The Declaration of Helsinki (DoH, Finnish: Helsingin julistus, Swedish: Helsingfors-deklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). (wikipedia.org)
The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone seven revisions (the most recent at the General Assembly in October 2013) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 2013 version. (wikipedia.org)
Internationally, there is little argument that the pre-eminent document addressing research ethics is the Declaration of Helsinki, 3 adopted by the World Medical Association (WMA) in 1964. (cmaj.ca)
Since its original publication in 1964, the Declaration has become widely regarded as the cornerstone ethical document of research studies involving human subjects. (wma.net)
Declaration of Helsinki external icon - International doctrine, written in 1964 by the World Medical Organization and revised several times since then. (cdc.gov)
19962
why do we use 1996 version of the Declaration of Helsinki in the UK even though there have been more revisions to this? (mhra.gov.uk)
The GCP Directive stated that the Declaration of Helsinki 1996 was the standard for GCP. (mhra.gov.uk)
Ethical11
The protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). (wikipedia.org)
1. The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. (ahrp.org)
No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration. (ahrp.org)
14. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration. (ahrp.org)
Each research study involving human subjects must conform to the ethical norms and standards in the Declaration of Helsinki, including ethics committee approval statement, clinical trial registration statement, and informed consent statement. (journalanimalresearch.com)
The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. (aix-scientifics.com)
No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration. (aix-scientifics.com)
The objection is that the PACE investigators received funding and approval based on their protocol, and in their protocol they listed the Declaration of Helsinki as first among the ethical codes they intended to follow. (trialbyerror.org)
Compliance with GCP provides public assurance that the rights, safety, and wel -being of research subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. (who.int)
There was a consensus among the mandated by the Declaration of Hel- interesting by researchers and journals group of the importance of prospective sinki on Ethical Principles for Medical alike. (who.int)
Ethical procedures followed the Helsinki declaration (2013). (bvsalud.org)
World Medical Ass3
Its role was described by a Brazilian forum in 2000 in these words: "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity. (wikipedia.org)
3. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient. (ahrp.org)
WASHINGTON, D.C. - The National Bioethics Advisory Commission (NBAC) today released a report that would put the U.S. in the unenviable position of endorsing ethics standards for American researchers that are lower than those required by the World Medical Association?s Declaration of Helsinki. (citizen.org)
20002
The Declaration of Helsinki has been amended 5 times, most recently in 2000. (cmaj.ca)
Whereas the recently revised (October 2000) Declaration actually strengthened protections in a number of critical regards, the NBAC has undermined some of these important steps forward, Public Citizen said today. (citizen.org)
Ministerial1
While this Declaration on the Helsinki +40 process is meagre, previous Ministerial texts on Helsinki +40 provide us both with a framework from which to move forward in the Helsinki + 40 process, as well as with a key tool for addressing the crisis of Russia's aggression in Ukraine: focusing on implementing our commitments fully in good faith. (usmission.gov)
Physicians2
The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter. (wikipedia.org)
Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians, the WMA encourages others who are involved in medical research involving human subjects to adopt these principles. (aix-scientifics.com)
Revisions2
At a one-day meeting at the Hay-Adams Hotel on August 26, stakeholders, including delegates from National Medical Associations, and invited experts, will discuss further revisions to the Declaration. (wma.net)
MRCT Center at Harvard responded to the World Medical Association's request for comments or potential revisions to the Declaration of Helsinki (DoH), which will reach its 50th anniversary in 2014. (mrctcenter.org)
Principles6
Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. (wma.net)
Unfortunately, we have not been able to make the same reaffirmations in our Declaration this year for one simple reason: the egregious ongoing violations by the Russian Federation of its international legal obligations and its continuing contravention of the fundamental principles and the commitments of this Organization in its aggression in Ukraine. (usmission.gov)
Manuscripts not conforming to the principles of the Declaration of Helsinki should not be accepted for publication. (journalanimalresearch.com)
In Schedule 1, part 2 - the 'Conditions and principles of GCP…', point 6, states that Clinical Trials shall be conducted in accordance with the principles of the Declaration of Helsinki. (mhra.gov.uk)
The current study was approved by the Ethics Committee of Shanghai Skin Disease Hospital, and was performed according to the principles of the Declaration of Helsinki ( 3 ). (spandidos-publications.com)
The study adhered to the principles of the Declaration of Helsinki. (karger.com)
Paragraph2
The United States makes the following interpretative statement under paragraph IV.1(A) 6 of the OSCE rules of procedure and asks that it be attached to this Declaration. (usmission.gov)
In the PACE trial protocol , the investigators included a paragraph on "compliance" that featured this sentence: "The trial will be conducted in compliance with the Declaration of Helsinki, the trial protocol, MRC Good Clinical Practice (GCP) guidance, the Data Protection Act (1998), the Multi-centre Research Ethics Committee (MREC) and Local Research Ethics Committees (LREC) approvals and other regulatory requirements, as appropriate. (trialbyerror.org)
Accordance2
Written informed consent is obtained from all participants and the trial is conducted in accordance with the Declaration of Helsinki II. (lu.se)
Describes employee rights to information about the in accordance with the Berlin Declaration on Open workplace. (lu.se)
Consistent1
Hence, fixing the version of the Declaration of Helsinki to be followed is consistent with the Commissions previously stated view. (mhra.gov.uk)
Biomedical1
The Declaration defines basic tenets of human rights in biomedical research involving human subjects. (cdc.gov)
Research3
The Declaration is an important document in the history of research ethics as it is the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents. (wikipedia.org)
Washington August 26 2013 : Medical experts from around the world will gather in Washington D.C. later this month for the next stage in the process of revising the World Medical Association's Declaration of Helsinki on medical research. (wma.net)
The item mentioned first, the Declaration of Helsinki , was developed after World War II as an effort to protect human research subjects. (trialbyerror.org)
Conferences1
The WMA is now in the process of revising the document and in April, following several expert conferences, it published a draft revised version of the Declaration for public consultation. (wma.net)
Patients1
Adult patients receiving treatment for a suicide attempt in a Helsinki City general hospital emergency room in 2016-2017 were eligible to participate. (karger.com)
Standards2
Critics of the trial raise concerns that there was a failure to comply with the standards contained in the Declaration of Helsinki over the disclosure of conflicts of interest. (trialbyerror.org)
The main objection-at least my main objection-was not simply that there was "a failure to comply with the standards contained in the Declaration of Helsinki over the disclosure of conflicts of interest. (trialbyerror.org)
Comments2
The comments have been considered by the WMA's Declaration of Helsinki workgroup and many of the suggestions have now been incorporated into a new revised draft of the document which will be considered at the meeting in Washington. (wma.net)
Declaration of Helsinki comments: Declaration of Helsinki, i. (mrctcenter.org)
Discussion2
This addition to the Declaration has given rise to significant debate and discussion, including in the pages of the journal. (cmaj.ca)
Below, I have included the section of the HRA on "conflicts of interests," which includes discussion of the Declaration of Helsinki. (trialbyerror.org)
Site1
Zenon Panoussis has put the complete Fishman declaration (including both the full text of OT II and OT III and the Michael Robinson/Karin Spaink summaries) on a web site in Sweden. (cmu.edu)
Finland1
The Biafra Republic Government in Exile, BRGIE has adopted a charter on the Biafra Declaration in an extraordinary conference held in Helsinki Finland. (swiftreporters.com)
20201
The Helsinki Declaration 2020: Europe that protects. (nih.gov)
Participants1
The World Medical Association's revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. (nih.gov)
Clinical1
Partial Nephrectomy for T2 Kidney Cancer Might Violate the Declaration of Helsinki: Re-envisioning the Value of Clinical Research to Foster the Progress of Evidence-based Urology: The Case of Partial Nephrectomy for cT2 Renal Masses. (nih.gov)
Europe1
WASHINGTON-Yesterday, members of the Commission on Security and Cooperation in Europe, also known as the U.S. Helsinki Commission, Chairman Representative Joe Wilson (SC-02), Ranking Member Representative Steve Cohen (TN-09) and Commissioner Representative Victoria Spartz (IN-05) sent a letter to President Biden, requesting he grants the transfer of MGM-140 Army Tactical Missile System (ATACMS) to Ukraine. (csce.gov)
Human subjects1
World Medical Assembly issues the Declaration of Helsinki with 22 recommendations "as a guide to every physician in biomedical research involving human subjects. (nih.gov)
Title1
Declaration itself is simply filled, we write on the title side who we, from where and where are we going, is there a product for declaring. (drivecarve.com)