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Justification, Coherence and Consistency of Provisions in The Declaration of Helsinki Th is expanded requirement also highlights Justifi cation, Coherence and Consistency a tension with the DoH. On the one hand, it claims to explicitly address only physi- of Provisions in the Revised Declaration cians. But to the extent that its require- ments apply to every study involving hu- of Helsinki man subjects, they would apply to research covered by non-physicians as well. Limiting To make this argument, I provide a read- the scope of the provisions to only research ing of several revised passages in the 2013 with human subjects that is conducted by DoH. Th is reading draws on a normative physicians seems arbitrary, at best. More- framework that emphasizes a particular over, the requirement that research results view of the proper division of labor be- be published has been expanded to include tween research and medical and public “publication and dissemination” and this health systems and the threat that biased obligation is now ascribed to sponsors as or poor quality research poses to those well as researchers, authors and editors (par. systems. It also treats various provisions 36). Th e language of this paragraph has also of the DoH as helping to provide a pub- been strengthened from “should” to “must” lic assurance to stakeholders that the re- in several places, including the obligation to search enterprise functions as a system of publish negative and inconclusive fi ndings mutually benefi cial social cooperation in and to report confl icts of interest. which all parties are respected as free and equal contributors [1]. Although these Th ese concrete prescriptions assign poten- commitments are not expressed within tially costly duties to a range of stakeholders the DoH itself, this reading illustrates and their requirements are not limited by Alex John London strengths and weakness of the new docu- disciplinary orientation or by the degree of ment and highlights areas for improve- risk posed to study participants. It is some- Since the fi rst version of the Declara- ment. what surprising, therefore, that the DoH tion of Helsinki (DoH) was adopted in does not contain an explicit statement of 1964, it has been revised nine times and their normative grounding or justifi cation. numerous other bodies have promulgated Integrity of Scientifi c In particular, there have been a number of ethics guidance documents. During this Information proposals recently to titrate the level of re- same period, scientifi c research with hu- search oversight to risk as a way of reign- man subjects has dramatically increased in Th e 2013 version of the DoH contains ing in what is criticized as costly regulatory size, scope, and importance. If the DoH several changes that signifi cantly expand overreach [2, 3]. Th e only explicit discus- is to continue to play a signifi cant role in the scope of requirements relating to the sion of the “importance” of a “research ob- regulating the research enterprise, it must registration of research and the disclosure jective” in the DoH is to state that it must convincingly convey a coherent, if highly of fi ndings. For example, the requirement outweigh the risks and burdens imposed on general, view of the research enterprise for trial registration has been expanded participants (par. 16, 2013). If a study poses and the basic normative requirements nec- from “every clinical trial” in the 2008 ver- little to no risk to participants, there is no essary to preserve its integrity and protect sion to “every research study involving hu- independent ground stated in the DoH to the rights and welfare of participants. In man subjects” (par. 35). With this expanded justify requiring uniformly high oversight what follows, I argue that the emphasis in scope, this requirement now covers a wider for it and risker or more burdensome stud- the DoH on detailed prescriptive require- range of research activities. For example, ies. ments untethered from general justifi ca- the 2008 wording would not cover sub- tory grounds means that it is particularly studies carried out within larger trials, such Th e DoH would benefi t, therefore, from dependent on readers to supply underlying as biomarker studies, because these are not an explicit statement that these require- normative justifi cations. Without these separate clinical trials. Such sub-studies are ments are justifi ed because registration of normative grounds, its provisions might covered under the new language because studies and comprehensive reporting of all appear inconsistent, unfounded, or arbi- they are research studies involving human study data, including negative and incon- trary. subjects. clusive results, are necessary to ensure the 188 Declaration of Helsinki reliability, relevance, and validity of scien- Th e WMA may be uncomfortable stating Medical research with a vulnerable group is tifi c information. As the DoH states, the moral requirements for stakeholders beyond only justifi ed if the research is responsive to the primary purpose of research involving hu- physicians, but omitting the obligations of health needs or priorities of this group and the man subjects is “to understand the causes, others would either cripple the document’s research cannot be carried out in a non-vul- development and eff ects of diseases and ability to provide comprehensive ethical nerable group. In addition, this group should improve preventive, diagnostic and thera- guidance across the lifecycle of research or stand to benefi t from the knowledge, practices peutic interventions (methods, procedures it would lead to unfairly attributing to phy- or interventions that result from the research and treatments)” (par. 6). Reliable, rel- sicians responsibilities that vest in and must (par 20). evant, and valid data are essential to the be discharged by other parties. ability of the research enterprise to fulfi ll Although the responsiveness requirement this purpose. will undoubtedly be subject to further criti- Responsiveness and Benefi ts cism for vagueness, this language makes it In modern health systems and health pol- clear that the primary consideration in eval- icy, many forms of research with human In several places, the 2008 DoH states that uating research in vulnerable groups should subjects contribute data on which clini- populations in which research is carried out be the relationship of the questions being cians, patients, researchers, institutions, should stand to benefi t from the results of investigated, and the knowledge that is ex- policy makers, and others rely in making research. Paragraph 17 of the 2008 ver- pected to be generated, to the health needs decisions that aff ect the health and wel- sion reads, “Medical research involving a or health priorities of that group. fare of individuals and groups and the al- disadvantaged or vulnerable population or location of scarce resources [4]. Because community is only justifi ed if the research Th e current version of the DoH does not research data are the bedrock of evidence- is responsive to the health needs and pri- contain a justifi cation for this requirement, based health systems and social policy, the orities of this population or community and and some changes to the text obscure one quality and reliability of that information if there is a reasonable likelihood that this potential justifi catory ground. Th at is, in aff ects the health, welfare, and rights of the population or community stands to benefi t the 2008 version, the statement “Medical individuals who rely on those health sys- from the results of the research.” Paragraph progress is based on research that ultimate- tems to address their health needs. Even 33 of the 2008 version uses even broader ly must include studies involving human research that imposes little or no risk to language, “At the conclusion of the study, subjects” is followed immediately by the study participants can generate data that is patients entered into the study are entitled claim that “Populations that are underrep- biased or of poor quality. Concerns about to be informed about the outcome of the resented in medical research should be pro- the quality of low risk studies have sur- study and to share any benefi ts that result vided appropriate access to participation faced frequently in the context of postmar- from it, for example, access to interventions in research,” (par 5, 2008). Although both keting research, where decreased oversight identifi ed as benefi cial in the study or to claims are retained in the 2013 revision, removes incentives and safeguards against other appropriate care or benefi ts.” the second now appears as an independent using biased evidence to advance market- statement (par. 13), eight paragraphs after ing objectives, sometimes at the expense of Although the most direct result of research the former claim (par. 5). Separating these patient health [5,6]. Similar concerns have is new information and knowledge, re- claims severs the natural justifi catory link emerged recently in biomarker studies as search can also produce new interventions, that was at least implied in the previous well [7,8]. improved infrastructure, and potentially version. lucrative fi nancial rewards. If the core re- Strengthening registration, publication quirement for research in disadvantaged Th e link that is more clearly implied in the and reporting requirements is justifi ed by populations is that those populations ben- 2008 version is that inclusion in research their contribution to ensuring the quality efi t from participation, and if there are is necessary for vulnerable groups to share and reliability of research data. Ascribing myriad benefi ts that can fl ow from research, in medical progress. Excluding vulner- obligations for registration, reporting, and then critics might wonder why research able groups from research stifl es what is, dissemination of study fi ndings to a broad should be required to meet the responsive- if not the only, then the most effi cient, av- range of stakeholders is also warranted ness requirement at all [9].
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