doh2008.sync.norm.md | doh2013.sync.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 | [SYNC1-1] | 24 | [SYNC1-1] |
24 | | 25 | |
25 | 1) The World Medical Association (WMA) has developed the Declaration of | 26 | 1) The World Medical Association (WMA) has developed the Declaration of |
26 | Helsinki as a statement of ethical principles for medical research | 27 | Helsinki as a statement of ethical principles for medical research |
27 | involving human subjects, including research on identifiable human | 28 | involving human subjects, including research on identifiable human |
28 | material and data. | 29 | material and data. |
29 | | 30 | |
30 | The Declaration is intended to be read as a whole and each of its | 31 | The Declaration is intended to be read as a whole and each of its |
31 | constituent paragraphs should not be applied without consideration of | 32 | constituent paragraphs should be applied with consideration of all other |
32 | all other relevant paragraphs. | 33 | relevant paragraphs. |
33 | | 34 | |
34 | 2) Although the Declaration is addressed primarily to physicians, the | 35 | 2) Consistent with the mandate of the WMA, the Declaration is addressed |
35 | WMA encourages other participants in medical research involving human | 36 | primarily to physicians. The WMA encourages others who are involved in |
36 | subjects to adopt these principles. | 37 | medical research involving human subjects to adopt these principles. |
| 38 | |
| 39 | ## GENERAL PRINCIPLES |
37 | | 40 | |
38 | [SYNC4-3] | 41 | [SYNC4-3] |
39 | | 42 | |
40 | 4) The Declaration of Geneva of the WMA binds the physician with the | 43 | 3) The Declaration of Geneva of the WMA binds the physician with the |
41 | words, “The health of my patient will be my first consideration,” and | 44 | words, “The health of my patient will be my first consideration,” and |
42 | the International Code of Medical Ethics declares that, “A physician | 45 | the International Code of Medical Ethics declares that, “A physician |
43 | shall act in the patient's best interest when providing medical care.” | 46 | shall act in the patient's best interest when providing medical care.” |
44 | | 47 | |
45 | 3) It is the duty of the physician to promote and safeguard the health | 48 | 4) It is the duty of the physician to promote and safeguard the health, |
46 | ·················· of patients, including those who are involved in | 49 | well-being and rights of patients, including those who are involved in |
47 | medical research. The physician's knowledge and conscience are dedicated | 50 | medical research. The physician's knowledge and conscience are dedicated |
48 | to the fulfilment of this duty. | 51 | to the fulfilment of this duty. |
49 | | 52 | |
50 | 5) Medical progress is based on research that ultimately must include | 53 | 5) Medical progress is based on research that ultimately must include |
51 | studies involving human subjects. {[TO5'] Populations that …} | 54 | studies involving human subjects. |
52 | | 55 | |
53 | 7) The primary purpose of medical research involving human subjects is | 56 | 6) The primary purpose of medical research involving human subjects is |
54 | to understand the causes, development and effects of diseases and | 57 | to understand the causes, development and effects of diseases and |
55 | improve preventive, diagnostic and therapeutic interventions (methods, | 58 | improve preventive, diagnostic and therapeutic interventions (methods, |
56 | procedures and treatments). Even the best current interventions must be | 59 | procedures and treatments). Even the best proven interventions must be |
57 | evaluated continually through research for their safety, effectiveness, | 60 | evaluated continually through research for their safety, effectiveness, |
58 | efficiency, accessibility and quality. | 61 | efficiency, accessibility and quality. |
59 | | 62 | |
60 | 9) Medical research is subject to ethical standards that promote respect | 63 | 7) Medical research is subject to ethical standards that promote and |
61 | for all human subjects and protect their health and rights. Some | 64 | ensure respect for all human subjects and protect their health and |
62 | research populations are particularly vulnerable and need special | 65 | rights. |
63 | protection. These include those who cannot give or refuse consent for | |
64 | themselves and those who may be vulnerable to coercion or undue | |
65 | influence. | |
66 | | 66 | |
67 | 6) In medical research involving human subjects, the well-being of the | 67 | 8) While the primary purpose of medical research is to generate new |
68 | individual research subject must take precedence over all other | 68 | knowledge, this goal can never take precedence over the rights and |
69 | interests. | 69 | interests of individual research subjects. |
70 | | 70 | |
71 | 11) It is the duty of physicians who participate in medical research to | 71 | 9) It is the duty of physicians who are involved in medical research to |
72 | protect the life, health, dignity, integrity, right to | 72 | protect the life, health, dignity, integrity, right to |
73 | self-determination, privacy, and confidentiality of personal information | 73 | self-determination, privacy, and confidentiality of personal information |
74 | of research subjects. {The responsibility for the protection of research | 74 | of research subjects. The responsibility for the protection of research |
75 | subjects must always rest with the physician or other health care | 75 | subjects must always rest with the physician or other health care |
76 | professional and never the research subjects, even though they have | 76 | professionals and never with the research subjects, even though they |
77 | given consent. [FROM16]} | 77 | have given consent. |
78 | | 78 | |
79 | 10) Physicians should consider the ethical, legal and regulatory norms | 79 | 10) Physicians must · consider the ethical, legal and regulatory norms |
80 | and standards for research involving human subjects in their own | 80 | and standards for research involving human subjects in their own |
81 | countries as well as applicable international norms and standards. No | 81 | countries as well as applicable international norms and standards. No |
82 | national or international ethical, legal or regulatory requirement | 82 | national or international ethical, legal or regulatory requirement |
83 | should reduce or eliminate any of the protections for research subjects | 83 | should reduce or eliminate any of the protections for research subjects |
84 | set forth in this Declaration. | 84 | set forth in this Declaration. |
85 | | 85 | |
86 | 13) Appropriate caution must be exercised in the conduct of medical | 86 | 11) Medical research should be conducted in a manner that minimises |
87 | research that may harm the environment. | 87 | possible harm to the environment. |
88 | | 88 | |
89 | 16) Medical research involving human subjects must be conducted only by | 89 | 12) Medical research involving human subjects must be conducted only by |
90 | individuals with the appropriate scientific ···················· | 90 | individuals with the appropriate ethics and scientific education, |
91 | training and qualifications. Research on patients or healthy volunteers | 91 | training and qualifications. Research on patients or healthy volunteers |
92 | requires the supervision of a competent and appropriately qualified | 92 | requires the supervision of a competent and appropriately qualified |
93 | physician or other health care professional. {[TO11] The responsibility | 93 | physician or other health care professional. |
94 | for …} | |
95 | | 94 | |
96 | {5') Populations that are underrepresented in medical research should be | 95 | 13) Groups that are underrepresented in medical research should be |
97 | provided appropriate access to participation in research. [FROM5]} | 96 | provided appropriate access to participation in research. |
98 | | 97 | |
99 | [SYNC31-14] | 98 | [SYNC31-14] |
100 | | 99 | |
101 | 31) The physician may combine medical research with medical care only | 100 | 14) Physicians who combine medical research with medical care should |
102 | ································ to the extent that the research is | 101 | involve their patients in research only to the extent that this is |
103 | justified by its potential preventive, diagnostic or therapeutic value | 102 | justified by its potential preventive, diagnostic or therapeutic value |
104 | and if the physician has good reason to believe that participation in | 103 | and if the physician has good reason to believe that participation in |
105 | the research study will not adversely affect the health of the patients | 104 | the research study will not adversely affect the health of the patients |
106 | who serve as research subjects. | 105 | who serve as research subjects. |
107 | | 106 | |
| 107 | 15) Appropriate compensation and treatment for subjects who are harmed |
| 108 | as a result of participating in research must be ensured. |
| 109 | |
| 110 | ## RISKS, BURDENS AND BENEFITS |
| 111 | |
108 | [SYNC8-16] | 112 | [SYNC8-16] |
109 | | 113 | |
110 | 8) In medical practice and in medical research, most interventions | 114 | 16) In medical practice and in medical research, most interventions |
111 | involve risks and burdens. | 115 | involve risks and burdens. |
112 | | 116 | |
113 | 21) Medical research involving human subjects may only be conducted if | 117 | Medical research involving human subjects may only be conducted if ·· |
114 | the importance of the objective outweighs the inherent risks and burdens | 118 | the importance of the objective outweighs the ······ risks and burdens |
115 | to the research subjects. | 119 | to the research subjects. |
116 | | 120 | |
117 | [SYNC18-17] | 121 | [SYNC18-17] |
118 | | 122 | |
119 | 18) Every medical research study involving human subjects must be | 123 | 17) All medical research involving human subjects must be ······ |
120 | preceded by careful assessment of predictable risks and burdens to the | 124 | preceded by careful assessment of predictable risks and burdens to the |
121 | individuals and communities involved in the research in comparison with | 125 | individuals and groups involved in the research in comparison with |
122 | foreseeable benefits to them and to other individuals or communities | 126 | foreseeable benefits to them and to other individuals or groups affected |
123 | affected by the condition under investigation. | 127 | by the condition under investigation. |
| 128 | |
| 129 | Measures to minimise the risks must be implemented. The risks must be |
| 130 | continuously monitored, assessed and documented by the researcher. |
124 | | 131 | |
125 | [SYNC20-18] | 132 | [SYNC20-18] |
126 | | 133 | |
127 | 20) Physicians may not participate in a research study involving human | 134 | 18) Physicians may not be involved in a research study involving human |
128 | subjects unless they are confident that the risks involved have been | 135 | subjects unless they are confident that the risks have been adequately |
129 | adequately assessed and can be satisfactorily managed. Physicians must | 136 | assessed and can be satisfactorily managed. |
130 | immediately stop a study when the risks are found to outweigh the | 137 | |
131 | potential benefits or when there is conclusive proof of positive and | 138 | When the risks are found to outweigh the potential benefits or when |
132 | beneficial results. | 139 | there is conclusive proof of definitive outcomes, physicians must assess |
| 140 | whether to continue, modify or immediately stop the study. |
| 141 | |
| 142 | ## VULNERABLE GROUPS AND INDIVIDUALS |
| 143 | |
| 144 | 19) Some groups and individuals are particularly vulnerable and may have |
| 145 | an increased likelihood of being wronged or of incurring additional |
| 146 | harm. |
| 147 | |
| 148 | All vulnerable groups and individuals should receive specifically |
| 149 | considered protection. |
133 | | 150 | |
134 | [SYNC17-20] | 151 | [SYNC17-20] |
135 | | 152 | |
136 | 17) Medical research involving a disadvantaged or vulnerable population | 153 | 20) Medical research with a vulnerable group is only justified if the |
137 | or community is only justified if the research is responsive to the | 154 | research is responsive to the health needs or priorities of this group |
138 | health needs and priorities of this population or community and if there | 155 | and the research cannot be carried out in a non-vulnerable group. In |
139 | is a reasonable likelihood that this population or community stands to | 156 | addition, this group should stand to benefit from the knowledge, |
140 | benefit from the results of the research. | 157 | practices or interventions that result from the research. |
141 | | 158 | |
142 | ## PRINCIPLES FOR ALL MEDICAL RESEARCH | 159 | ## SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS |
143 | | 160 | |
144 | [SYNC12-21] | 161 | [SYNC12-21] |
145 | | 162 | |
146 | 12) Medical research involving human subjects must conform to generally | 163 | 21) Medical research involving human subjects must conform to generally |
147 | accepted scientific principles, be based on a thorough knowledge of the | 164 | accepted scientific principles, be based on a thorough knowledge of the |
148 | scientific literature, other relevant sources of information, and | 165 | scientific literature, other relevant sources of information, and |
149 | adequate laboratory and, as appropriate, animal experimentation. The | 166 | adequate laboratory and, as appropriate, animal experimentation. The |
150 | welfare of animals used for research must be respected. | 167 | welfare of animals used for research must be respected. |
151 | | 168 | |
152 | 14) The design and performance of each research study involving human | 169 | 22) The design and performance of each research study involving human |
153 | subjects must be clearly described in a research protocol. | 170 | subjects must be clearly described and justified in a research protocol. |
154 | | 171 | |
155 | The protocol should contain a statement of the ethical considerations | 172 | The protocol should contain a statement of the ethical considerations |
156 | involved and should indicate how the principles in this Declaration have | 173 | involved and should indicate how the principles in this Declaration have |
157 | been addressed. The protocol should include information regarding | 174 | been addressed. The protocol should include information regarding |
158 | funding, sponsors, institutional affiliations, other potential conflicts | 175 | funding, sponsors, institutional affiliations, potential conflicts of |
159 | of interest, incentives for subjects and provisions for treating and/or | 176 | interest, incentives for subjects and information regarding provisions |
160 | compensating subjects who are harmed as a consequence of participation | 177 | for treating and/or compensating subjects who are harmed as a |
161 | in the research study. The protocol should describe arrangements for | 178 | consequence of participation in the research study. |
162 | post-study access by study subjects to interventions identified as | 179 | |
163 | beneficial in the study or access to other appropriate care or benefits. | 180 | In clinical trials, the protocol must also describe appropriate |
| 181 | arrangements for post-trial provisions. |
| 182 | |
| 183 | ## RESEARCH ETHICS COMMITTEES |
164 | | 184 | |
165 | [SYNC15-23] | 185 | [SYNC15-23] |
166 | | 186 | |
167 | 15) The research protocol must be submitted for consideration, comment, | 187 | 23) The research protocol must be submitted for consideration, comment, |
168 | guidance and approval to a research ethics committee before the study | 188 | guidance and approval to the concerned research ethics committee before |
169 | begins. This committee must be independent of the researcher, the | 189 | the study begins. This committee must be transparent in its functioning, |
170 | sponsor and any other undue influence. It must take into consideration | 190 | must be independent of the researcher, the sponsor and any other undue |
| 191 | influence and must be duly qualified. It must take into consideration |
171 | the laws and regulations of the country or countries in which the | 192 | the laws and regulations of the country or countries in which the |
172 | research is to be performed as well as applicable international norms | 193 | research is to be performed as well as applicable international norms |
173 | and standards but these must not be allowed to reduce or eliminate any | 194 | and standards but these must not be allowed to reduce or eliminate any |
174 | of the protections for research subjects set forth in this Declaration. | 195 | of the protections for research subjects set forth in this Declaration. |
| 196 | |
175 | The committee must have the right to monitor ongoing studies. The | 197 | The committee must have the right to monitor ongoing studies. The |
176 | researcher must provide monitoring information to the committee, | 198 | researcher must provide monitoring information to the committee, |
177 | especially information about any serious adverse events. No change to | 199 | especially information about any serious adverse events. No amendment to |
178 | the protocol may be made without consideration and approval by the | 200 | the protocol may be made without consideration and approval by the |
179 | committee. | 201 | committee. After the end of the study, the researchers must submit a |
| 202 | final report to the committee containing a summary of the study’s |
| 203 | findings and conclusions. |
| 204 | |
| 205 | ## PRIVACY AND CONFIDENTIALITY |
180 | | 206 | |
181 | [SYNC23-24] | 207 | [SYNC23-24] |
182 | | 208 | |
183 | 23) Every precaution must be taken to protect the privacy of research | 209 | 24) Every precaution must be taken to protect the privacy of research |
184 | subjects and the confidentiality of their personal information and to | 210 | subjects and the confidentiality of their personal information. |
185 | minimize the impact of the study on their physical, mental and social | |
186 | integrity. | |
187 | | 211 | |
188 | 22) Participation by competent individuals as subjects in medical | 212 | ## INFORMED CONSENT |
189 | research must be voluntary. Although it may be appropriate to consult | 213 | |
190 | family members or community leaders, no competent individual may be | 214 | 25) Participation by individuals capable of giving informed consent as |
191 | enrolled in a research study unless he or she freely agrees. | 215 | subjects in medical research must be voluntary. Although it may be |
| 216 | appropriate to consult family members or community leaders, no |
| 217 | individual capable of giving informed consent may be enrolled in a |
| 218 | research study unless he or she freely agrees. |
192 | | 219 | |
193 | [SYNC24-26] | 220 | [SYNC24-26] |
194 | | 221 | |
195 | 24) In medical research involving competent human subjects ··· | 222 | 26) In medical research involving human subjects capable of giving |
196 | ················, each potential subject must be adequately informed of | 223 | informed consent, each potential subject must be adequately informed of |
197 | the aims, methods, sources of funding, any possible conflicts of | 224 | the aims, methods, sources of funding, any possible conflicts of |
198 | interest, institutional affiliations of the researcher, the anticipated | 225 | interest, institutional affiliations of the researcher, the anticipated |
199 | benefits and potential risks of the study and the discomfort it may | 226 | benefits and potential risks of the study and the discomfort it may |
200 | entail, ···················· and any other relevant aspects of the | 227 | entail, post-study provisions and any other relevant aspects of the |
201 | study. The potential subject must be informed of the right to refuse to | 228 | study. The potential subject must be informed of the right to refuse to |
202 | participate in the study or to withdraw consent to participate at any | 229 | participate in the study or to withdraw consent to participate at any |
203 | time without reprisal. Special attention should be given to the specific | 230 | time without reprisal. Special attention should be given to the specific |
204 | information needs of individual potential subjects as well as to the | 231 | information needs of individual potential subjects as well as to the |
205 | methods used to deliver the information. | 232 | methods used to deliver the information. |
206 | | 233 | |
207 | After ensuring that the potential subject has understood the | 234 | After ensuring that the potential subject has understood the |
208 | information, the physician or another appropriately qualified individual | 235 | information, the physician or another appropriately qualified individual |
209 | must then seek the potential subject’s freely-given informed consent, | 236 | must then seek the potential subject’s freely-given informed consent, |
210 | preferably in writing. If the consent cannot be expressed in writing, | 237 | preferably in writing. If the consent cannot be expressed in writing, |
211 | the non-written consent must be formally documented and witnessed. | 238 | the non-written consent must be formally documented and witnessed. |
212 | | 239 | |
213 | 33) At the conclusion of the study, patients entered into the study are | 240 | All medical research subjects should be given the option of being |
214 | entitled to be informed about the outcome of the study and to share any | 241 | informed about the general outcome and results of the study. |
215 | benefits that result from it, for example, access to interventions | |
216 | identified as beneficial in the study or to other appropriate care or | |
217 | benefits. | |
218 | | 242 | |
219 | [SYNC26-27] | 243 | [SYNC26-27] |
220 | | 244 | |
221 | 26) When seeking informed consent for participation in a research study | 245 | 27) When seeking informed consent for participation in a research study |
222 | the physician should be particularly cautious if the potential subject | 246 | the physician must be particularly cautious if the potential subject is |
223 | is in a dependent relationship with the physician or may consent under | 247 | in a dependent relationship with the physician or may consent under |
224 | duress. In such situations the informed consent should be sought by an | 248 | duress. In such situations the informed consent must be sought by an |
225 | appropriately qualified individual who is completely independent of this | 249 | appropriately qualified individual who is completely independent of this |
226 | relationship. | 250 | relationship. |
227 | | 251 | |
228 | 27) For a potential research subject who is incompetent, ······· | 252 | 28) For a potential research subject who is incapable of giving informed |
229 | ········ the physician must seek informed consent from the legally | 253 | consent, the physician must seek informed consent from the legally |
230 | authorized representative. These individuals must not be included in a | 254 | authorised representative. These individuals must not be included in a |
231 | research study that has no likelihood of benefit for them unless it is | 255 | research study that has no likelihood of benefit for them unless it is |
232 | intended to promote the health of the population represented by the | 256 | intended to promote the health of the group represented by the potential |
233 | potential subject, the research cannot instead be performed with | 257 | subject, the research cannot instead be performed with persons capable |
234 | ············ competent persons, and the research entails only minimal | 258 | of providing informed consent, and the research entails only minimal |
235 | risk and minimal burden. | 259 | risk and minimal burden. |
236 | | 260 | |
237 | 28) When a potential research subject who is deemed incompetent | 261 | 29) When a potential research subject who is deemed incapable of giving |
238 | ················ is able to give assent to decisions about participation | 262 | informed consent is able to give assent to decisions about participation |
239 | in research, the physician must seek that assent in addition to the | 263 | in research, the physician must seek that assent in addition to the |
240 | consent of the legally authorized representative. The potential | 264 | consent of the legally authorised representative. The potential |
241 | subject’s dissent should be respected. | 265 | subject’s dissent should be respected. |
242 | | 266 | |
243 | 29) Research involving subjects who are physically or mentally incapable | 267 | 30) Research involving subjects who are physically or mentally incapable |
244 | of giving consent, for example, unconscious patients, may be done only | 268 | of giving consent, for example, unconscious patients, may be done only |
245 | if the physical or mental condition that prevents giving informed | 269 | if the physical or mental condition that prevents giving informed |
246 | consent is a necessary characteristic of the research population. In | 270 | consent is a necessary characteristic of the research group. ····· In |
247 | such circumstances the physician should seek informed consent from the | 271 | such circumstances the physician must seek informed consent from the |
248 | legally authorized representative. If no such representative is | 272 | legally authorised representative. If no such representative is |
249 | available and if the research cannot be delayed, the study may proceed | 273 | available and if the research cannot be delayed, the study may proceed |
250 | without informed consent provided that the specific reasons for | 274 | without informed consent provided that the specific reasons for |
251 | involving subjects with a condition that renders them unable to give | 275 | involving subjects with a condition that renders them unable to give |
252 | informed consent have been stated in the research protocol and the study | 276 | informed consent have been stated in the research protocol and the study |
253 | has been approved by a research ethics committee. Consent to remain in | 277 | has been approved by a research ethics committee. Consent to remain in |
254 | the research should be obtained as soon as possible from the subject or | 278 | the research must be obtained as soon as possible from the subject or a |
255 | a legally authorized representative. | 279 | legally authorised representative. |
256 | | |
257 | ## ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE | |
258 | | 280 | |
259 | [SYNC34-31] | 281 | [SYNC34-31] |
260 | | 282 | |
261 | 34) The physician must fully inform the patient which aspects of the | 283 | 31) The physician must fully inform the patient which aspects of their |
262 | care are related to the research. The refusal of a patient to | 284 | care are related to the research. The refusal of a patient to |
263 | participate in a study or the patient’s decision to withdraw from the | 285 | participate in a study or the patient’s decision to withdraw from the |
264 | study must never interfere with the patient-physician relationship. | 286 | study must never adversely affect the patient-physician relationship. |
265 | | 287 | |
266 | 25) For medical research using identifiable human material or data, ···· | 288 | 32) For medical research using identifiable human material or data, such |
267 | ······································································ | 289 | as research on material or data contained in biobanks or similar |
268 | ··········· physicians must normally seek consent for the collection, | 290 | repositories, physicians must seek informed consent for its collection, |
269 | analysis, storage and/or reuse. There may be situations where consent | 291 | storage and/or reuse. There may be exceptional situations where consent |
270 | would be impossible or impractical to obtain for such research or would | 292 | would be impossible or impracticable to obtain for such research. In |
271 | pose a threat to the validity of the research. ······················ In | |
272 | such situations the research may be done only after consideration and | 293 | such situations the research may be done only after consideration and |
273 | approval of a research ethics committee. | 294 | approval of a research ethics committee. |
274 | | 295 | |
| 296 | ## USE OF PLACEBO |
| 297 | |
275 | [SYNC32-33] | 298 | [SYNC32-33] |
276 | | 299 | |
277 | 32) The benefits, risks, burdens and effectiveness of a new intervention | 300 | 33) The benefits, risks, burdens and effectiveness of a new intervention |
278 | must be tested against those of the best current proven intervention, | 301 | must be tested against those of the best proven intervention(s), except |
279 | except in the following circumstances: | 302 | in the following circumstances: |
280 | | 303 | |
281 | ° The use of placebo, or no treatment, is acceptable in studies where no | 304 | Where no proven intervention exists, the use of placebo, or no |
282 | current proven intervention exists; or | 305 | intervention, is acceptable; or |
283 | | 306 | |
284 | ° Where for compelling and scientifically sound methodological reasons | 307 | Where for compelling and scientifically sound methodological reasons the |
285 | the use of placebo is necessary to determine the efficacy or safety of | 308 | use of any intervention less effective than the best proven one, the use |
286 | an intervention and the patients who receive placebo or no treatment | 309 | of placebo, or no intervention is necessary to determine the efficacy or |
287 | will not be subject to any risk of serious or irreversible harm. | 310 | safety of an intervention |
| 311 | |
| 312 | and the patients who receive any intervention less effective than the |
| 313 | best proven one, placebo, or no intervention will not be subject to |
| 314 | additional risks of serious or irreversible harm as a result of not |
| 315 | receiving the best proven intervention. |
288 | | 316 | |
289 | Extreme care must be taken to avoid abuse of this option. | 317 | Extreme care must be taken to avoid abuse of this option. |
290 | | 318 | |
| 319 | ## POST-TRIAL PROVISIONS |
| 320 | |
| 321 | 34) In advance of a clinical trial, sponsors, researchers and host |
| 322 | country governments should make provisions for post-trial access for all |
| 323 | participants who still need an intervention identified as beneficial in |
| 324 | the trial. This information must also be disclosed to participants |
| 325 | during the informed consent process. |
| 326 | |
| 327 | ## RESEARCH REGISTRATION AND PUBLICATION AND DISSEMINATION OF RESULTS |
| 328 | |
291 | [SYNC19-35] | 329 | [SYNC19-35] |
292 | | 330 | |
293 | 19) Every clinical trial must be registered in a publicly accessible | 331 | 35) Every research study involving human subjects must be registered in |
294 | database before recruitment of the first subject. | 332 | a publicly accessible database before recruitment of the first subject. |
295 | | 333 | |
296 | 30) Authors, editors ····················· and publishers all have | 334 | 36) Researchers, authors, sponsors, editors and publishers all have |
297 | ethical obligations with regard to the publication ················· of | 335 | ethical obligations with regard to the publication and dissemination of |
298 | the results of research. Authors · have a duty to make publicly | 336 | the results of research. Researchers have a duty to make publicly |
299 | available the results of their research on human subjects and are | 337 | available the results of their research on human subjects and are |
300 | accountable for the completeness and accuracy of their reports. They | 338 | accountable for the completeness and accuracy of their reports. All |
301 | should adhere to accepted guidelines for ethical reporting. Negative and | 339 | parties should adhere to accepted guidelines for ethical reporting. |
302 | inconclusive as well as positive results should be published or | 340 | Negative and inconclusive as well as positive results must be published |
303 | otherwise made publicly available. Sources of funding, institutional | 341 | or otherwise made publicly available. Sources of funding, institutional |
304 | affiliations and conflicts of interest should be declared in the | 342 | affiliations and conflicts of interest must be declared in the |
305 | publication. Reports of research not in accordance with the principles | 343 | publication. Reports of research not in accordance with the principles |
306 | of this Declaration should not be accepted for publication. | 344 | of this Declaration should not be accepted for publication. |
307 | | 345 | |
| 346 | ## UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE |
| 347 | |
308 | [SYNC35-37] | 348 | [SYNC35-37] |
309 | | 349 | |
310 | 35) In the treatment of a ·············· patient, where proven | 350 | 37) In the treatment of an individual patient, where proven |
311 | interventions do not exist or ························ have been | 351 | interventions do not exist or other known interventions have been |
312 | ineffective, the physician, after seeking expert advice, with informed | 352 | ineffective, the physician, after seeking expert advice, with informed |
313 | consent from the patient or a legally authorized representative, may use | 353 | consent from the patient or a legally authorised representative, may use |
314 | an unproven intervention if in the physician's judgement it offers hope | 354 | an unproven intervention if in the physician's judgement it offers hope |
315 | of saving life, re-establishing health or alleviating suffering. Where | 355 | of saving life, re-establishing health or alleviating suffering. This |
316 | possible, this intervention should be made the object of research, | 356 | intervention should subsequently be made the object of research, |
317 | designed to evaluate its safety and efficacy. In all cases, new | 357 | designed to evaluate its safety and efficacy. In all cases, new |
318 | information should be recorded and, where appropriate, made publicly | 358 | information must be recorded and, where appropriate, made publicly |
319 | available. | 359 | available. |
320 | | 360 | |
| 361 | ## ARTICLE INFORMATION |
| 362 | |
| 363 | Published Online: October 19, 2013. doi:10.1001/jama.2013.281053. |
| 364 | |
| 365 | Disclaimer: ©2013 World Medical Association, Inc. All Rights Reserved. |
| 366 | All intellectual property rights in the Declaration of Helsinki are |
| 367 | vested in the World Medical Association. |
| 368 | |
321 | ## SOURCE | 369 | ## SOURCE |
322 | | 370 | |
323 | http://www.wma.net/en/30publications/10policies/b3/17c.pdf | 371 | http://www.wma.net/en/30publications/10policies/b3/ |
| 372 | |
| 373 | http://jama.jamanetwork.com/article.aspx?articleid=1760318 |