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  IN THIS Article
 ::  A. introduction
 ::  B. basic princip...
 ::  C. additional pr...

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Year : 2002  |  Volume : 48  |  Issue : 3  |  Page : 206-8

World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

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PMID: 12432198

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Keywords: Ethics, Medical, Helsinki Declaration, Human, Human Experimentation, Research, standards,

How to cite this article:
. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Postgrad Med 2002;48:206

How to cite this URL:
. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Postgrad Med [serial online] 2002 [cited 2023 Mar 28];48:206. Available from:

  ::   A. introduction Top

1. The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.

2. It is the duty of the physician to promote and safeguard the health of the people. The physician's knowledge and conscience are dedicated to the fulfillment of this duty.

3. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

4. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.

5. In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.

6. The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality.

7. In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens.

8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.

9. Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration.

  ::   B. basic principles for all medical research Top

10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.

11. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.

12. Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

13. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.

14. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration.

15. Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent.

16. Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available.

17. Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results.

18. Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.

19. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.

20. The subjects must be volunteers and informed participants in the research project.

21. The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.

22. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.

23. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship.

24. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons.

25. When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative.

26. Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate.

27. Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

  ::   C. additional principles for medical research combined with medical care Top

28. The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects.

29. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.

30. At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.

31. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship.

32. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed.

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Huisarts en Wetenschap. 2008; 51(8): 361-369
64 Needle-free powder lidocaine delivery system provides rapid effective analgesia for venipuncture or cannulation pain in children: Randomized, double- blind comparison of venipuncture and venous cannulation pain after fast-onset needle-free powder lidocaine or placebo treatment trial
Zempsky, W.T. and Bean-Lijewski, J. and Kauffman, R.E. and Koh, J.L. and Malviya, S.V. and Rose, J.B. and Richards, P.T. and Gennevois, D.J.
Pediatrics. 2008; 121(5): 979-987
65 Relation of plasma protein oxidation parameters and paraoxonase activity in the ageing population
Çakatay, U. and Kayali, R. and Uzun, H.
Clinical and Experimental Medicine. 2008; 8(1): 51-57
66 Worst experiences of pain and conceptions of worst pain imaginable among nursing students
Bergh, I. and Jakobsson, E. and Sjöström, B.
Journal of Advanced Nursing. 2008; 61(5): 484-491
67 Life events associated with major depression in Ugandan primary healthcare (Phc) patients: Issues of cultural specificity
Muhwezi, W.W. and Ă…gren, H. and Neema, S. and Koma Maganda, A. and Musisi, S.
International Journal of Social Psychiatry. 2008; 54(2): 144-163
68 Flow cytometric detection of circulating dendritic cells in healthy subjects
Rovati, B. and Mariucci, S. and Manzoni, M. and Bencardino, K. and Danova, M.
European Journal of Histochemistry. 2008; 52(1): 45-51
69 No midpregnancy fall in diastolic blood pressure in women with a low educational level: The generation R study
Silva, L.M. and Steegers, E.A.P. and Burdorf, A. and Jaddoe, V.W.V. and Arends, L.R. and Hofman, A. and Mackenbach, J.P. and Raat, H.
Hypertension. 2008; 52(4): 645-651
70 Abuse liability of intra-nasal midazolam in inhaled-cocaine abusers
Braun, I.M. and Tavares, H. and de Nucci, G. and Bernik, M.
European Neuropsychopharmacology. 2008; 18(10): 723-728
71 Managing consequences and finding hope - Experiences of Swedish women and men 4-6 months after myocardial infarction
Kristofferzon, M.-L. and Löfmark, R. and Carlsson, M.
Scandinavian Journal of Caring Sciences. 2008; 22(3): 367-375
72 Brain lesion volume and capacity for consent in stroke trials: Potential regulatory barriers to the use of surrogate markers
Dani, K.A. and McCormick, M.T. and Muir, K.W.
Stroke. 2008; 39(8): 2336-2340
73 Factors associated with poor prognosis among patients admitted with heart failure in a Nigerian tertiary medical centre: A cross-sectional study
Karaye, K.M. and Sani, M.U.
BMC Cardiovascular Disorders. 2008; 8(16)
74 Slow cortical potentials in human aversive trace conditioning
Hellwig, S. and Weisbrod, M. and Jochum, V. and Rentrop, M. and Unger, J. and Walther, S. and Haefner, K. and Roth, A. and Fiedler, P. and Bender, S.
International Journal of Psychophysiology. 2008; 69(1): 41-51
75 A comparison of craving and emotional states between pathological gamblers and alcoholics
de Castro, V., Fong, T., Rosenthal, R.J., Tavares, H.
Addictive Behaviors. 2007; 32(8): 1555-1564
76 Quantification of the pain terms hurt, ache and pain among nursing students
Bergh, I., Sjöström, B.
Scandinavian Journal of Caring Sciences. 2007; 21(2): 163-168
77 The loss of entropy circadian rhythm in sinusal R-R intervals of type 1 diabetic pregnant women suggests an indeterministic chaos in cardiac pacing (minimum delirium cordis syndrome). A newly identifiable type of silent cardiac dysautonomia?
Cugini, P., Curione, M., Castro, C., Napoli, A., Francia, P., Colatrella, A., Di Bona, S., (...), Fallucca, F.
Acta Cardiologica. 2007; 62(3): 257-264
78 Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: The EVEREST clinical status trials
Gheorghiade, M., Konstam, M.A., Burnett Jr., J.C., Grinfeld, L., Maggioni, A.P., Swedberg, K., Udelson, J.E., (...), Orlandi, C.
Journal of the American Medical Association. 2007; 297(12): 1332-1343
79 The impact of gender, depression, and personality on craving
Zilberman, M.L., Tavares, H., Hodgins, D.C., El-Guebaly, N.A.
Journal of Addictive Diseases. 2007; 26(1): 79-84
80 Thorough QT study with recommended and supratherapeutic doses of tolterodine
Malhotra, B.K., Glue, P., Sweeney, K., Anziano, R., Mancuso, J., Wicker, P.
Clinical Pharmacology and Therapeutics. 2007; 81(3): 377-385
81 Lessons from placebo effects in migraine treatment
Antonaci, F., Chimento, P., Diener, H.-C., Sances, G., Bono, G.
Journal of Headache and Pain. 2007; 8(1): 63-66
82 Effect of standard medication on quality of life of patients with atopic dermatitis
Kawashima, M., Harada, S.
Journal of Dermatology. 2007; 34(1): 9-16
83 Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: a randomized equivalence trial
Hermens MLM, Van Hout HPJ, Terluin B, et al.
84 Cognitive Function Impairment in Patients with Neuropathic Pain Under Standard Conditions of Care
Povedano, M., Gascón, J., Gálvez, R., Ruiz, M., Rejas, J.
Journal of Pain and Symptom Management. 2007; 33(1): 78-89
85 A randomized clinical trial of targeted cognitive behavioral treatment to reduce catastrophizing in chronic headache sufferers
Thorn BE, Pence LB, Ward LC, et al.
JOURNAL OF PAIN. 2007; 8 (12): 938-949
86 Administering the MADRS by telephone or face-to-face: A validity study
Hermens, M.L.M., Adèr, H.J., van Hout, H.P.J., Terluin, B., van Dyck, R., de Haan, M.
Annals of General Psychiatry. 2006; 5: Art no 3
87 Neurophatic pain as a cause of anxiety, depressión and sleep disturbance in standard condition of care: DONEGA naturalistic study | [El dolor neuropático como causa de ansiedad, depresión y trastornos del sueño en condiciones de práctica médica habitual: Resultados del estudio naturalístico DONEGA]
Gálvez, R., Marsal, C., Vidal, J., Del Real, Ma.A., Ruiz, M., Rejas, J.
Revista de la Sociedad Espanola del Dolor. 2006; 13(2): 81-95
88 Neurophatic pain as a cause of anxiety, depressión and sleep disturbance in standard condition of care: DONEGA naturalistic study [El dolor neuropático como causa de ansiedad, depresión y trastornos del sueño en condiciones de práctica médica habitual: Resultados del estudio naturalístico DONEGA]
Gálvez, R. and Marsal, C. and Vidal, J. and Del Real, Ma.A. and Ruiz, M. and Rejas, J.
Revista de la Sociedad Espanola del Dolor. 2006; 13(2): 81-95
89 Preliminary evidence for a structural benefit of the new bisphosphonate zoledronic acid in early rheumatoid arthritis
Jarrett SJ, Conaghan PG, Sloan VS, et al.
ARTHRITIS AND RHEUMATISM. 2006; 54 (5): 1410-1414
90 The homeopathic preparation Vertigoheel® versus Ginkgo biloba in the treatment of vertigo in an elderly population: A double-blinded, randomized, controlled clinical trial
Issing, W. and Klein, P. and Weiser, M.
Journal of Alternative and Complementary Medicine. 2005; 11(1): 155-160
91 Report of an adverse incident in a randomized clinical trial
McAlinden, R.L. and Ellis, P.E. and Sandy, J.R.
Journal of Orthodontics. 2005; 32(3): 203-205
92 Protein oxidation parameters in type 2 diabetic patients with good and poor glycaemic control
Çakatay, U.
Diabetes and Metabolism. 2005; 31(6): 551-557
93 QT and QTc interval with standard and supratherapeutic doses of darifenacin, a muscarinic M3 selective receptor antagonist for the treatment of overactive bladder
Serra, D.B., Affrime, M.B., Bedigian, M.P., Greig, G., Milosavljev, S., Skerjanec, A., Wang, Y.
Journal of Clinical Pharmacology. 2005; 45(9): 1038-1047
94 Comparison of craving between pathological gamblers and alcoholics
Tavares, H., Zilberman, M.L., Hodgins, D.C., El-Guebaly, N.
Alcoholism: Clinical and Experimental Research. 2005; 29(8): 1427-1431
95 Cognitive influences on predictive saccadic tracking
Isotalo, E., Lasker, A.G., Zee, D.S.
Experimental Brain Research. 2005; 165(4): 461-469
96 Behavioral research and the double-blind placebo-controlled methodology: Challenges in applying the biomedical standard to behavioral headache research
Rains, J.C., Penzien, D.B.
Headache. 2005; 45(5): 479-486
97 Absolute reduction in lower limb lean body mass in Japanese women with knee osteoarthritis
Segal, N.A., Toda, Y.
Journal of Clinical Rheumatology. 2005; 11(5): 245-249
98 Intrusion and confusion - The impact of medication and health professionals after acute myocardial infarction
Attebring, M.F., Herlitz, J., Ekman, I.
European Journal of Cardiovascular Nursing. 2005; 4(2): 153-159
99 Behavioral headache research: Methodologic considerations and research design alternatives
Hursey, K.G., Rains, J.C., Penzien, D.B., Nash, J.M., Nicholson, R.A.
Headache. 2005; 45(5): 466-478
100 Guidelines for trials of behavioral treatments for recurrent headache, first edition: American Headache Society behavioral clinical trials workgroup
Penzien, D.B., Andrasik, F., Freidenberg, B.M., Houle, T.T., Lake III, A.E., Lipchik, G.L., Holroyd, K.A., (...), Wittrock, D.A.
Headache. 2005; 45(Supp 2): S110-S132
101 The gambling follow-up scale: Development and reliability testing of a scale for pathological gamblers under treatment
De Castro, V., Fuentes, D., Tavares, H.
Canadian Journal of Psychiatry. 2005; 50(2): 81-86
102 The homeopathic preparation Vertigoheel® versus Ginkgo biloba in the treatment of vertigo in an elderly population: A double-blinded, randomized, controlled clinical trial
Issing, W., Klein, P., Weiser, M.
Journal of Alternative and Complementary Medicine. 2005; 11(1): 155-160
103 Immediate loading of single-tooth implants in the posterior region
Abboud, M., Koeck, B., Stark, H., Wahl, G., Paillon, R.
International Journal of Oral and Maxillofacial Implants. 2005; 20(1): 61-68
104 The ethics of research on pregnant women: Is maternal consent sufficient?
Lupton, M.G.F., Williams, D.J.
BJOG: An International Journal of Obstetrics and Gynaecology. 2004; 111(12): 1307-1312
105 Bioequivalence of L-thyroxine tablets and a liquid L-thyroxine solution in the treatment of hypothyroid patients | [Bioäquivalenz von L-thyroxin-tabletten und L-thyroxin-tropfen bei der behandlung der hypothyreose in der täglichen praxis]
Grussendorf, M., Vaupel, R., Wegscheider, K.
Medizinische Klinik. 2004; 99(11): 639-644
106 Genomewide search and association studies in a finnish celiac disease population: Identification of a novel locus and replication of the HLA and CTLA4 loci
Rioux, J.D., Karinen, H., Kocher, K., McMahon, S.G., Kärkkäinen, P., Janatuinen, E., Heikkinen, M., (...), Laakso, M.
American Journal of Medical Genetics. 2004; 130 A(4): 345-350
107 Prevalence and regional differences in overweight in 2001 and trends in BMI distribution in Swedish children from 1987 to 2001
Ekblom, Ö.B., Oddsson, K., Ekblom, B.T.
Scandinavian Journal of Public Health. 2004; 23(4): 257-263
108 Bioequivalence of L-thyroxine tablets and a liquid L-thyroxine solution in the treatment of hypothyroid patients [Bioäquivalenz von L-thyroxin-tabletten und L-thyroxin-tropfen bei der behandlung der hypothyreose in der täglichen praxis]
Grussendorf, M. and Vaupel, R. and Wegscheider, K.
Medizinische Klinik. 2004; 99(11): 639-644
109 Prevalence of human T-cell leukemia virus types I and II in Switzerland
Boni J, Bisset LR, Burckhardt JJ, et al.
Journal of Medical Virology. 2004; 72(2): 328-337
110 Reference values for peripheral blood lymphocyte phenotypes applicable to the healthy adult population in Switzerland
Bisset LR, Lung TL, Kaelin M, et al.
European Journal of Haematology. 2004; 72(3): 203-212
111 Microphthalmia-associated transcription factor and tyrosinase as markers of melanoma cells in blood of patients with melanoma
Samija I, Lukac J, Maric-Brozic J, et al.
Croatian Medical Journal. 2004; 45(2): 142-148
112 Smoking habits and predictors of continued smoking in patients with acute coronary syndromes
Attebring MF, Hartford M, Hjalmarson A, et al.
Journal of Advanced Nursing. 2004; 46(6): 614-623
113 Increased pulse wave velocity and shortened pulse wave propagation time in young patients with rheumatoid arthritis
Yildiz, M., Soy, M., Kurum, T., Ozbay, G.
Canadian Journal of Cardiology. 2004; 20(11): 1097-1100
114 Matrix Metalloproteinases and Tissue Inhibitors of Matrix Metalloproteinases in the Human Lens: Implications for Cortical Cataract Formation
Sachdev NH, Di Girolamo N, Nolan TM, McCluskey, P.J., Wakefield, D., Coroneo, M.T.
Investigative Ophthalmology and Visual Science. 2004; 45: 4075-4082
[Pubmed] | [PDF]
115 Pharmacokinetics and renal excretion of desmopressin after intravenous administration to healthy subjects and renally impaired patients
Agersř, H., Larsen, L.S., Riis, A., Lövgren, U., Karlsson, M.O., Senderovitz, T.
British Journal of Clinical Pharmacology. 2004; 58(4): 352-358
116 Nitric oxide and inflammatory response in simulated extracorporeal circulation
Lahtinen M, Melki V, Adamik B, et al.
Thoracic and Cardiovascular Surgeon. 2003; 51(3): 130-137
117 Monitoring ethical, legal, and social issues in developing population genetic databases
Austin MA, Harding SE, McElroy CE
Genetics in Medicine. 2003; 5(6): 451-457
118 Alzheimer Disease Ethics - Informed Consent and Related Issues in Clinical Trials: Results of a Survey among the Members of the Research Ethics Committees in Sweden
Peterson, G., Wallin, A.
International Psychogeriatrics. 2003; 15(2): 157-170
119 Monitoring ethical, legal, and social issues in developing population genetics databases
Austin, M.A. and Harding, S.E. and McElroy, C.E.
Genetics in Medicine. 2003; 5(6): 451-457


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Online since 12th February '04
© 2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
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