Abstract S3

obese patients with T2DM. Cost-effectiveness (INR/unit of effective- vaccines, the coverage was low, varying from 5.5% to 35.4%. The
ness) varied from 3.7 to 45.2. Seventeen percent of the patients with vaccination coverage was better in respondents with higher educated
T2DM included in this study received less cost-effective antidiabetic and higher income parents. We suggest that patient education, plan-
drugs. ning by government for the implementation of a policy for adult
Conclusions:  Prescriptions of cost-effective antidiabetic drugs (83%) vaccination, and involvement of physicians are needed for better
were more common than less cost-effective antidiabetic drugs (17%) adult vaccination coverage.
in patients with T2DM from Mumbai, India. Key words:  adult vaccines; education; income; Mumbai, India; uni-
Key words:  antidiabetic, cost-effectiveness, diabetes mellitus, India. versity students.
Disclosure of Interest:  None declared. Disclosure of Interest:  None declared.

References References
1. Kaveeshwar S, Cornwall J. The current state of diabetes mellitus 1. Andre FE, Booy R, Bock HL, et al. Vaccination greatly reduces
in India. Australasian Medical Journal. 2014;7(1):45-48. disease, disability, death and inequity worldwide. Bull World
2. Yesudian C, Grepstad M, Visintin E, Ferrario A. The economic Health Organ 2008; 86:140–146.
burden of diabetes in India: a review of the literature. Globalization 2. Verma R, Khanna P, Chawla S. Adult immunization in India:
and Health 2014;10:80. Importance and recommendations. Human Vaccines & Immuno­
therapeutics. 2015; 11(9):2180–2182.

A Study to Assess the Vaccination

Coverage of University Students in In Defense of Medically Enhancing Human
Mumbai, India Morality
V. Limaye; D. Limaye; and G. Fortwengel E.D. Protopapadakis
Hochschule Hannover, Hannover, Germany National and Kapodistrian University of Athens, Athens, Greece
Background:  Immunization is the most cost-effective intervention Our species may plausibly boast that, in the relatively short period
for infectious diseases, which are the major cause of morbidity and since it first emerged, it has enormously advanced in knowledge,
mortality worldwide. Vaccines not only protect the individual who science, and technical progress. When it comes to our moral develop-
is vaccinated but also reduce the burden of infectious vaccine-pre- ment, however, the distance we have covered is comparatively negligi-
ventable diseases for the entire community.1 Adult vaccination is very ble. As a result, man today resembles a mighty giant who has no clue
important given that > 25% of mortality is due to infectious diseases.2 how to use his powers; and just like a child playing with grenades,
There is a scarcity of information on the vaccination status of young man has become utterly dangerous to himself, to other species, and
adults and the role of socioeconomic conditions in India. to the globe in general. The situation is bound to steadily deteriorate
Objectives:  The present study explored the adult vaccination status as long as the gap between our powers and our morality continues
and influence of income and education of parents on adult vaccina- to increase. What if, however, we could medically accelerate our
tion status in university students from Mumbai, India. moral development? Even better, what if we could one and for all
Methods:  This descriptive study was performed from January to render our species totally immune to certain vices? The advances in
April 2015 among undergraduate pharmacy students from Mumbai biomedicine nowadays seem to hold such a promise. In this essay,
University, India, by using a validated study questionnaire. Students I will discuss the prospect of medically intervening with the moral
were contacted by a study team member in their classrooms and were disposition of humans in such a way as to even eliminate morally
given a brief introduction about the research project. Those who unjustifiable choices. I will claim that such an intervention would
desired to participate in the study were explained the purpose and not necessarily compromise either the free will or the autonomy of
objectives of the study. On the basis of the eligibility criteria (those moral agents. To support my view, I will provide a set of arguments
who gave written informed consent and were between the age group based on the Kantian tradition in ethics, since the opponents of moral
of 18–25 years), 149 students were selected for the present study. enhancement mostly evoke arguments that focus on autonomy and
A total of 8 vaccines (namely, Tdap/DTP, varicella, measles-mumps- free will. I will conclude with the view that moral enhancement by
rubella [MMR], influenza, pneumococcal, hepatitis A, hepatitis B, means of pharmaceutical intervention might even be a perfect duty
and meningococcal) were included in this study for all the respond- for moral agents in the light of Kantian ethics.
ents. In addition to these vaccines, human papillomavirus (HPV) Key words:  autonomy, biomedicine, free will, Kantian ethics, moral
vaccine was also included for female respondents. enhancement, utilitarianism.
Results:  There were total of 149 (75 males and 74 females) respond- Disclosure of Interest:  None declared.
ents with a mean age of 21.5 years. The top 3 immunizations were
Td/Tdap (97.3%), MMR (66.4%), and hepatitis B (55%) among the
respondents. Only 4 (5.5%) female respondents had been immunized
against HPV. The lowest income group (< 50,000 INR/month) had Unethical Academic Clinical Trials
the least vaccination coverage for all the vaccines, except for MMR P.D. Walson
and HPV. Vaccination coverage was lesser for respondents with par- University Medical Center, Goettingen, Germany
ent’s education below a high school than those with parent’s edu- Background:  Many clinical trials, including those performed in the
cation of graduation and above, except for pneumococcal vaccine. developing world, are designed and conducted by academics without
Conclusions:  India’s National Centre for Disease Control has recom- pharmaceutical sponsorship, input, or supervision. Although many
mended Td/Tdap, MMR, and varicella for all adults and influenza, academics are adept at asking and answering basic scientific ques-
pneumococci, hepatitis A, hepatitis B, meningococcal, and HPV for tions, unfortunately few academic institutions or investigators are
adults with certain risk factors. Td/Tdap (97.3%) and MMR (66.4%) equipped to provide the same quality of clinical trial design, conduct,
coverage was in line with the recommendations. For all the other and oversight as those done by the pharmaceutical industry.
 S4 Abstract

Methods:  A review of academic clinical trials and documents dealing Background:  Ever since the 1996 revision of the Declaration of
with the proper conduct of clinical trials was combined with both Helsinki, the World Medical Association has attempted to address
personal and published regulatory experience concerning the quality ethical and scientific concerns of its diverse stakeholders for Articles
of data produced by academic clinical trials. 33 (use of placebo) and 34 (posttrial provisions), most recently in
Results:  Academic clinical trials often produce data that are not 2013. Both are inextricably linked to standard of care, an essential
accepted by regulatory authorities for the approval or labeling of element of any comparative, interventional clinical trial. But has
the treatments studied in the trials. Participants in such trials are this now 20-year-long ethical debate truly been put to rest? The
therefore exposed to risks without producing any personal or societal choice of standard of care in clinical trials remains a complex issue,
benefits; by definition, such trials are unethical. particularly for comparative trials conducted in emerging countries.
Conclusions:  It is proposed that only clinical studies, including those Interpretations of the Declaration of Helsinki as the cornerstone
done by academics, that are designed, conducted and monitored in document for medical ethics range from best intervention available
such a way as to produce data suitable for regulatory approval should worldwide to any locally available standard of care for the compara-
be funded, approved by institutional review boards/ethics commit- tor group, which in the worst case could mean no interventional
tees, or conducted in the developed or developing world. Increased care at all.1,2
training of academic investigators, institutional review boards/ethics Objectives:  Our aim was to examine the current status of clinical
committees, as well as the public and private groups that fund clini- research practice and ethical guidance on standard of care, with a
cal trials, are needed to decrease the number of unethical academic focus on international health research, and to review corresponding
clinical trials performed. guidance issued by pharmaceutical sponsors in their publicly acces-
Key words:  academic clinical trials, developing world, ethics, regula- sible policies on clinical research.
tory approval. Methods:  We reviewed ethical recommendations before and after
Disclosure of Interest:  None declared. 2013 and scientific literature, as well as major clinical trial registries
(European Union, United States, and World Health Organization),
to assess current clinical research practice related to standard of
Research Proposal Writing care. Furthermore, the websites of the top-ranked 25 pharmaceuti-
Z. Osman cal companies on sales figures in 20143 were reviewed for publicly
accessible policies with reference to standard of care in clinical trials
National Centre for Research, Khartoum, Sudan
in emerging regions.
Background:  Proposal writing is a skill of fundamental importance
Results:  After a period of active scientific-ethical debate before the
to the researchers, and the proposal is an important step in develop-
2013 revision of the Declaration of Helsinki, few ethical discussions
ing a research project that gives an overview of it. It enables other
or recommendations have since been published that could provide
people to understand the scope of the research and the significance
additional guidance to clinical researchers. The recent scientific lit-
of the research, as well as the proposed methodology and chosen
erature reflects the continued challenge for researchers to design
research method. The purpose of this paper is to define the research
an ethically and scientifically sound study, especially in vulnerable
proposal and review its importance and its different types. It also
populations. However, ~20% of registered open clinical trials across
provides a generic outline that focuses on the components and sec-
major trial registries are designed with a placebo control, suggest-
tions of the research proposal and the basic format of each section.
ing that the question of standard of care remains highly pertinent.
Objectives:  The main objectives are to highlight the importance of
The review of pharmaceutical sponsor websites revealed a highly
writing a research proposal. It also aims to define the research and
variable picture with regard to publicly available policies or state-
its different types as well as to identify the components and sections
ments on this issue, particularly for research conducted in low- to
of a research proposal and to explain the content of each section.
middle-income countries. The review outcome spans results from
Methods:  A comprehensive literature review on research proposal writ-
any policy published to very clearly worded statements on clinical
ing has been conducted by using academic databases and some search
research in developing countries, the standard of care aspect dur-
engines. The focus was on the general format, guidelines, and presenta-
ing the trial conduct, and regulatory strategies after completion of
tion that suit students and scholars in different disciplines of life sciences.
product development.
Various sections of a research proposal are discussed in detail. The focus
is to motivate young researchers to take up challenging problems. Conclusions:  Investigators, ethics committees, and sponsors continue
to be confronted with the challenge of ensuring ethically and scien-
Results:  The basic definitions of research and proposal in general and
tifically sound clinical studies with appropriate standard of care. We
in health in particular were given and explained. Useful guidelines
have attempted to examine available ethical guidance and summarize
for the identification and selection of a research topic were also dis-
recommendations for clinical trial designs that could assist in address-
cussed in detail. The questions relating to whether a research problem
ing these challenges. Care should be taken to maintain a high level
is adequately analyzed and whether it is clearly stated were also
of awareness for the importance of a sound ethical framework for a
addressed. Development of research objectives and literature reviews
scientifically valid clinical trial design. Pharmaceutical companies, as
were also discussed. A special emphasis was given to elements of the
major sponsors of clinical research, should demonstrate awareness and
“Methods” section of a research proposal, as well as the development
an appropriate management of these aspects, particularly in regions
of a work plan, and the preparation of a budget was highlighted.
with limited resources. As part of the ongoing debate on transparency,
Key words: proposal, research, research health system, research
one option could be to formulate positions and make them available to
methodology.
the public, regardless of whether such a statement is legally required.
Disclosure of Interest:  None declared.
A few examples already exist where such clarifying statements have
been provided. This approach would prepare the ground for an open
and transparent communication to agencies, ethics committee, and,
Clinical Research and Standard of last but not least, patients.
Care—An Unresolved Question? Key words: bioethics, clinical research, Declaration of Helsinki,
N.G. Tornieporth; F. Fneish; and G. Fortwengel international health research, placebo, standard of care.
Hochschule Hannover, Hannover, Germany Disclosure of Interest:  None declared.