RESEARCH ETHICS NEED CONSIDERATION

Abstract

Objectives of medical research includedeveloping knowledge that could be generalised toincrease understanding of biomedical subjects withthe ultimate goal of improving health of thepopulation.1 In the past century, research hascontributed to identifying many risk factors causingmiseries for human populations and has beeninstrumental in decreasing the morbidity andmortality due to many diseases. Many vaccines,drugs, and other diagnostic and therapeuticprocedures were approved after evidence created byresearchers through their tireless efforts. However,there is a risk of exploitation of human subjectsenrolled in research projects especially those withinterventional designs.2The history of medical ethics dates back toHippocrates who merged ethics, a branch ofphilosophy, with medicine. The real emphasis onmedical ethics concerning research emanated fromthe Nuremberg trial necessitated by the unabated andruthless experiments on human subjects in Naziconcentration camps having state patronage. Theseexperiments were not only physically brutal but alsohad little respect for human dignity in the quest oflooking for the attributes of a so-called best race onearth.3 After the Nuremberg Code, the WorldMedical Association (WMA) that came into being in1947 as the international organization that seeks torepresent all physicians, regardless of nationality orspecialty. The WMA has the role of establishinggeneral standards in medical ethics that are applicableworldwide. The WMA has worked to prevent anyrecurrence of the unethical conduct exhibited byphysicians in Nazi Germany and elsewhere. TheWMA updated the Hippocratic Oath for 20th centuryuse through the Declaration of Geneva, adopted at theWMA’s 2nd General Assembly in 1948. The Oath hasbeen revised several times since, most recently in2006. Besides developing International Code ofMedical Ethics, it also developed ethical guidelinesfor research on human subjects. The final draft ofsuch guidelines took a decade and a half and wasadopted as the Declaration of Helsinki in 1964.4 Thisdocument has also undergone periodic revision, mostrecently in 2008 in the 59th WMA General Assemblyheld at Seoul, Korea.5Based on these, universities, colleges, andprofessional organizations have developed ethicalguidelines for research that are updated from time totime. This has resulted in the establishment ofInstitutional Ethical Review Boards in all institutionscarrying out research through different study designs.Dissertations, theses, and other research projectsundergo reviews at planning, implementation, andreporting stages. Funding agencies also ask forapproval of projects from such committees/boards.Moreover, medical journals also require suchcertification that is rigorously implemented especiallyin the developed countries. International Committeeof Medical Journal Editors (ICMJE) also requires thatethical approval should be obtained and published.Over 500 journals now follow these guidelines ofICMJE. Though there are guidelines at all levels, itis a matter of concern that implementation of suchguidelines is below expectations seen in the light ofthe spirit of Nuremberg Code and HelsinkiDeclaration. It would be expected that they might notbe followed in letter and spirit in under developedand developing countries but in reality the developedcountries also lag behind in following these codes.Even in a country like United States, five medicaljournals that were studied were found deficient inreporting ethical approval. Though ethical approvalwas reported in 97% cases of randomised controlledtrials (RCT), but in the case of other study designs itwas found to be on the lower side.6Most of the researchers consider obtainingconsent synonymous with ethics. Research ethics,however, go beyond consents. Privacy andconfidentiality are universal contents of consents andneed to be followed. Benchmarks need to bedeveloped at every level with operational principlesidentified in a perspective by Emanuel et al as:‘collaborative partnership, social values, scientificvalidity, fair selection of study population, favourablerisk-benefit ratio, independent review, informedconsent, and respect for recruited participants andstudy communities’.7These principles need to be adhered to in thelight of the widely known principles of medicalethics: autonomy, beneficence, non-maleficence, andjustice. Institutional Review Boards need to includequalified and scrupulous people to develop properguidelines with rigorous enforcement. TheInstitutional Review Boards and Committees shouldnot only review the projects at planning level but alsoat implementation and reporting levels. The medicaljournals include guidelines for authors how to writetheir manuscripts. Unfortunately many journals donot include guidelines regarding ethics on research. Itis imperative that medical journals include properguidelines in this regard and shall be rated forinclusion of guidelines and reporting of ethicalapproval of relevant boards. In this way the journalswould contribute meaningfully in upholding theuniversal principles of ethics.