CONTEXTS

Applied TheoryTatiana BatovaThe United States and Russia: The Impactof Legal and Cultural Differences onInformed Consent DocumentsThe benefits of offshoring clinical trials are evident,but critics wonder if, in the rush for savings,pharmaceutical companies fail to consider the ethicalpitfalls (e.g., Normile, 2008). Bioethicists point outthat the rights of participants in international studiesare often trampled, because people in other countriesrespond differently to informed consent proceduresand documents (Moodley, Pather, & Myer, 2005).In addition, some guidelines in the internationalstandardization regulations leave much open tointerpretation, which allows the companies to takeadvantage of the participants. For example, the ICH-GCP requirement for sponsors to make sure thatclinical trials are “adequately monitored” can only beeffective if it is effectively implemented (Glickmanet al., 2009). Some U.S. laws governing clinical trialscontradict international laws; this affects clinicalstudies in Russia, as Russia is still developing its owncode for medical research and, in the meantime,abides by international standards. Moreover, both theU.S. and international legal systems can be in conflictwith the contexts of people’s lives and their culturallydetermined mindsets. The following examples illustratehow legal differences and cultural contradictions affectinformed consent documentation to the detriment ofparticipants of clinical trials.International Legal Debate: The Use of PlaceboInternational regulation and standardization attemptshave often run into trouble because new directivesare in conflict with the laws of a specific country.For example, regulations of the U.S.-based FDAcontradict some of the international guidelines of theWorld Medical Association (WMA). The Declarationof Helsinki—the best-known policy statementof WMA regarding clinical trials—was amendedin 2000–2002 on three major issues: limitation ofplacebo use, stronger requirement for trial sponsorsto provide medical care to participants after the studyis finished, and public registration of clinical trialsbefore recruiting the first subject (Normile & Marshall,2008). In October 2008, the FDA—which previouslyreferenced the Helsinki Declaration as the basis forclinical trial regulation—amended its requirements. Toavoid inconsistency, the FDA now accepts results ofclinical trials from overseas if they do not comply withthe Helsinki Declaration but rather with the ICH-GCP(Fiscus, 2009).As a result, critics say that the FDA requirementsare now less demanding in the protection of humanrights of participants. According to Stuart Rennie, abioethicist at the University of North Carolina, thisdecision by the FDA does not stand up to scrutiny sinceit “would seem to encourage pharmaceutical companiesto cut ethical corners when working abroad. … TheGCP is more open to the use of placebos and does notmention conflicts of interest, the need to publish results,or post-trial access to care” (Normile & Marshall, 2008,p. 516).Many U.S. informed consent documents are createdand sent to foreign countries without addressing thisconflict. In my translation work with informed consentdocuments, I often encountered sentences such asthese two [emphasis added]: “There is an agreementbetween health care experts and regulatory authoritiesthat in order to obtain reliable and valid results ofmedication efficacy placebo-controlled studies are necessary”and “Regulatory authorities such as the FDA (Foodand Drug Administration) and the EMEA (EuropeanMedicine Evaluation Agency) can only grant approvalfor medications if their efficacy has been proven to beunambiguous, which means superior to placebo.”Such statements can be hard to decipher for anEnglish-speaking patient because of their jargon, andthey could become utterly confusing in an internationalsetting, as well as provide grounds for litigation. Thetwo sentences assume that all health care experts andall regulatory authorities agree on using a placebo;they imply that the only way to prove unambiguousefficacy of a drug is to compare it with placebos.However, many experts and regulatory agencies (e.g.,WMA) consider the use of a placebo necessary onlyif no known medication exists for a particular disease.Comparing the experimental medication with an existingdrug can provide conclusive results. Thus, treatingparticipants with placebos in a blind study (a study inwhich participants do not know whether they are takinga placebo, an experimental drug, or a patented drug)when they could be treated with a patented medicationVolume 57, Number 3, August 2010 l Technical Communication 271