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This comparision has been improved, see doh_2008_2013_sync.diff.html and the corresponding article Revised WMA Declaration of Helsinki 2013: Improved Side-by-Side Comparison

doh2008.norm.md		doh2013.norm.md
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1	# WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI	1	# WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
2		2
3	Ethical Principles for Medical Research Involving Human Subjects	3	Ethical Principles for Medical Research Involving Human Subjects
4		4
5	World Medical Association	5	World Medical Association
6		6
7	Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964,	7	Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964,
8	and amended by the:	8	and amended by the:
9	29th WMA General Assembly, Tokyo, Japan, October 1975	9	29th WMA General Assembly, Tokyo, Japan, October 1975
10	35th WMA General Assembly, Venice, Italy, October 1983	10	35th WMA General Assembly, Venice, Italy, October 1983
11	41st WMA General Assembly, Hong Kong, September 1989	11	41st WMA General Assembly, Hong Kong, September 1989
12	48th WMA General Assembly, Somerset West, Republic of South Africa,	12	48th WMA General Assembly, Somerset West, Republic of South Africa,
13	October 1996	13	October 1996
14	52nd WMA General Assembly, Edinburgh, Scotland, October 2000	14	52nd WMA General Assembly, Edinburgh, Scotland, October 2000
15	53rd WMA General Assembly, Washington 2002 (Note of Clarification on	15	53rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of
16	paragraph 29 added)	16	Clarification added)
17	55th WMA General Assembly, Tokyo 2004 (Note of Clarification on	17	55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of
18	Paragraph 30 added)	18	Clarification added)
19	59th WMA General Assembly, Seoul, October 2008	19	59th WMA General Assembly, Seoul, Republic of Korea, October 2008
		20	64th WMA General Assembly, Fortaleza, Brazil, October 2013
20		21
21	## INTRODUCTION	22	## PREAMBLE
22		23
23	1) The World Medical Association (WMA) has developed the Declaration of	24	1) The World Medical Association (WMA) has developed the Declaration of
24	Helsinki as a statement of ethical principles for medical research	25	Helsinki as a statement of ethical principles for medical research
25	involving human subjects, including research on identifiable human	26	involving human subjects, including research on identifiable human
26	material and data.	27	material and data.
27		28
28	The Declaration is intended to be read as a whole and each of its	29	The Declaration is intended to be read as a whole and each of its
29	constituent paragraphs should not be applied without consideration of	30	constituent paragraphs should be applied with consideration of all other
30	all other relevant paragraphs.	31	relevant paragraphs.
31		32
32	2) Although the Declaration is addressed primarily to physicians, the	33	2) Consistent with the mandate of the WMA, the Declaration is addressed
33	WMA encourages other participants in medical research involving human	34	primarily to physicians. The WMA encourages others who are involved in
34	subjects to adopt these principles.	35	medical research involving human subjects to adopt these principles.
35		36
36	3) It is the duty of the physician to promote and safeguard the health	37	## GENERAL PRINCIPLES
37	of patients, including those who are involved in medical research. The
38	physician's knowledge and conscience are dedicated to the fulfilment of
39	this duty.
40		38
41	4) The Declaration of Geneva of the WMA binds the physician with the	39	3) The Declaration of Geneva of the WMA binds the physician with the
42	words, “The health of my patient will be my first consideration,” and	40	words, “The health of my patient will be my first consideration,” and
43	the International Code of Medical Ethics declares that, “A physician	41	the International Code of Medical Ethics declares that, “A physician
44	shall act in the patient's best interest when providing medical care.”	42	shall act in the patient's best interest when providing medical care.”
45		43
46	5) Medical progress is based on research that ultimately must include	44	4) It is the duty of the physician to promote and safeguard the health,
47	studies involving human subjects. Populations that are underrepresented	45	well-being and rights of patients, including those who are involved in
48	in medical research should be provided appropriate access to	46	medical research. The physician's knowledge and conscience are dedicated
49	participation in research.	47	to the fulfilment of this duty.
50		48
51	6) In medical research involving human subjects, the well-being of the	49	5) Medical progress is based on research that ultimately must include
52	individual research subject must take precedence over all other	50	studies involving human subjects.
53	interests.
54		51
55	7) The primary purpose of medical research involving human subjects is	52	6) The primary purpose of medical research involving human subjects is
56	to understand the causes, development and effects of diseases and	53	to understand the causes, development and effects of diseases and
57	improve preventive, diagnostic and therapeutic interventions (methods,	54	improve preventive, diagnostic and therapeutic interventions (methods,
58	procedures and treatments). Even the best current interventions must be	55	procedures and treatments). Even the best proven interventions must be
59	evaluated continually through research for their safety, effectiveness,	56	evaluated continually through research for their safety, effectiveness,
60	efficiency, accessibility and quality.	57	efficiency, accessibility and quality.
61		58
62	8) In medical practice and in medical research, most interventions	59	7) Medical research is subject to ethical standards that promote and
		60	ensure respect for all human subjects and protect their health and
		61	rights.
		62
		63	8) While the primary purpose of medical research is to generate new
		64	knowledge, this goal can never take precedence over the rights and
		65	interests of individual research subjects.
		66
		67	9) It is the duty of physicians who are involved in medical research to
		68	protect the life, health, dignity, integrity, right to
		69	self-determination, privacy, and confidentiality of personal information
		70	of research subjects. The responsibility for the protection of research
		71	subjects must always rest with the physician or other health care
		72	professionals and never with the research subjects, even though they
		73	have given consent.
		74
		75	10) Physicians must consider the ethical, legal and regulatory norms and
		76	standards for research involving human subjects in their own countries
		77	as well as applicable international norms and standards. No national or
		78	international ethical, legal or regulatory requirement should reduce or
		79	eliminate any of the protections for research subjects set forth in this
		80	Declaration.
		81
		82	11) Medical research should be conducted in a manner that minimises
		83	possible harm to the environment.
		84
		85	12) Medical research involving human subjects must be conducted only by
		86	individuals with the appropriate ethics and scientific education,
		87	training and qualifications. Research on patients or healthy volunteers
		88	requires the supervision of a competent and appropriately qualified
		89	physician or other health care professional.
		90
		91	13) Groups that are underrepresented in medical research should be
		92	provided appropriate access to participation in research.
		93
		94	14) Physicians who combine medical research with medical care should
		95	involve their patients in research only to the extent that this is
		96	justified by its potential preventive, diagnostic or therapeutic value
		97	and if the physician has good reason to believe that participation in
		98	the research study will not adversely affect the health of the patients
		99	who serve as research subjects.
		100
		101	15) Appropriate compensation and treatment for subjects who are harmed
		102	as a result of participating in research must be ensured.
		103
		104	## RISKS, BURDENS AND BENEFITS
		105
		106	16) In medical practice and in medical research, most interventions
63	involve risks and burdens.	107	involve risks and burdens.
64		108
65	9) Medical research is subject to ethical standards that promote respect	109	Medical research involving human subjects may only be conducted if the
66	for all human subjects and protect their health and rights. Some	110	importance of the objective outweighs the risks and burdens to the
67	research populations are particularly vulnerable and need special	111	research subjects.
68	protection. These include those who cannot give or refuse consent for
69	themselves and those who may be vulnerable to coercion or undue
70	influence.
71		112
72	10) Physicians should consider the ethical, legal and regulatory norms	113	17) All medical research involving human subjects must be preceded by
73	and standards for research involving human subjects in their own	114	careful assessment of predictable risks and burdens to the individuals
74	countries as well as applicable international norms and standards. No	115	and groups involved in the research in comparison with foreseeable
75	national or international ethical, legal or regulatory requirement	116	benefits to them and to other individuals or groups affected by the
76	should reduce or eliminate any of the protections for research subjects	117	condition under investigation.
77	set forth in this Declaration.
78		118
79	## PRINCIPLES FOR ALL MEDICAL RESEARCH	119	Measures to minimise the risks must be implemented. The risks must be
		120	continuously monitored, assessed and documented by the researcher.
80		121
81	11) It is the duty of physicians who participate in medical research to	122	18) Physicians may not be involved in a research study involving human
82	protect the life, health, dignity, integrity, right to	123	subjects unless they are confident that the risks have been adequately
83	self-determination, privacy, and confidentiality of personal information	124	assessed and can be satisfactorily managed.
84	of research subjects.
85		125
86	12) Medical research involving human subjects must conform to generally	126	When the risks are found to outweigh the potential benefits or when
		127	there is conclusive proof of definitive outcomes, physicians must assess
		128	whether to continue, modify or immediately stop the study.
		129
		130	## VULNERABLE GROUPS AND INDIVIDUALS
		131
		132	19) Some groups and individuals are particularly vulnerable and may have
		133	an increased likelihood of being wronged or of incurring additional
		134	harm.
		135
		136	All vulnerable groups and individuals should receive specifically
		137	considered protection.
		138
		139	20) Medical research with a vulnerable group is only justified if the
		140	research is responsive to the health needs or priorities of this group
		141	and the research cannot be carried out in a non-vulnerable group. In
		142	addition, this group should stand to benefit from the knowledge,
		143	practices or interventions that result from the research.
		144
		145	## SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS
		146
		147	21) Medical research involving human subjects must conform to generally
87	accepted scientific principles, be based on a thorough knowledge of the	148	accepted scientific principles, be based on a thorough knowledge of the
88	scientific literature, other relevant sources of information, and	149	scientific literature, other relevant sources of information, and
89	adequate laboratory and, as appropriate, animal experimentation. The	150	adequate laboratory and, as appropriate, animal experimentation. The
90	welfare of animals used for research must be respected.	151	welfare of animals used for research must be respected.
91		152
92	13) Appropriate caution must be exercised in the conduct of medical	153	22) The design and performance of each research study involving human
93	research that may harm the environment.	154	subjects must be clearly described and justified in a research protocol.
94		155
95	14) The design and performance of each research study involving human	156	The protocol should contain a statement of the ethical considerations
96	subjects must be clearly described in a research protocol. The protocol	157	involved and should indicate how the principles in this Declaration have
97	should contain a statement of the ethical considerations involved and	158	been addressed. The protocol should include information regarding
98	should indicate how the principles in this Declaration have been	159	funding, sponsors, institutional affiliations, potential conflicts of
99	addressed. The protocol should include information regarding funding,	160	interest, incentives for subjects and information regarding provisions
100	sponsors, institutional affiliations, other potential conflicts of	161	for treating and/or compensating subjects who are harmed as a
101	interest, incentives for subjects and provisions for treating and/or	162	consequence of participation in the research study.
102	compensating subjects who are harmed as a consequence of participation
103	in the research study. The protocol should describe arrangements for
104	post-study access by study subjects to interventions identified as
105	beneficial in the study or access to other appropriate care or benefits.
106		163
107	15) The research protocol must be submitted for consideration, comment,	164	In clinical trials, the protocol must also describe appropriate
108	guidance and approval to a research ethics committee before the study	165	arrangements for post-trial provisions.
109	begins. This committee must be independent of the researcher, the	166
110	sponsor and any other undue influence. It must take into consideration	167	## RESEARCH ETHICS COMMITTEES
		168
		169	23) The research protocol must be submitted for consideration, comment,
		170	guidance and approval to the concerned research ethics committee before
		171	the study begins. This committee must be transparent in its functioning,
		172	must be independent of the researcher, the sponsor and any other undue
		173	influence and must be duly qualified. It must take into consideration
111	the laws and regulations of the country or countries in which the	174	the laws and regulations of the country or countries in which the
112	research is to be performed as well as applicable international norms	175	research is to be performed as well as applicable international norms
113	and standards but these must not be allowed to reduce or eliminate any	176	and standards but these must not be allowed to reduce or eliminate any
114	of the protections for research subjects set forth in this Declaration.	177	of the protections for research subjects set forth in this Declaration.
		178
115	The committee must have the right to monitor ongoing studies. The	179	The committee must have the right to monitor ongoing studies. The
116	researcher must provide monitoring information to the committee,	180	researcher must provide monitoring information to the committee,
117	especially information about any serious adverse events. No change to	181	especially information about any serious adverse events. No amendment to
118	the protocol may be made without consideration and approval by the	182	the protocol may be made without consideration and approval by the
119	committee.	183	committee. After the end of the study, the researchers must submit a
120		184	final report to the committee containing a summary of the study’s
121	16) Medical research involving human subjects must be conducted only by	185	findings and conclusions.
122	individuals with the appropriate scientific training and qualifications.
123	Research on patients or healthy volunteers requires the supervision of a
124	competent and appropriately qualified physician or other health care
125	professional. The responsibility for the protection of research subjects
126	must always rest with the physician or other health care professional
127	and never the research subjects, even though they have given consent.
128
129	17) Medical research involving a disadvantaged or vulnerable population
130	or community is only justified if the research is responsive to the
131	health needs and priorities of this population or community and if there
132	is a reasonable likelihood that this population or community stands to
133	benefit from the results of the research.
134
135	18) Every medical research study involving human subjects must be
136	preceded by careful assessment of predictable risks and burdens to the
137	individuals and communities involved in the research in comparison with
138	foreseeable benefits to them and to other individuals or communities
139	affected by the condition under investigation.
140		186
141	19) Every clinical trial must be registered in a publicly accessible	187	## PRIVACY AND CONFIDENTIALITY
142	database before recruitment of the first subject.
143		188
144	20) Physicians may not participate in a research study involving human	189	24) Every precaution must be taken to protect the privacy of research
145	subjects unless they are confident that the risks involved have been	190	subjects and the confidentiality of their personal information.
146	adequately assessed and can be satisfactorily managed. Physicians must
147	immediately stop a study when the risks are found to outweigh the
148	potential benefits or when there is conclusive proof of positive and
149	beneficial results.
150		191
151	21) Medical research involving human subjects may only be conducted if	192	## INFORMED CONSENT
152	the importance of the objective outweighs the inherent risks and burdens
153	to the research subjects.
154		193
155	22) Participation by competent individuals as subjects in medical	194	25) Participation by individuals capable of giving informed consent as
156	research must be voluntary. Although it may be appropriate to consult	195	subjects in medical research must be voluntary. Although it may be
157	family members or community leaders, no competent individual may be	196	appropriate to consult family members or community leaders, no
158	enrolled in a research study unless he or she freely agrees.	197	individual capable of giving informed consent may be enrolled in a
		198	research study unless he or she freely agrees.
159		199
160	23) Every precaution must be taken to protect the privacy of research	200	26) In medical research involving human subjects capable of giving
161	subjects and the confidentiality of their personal information and to	201	informed consent, each potential subject must be adequately informed of
162	minimize the impact of the study on their physical, mental and social	202	the aims, methods, sources of funding, any possible conflicts of
163	integrity.	203	interest, institutional affiliations of the researcher, the anticipated
		204	benefits and potential risks of the study and the discomfort it may
		205	entail, post-study provisions and any other relevant aspects of the
		206	study. The potential subject must be informed of the right to refuse to
		207	participate in the study or to withdraw consent to participate at any
		208	time without reprisal. Special attention should be given to the specific
		209	information needs of individual potential subjects as well as to the
		210	methods used to deliver the information.
164		211
165	24) In medical research involving competent human subjects, each	212	After ensuring that the potential subject has understood the
166	potential subject must be adequately informed of the aims, methods,	213	information, the physician or another appropriately qualified individual
167	sources of funding, any possible conflicts of interest, institutional	214	must then seek the potential subject’s freely-given informed consent,
168	affiliations of the researcher, the anticipated benefits and potential	215	preferably in writing. If the consent cannot be expressed in writing,
169	risks of the study and the discomfort it may entail, and any other	216	the non-written consent must be formally documented and witnessed.
170	relevant aspects of the study. The potential subject must be informed of
171	the right to refuse to participate in the study or to withdraw consent
172	to participate at any time without reprisal. Special attention should be
173	given to the specific information needs of individual potential subjects
174	as well as to the methods used to deliver the information. After
175	ensuring that the potential subject has understood the information, the
176	physician or another appropriately qualified individual must then seek
177	the potential subject’s freely-given informed consent, preferably in
178	writing. If the consent cannot be expressed in writing, the non-written
179	consent must be formally documented and witnessed.
180		217
181	25) For medical research using identifiable human material or data,	218	All medical research subjects should be given the option of being
182	physicians must normally seek consent for the collection, analysis,	219	informed about the general outcome and results of the study.
183	storage and/or reuse. There may be situations where consent would be
184	impossible or impractical to obtain for such research or would pose a
185	threat to the validity of the research. In such situations the research
186	may be done only after consideration and approval of a research ethics
187	committee.
188		220
189	26) When seeking informed consent for participation in a research study	221	27) When seeking informed consent for participation in a research study
190	the physician should be particularly cautious if the potential subject	222	the physician must be particularly cautious if the potential subject is
191	is in a dependent relationship with the physician or may consent under	223	in a dependent relationship with the physician or may consent under
192	duress. In such situations the informed consent should be sought by an	224	duress. In such situations the informed consent must be sought by an
193	appropriately qualified individual who is completely independent of this	225	appropriately qualified individual who is completely independent of this
194	relationship.	226	relationship.
195		227
196	27) For a potential research subject who is incompetent, the physician	228	28) For a potential research subject who is incapable of giving informed
197	must seek informed consent from the legally authorized representative.	229	consent, the physician must seek informed consent from the legally
198	These individuals must not be included in a research study that has no	230	authorised representative. These individuals must not be included in a
199	likelihood of benefit for them unless it is intended to promote the	231	research study that has no likelihood of benefit for them unless it is
200	health of the population represented by the potential subject, the	232	intended to promote the health of the group represented by the potential
201	research cannot instead be performed with competent persons, and the	233	subject, the research cannot instead be performed with persons capable
202	research entails only minimal risk and minimal burden.	234	of providing informed consent, and the research entails only minimal
		235	risk and minimal burden.
203		236
204	28) When a potential research subject who is deemed incompetent is able	237	29) When a potential research subject who is deemed incapable of giving
205	to give assent to decisions about participation in research, the	238	informed consent is able to give assent to decisions about participation
206	physician must seek that assent in addition to the consent of the	239	in research, the physician must seek that assent in addition to the
207	legally authorized representative. The potential subject’s dissent	240	consent of the legally authorised representative. The potential
208	should be respected.	241	subject’s dissent should be respected.
209		242
210	29) Research involving subjects who are physically or mentally incapable	243	30) Research involving subjects who are physically or mentally incapable
211	of giving consent, for example, unconscious patients, may be done only	244	of giving consent, for example, unconscious patients, may be done only
212	if the physical or mental condition that prevents giving informed	245	if the physical or mental condition that prevents giving informed
213	consent is a necessary characteristic of the research population. In	246	consent is a necessary characteristic of the research group. In such
214	such circumstances the physician should seek informed consent from the	247	circumstances the physician must seek informed consent from the legally
215	legally authorized representative. If no such representative is	248	authorised representative. If no such representative is available and if
216	available and if the research cannot be delayed, the study may proceed	249	the research cannot be delayed, the study may proceed without informed
217	without informed consent provided that the specific reasons for	250	consent provided that the specific reasons for involving subjects with a
218	involving subjects with a condition that renders them unable to give	251	condition that renders them unable to give informed consent have been
219	informed consent have been stated in the research protocol and the study	252	stated in the research protocol and the study has been approved by a
220	has been approved by a research ethics committee. Consent to remain in	253	research ethics committee. Consent to remain in the research must be
221	the research should be obtained as soon as possible from the subject or	254	obtained as soon as possible from the subject or a legally authorised
222	a legally authorized representative.	255	representative.
223		256
224	30) Authors, editors and publishers all have ethical obligations with	257	31) The physician must fully inform the patient which aspects of their
225	regard to the publication of the results of research. Authors have a	258	care are related to the research. The refusal of a patient to
226	duty to make publicly available the results of their research on human	259	participate in a study or the patient’s decision to withdraw from the
227	subjects and are accountable for the completeness and accuracy of their	260	study must never adversely affect the patient-physician relationship.
228	reports. They should adhere to accepted guidelines for ethical
229	reporting. Negative and inconclusive as well as positive results should
230	be published or otherwise made publicly available. Sources of funding,
231	institutional affiliations and conflicts of interest should be declared
232	in the publication. Reports of research not in accordance with the
233	principles of this Declaration should not be accepted for publication.
234		261
235	## ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE	262	32) For medical research using identifiable human material or data, such
		263	as research on material or data contained in biobanks or similar
		264	repositories, physicians must seek informed consent for its collection,
		265	storage and/or reuse. There may be exceptional situations where consent
		266	would be impossible or impracticable to obtain for such research. In
		267	such situations the research may be done only after consideration and
		268	approval of a research ethics committee.
236		269
237	31) The physician may combine medical research with medical care only to	270	## USE OF PLACEBO
238	the extent that the research is justified by its potential preventive,
239	diagnostic or therapeutic value and if the physician has good reason to
240	believe that participation in the research study will not adversely
241	affect the health of the patients who serve as research subjects.
242		271
243	32) The benefits, risks, burdens and effectiveness of a new intervention	272	33) The benefits, risks, burdens and effectiveness of a new intervention
244	must be tested against those of the best current proven intervention,	273	must be tested against those of the best proven intervention(s), except
245	except in the following circumstances:	274	in the following circumstances:
246		275
247	- The use of placebo, or no treatment, is acceptable in studies where	276	Where no proven intervention exists, the use of placebo, or no
248	no current proven intervention exists; or	277	intervention, is acceptable; or
249	- Where for compelling and scientifically sound methodological reasons
250	the use of placebo is necessary to determine the efficacy or safety
251	of an intervention and the patients who receive placebo or no
252	treatment will not be subject to any risk of serious or irreversible
253	harm. Extreme care must be taken to avoid abuse of this option.
254		278
255	33) At the conclusion of the study, patients entered into the study are	279	Where for compelling and scientifically sound methodological reasons the
256	entitled to be informed about the outcome of the study and to share any	280	use of any intervention less effective than the best proven one, the use
257	benefits that result from it, for example, access to interventions	281	of placebo, or no intervention is necessary to determine the efficacy or
258	identified as beneficial in the study or to other appropriate care or	282	safety of an intervention
259	benefits.
260		283
261	34) The physician must fully inform the patient which aspects of the	284	and the patients who receive any intervention less effective than the
262	care are related to the research. The refusal of a patient to	285	best proven one, placebo, or no intervention will not be subject to
263	participate in a study or the patient’s decision to withdraw from the	286	additional risks of serious or irreversible harm as a result of not
264	study must never interfere with the patient-physician relationship.	287	receiving the best proven intervention.
265		288
266	35) In the treatment of a patient, where proven interventions do not	289	Extreme care must be taken to avoid abuse of this option.
267	exist or have been ineffective, the physician, after seeking expert	290
268	advice, with informed consent from the patient or a legally authorized	291	## POST-TRIAL PROVISIONS
269	representative, may use an unproven intervention if in the physician's	292
270	judgement it offers hope of saving life, re-establishing health or	293	34) In advance of a clinical trial, sponsors, researchers and host
271	alleviating suffering. Where possible, this intervention should be made	294	country governments should make provisions for post-trial access for all
272	the object of research, designed to evaluate its safety and efficacy. In	295	participants who still need an intervention identified as beneficial in
273	all cases, new information should be recorded and, where appropriate,	296	the trial. This information must also be disclosed to participants
274	made publicly available.	297	during the informed consent process.
		298
		299	## RESEARCH REGISTRATION AND PUBLICATION AND DISSEMINATION OF RESULTS
		300
		301	35) Every research study involving human subjects must be registered in
		302	a publicly accessible database before recruitment of the first subject.
		303
		304	36) Researchers, authors, sponsors, editors and publishers all have
		305	ethical obligations with regard to the publication and dissemination of
		306	the results of research. Researchers have a duty to make publicly
		307	available the results of their research on human subjects and are
		308	accountable for the completeness and accuracy of their reports. All
		309	parties should adhere to accepted guidelines for ethical reporting.
		310	Negative and inconclusive as well as positive results must be published
		311	or otherwise made publicly available. Sources of funding, institutional
		312	affiliations and conflicts of interest must be declared in the
		313	publication. Reports of research not in accordance with the principles
		314	of this Declaration should not be accepted for publication.
		315
		316	## UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE
		317
		318	37) In the treatment of an individual patient, where proven
		319	interventions do not exist or other known interventions have been
		320	ineffective, the physician, after seeking expert advice, with informed
		321	consent from the patient or a legally authorised representative, may use
		322	an unproven intervention if in the physician's judgement it offers hope
		323	of saving life, re-establishing health or alleviating suffering. This
		324	intervention should subsequently be made the object of research,
		325	designed to evaluate its safety and efficacy. In all cases, new
		326	information must be recorded and, where appropriate, made publicly
		327	available.
		328
		329	## ARTICLE INFORMATION
		330
		331	Corresponding Author: World Medical Association, 13, ch. du Levant, CIB
		332	- Bâtiment A, 01210 Ferney-Voltaire, France; wma@wma.net.
		333
		334	Published Online: October 19, 2013. doi:10.1001/jama.2013.281053.
		335
		336	Disclaimer: ©2013 World Medical Association, Inc. All Rights Reserved.
		337	All intellectual property rights in the Declaration of Helsinki are
		338	vested in the World Medical Association. The WMA has granted JAMA
		339	exclusive rights to publish the English-language version of the
		340	Declaration through December 31, 2013.
		341
		342	Online-Only Content: Audio podcast is available at www.jama.com.
		343	Copyright ©2013 American Medical Association
275		344
276	## SOURCE	345	## SOURCE
277		346
278	http://www.wma.net/en/30publications/10policies/b3/17c.pdf	347	http://www.wma.net/en/30publications/10policies/b3/
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		349	http://jama.jamanetwork.com/article.aspx?articleid=1760318