Editorial
Happy (Belated) Anniversary, Helsinki are important to producers and publishers of medical research. Many who attest to ascribing to the Declaration’s principles may be unaware of its entire contents. Over the next 2 months, I will focus on issues that have been especially contentious or are particularly relevant to orthopaedic sports medicine. One result of the revision process has been the organization of the statement into 12 titled sections containing 37 numbered bullet points, so I will refer to these paragraphs by number. In its ‘‘Preamble,’’ the DoH immediately reminds readers that the mandate of the WMA dictates that the Declaration be directed primarily at physicians. This is evident in paragraph 3 of the ensuing section, ‘‘General Principles,’’ which recalls the admonitions of the Hippocratic Oath and the Declaration of Geneva: ‘‘The health of my patient will be my first consideration.’’ As physicians, we owe our primary allegiance to the vulnerable individual who has sought our help and sits before us. Because medical progress ultimately requires studies involving human participants (paragraph 5), an ethical tension is established between the welfare of the individual patient and the welfare of humanity. Opinions may differ as to how these two potentially contradictory allegiances should be balanced, but in paragraph 8 the DoH clearly weighs in on the side of the individual: ‘‘While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.’’ Astute readers will note the use of the term subjects in this quote. Some authorities, arguing that subjects has a condescending connotation and denotes a subservient position, have suggested that participants is a preferable word.3,15 On the other hand, while the tone throughout the DoH emphasizes respect for the individuals who are being studied, it also recognizes that they are unavoidably less knowledgeable than the investigators about the nature and risks of the research. This puts the subjects in a dependent position, so the researchers are called upon to inform and educate them in order to reduce this inherent inequality as much as possible. ‘‘The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects.’’ The semantic debate between subjects and participants may strike some as quibbling over minutiae, but it typifies the level of scrutiny that critics have applied to the DoH, reminiscent of the microscopic analysis of a scholar poring over a liturgical text.1,26 In paragraphs 19 and 20, the DoH addresses the special treatment of subjects belonging to a vulnerable group. The 2013 version has been criticized for not explicitly naming these groups, although the motivation behind this omission would seem to be a desire to avoid limiting the application of this designation to a narrowly defined list.11 This
The progress of science is far ahead of man’s ethical behavior. —Sir Charles Spencer Chaplin, My Autobiography (1964, Ch 29) Amid the bustle of events in 2014, The American Journal of Sports Medicine neglected to acknowledge the golden anniversary of the Declaration of Helsinki, adopted by the World Medical Association (WMA) in that northern capital in 1964. The DoH, as it is widely known, has been called the North Star24 and the gold standard15 of medical research ethics. Despite its iconic status, the DoH has not been the object of universal acclaim. It has been reviled as well as revered; criticized as both too restrictive7,12,23 and too liberal,21 too ambiguous2,9,13,15 and too specific,7,21 too short15 and too long.7 While regarded by many as the touchstone for ethical research,4,6 it has been abandoned by some prominent government agencies in favor of their own standards and regulations.10,15,21,25 The WMA has described the Declaration as a living document, subject to periodic revision and refinement to correct perceived shortcomings and adapt to new situations.18 Since its creation, the DoH has undergone 7 revisions and more than doubled in length. Perhaps it was inevitable that it would be treated less reverentially as it aged. The most recent version,27 finalized in late 2013 after internal debate and public comment, has been the object of both praise and potshots. A degree of dissent was probably predictable: to paraphrase Lincoln, you can’t please all of the people all of the time. Much of the criticism of the DoH seems to stem from its very nature. As the policy statement of an association of physicians, it is directed primarily at physician-researchers.18,19 This has led to complaints that it should do more to address the ethical obligations of other stakeholders in the process of conducting and disseminating medical research.13,26 Since it is the product of a consensus process, its composition undoubtedly required compromises and decisions to remain silent or indeterminate on issues for which no clear agreement was attainable.16,18 It thus seems unavoidable that it would be disparaged for not being bold enough, precise enough, or absolute enough. Nevertheless, the latest iteration of the DoH builds on its predecessors and highlights a large number of topics that
Keywords: Declaration of Helsinki; research subjects; research ethics committees; institutional review boards; vulnerable populations; posttrial provisions
The American Journal of Sports Medicine, Vol. 43, No. 3 DOI: 10.1177/0363546515573725 Ó 2015 American Orthopaedic Society for Sports Medicine
539
540
Editorial
section specifies that research in vulnerable populations should stand to benefit those individuals and should only be undertaken when it is not feasible in a nonvulnerable group. Vulnerable groups clearly include the populations of developing countries, economically disadvantaged people in all countries, and anyone with a diminished capacity to understand the risks and implications of a research project. One effect of this portion of the Declaration is to proscribe the practice of developing a treatment among a disadvantaged group for the exclusive use of a more advantaged population. In the realm of sports medicine research, medical students and employees, service members, student athletes, and children are the vulnerable groups of greatest relevance. Researchers in our field should always be sensitive to the welfare of these individuals, who may feel obligated to participate in our clinical research endeavors despite any personal reservations. Paragraphs 21 and 22, which compose the section entitled ‘‘Scientific Requirements and Research Protocols,’’ contain material that I have long felt deserves particular emphasis. ‘‘Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature . [and] must be clearly described and justified in a research protocol.’’ In other words, casually assembled, poorly designed research projects, which we sometimes see in orthopaedic sports medicine, are actually unethical. Shoddy research exposes the subjects to varying degrees of risk, but its flaws preclude any possibility of eventual benefit. A recent literature review has shown that sports medicine research is moving in the direction of prospective, comparative study designs5; the DoH tells us that this trend follows not just a scientific, but an ethical imperative. The final sentence of paragraph 22 has generated considerable controversy, as it states, ‘‘In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.’’ This element is elaborated upon further in paragraph 34, ‘‘In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.’’ Some critics have expressed fear that these stipulations could discourage clinical research because of the looming possibility that they might be interpreted as requiring costly, perpetual care of trial participants.20,21 In addition, it is not clear how sponsors, researchers, and governments would share the expense of providing this care. Others have pointed out the practical dilemma of observing the requirement to provide access to ‘‘an intervention identified as beneficial in the trial.’’ In fact, considerable time may elapse before the results of a trial are fully determined, reviewed, and published; and even more time before an intervention deemed beneficial is approved for use by regulatory authorities.17,23,25 This could create an impasse if the text is interpreted to mean that the provision of care should begin immediately upon termination of the trial, or alternatively carry the risk that stakeholders might be responsible for the organizational logistics
The American Journal of Sports Medicine
and expense of initiating treatment of subjects years after the trial is over. In addition, it is often debatable whether a positive outcome in one trial definitively establishes the efficacy of the tested intervention. While concern over the ambiguity of this provision has been expressed most commonly in the context of treatments for chronic medical conditions, it is possible to envision how it might be applied to emerging areas in orthopaedic sports medicine, such as injection therapy for posttraumatic arthrosis. An extreme interpretation might extend its use to surgical studies as well: If a study comparing 2 surgical techniques finds one of them to produce superior outcomes, does the DoH imply that the more successful procedure must be offered to patients who underwent the inferior operation? One of the most important features of the DoH, in my opinion, is the requirement that all research must be vetted and approved by an ethics committee, a concept introduced in the 1975 revision. Although the DoH may be vague in some places, the text in this section makes it clear that approval of research regarding human subjects by such a committee, often called an institutional review board (IRB), is not optional. ‘‘The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee.’’ Several details of the review process are specified in the relevant paragraphs: First, the review and approval is done prior to commencing the study. For a prospective study, this means prior to enrolling the first patient. For retrospective studies, which deal with data that already exist, this would mean prior to collecting and analyzing the data. Second, the committee must be qualified for its task, transparent, and independent of the researchers. Third, while the operations of the committee must take into consideration local and international laws and norms, these should not be allowed to diminish the protections of the research subjects otherwise provided by the Declaration. Fourth, the committee must be able to monitor the investigation as it progresses and must approve any proposed modifications. Finally, the researcher must submit a summary report to the committee when the study is completed. These provisions allow ethics committees to serve 2 important functions. First, they provide for oversight and enforcement to verify that research is conducted along ethical guidelines. Just as importantly, they allow for the interpretation and adaptation of those guidelines according to local norms. In my mind, this role of the ethics committee blunts many of the complaints of vagueness that have been leveled at the DoH. On matters where the Declaration is inadvertently or intentionally imprecise, it has provided for independent ethics committees to hash out the details according to local standards. While the core principles of research ethics should be considered absolute, widespread variation across cultures and jurisdictions demands such a mechanism to interpret the specifics of their application. Reviews conducted in a number of disciplines have shown that medical journals have a poor track record when it comes to documenting ethics committee approval of published studies.8,14,22 Over the years, AJSM has
Vol. 43, No. 3, 2015
Happy (Belated) Anniversary, Helsinki
revised and refined its requirements for documentation of ethical review for submitted research. Current policy calls for authors to upload an actual copy of the approval or waiver statement from the appropriate ethics committee at the time that studies involving humans, human tissue, or animals are submitted for review. As an international journal, AJSM does provide for regional variation in the review process for certain types of research. For example, since many or most institutions or jurisdictions do not require committee approval for research involving cadaveric specimens, AJSM will waive the requirement for such documentation if the authors certify that approval for cadaveric research is not required in their institution or locality. Some jurisdictions do not require committee approval for research using data collected in the course of routine medical care. In these instances, authors must submit a valid copy of the pertinent government policy. In addition, the editors always reserve the right to disallow any study that they deem to be ethically questionable, regardless of what type of approval may have been obtained. Although questions of research ethics rarely find themselves featured on the programs of major orthopaedic congresses, they should be hovering somewhere in our consciousness whenever we plan, conduct, or read the results of a clinical study. Hoping that I have provided enough food for thought to nourish AJSM readers over the next month, or alternatively to bring relief to those battling chronic insomnia, I will return to the DoH in April to discuss several more important issues addressed in the Declaration.
5.
6. 7. 8.
9.
10.
11. 12.
13. 14.
15.
16. 17. 18. 19.
20. 21.
Bruce Reider, MD Chicago, Illinois
22.
23.
REFERENCES 1. Carlson RV, Boyd KM, Webb DJ. The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695-713. 2. Colledge F, Elger BS. Impossible, impractical, and non-identifiable? New criteria regarding consent for human tissue research in the Declaration of Helsinki. Biopreserv Biobank. 2013;11(3):149-152. 3. Corrigan O, Tutton R. What’s in a name? Subjects, volunteers, participants and activists in clinical research. Clin Ethics. 2006;1:101-104. 4. Coursen JS, Hollier LH Jr. Review of ‘‘Fifty Years at the Forefront of Ethical Guidance: The World Medical Association Declaration of
24. 25.
26.
27.
541
Helskinki’’ by Parsa-Parsi RW, Ellis R, Weising Y in South Med J 107:405-406, 2014. J Craniofac Surg. 2015;26(1):308. Cvetanovich GL, Fillingham YA, Harris JD, et al. Publication and level of evidence trends in The American Journal of Sports Medicine from 1996 to 2011. Am J Sports Med. 2014;43(1):220-225. Dhai A. The research ethics evolution: from Nuremberg to Helsinki. S Afr Med J. 2014;104(3):178-180. Emanuel EJ. Reconsidering the Declaration of Helsinki. Lancet. 2013;381:1532-1533. Freshwater MF, Garcia-Zalisnak DE, Gonzalez-Ortiz NE. Failure of plastic surgical clinical trials to document compliance with international ethics guidelines: a systematic review. J Plast Reconstr Aesthet Surg. 2013;66(1):3-8. Hellmann F, Verdi M, Schlemper BR, Caponi S. 50th anniversary of the Declaration of Helsinki: the double standard was introduced. Arch Med Res. 2014;45(7):600-601. Heringa J, Dute J. The proposed EU-regulation on clinical trial on medicinal products: an unethical proposal? Eur J Health Law. 2013;20(4):347-362. Hurst SA. Declaration of Helsinki and protection of vulnerable research participants [letter]. JAMA. 2014;311(12):1252. Lie RK, Emanuel E, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics. 2004;30(2):190-193. Millum J, Grady C. The ethics of placebo-controlled trials: methodological justifications. Contemp Clin Trials. 2013;36(2):510-514. Murphy S, Nolan C, O’Rourke C, Fenton JE. The reporting of research ethics committee approval and informed consent in otolaryngology journals. Clin Otolaryngol. 2015;40(1):36-40. Muthuswamy V. The new 2013 seventh version of the Declaration of Helsinki—more old wine in a new bottle? Indian J Med Ethics. 2014;11(1):2-4. Nathanson V. Revising the Declaration of Helsinki: your chance to influence research governance. BMJ. 2013;346:f2837. Palacios R. Post-trial access and the new version of the Declaration of Helsinki. Colomb Med. 2013;44(4):206-207. Parsa-Parsi R, Blackmer J, Ehni HJ, et al. Reconsidering the Declaration of Helsinki [letter]. Lancet. 2013;382:1246-1247. Parsa-Parsi RW, Ellis R, Wiesing U. Fifty years at the forefront of ethical guidance: the World Medical Association Declaration of Helsinki. South Med J. 2014;107(7):405-406. Shah P. Practical issues in implementation of WMA’s draft Declaration of Helsinki [letter]. Indian J Med Ethics. 2014;11(1):63-64. Shaw D, McMahon A. Ethicovigilance in clinical trials. Bioethics. 2013;27(9):508-513. Strech D, Metz C, Knuppel H. Do editorial policies support ethics research? A thematic text analysis of author instructions in psychiatry journals. PLoS One. 2014;9(6):e97492. Vastag B. Helsinki discord? A controversial declaration. JAMA. 2000;284(23):2983-2985. Wilson CB. An updated Declaration of Helsinki will provide more protection. Nat Med. 2013;19(6):664. Wolinsky H. The battle of Helsinki: two troublesome paragraphs in the Declaration of Helsinki are causing a furore over medical research ethics. EMBO Rep. 2006;7(7):670-672. Woods S, McCormack P. Disputing the ethics of research: the challenge from bioethics and patient activism to the interpretation of the Declaration of Helsinki in clinical trials. Bioethics. 2013;27(5):243250. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-2194.
For reprints and permission queries, please visit SAGE’s Web site at http://www.sagepub.com/journalsPermissions.nav
Copyright of American Journal of Sports Medicine is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Happy (Belated) Anniversary, Helsinki are important to producers and publishers of medical research. Many who attest to ascribing to the Declaration’s principles may be unaware of its entire contents. Over the next 2 months, I will focus on issues that have been especially contentious or are particularly relevant to orthopaedic sports medicine. One result of the revision process has been the organization of the statement into 12 titled sections containing 37 numbered bullet points, so I will refer to these paragraphs by number. In its ‘‘Preamble,’’ the DoH immediately reminds readers that the mandate of the WMA dictates that the Declaration be directed primarily at physicians. This is evident in paragraph 3 of the ensuing section, ‘‘General Principles,’’ which recalls the admonitions of the Hippocratic Oath and the Declaration of Geneva: ‘‘The health of my patient will be my first consideration.’’ As physicians, we owe our primary allegiance to the vulnerable individual who has sought our help and sits before us. Because medical progress ultimately requires studies involving human participants (paragraph 5), an ethical tension is established between the welfare of the individual patient and the welfare of humanity. Opinions may differ as to how these two potentially contradictory allegiances should be balanced, but in paragraph 8 the DoH clearly weighs in on the side of the individual: ‘‘While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.’’ Astute readers will note the use of the term subjects in this quote. Some authorities, arguing that subjects has a condescending connotation and denotes a subservient position, have suggested that participants is a preferable word.3,15 On the other hand, while the tone throughout the DoH emphasizes respect for the individuals who are being studied, it also recognizes that they are unavoidably less knowledgeable than the investigators about the nature and risks of the research. This puts the subjects in a dependent position, so the researchers are called upon to inform and educate them in order to reduce this inherent inequality as much as possible. ‘‘The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects.’’ The semantic debate between subjects and participants may strike some as quibbling over minutiae, but it typifies the level of scrutiny that critics have applied to the DoH, reminiscent of the microscopic analysis of a scholar poring over a liturgical text.1,26 In paragraphs 19 and 20, the DoH addresses the special treatment of subjects belonging to a vulnerable group. The 2013 version has been criticized for not explicitly naming these groups, although the motivation behind this omission would seem to be a desire to avoid limiting the application of this designation to a narrowly defined list.11 This
The progress of science is far ahead of man’s ethical behavior. —Sir Charles Spencer Chaplin, My Autobiography (1964, Ch 29) Amid the bustle of events in 2014, The American Journal of Sports Medicine neglected to acknowledge the golden anniversary of the Declaration of Helsinki, adopted by the World Medical Association (WMA) in that northern capital in 1964. The DoH, as it is widely known, has been called the North Star24 and the gold standard15 of medical research ethics. Despite its iconic status, the DoH has not been the object of universal acclaim. It has been reviled as well as revered; criticized as both too restrictive7,12,23 and too liberal,21 too ambiguous2,9,13,15 and too specific,7,21 too short15 and too long.7 While regarded by many as the touchstone for ethical research,4,6 it has been abandoned by some prominent government agencies in favor of their own standards and regulations.10,15,21,25 The WMA has described the Declaration as a living document, subject to periodic revision and refinement to correct perceived shortcomings and adapt to new situations.18 Since its creation, the DoH has undergone 7 revisions and more than doubled in length. Perhaps it was inevitable that it would be treated less reverentially as it aged. The most recent version,27 finalized in late 2013 after internal debate and public comment, has been the object of both praise and potshots. A degree of dissent was probably predictable: to paraphrase Lincoln, you can’t please all of the people all of the time. Much of the criticism of the DoH seems to stem from its very nature. As the policy statement of an association of physicians, it is directed primarily at physician-researchers.18,19 This has led to complaints that it should do more to address the ethical obligations of other stakeholders in the process of conducting and disseminating medical research.13,26 Since it is the product of a consensus process, its composition undoubtedly required compromises and decisions to remain silent or indeterminate on issues for which no clear agreement was attainable.16,18 It thus seems unavoidable that it would be disparaged for not being bold enough, precise enough, or absolute enough. Nevertheless, the latest iteration of the DoH builds on its predecessors and highlights a large number of topics that
Keywords: Declaration of Helsinki; research subjects; research ethics committees; institutional review boards; vulnerable populations; posttrial provisions
The American Journal of Sports Medicine, Vol. 43, No. 3 DOI: 10.1177/0363546515573725 Ó 2015 American Orthopaedic Society for Sports Medicine
539
540
Editorial
section specifies that research in vulnerable populations should stand to benefit those individuals and should only be undertaken when it is not feasible in a nonvulnerable group. Vulnerable groups clearly include the populations of developing countries, economically disadvantaged people in all countries, and anyone with a diminished capacity to understand the risks and implications of a research project. One effect of this portion of the Declaration is to proscribe the practice of developing a treatment among a disadvantaged group for the exclusive use of a more advantaged population. In the realm of sports medicine research, medical students and employees, service members, student athletes, and children are the vulnerable groups of greatest relevance. Researchers in our field should always be sensitive to the welfare of these individuals, who may feel obligated to participate in our clinical research endeavors despite any personal reservations. Paragraphs 21 and 22, which compose the section entitled ‘‘Scientific Requirements and Research Protocols,’’ contain material that I have long felt deserves particular emphasis. ‘‘Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature . [and] must be clearly described and justified in a research protocol.’’ In other words, casually assembled, poorly designed research projects, which we sometimes see in orthopaedic sports medicine, are actually unethical. Shoddy research exposes the subjects to varying degrees of risk, but its flaws preclude any possibility of eventual benefit. A recent literature review has shown that sports medicine research is moving in the direction of prospective, comparative study designs5; the DoH tells us that this trend follows not just a scientific, but an ethical imperative. The final sentence of paragraph 22 has generated considerable controversy, as it states, ‘‘In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.’’ This element is elaborated upon further in paragraph 34, ‘‘In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.’’ Some critics have expressed fear that these stipulations could discourage clinical research because of the looming possibility that they might be interpreted as requiring costly, perpetual care of trial participants.20,21 In addition, it is not clear how sponsors, researchers, and governments would share the expense of providing this care. Others have pointed out the practical dilemma of observing the requirement to provide access to ‘‘an intervention identified as beneficial in the trial.’’ In fact, considerable time may elapse before the results of a trial are fully determined, reviewed, and published; and even more time before an intervention deemed beneficial is approved for use by regulatory authorities.17,23,25 This could create an impasse if the text is interpreted to mean that the provision of care should begin immediately upon termination of the trial, or alternatively carry the risk that stakeholders might be responsible for the organizational logistics
The American Journal of Sports Medicine
and expense of initiating treatment of subjects years after the trial is over. In addition, it is often debatable whether a positive outcome in one trial definitively establishes the efficacy of the tested intervention. While concern over the ambiguity of this provision has been expressed most commonly in the context of treatments for chronic medical conditions, it is possible to envision how it might be applied to emerging areas in orthopaedic sports medicine, such as injection therapy for posttraumatic arthrosis. An extreme interpretation might extend its use to surgical studies as well: If a study comparing 2 surgical techniques finds one of them to produce superior outcomes, does the DoH imply that the more successful procedure must be offered to patients who underwent the inferior operation? One of the most important features of the DoH, in my opinion, is the requirement that all research must be vetted and approved by an ethics committee, a concept introduced in the 1975 revision. Although the DoH may be vague in some places, the text in this section makes it clear that approval of research regarding human subjects by such a committee, often called an institutional review board (IRB), is not optional. ‘‘The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee.’’ Several details of the review process are specified in the relevant paragraphs: First, the review and approval is done prior to commencing the study. For a prospective study, this means prior to enrolling the first patient. For retrospective studies, which deal with data that already exist, this would mean prior to collecting and analyzing the data. Second, the committee must be qualified for its task, transparent, and independent of the researchers. Third, while the operations of the committee must take into consideration local and international laws and norms, these should not be allowed to diminish the protections of the research subjects otherwise provided by the Declaration. Fourth, the committee must be able to monitor the investigation as it progresses and must approve any proposed modifications. Finally, the researcher must submit a summary report to the committee when the study is completed. These provisions allow ethics committees to serve 2 important functions. First, they provide for oversight and enforcement to verify that research is conducted along ethical guidelines. Just as importantly, they allow for the interpretation and adaptation of those guidelines according to local norms. In my mind, this role of the ethics committee blunts many of the complaints of vagueness that have been leveled at the DoH. On matters where the Declaration is inadvertently or intentionally imprecise, it has provided for independent ethics committees to hash out the details according to local standards. While the core principles of research ethics should be considered absolute, widespread variation across cultures and jurisdictions demands such a mechanism to interpret the specifics of their application. Reviews conducted in a number of disciplines have shown that medical journals have a poor track record when it comes to documenting ethics committee approval of published studies.8,14,22 Over the years, AJSM has
Vol. 43, No. 3, 2015
Happy (Belated) Anniversary, Helsinki
revised and refined its requirements for documentation of ethical review for submitted research. Current policy calls for authors to upload an actual copy of the approval or waiver statement from the appropriate ethics committee at the time that studies involving humans, human tissue, or animals are submitted for review. As an international journal, AJSM does provide for regional variation in the review process for certain types of research. For example, since many or most institutions or jurisdictions do not require committee approval for research involving cadaveric specimens, AJSM will waive the requirement for such documentation if the authors certify that approval for cadaveric research is not required in their institution or locality. Some jurisdictions do not require committee approval for research using data collected in the course of routine medical care. In these instances, authors must submit a valid copy of the pertinent government policy. In addition, the editors always reserve the right to disallow any study that they deem to be ethically questionable, regardless of what type of approval may have been obtained. Although questions of research ethics rarely find themselves featured on the programs of major orthopaedic congresses, they should be hovering somewhere in our consciousness whenever we plan, conduct, or read the results of a clinical study. Hoping that I have provided enough food for thought to nourish AJSM readers over the next month, or alternatively to bring relief to those battling chronic insomnia, I will return to the DoH in April to discuss several more important issues addressed in the Declaration.
5.
6. 7. 8.
9.
10.
11. 12.
13. 14.
15.
16. 17. 18. 19.
20. 21.
Bruce Reider, MD Chicago, Illinois
22.
23.
REFERENCES 1. Carlson RV, Boyd KM, Webb DJ. The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695-713. 2. Colledge F, Elger BS. Impossible, impractical, and non-identifiable? New criteria regarding consent for human tissue research in the Declaration of Helsinki. Biopreserv Biobank. 2013;11(3):149-152. 3. Corrigan O, Tutton R. What’s in a name? Subjects, volunteers, participants and activists in clinical research. Clin Ethics. 2006;1:101-104. 4. Coursen JS, Hollier LH Jr. Review of ‘‘Fifty Years at the Forefront of Ethical Guidance: The World Medical Association Declaration of
24. 25.
26.
27.
541
Helskinki’’ by Parsa-Parsi RW, Ellis R, Weising Y in South Med J 107:405-406, 2014. J Craniofac Surg. 2015;26(1):308. Cvetanovich GL, Fillingham YA, Harris JD, et al. Publication and level of evidence trends in The American Journal of Sports Medicine from 1996 to 2011. Am J Sports Med. 2014;43(1):220-225. Dhai A. The research ethics evolution: from Nuremberg to Helsinki. S Afr Med J. 2014;104(3):178-180. Emanuel EJ. Reconsidering the Declaration of Helsinki. Lancet. 2013;381:1532-1533. Freshwater MF, Garcia-Zalisnak DE, Gonzalez-Ortiz NE. Failure of plastic surgical clinical trials to document compliance with international ethics guidelines: a systematic review. J Plast Reconstr Aesthet Surg. 2013;66(1):3-8. Hellmann F, Verdi M, Schlemper BR, Caponi S. 50th anniversary of the Declaration of Helsinki: the double standard was introduced. Arch Med Res. 2014;45(7):600-601. Heringa J, Dute J. The proposed EU-regulation on clinical trial on medicinal products: an unethical proposal? Eur J Health Law. 2013;20(4):347-362. Hurst SA. Declaration of Helsinki and protection of vulnerable research participants [letter]. JAMA. 2014;311(12):1252. Lie RK, Emanuel E, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics. 2004;30(2):190-193. Millum J, Grady C. The ethics of placebo-controlled trials: methodological justifications. Contemp Clin Trials. 2013;36(2):510-514. Murphy S, Nolan C, O’Rourke C, Fenton JE. The reporting of research ethics committee approval and informed consent in otolaryngology journals. Clin Otolaryngol. 2015;40(1):36-40. Muthuswamy V. The new 2013 seventh version of the Declaration of Helsinki—more old wine in a new bottle? Indian J Med Ethics. 2014;11(1):2-4. Nathanson V. Revising the Declaration of Helsinki: your chance to influence research governance. BMJ. 2013;346:f2837. Palacios R. Post-trial access and the new version of the Declaration of Helsinki. Colomb Med. 2013;44(4):206-207. Parsa-Parsi R, Blackmer J, Ehni HJ, et al. Reconsidering the Declaration of Helsinki [letter]. Lancet. 2013;382:1246-1247. Parsa-Parsi RW, Ellis R, Wiesing U. Fifty years at the forefront of ethical guidance: the World Medical Association Declaration of Helsinki. South Med J. 2014;107(7):405-406. Shah P. Practical issues in implementation of WMA’s draft Declaration of Helsinki [letter]. Indian J Med Ethics. 2014;11(1):63-64. Shaw D, McMahon A. Ethicovigilance in clinical trials. Bioethics. 2013;27(9):508-513. Strech D, Metz C, Knuppel H. Do editorial policies support ethics research? A thematic text analysis of author instructions in psychiatry journals. PLoS One. 2014;9(6):e97492. Vastag B. Helsinki discord? A controversial declaration. JAMA. 2000;284(23):2983-2985. Wilson CB. An updated Declaration of Helsinki will provide more protection. Nat Med. 2013;19(6):664. Wolinsky H. The battle of Helsinki: two troublesome paragraphs in the Declaration of Helsinki are causing a furore over medical research ethics. EMBO Rep. 2006;7(7):670-672. Woods S, McCormack P. Disputing the ethics of research: the challenge from bioethics and patient activism to the interpretation of the Declaration of Helsinki in clinical trials. Bioethics. 2013;27(5):243250. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-2194.
For reprints and permission queries, please visit SAGE’s Web site at http://www.sagepub.com/journalsPermissions.nav
Copyright of American Journal of Sports Medicine is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
