using the technique of "Tip-Dip", we have shown the existence of a cation channel of large conductance in mitochondria. The characteristics of this channel differ from that of the other mitochondrial anion channels. A positively charged 13-residue synthetic peptide, with the sequence of the amino terminal extremity of the nuclear-coded subunit IV of yeast cytochrome C oxidase, induces a blockade of the cationic channel. From the characteristics of the blockade, it is likely that the channel could be permeable to the peptide. The specificity of this effect suggests that this channel might be involved in protein translocation.
This essay explores the process and issues related to community collaborative research that involves Native Americans generally, and specifically examines the Navajo Nation's efforts to regulate research within its jurisdiction. Researchers need to account for both the experience of Native Americans and their own preconceptions about Native Americans when conducting research about Native Americans. The Navajo Nation institutionalized an approach to protecting members of the nation when it took over Institutional Review Board (IRB) responsibilities from the US Indian Health Service (IHS) in 1996. While written regulations for the Navajo Nation IRB are not dissimilar, and in some ways are less detailed than those of the IHS IRB, in practice the Navajo Nation allows less flexibility. Primary examples of this include not allowing expedited review and requiring prepublication review of all manuscripts. Because of its broad mandate, the Navajo Nation IRB may also require review of some projects that would not normally be subject to IRB approval, including investigative journalism and secondary research about Navajo People that does not involve direct data collection from human subjects.
It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.