Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Helsinki Declaration”

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 307 records · Page 17Linked to original sources
PubMed2006

Comparative analysis of the risk-handling procedures for gene technology applications in medical and plant science.

In this paper we analyse how the risks associated with research on transgenic plants are regulated in Sweden. The paper outlines the way in which pilot projects in the plant sciences are overseen in Sweden, and discusses the international and national background to the current regulatory system. The historical, and hitherto unexplored, reasons for the evolution of current administrative and legislative procedures in plant science are of particular interest. Specifically, we discuss similarities and differences in the regulation of medicine and plant science, and we examine the tendency towards dichotomizing risk--focusing on social/ethical risks in medicine and biological risks in plant science. The context of this article is the Synpraxia research project, an inter-disciplinary program combining expertise in sciences and the humanities.

Biomedical Technology↗
PubMed1979

Ethics of psychopharmacological research.

1. Psychiatry is in dire need of research in all areas--from psychopharmacology to psychotherapy. 2. It is unethical not to undertake research as long as hundreds of thousands of patients suffer from incapacitating mental disorders. 3. It is unethical not to apply proper research principles to obtain maximal information from the observations of patients treated by different drugs or techniques. 4. The Tokyo (Helsinki II) declaration takes cognizance of the special problems in psychiatric (and certain other areas of) research, and should help to heighten the standard of all clinical research. 5. Psychopharmacology is based on the principles of the biological sciences. In the behavioral aspects of clinical psychopharmacological research non-objective observations cannot solely be based on these principles, but we should always be able to aim at: a. Description of spontaneous history. b. Description of diagnostic and therapeutic techniques and processes. c. Description of goals. d. Description of results (with as detailed information on treatment failures as on treatment successes). e. Prospective studies instead of retrospective ones. 6. Psychopharmacology is probably the area within psychiatry where the ethical issues have been most protected against the uncritical introduction of unproven therapeutic principles.

Ethics, Medical↗
PubMed2006

Ethical process in human research published in thoracic surgery journals.

BACKGROUND: Media reports of ethical transgressions in research with human subjects have increasingly focused attention on clinical investigators and have served to undermine public confidence in medical research. A series of editorials in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery in 2002 and 2003 emphasized integrity in research publication. We investigated the extent to which the ethical process was mentioned in reports of thoracic surgical research with human subjects since 2002. METHODS: We reviewed all reports of research involving human subjects published in these journals during the first 6 months of 2002, the first 6 months of 2003, and the last 6 months of 2004 (n = 273, 291 and 288 for each time period, respectively with a total of 852). RESULTS: Ethical process was mentioned in 346 of 852 (41%) investigations. Comparing US and non-US studies, the rates of mentioning ethical process for prospective studies were 76 of 83 (92%) and 178 of 216 (82%), respectively, and for retrospective studies were 75 of 220 (34%) and 18 of 334 (5%), respectively. Between 2002 and 2004, the rates of mentioning ethical process for prospective studies increased from 79 of 101 (78%) to 80 of 89 (90%), and for retrospective studies it increased from 17 of 172 (10%) to 59 of 199 (30%). CONCLUSIONS: There was a significant increase in mention of ethical process from early 2002 to late 2004; however, documentation of appropriate ethical process in human research published in cardiothoracic journals remains less than ideal. The main burden of ensuring ethical process in human investigations rests with researchers, their institutions, and institutional review boards; however, editors can help rectify this problem by requiring adherence to national and international standards in the human subjects' research studies they publish. In adhering to ethical standards, investigators respect the research subjects' right of self-determination and foster public confidence in human research.

Bibliometrics↗
PubMed2004

Conducting international collaborative research in developing nations.

International research partnerships bring together some of the best and the brightest in an effort to tackle global health problems. Such collaborations also pose complex challenges, such as maintaining ethical principles in the conduct of research in developing nations. In implementing a randomized clinical trial to reduce postpartum hemorrhage (PPH) during childbirth in rural India, U.S. and Indian collaborators addressed three such issues: the appropriateness of an ethical randomized controlled trial in the developing world, the inclusion of a placebo arm, and the relevance of informed consent in a semiliterate rural population.

Administration, Oral↗
PubMed2006

Conducting ethical research in pediatrics: a brief historical overview and review of pediatric regulations.

Achieving proper balance between the social good that comes from performing research that involves children and offering the appropriate level of protection to children who participate in research is a significant challenge. As investigators design and implement research protocols, they should be aware of the ethical and legal requirements that govern research with human participants. This is especially true of research that involves children and other vulnerable groups. The welfare of children participating in research depends on knowledgeable, caring, and responsible investigators who place the well-being of the research participant above all other aspects of the research project. The purpose of this article is to provide a brief overview of the history of research involving children, to provide a basis for understanding the context within which the current federal regulations were written, and to provide an overview of the regulatory requirements that relate to research involving children. Good research is ethical research, and that requires investigators who take seriously the importance of participant welfare, meaningful informed consent, and respect for research participants.

Child↗
PubMedDate not supplied

Scientific misconduct and unethical human experimentation: historic parallels and moral implications.

Although a great deal of human experimentation has been performed to elucidate information otherwise not obtainable, there are many recorded instances of unethical human experimentation. There is also a history of crimes that were committed and disguised as human experiments, best exemplified by the activities of some physicians in Nazi Germany from 1933 until 1945. As a direct result of these activities, a war-crimes trial after World War II resulted in the creation of the Nuremberg Code, to guide future human experimentation. Despite this, unethical experiments were conducted at major academic institutions in the United States in the years after World War II by otherwise normal physicians who did not feel that the Nuremberg Code applied to them personally. There are several possible explanations for such activities, but the desire for personal advancement is prominent among these. Episodes of scientific misconduct such as falsification of experimental data or of personal qualifications seem to be more commonly reported recently and have also been described in the popular press. This activity may also be motivated by desire for personal advancement, giving it a parallel to the conduct of unethical human experimentation. Education may be the best way to prevent these activities that may have similar motivating factors.

Codes of Ethics↗
PubMed2004

The use of personal data from medical records and biological materials: ethical perspectives and the basis for legal restrictions in health research.

This paper discusses the moral justification for using personal data without informed consent, from both medical records and biological materials, in research where subjects are not physically present in the study and will never have any contact with the study investigators. Although the idea of waiving the requirement for informed consent in certain investigations has been mentioned in several ethical guidelines formulated by epidemiologists and physicians since the late 1980s, these guidelines are now of limited use due to legal restrictions on the use of personal data in most western countries. Several misconceptions that form the basis for legal restriction of health research are discussed: lack of knowledge of the need to link personal information from health services with personal information produced outside the health system in many biomedical investigations; the assumption of a deterministic model of disease causation in which the prediction of disease occurrence is based on a genetic association despite the fact that most genotypes for common diseases are incompletely penetrant; the lack of a logical rationale for the recommendation in the Declaration of Helsinki that only research that offers some benefit to study subjects is justified; the great lack of knowledge about research methodology revealed in some alternatives proposed to avoid using personal data; and the lack of a debate about the ethical double standard of institutions and investigators in countries that prohibit the use of personal data but finance and carry out studies in other countries where it is permitted.

Biomedical Research↗
PubMedDate not supplied

The pharmacokinetics of equoral versus neoral in stable renal transplant patients: a multinational multicenter study.

We studied the pharmacokinetics (PKs) of the new generic cyclosporine formulation, Equoral capsules, after the switch from original formulation Neoral capsules in stable renal transplant patients. The study was carried out in accordance with the basic principles defined in the US 21 CFR Part 312.20 and the principles of the Declaration of Helsinki. The study included clinically stable first renal transplant patients maintained on cyclosporine with no rejection episode during the past 6 months. Hematology, biochemistry, and urine chemistry were determined on day 7, and day 21. The patients were all switched to Neoral (lot number 416MFD0601) on day 0 when the first sparse sampling PK was performed. On day 14 a 12-hour PK profile included predose, 30 minutes; 1 hour; 1 hour 30 minutes; 2 hours; 3 hours; 4 hours; 5 hours; 6 hours; 8 hours; 10-hours and 12-hour samples. Cyclosporine levels were determined using a CYA kit (Abbott TDx). On day 15 the patients were switched from Neoral capsules to Equoral capsules (lot 5T111014) at an equivalent dosage (mg/mg). The second sparse sampling PK was performed on day 21 and a 12-hour PK was performed on day 28. On the morning of day 29 patients were switched from Equoral capsules to Neoral capsules at an equivalent dosage (mg/mg). Additional concentrations were measured on days -7, 18, and 35. Safety parameters were monitored at each visit. The pharmacokinetics of both formulations were equivalent. The mean AUC for Neoral and Equoral was 2856 and 2892, respectively. The ratios of LSM and the 90% confidence intervals for the in-transformed parameters (AUC o-t, AUC inf, and Cmax) of Equoral and Neoral SGC were 98% and 95%, respectively, suggesting that Equoral and Neoral SGC are bioequivalent.

Area Under Curve↗
PubMed2003

Standard CYP2D6 genotyping procedures fail for the CYP2D6*5 and duplication alleles when hair roots are used as a source of DNA.

BACKGROUND: Hair roots provide a useful alternative to blood as a source of DNA for genotyping. Besides simple and non-invasive collections, the DNA extraction step is also easy to perform and is fast. The aim of our study is to determine if hair roots can be used to genotype all of the common CYP2D6 alleles for routine screening purposes. METHOD: The study complies with the Declaration of Helsinki. After obtaining informed consents, both blood and hair samples were collected from 92 patients for genotyping of the CYP2D6 gene. PCR was used to detect the following mutations: CYP2D6*1, *3, *4, *5, *9, *10, *17 and duplication gene. The results were compared where hair roots and blood were used as templates for DNA respectively. RESULTS: When blood was used as a source of DNA for genotyping, all of the investigated CYP2D6 alleles were successfully amplified. However, with hair roots, the genes with the larger fragment sizes: CYP2D6*5 and the duplication gene could not be amplified and the bands of other alleles investigated were faint when visualized under UV light. CONCLUSIONS: DNA extraction from hair roots and leucocytes yielded similar results but the DNA extracted from hair roots did not allow successful amplification of the longer genes such as the CYP2D6*5 and the duplication gene.

Alleles↗