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/ |
348 | |||
349 | http://jama.jamanetwork.com/article.aspx?articleid=1760318 |