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Declaration of Helsinki

Declaration of Helsinki

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The Declaration of Helsinki is a set of ethical principles regarding human experimentation
Human experimentation
Human subject research includes experiments and observational studies. Human subjects are commonly participants in research on basic biology, clinical medicine, nursing, psychology, and all other social sciences. Humans have been participants in research since the earliest studies...

 developed for the medical community by the World Medical Association
World Medical Association
The World Medical Association is an international and independent confederation of free professional Medical Associations, therefore representing physicians worldwide...

 (WMA). It is widely regarded as the cornerstone document of human research ethics
Research ethics
Research ethics involves the application of fundamental ethical principles to a variety of topics involving scientific research. These include the design and implementation of research involving human experimentation, animal experimentation, various aspects of academic scandal, including scientific...

. (WMA 2000, Bošnjak 2001, Tyebkhan 2003)

It is not a legally binding instrument in international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations (Human and Fluss 2001). 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" (Human and Fluss 2001).

History


The Declaration was originally adopted in June 1964 in Helsinki
Helsinki
Helsinki is the capital and largest city in Finland. It is in the region of Uusimaa, located in southern Finland, on the shore of the Gulf of Finland, an arm of the Baltic Sea. The population of the city of Helsinki is , making it by far the most populous municipality in Finland. Helsinki is...

, Finland
Finland
Finland , officially the Republic of Finland, is a Nordic country situated in the Fennoscandian region of Northern Europe. It is bordered by Sweden in the west, Norway in the north and Russia in the east, while Estonia lies to its south across the Gulf of Finland.Around 5.4 million people reside...

, and has since undergone six revisions (the most recent at the General Assembly in October 2008) and two clarifications, growing considerably in length from 11 to 32 paragraphs (35 paragraphs in 2008 version). The Declaration is an important document in the history of research ethics as the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents.

Prior to the 1947 Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...

 there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies [3a]. The Declaration developed the ten principles first stated in the Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...

, and tied them to the Declaration of Geneva
Declaration of Geneva
The Declaration of Geneva was adopted by the General Assembly of the World Medical Association at Geneva in 1948 and amended in 1968, 1984, 1994, 2005 and 2006. It is a declaration of physicians' dedication to the humanitarian goals of medicine, a declaration that was especially important in view...

 (1948), a statement of physician's ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation
Human experimentation
Human subject research includes experiments and observational studies. Human subjects are commonly participants in research on basic biology, clinical medicine, nursing, psychology, and all other social sciences. Humans have been participants in research since the earliest studies...

' used in the Nuremberg Code. A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1).

First revision (1975)


The 1975 revision was almost twice the length of the original, and introduced the concept of oversight by an 'independent committee' (Article I.2) which became a system of Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

s (IRB) in the US, and research ethics committees or ethical review boards in other countries (Riis 1977). In the United States regulations governing IRBs came into effect in 1981 and are now encapsulated in the Common Rule
Common rule
The Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. These regulations governing Institutional Review Boards for oversight of human research came into effect in 1981 following the 1975 revision of the Declaration of...

. Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. 'Legal guardian' was replaced with 'responsible relative'. The duty to the individual was given primacy over that to society (Article I.5), and concepts of publication ethics were introduced (Article I.8). Any experimental manoeuvre was to be compared to the best available care as a comparator (Article II.2), and access to such care was assured (Article I.3). The document was also made gender neutral and

Second to Fourth revisions (1975-2000)


Subsequent revisions between 1975 and 2000 were relatively minor, so the 1975 version was effectively that which governed research over a quarter of a century of relative stability.

Second and Third Revisions (1983, 1989)


The second revision (1983) included seeking the consent of minors where possible. The third revision (1989) dealt further with the function and structure of the independent committee. However from 1982 onwards, the Declaration was not alone as a universal guide since CIOMS and the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 (WHO) had also developed their International Ethical Guidelines for Biomedical Research Involving Human Subjects.
Background

The AIDS Clinical Trials Group (ACTG) Study 076 of Zidovudine
Zidovudine
Zidovudine or azidothymidine is a nucleoside analog reverse-transcriptase inhibitor , a type of antiretroviral drug used for the treatment of HIV/AIDS. It is an analog of thymidine....

 in maternal-infant transmission of HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...

 had been published in 1994 (Connor et al. 1994). This was a placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...

 controlled trial which showed a reduction of nearly 70% in the risk of transmission, and Zidovudine became a de facto standard of care
Standard of care
In tort law, the standard of care is the degree of prudence and caution required of an individual who is under a duty of care.The requirements of the standard are closely dependent on circumstances. Whether the standard of care has been breached is determined by the trier of fact, and is usually...

. The subsequent initiation of further placebo controlled trials in developing countries and funded by the United States Center for Disease Control or National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...

 raised considerable concern when it was learned that US patients in trials had essentially unrestricted access to the drug, but not in developing countries. Justification was provided by a 1994 WHO group in Geneva which concluded "Placebo-controlled trials offer the best option for a rapid and scientifically valid assessment of alternative antiretroviral drug regimens to prevent transmission of HIV".
These trials appeared to be in direct conflict with recently published guidelines (Levine 1993) for international research by CIOMS, which stated "The ethical standards applied should be no less exacting than they would be in the case of research carried out in country", referring to the sponsoring or initiating country.
In fact a schism between ethical universalism and ethical pluralism was already apparent before the 1993 revision of the CIOMS guidelines (Levine 1993).
Fourth revision

In retrospect, this was one of the most significant revisions because it added the phrase "This does not exclude the use of inert placebo in studies of where no proven diagnostic or therapeutic method exists" to Article II.3. This led to the US Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA) ignoring this and all subsequent revisions.
The European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

 similarly only cites the 1996 version in the EU Clinical Trials Directive published in 2001.

Background


Following the fourth revision in 1996 pressure began to build almost immediately for a more fundamental approach to revising the declaration (Levine 1999). In 1997 Lurie and Wolfe published their seminal paper on HIV trials, raising awareness of a number of central issues. These included the claims that the continuing trials in developing countries were unethical, and pointing out a fundamental discrepancy in decisions to change the study design in Thailand but not Africa. The issue of the use of placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...

 in turn raised questions about the standard of care in developing counties and whether, as Marcia Angell
Marcia Angell
Marcia Angell, M.D. is an American physician, author, and the first woman to serve as editor-in-chief of the New England Journal of Medicine...

 wrote "Human subjects in any part of the world should be protected by an irreducible set of ethical standards" (1988). The American Medical Association put forward a proposed revision in November that year,
and a proposed revision (17.C/Rev1/99) was circulated the following year,
causing considerable debate and resulting in a number of symposia and conferences.
Recommendations included limiting the document to basic guiding principles.
Many editorials and commentaries were published reflecting a variety of views including concerns that the Declaration was being weakened by a shift towards efficiency-based and utilitarian standards (Stockhausen 2000, Loff and Black 2000, Zion, Gillam and Loff 2000, Brennan 1999, Rothman, Michaels and Baum 2000), and an entire issue of the Bulletin of Medical Ethics was devoted to the debate. Others saw it as an example of Angell's 'Ethical Imperialism', an imposition of US needs on the developing world,

and resisted any but the most minor changes, or even a partitioned document with firm principles and commentaries, as used by CIOMS. Brennan summarises this by stating "The principles exemplified by the current Declaration of Helsinki represent a delicate compromise that we should modify only after careful deliberation". Nevertheless, what had started as a controversy around a specific series of trials and their designs in Sub-Saharan Africa, now had potential implications for all research.

Fifth revision


Even though most meetings around the proposed revisions failed to achieve consensus, and many argued that the declaration should remain unchanged or only minimally altered, after extensive consultation the Workgroup

eventually came up with a text that was endorsed by WMA's Council and passed by the General Assembly on October 7, 2000,

and which proved to be the most far reaching and contentious revision to date. The justification for this was partly to take account of expanded scope of biomedical research since 1975 (Riis 2000). This involved a restructuring of the document, including renumbering and re-ordering of all the articles, the changes in which are outlined in this Table. The Introduction establishes the rights of subjects and describes the inherent tension between the need for research to improve the common good, and the rights of the individual. The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards. The distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine (1999, 2000) was removed to emphasise the more general application of ethical principles, but the application of the principles to healthy volunteers is spelt out in Articles 18-9, and they are referred to in Article 8 ('those who will not benefit personally from the research') as being especially vulnerable. The scope of ethical review was increased to include human tissue and data (Article 1), the necessity to challenge accepted care was added (Article 6), as well as establishing the primacy of the ethical requirements over laws and regulations (Article 9).

Amongst the many changes was an increased emphasis on the need to benefit the communities in which research is undertaken, and to draw attention to the ethical problems of experimenting on those who would not benefit from the research, such as developing countries in which innovative medications would not be available. Article 19 first introduces the concept of social justice, and extends the scope from individuals to the community as a whole by stating that 'research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research'. This new role for the Declaration has been both denounced

and praised,

and even considered for a clarification footnote (Carlson 2004). Article 27 expanded the concept of publication ethics, adding the necessity to disclose conflict of interest (echoed in Articles 13 and 22), and to include publication bias amongst ethically problematic behaviour.

Additional Principles:

The most controversial revisions

(Articles 29, 30) were placed in this new category. These predictably were those that like the fourth revision were related to the ongoing debate in international health research. The discussions (Christie 2000) indicate that there was felt a need to send a strong signal that exploitation of poor populations as a means to an end, by research from which they would not benefit, was unacceptable. In this sense the Declaration endorsed ethical universalism.

Article 29 restates the use of placebo where 'no proven' intervention exists. Surprisingly, although the wording was virtually unchanged, this created far more protest in this revision. The implication being that placebos are not permitted where proven interventions are available. The placebo question was already an active debate prior to the fourth revision but had intensified, while at the same time the placebo question was still causing controversy in the international setting. This revision implies that in choosing a study design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries. The wording of the fourth and fifth revisions reflect the position taken by Rothman and Michel (1994), and Freedman et al. (1996), known as 'active-control orthodoxy'. The opposing view, as expressed by Levine (1999) and by Temple and Ellenberg (2000) is referred to as 'placebo orthodoxy', insisting that placebo controls are more scientifically efficient and are justifiable where the risk of harm is low. This viewpoint argues that where no standards of care exist, as for instance in developing countries, then placebo-controlled trials are appropriate. The utilitarian argument (Elander and Hermerén 1995) held that the disadvantage to a few (such as denial of potentially beneficial interventions) was justifiable for the advantage of many future patients. These arguments are intimately tied to the concept of distributive justice
Distributive justice
Distributive justice concerns what some consider to be socially just allocation of goods in a society. A society in which incidental inequalities in outcome do not arise would be considered a society guided by the principles of distributive justice...

, the equitable distribution of the burdens of research (Brennan 1999, Benatar 2001). As with much of the Declaration, there is room for interpretation of words. 'Best current' has been variously held to refer to either global or local contexts (Nuffield Council on Bioethics 2005).

Article 30 introduced another new concept, that after the conclusion of the study patients 'should be assured of access to the best proven' intervention arising from the study, a justice issue. Arguments around this have dealt with whether subjects derive benefit from the trial and are no worse off at the end than the status quo prior to the trial, or of not participating, versus the harm of being denied access to that which they have contributed to. There are also operational issues that are unclear.

Aftermath


Given the lack of consensus on many issues prior to the fifth revision it is no surprise that the debates continued unabated (Macklin 2001, Williams 2004). The debate over these and related issues also revealed differences in perspectives between developed and developing countries (Loff 2000, Schuklenk 2001; CMAJ 2003). Zion and colleagues (Zion 2000, Loff and Black 2000, Loff 2000) have attempted to frame the debate more carefully, exploring the broader social and ethical issues and the lived realities of potential subjects lives as well as acknowledging the limitations of absolute universality in a diverse world, particularly those framed in a context that might be considered elitist and structured by gender and geographic identity. As Macklin (2001) points out, both sides may be right, since justice "is not an unambiguous concept".

Clarifications of Articles 29, 30 (2002-2004)


Eventually Notes of Clarification (footnotes) to articles 29 and 30 were added in 2002 and 2004 respectively, predominantly under pressure from the US (CMAJ 2003, Blackmer 2005). The 2002 clarification to Article 29 was in response to many concerns about WMA's apparent position on placebos. As WMA states in the note, there appeared to be 'diverse interpretations and possibly confusion'. It then outlined circumstances in which a placebo might be 'ethically acceptable', namely 'compelling… methodological reasons', or 'minor conditions' where the 'risk of serious or irreversible harm' was considered low. Effectively this shifted the WMA position to what has been considered a 'middle ground' (Emmanuel 2001, Huston 2001). Given the previous lack of consensus, this merely shifted the ground of debate,

which now extended to the use of the 'or' connector. For this reason the footnote indicates that the wording must be interpreted in the light of all the other principles of the Declaration.

Article 30 was debated further at the 2003 meeting, with another proposed clarification (CMAJ 2003) but did not result in any convergence of thought, and so decisions were postponed for another year (De Roy 2004, WMA 2003), but again a commitment was made to protecting the vulnerable. A new working group examined article 30, and recommended not amending it in January 2004.

Later that year the American Medical Association proposed a further note of clarification that was incorporated (Blackmer 2005). In this clarification the issue of post trial care now became something to consider, not an absolute assurance.

Despite these changes, as Macklin predicted, consensus was no closer and the Declaration was considered by some to be out of touch with contemporary thinking (Lie 2004), and even the question of the future of the Declaration became a matter for conjecture (Wolinsky 2006)

Sixth revision (2008)


The sixth revision cycle commenced in May 2007. This consisted of a call for submissions, completed in August 2007. The terms of reference included only a limited revision compared to 2000.
In November 2007 a draft revision

was issued for consultation till February 2008, and led to a workshop in Helsinki in March.

Those comments were then incorporated into a second draft in May.
Further workshops were held in Cairo
Cairo
Cairo , is the capital of Egypt and the largest city in the Arab world and Africa, and the 16th largest metropolitan area in the world. Nicknamed "The City of a Thousand Minarets" for its preponderance of Islamic architecture, Cairo has long been a centre of the region's political and cultural life...

 and São Paulo
São Paulo
São Paulo is the largest city in Brazil, the largest city in the southern hemisphere and South America, and the world's seventh largest city by population. The metropolis is anchor to the São Paulo metropolitan area, ranked as the second-most populous metropolitan area in the Americas and among...

 and the comments collated in August 2008. A final text was then developed by the Working Group for consideration by the Ethics Committee and finally the General Assembly, which approved it on October 18. Public debate was relatively slight compared to previous cycles, and in general supportive.
Input was received from a wide number of sources, some of which have been published, such as Feminist Approaches to Bioethics.

Others include CIOMS and the US Government.

Principles


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. Investigators still have to abide by local legislation but will be held to the higher standard.

Basic principles


The fundamental principle is respect for the individual (Article 8), their right to self determination and the right to make informed decisions
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...

 (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the subject's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9).

The recognition of the increased vulnerability of individuals and groups calls for special vigilance (Article 8). It is recognised that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor (Articles 23, 24), then allowance should be considered for surrogate consent by an individual acting in the subject's best interest. In which case their assent should still be obtained if at all possible (Article 25).

Operational principles


Research should be based on a thorough knowledge of the scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ethical review and oversight by a properly convened committee (Article 13). The protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). Information regarding the study should be publicly available (Article 16). Ethical publications extend to publication of the results and consideration of any potential conflict of interest (Article 27). Experimental investigations should always be compared against the best methods, but under certain circumstances a placebo or no treatment group may be utilised (Article 29). The interests of the subject after the study is completed should be part of the overall ethical assessment, including assuring their access to the best proven care (Article 30). Wherever possible unproven methods should be tested in the context of research where there is reasonable belief of possible benefit (Article 32).

Additional guidelines or regulations


Investigators often find themselves in the position of having to follow several different codes or guidelines, and are therefore required to understand the differences between them. One of these is Good Clinical Practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...

 (GCP), an international guide, while each country may also have local regulations such as the Common Rule in the US, in addition to the requirements of the FDA and Office for Human Research Protections (OHRP) in that country. There are a number of available tools which compare these.

Other countries have guides with similar roles, such as the Tri-Council Policy Statement in Canada. Additional international guidelines include those of the CIOMS, Nuffield Council and UNESCO.

Future


The controversies and national divisions over the text have continued. The US FDA rejected the 2000 and subsequent revisions, only recognizing the third (1989) revision (Wolinsky 2006), and in 2006 announced it would eliminate all reference to the Declaration. After consultation, which included expressions of concern,

a final rule was issued on April 28, 2008 replacing the Declaration of Helsinki with Good Clinical Practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...

 effective October 2008.

This has raised a number of concerns regarding the apparent weakening of protections for research subjects outside the United States.

The NIH training in human subject research participant protection no longer refers to the Declaration of Helsinki. The European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....

 refers to the fourth (1996) revision.

While the Declaration has been a central document guiding research practice, its future has been called into question. Challenges include the apparent conflict between guides, such as the CIOMS and Nuffield Council documents. Another is whether it should concentrate on basic principles as opposed to being more prescriptive, and hence controversial. It has continually grown and faced more frequent revisions (Carlson 2004). The recent controversies undermine the authority of the document, as does the apparent desertion by major bodies, and any rewording must embrace deeply and widely held values, since continual shifts in the text do not imply authority. the actual claims to authority particularly on a global level, by the insertion of the word "international" in article 10 has been challenged.
Carlson raises the question as to whether the document's utility should be more formally evaluated, rather than just relying on tradition.

Timeline (WMA meetings)

  • 1964: Original version. 18th Meeting, Helsinki
  • 1975: First revision. 29th Meeting, Tokyo
  • 1983: Second revision. 35th Meeting, Venice
  • 1989: Third revision. 41st Meeting, Hong Kong
  • 1996: Fourth revision. 48th Meeting, Somerset West (SA)
  • 2000: Fifth revision. 52nd Meeting, Edinburgh
  • 2002: First clarification, Washington
  • 2004: Second clarification, Tokyo
  • 2008: Sixth revision, 59th Meeting, Seoul

See also

  • Informed consent
    Informed consent
    Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...

  • Medical ethics
    Medical ethics
    Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...

  • Clinical trial
    Clinical trial
    Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

  • Human experimentation in the United States
    Human experimentation in the United States
    There have been numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects....


Training


2000-2008


2000
Prior to fifth revision
Following fifth revision
2001
(References)
2002
2003
2004
2005
2006
  • Williams JR. The Physician's Role in the Protection of Human Research Subjects. Science and Engineering Ethics 2006; 12: 5-12

2007
  • Carlson RV, van Ginneken NH, Pettigrew LM, Davies A, Boyd KM, Webb DJ. The three official language versions of the Declaration of Helsinki: what's lost in translation? J Med Ethics 2007; 33: 545-548
  • S Frewer A, Schmidt U, eds. History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics. Stuttgart: Franz Steiner Verlag, 2007.

Following sixth revision

WMA


Other codes and regulations

  • Nuremberg Code
    Nuremberg Code
    The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...

  • Declaration of Geneva
    Declaration of Geneva
    The Declaration of Geneva was adopted by the General Assembly of the World Medical Association at Geneva in 1948 and amended in 1968, 1984, 1994, 2005 and 2006. It is a declaration of physicians' dedication to the humanitarian goals of medicine, a declaration that was especially important in view...

  • Belmont Report
    Belmont Report
    The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission...

  • CIOMS
  • Good clinical practice
    Good clinical practice
    Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...

     (GCP)
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • Code of Federal Regulations
    Code of Federal Regulations
    The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...


External links