CONTEXTS

Applied TheoryWriting for the Participants of International Clinical Trialscan be unjustified and extremely detrimental to theirhealth. The conflict about the use of placebos is justone of many examples of legal tensions in multicountrytrials.Patients’ Access to Clinical Trial RegulationsWhile the FDA relies on GCP standards for questionsabout clinical trials, in Russia the situation is not sotransparent. A new law—Надлежащая клиническаяпрактика (Appropriate Clinical Practice)—waspassed in 2005, but it merely recommends ratherthan prescribes procedures for clinical trials.Another law—О лекарственных средствах (AboutPharmaceutical Products)—was passed in 1998 toregulate everything from clinical trials to wholesaleof medications; since then, it has been amendedfive times. An industry standard—ОСТ 42-511-99:Правила проведения качественных клиническихисследований в Российской Федерации (Rules forConducting Quality Clinical Studies in the RussianFederation)—was passed in 1998.The list of laws, decrees, and standards does notstop here. A model law—О защите прав и достоинствачеловека в биомедицинских исследованиях вгосударствах— участниках СНГ (Protection ofHuman Rights and Dignity in Biomedical Studiesin Countries—Members of the Commonwealthof Independent States, 2005)—regulates a state’sguarantee to protect the rights, dignity, autonomy, andintegrity of an individual in biomedical testing. Theopening paragraph of this law states that the statuteis based on the provisions of the state constitution,as well as the principles of the Nuremberg Code,the WMA’s International Code of Medical Ethics,the Helsinki Declaration, the Convention on HumanRights and Biomedicine of the Council of Europe,the International Ethical Guidelines for BiomedicalResearch Involving Human Subjects of the Councilfor International Organizations of Medical Sciences(CIOMS), the GCP provisions of the World HealthOrganization (WHO), and WHO recommendationsconcerning the ethics of clinical trials. It is apraiseworthy attempt to combine all these internationalstandards for clinical trials, but it fails to addressthe contradictions among the regulations. Thesecontradictions make it extremely hard for participantsto find information about clinical trials, especially in acountry such as Russia, where Internet access is still aluxury in many smaller towns.Problems with TerminologySince standardization of clinical trial laws is stillproblematic, it is no surprise that differences existbetween the United States and Russia in terminology,oversight, and understanding of the procedures. Forexample, in the United States you can only registera “pharmaceutical product,” while in Russia you canregister a substance. In clinical trials in Russia, forexample, the acetaminophen in TYLENOL ® ArthritisPain or the paracetamol in TYLENOL ® Extended Reliefcould be the study drug, while in the United States itwould have to be the specific form of acetaminophenused in children’s TYLENOL ® Suspension Liquid or theTYLENOL ® Arthritis Pain 150 mg caplet. Furthermore,differences exist in exclusion criteria between thetwo countries: In Russia, underage orphans, pregnantwomen, 1 military personnel, and prisoners may nottake part in clinical studies. In the United States, theparticipation of these groups is strictly regulated butpermitted. Even the terms “clinical trial” and “informedconsent” may cause difficulties. The concepts behindthe two terms are new to Russian patients, who oftenhave only a vague idea about them or completelymisunderstand what they entail.Agency and Privacy of the PatientsThe legal regulations of any country are paramount;by complying with them, technical writers can attemptto ensure the ethical treatment of the participants ofclinical studies. However, experiences in my careeras a translator and interpreter, along with recentpublications in the United States and Russia, indicatethat following laws sometimes creates an ethicalquestion in itself, because the traditions and mindsetsof the people involved in trials often contradict thelegal provisions. If law becomes the sole foundationfor information in informed consent, patients areoften unable to concentrate on the information, tomake an informed decision, and can sometimes evenrefuse to participate.In Russia, families of patients take an active rolein health care: They go with the patients to doctors’visits and research information on the condition. Whena serious illness or terminal condition is discovered,272 Technical Communication l Volume 57, Number 3, August 2010