RESEARCH ETHICS NEED CONSIDERATION

Abstract

Objectives of medical research include
developing knowledge that could be generalised to
increase understanding of biomedical subjects with
the ultimate goal of improving health of the
population.1 In the past century, research has
contributed to identifying many risk factors causing
miseries for human populations and has been
instrumental in decreasing the morbidity and
mortality due to many diseases. Many vaccines,
drugs, and other diagnostic and therapeutic
procedures were approved after evidence created by
researchers through their tireless efforts. However,
there is a risk of exploitation of human subjects
enrolled in research projects especially those with
interventional designs.2
The history of medical ethics dates back to
Hippocrates who merged ethics, a branch of
philosophy, with medicine. The real emphasis on
medical ethics concerning research emanated from
the Nuremberg trial necessitated by the unabated and
ruthless experiments on human subjects in Nazi
concentration camps having state patronage. These
experiments were not only physically brutal but also
had little respect for human dignity in the quest of
looking for the attributes of a so-called best race on
earth.3 After the Nuremberg Code, the World
Medical Association (WMA) that came into being in
1947 as the international organization that seeks to
represent all physicians, regardless of nationality or
specialty. The WMA has the role of establishing
general standards in medical ethics that are applicable
worldwide. The WMA has worked to prevent any
recurrence of the unethical conduct exhibited by
physicians in Nazi Germany and elsewhere. The
WMA updated the Hippocratic Oath for 20th century
use through the Declaration of Geneva, adopted at the
WMA's 2nd General Assembly in 1948. The Oath has
been revised several times since, most recently in
2006. Besides developing International Code of
Medical Ethics, it also developed ethical guidelines
for research on human subjects. The final draft of
such guidelines took a decade and a half and was
adopted as the Declaration of Helsinki in 1964.4 This
document has also undergone periodic revision, most
recently in 2008 in the 59th WMA General Assembly
held at Seoul, Korea.5
Based on these, universities, colleges, and
professional organizations have developed ethical
guidelines for research that are updated from time to
time. This has resulted in the establishment of
Institutional Ethical Review Boards in all institutions
carrying out research through different study designs.
Dissertations, theses, and other research projects
undergo reviews at planning, implementation, and
reporting stages. Funding agencies also ask for
approval of projects from such committees/boards.
Moreover, medical journals also require such
certification that is rigorously implemented especially
in the developed countries. International Committee
of Medical Journal Editors (ICMJE) also requires that
ethical approval should be obtained and published.
Over 500 journals now follow these guidelines of
ICMJE. Though there are guidelines at all levels, it
is a matter of concern that implementation of such
guidelines is below expectations seen in the light of
the spirit of Nuremberg Code and Helsinki
Declaration. It would be expected that they might not
be followed in letter and spirit in under developed
and developing countries but in reality the developed
countries also lag behind in following these codes.
Even in a country like United States, five medical
journals that were studied were found deficient in
reporting ethical approval. Though ethical approval
was reported in 97% cases of randomised controlled
trials (RCT), but in the case of other study designs it
was found to be on the lower side.6
Most of the researchers consider obtaining
consent synonymous with ethics. Research ethics,
however, go beyond consents. Privacy and
confidentiality are universal contents of consents and
need to be followed. Benchmarks need to be
developed at every level with operational principles
identified in a perspective by Emanuel et al as:
'˜collaborative partnership, social values, scientific
validity, fair selection of study population, favourable
risk-benefit ratio, independent review, informed
consent, and respect for recruited participants and
study communities'.7
These principles need to be adhered to in the
light of the widely known principles of medical
ethics: autonomy, beneficence, non-maleficence, and
justice. Institutional Review Boards need to include
qualified and scrupulous people to develop proper
guidelines with rigorous enforcement. The
Institutional Review Boards and Committees should
not only review the projects at planning level but also
at implementation and reporting levels. The medical
journals include guidelines for authors how to write
their manuscripts. Unfortunately many journals do
not include guidelines regarding ethics on research. It
is imperative that medical journals include proper
guidelines in this regard and shall be rated for
inclusion of guidelines and reporting of ethical
approval of relevant boards. In this way the journals
would contribute meaningfully in upholding the
universal principles of ethics.