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 469 records · Page 26Linked to original sources
PubMed2000

[Good clinical practice:impediment of source of progress?].

On the bases of the Declaration of Helsinki (1964), the law called Huriet-Sérusclat (1988) and several subsequent decrees have clearly defined the appropriate organization and management of clinical trials in France. The law on the Commission de l'informatique et des libertés (1978) and several European regulations have also to be taken into account. This extensive legal and regulatory system has been the source of a major improvement in the scientific quality of clinical trials and in the security of participating persons. Indirectly, it has also improved daily clinical care, as physicians have learned how to inform their patients and have been trained to use protocols and standard operative procedures. However, the legal and regulatory pressure has increased the cost and complexity of trials to such an extent that no clinician with his own resources is now able to be the sponsor of a trial involving more than a few patients. In addition to trials organized by pharmaceutical companies for drug development, health authorities in France and Europe should consider to support major clinical trials on therapeutic strategies with public health implications. A few examples can be acknowledged thus far, but a real policy remains to be defined.

Clinical Trials as Topic↗
PubMed1976

The role of the individual and the community in the research, development, and use of biologicals with criteria for guidelines: a memorandum.

In view of the widely recognized need to use available vaccines and other biologicals and to develop new ones to control many diseases of world-wide importance, this Memorandum considers the increasingly complex problems that face investigators and public authorities that must review and approve pre-licensing studies and also large-scale regular use. It is stressed that the proper conduct of biologicals research in human beings must be considered from the scientific, sociological, ethical, and legal points of view. The Declaration of Helsinki is regarded of fundamental importance and its applicability to biologicals research is discussed. Recommendations are made for continued international collaboration in this field and "Criteria on the Role of the Individual and the Community in the Research, Development, and Use of Biologicals" are formulated. General criteria and specific criteria related to the design of field trials, human involvement in field trials, and surveillance of safety and effectiveness of biologicals in routine use are discussed.

Biological Products↗
PubMed2000

[Ethical issues of human experimentation with special reference to informed consent].

Human experimentation in order to develop new medical therapies creates very complex ethical problems: when is it possible to test a new therapy on a human subject? Is it always necessary his/her consent? Which information should be given to the subject before requesting his/her consent? How to behave in the case of minors, psychiatric patients and other subjects not perfectly free or able to understand the information provided? Is it right to subject a person to an experimentation from which he/she will not get any direct advantage? Which results can be published? In other words, which are the ethical limits of human experimentation? These are difficult questions, to which the authors tried to answer referring to some ethically significant human experimentations, such as those performed by Lind and Jenner in the XVIII century, and those carried out by the nazi doctors, from whose trial derived the Nuremberg Code, which introduced for the first time, at an international level, the principle of the informed consent. Some of the limits of this document, including the impossibility of doing research on subjects not able to give their informed consent, such as minors and psychiatric patients, were overcome by the Declaration of Helsinki, whose current version resulted from several subsequent revisions. According to this document, a major role is played by the Institutional Review Boards or Institutional Ethical Committees that have the heavy responsibility of evaluating the ethical connotations of human experimentations.

Ethics, Medical↗
PubMed2000

Biotechnology-based foods: is there a third way between the precaution principle and an overly enthusiastic dissemination of GMO?

The demand for consumer safety with regard to the food-processing industry is becoming, legitimately, more and more urgent. If ingested drugs can carry deleterious effects that exceed the beneficial effect that the research was initially undertaken for, then the same can only be the case for foods that stem from the same new biotechnologies, zero risk being non existent.

Consumer Product Safety↗
PubMed2001

[Surgery and the Japan Surgical Society at the beginning of the 21st century].

Numerous advances in medicine occurred during the latter half of the 20th century, and progress will accelerate in the 21st century. In particular, research in molecular biology has made significant advances, and it was reported that the human genome was almost completely deciphered in June 2000. This will contribute greatly to genetic research in malignant diseases. The development of regenerative medicine, such as cell transplantation using differentiated embryonic or mesenchymal stem cell, will have a significant effect on the field of surgery. The Japan Surgical Society must apply the new knowledge being made available to realize the concept of integrative medicine, in which surgery will play a major role. Substantial changes in postgraduate and continuing education and training of surgeons may be necessary. Other topics for discussion include risk management in the case of surgical accidents and medical ethics based on the Declaration of Helsinki.

Education, Medical, Continuing↗
PubMedDate not supplied

Goodbye to all that. The end of moderate protectionism in human subjects research.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it is wise to do so, remains to be seen.

Bioethics↗