CHAPTER ONE
INTRODUCTION
1.1 BACKGROUND OF STUDY
Research is discovery of new facts,
enunciation of new principles, or fresh interpretation of the facts or
principles. It is a systematic Investigation to develop or contribute to
generalizable knowledge1. Research it is systemic and
organized wayof finding better answers to questions. It is a step in
searching for truth and the basic function of research is to answer why
and how of a phenomenon. It also involve searching answers to what,
when, how much, etc. All thesequestions have relevance to any discipline
but Medicine seems tohave special appetite for such enquiries. The goal
of medical researchis to improve health, and the purpose is to learn
how systems in human body work, why we get sick, and how to get back to
health and stay fit.It is a systematic process to better determine
ethology, patho-physiology, diagnosis, therapy and prognosis. Research
is the very foundation of improved medical care1.
The Nazi physicians conducted harmful
research on unwilling human subjects during World War II and were
unprecedented in their scope and the degree of harm and Suffering to
which human beings were subjected “Medical experiments” were performed
on thousands of concentration camp prisoners and included deadly studies
andtortures such as injecting people with Gasoline and live viruses,
immersing people in ice water, and forcing people to ingestpoisons2.
The rights of the subjects were violated
by physicians. The actions were condemned as crimes against humanity.
Permissible Medical Experiments were to be carried out and this
becameknown as theNuremberg Codeand was the first international code of
researchethics. The code stated the basic principles that must be
observed in order to satisfy moral, ethical, and legal concepts in the
conduct of human subject research2.
The approach of patient participation in
medical decision- making has been discussed openly in Germany. However,
the first publications in German3only discussed the approach
conceptually. Clinical trials fortheevaluation of patient participation
in medical Decision making were primarily initiated through the
research program of theFederal Ministry of Health4.
In 1999, theConference of German Health
Ministers adopted the document‘‘Patient rights in Germany today’’. It is
explicitly laid down that patients have the right to clear, expert and
satisfactory education and counselling in order to explain the usage
and risks of diagnostics, and advantages and risks of the treatment or
non-treatment options. Physicians must be sure that patients have
understood the information. It is pre-assigned that patients must be
informed about the type and Possibility of different risks and their
relation to recovery chances3.
Randomized controlled clinical trials
are the most rigorous way to determine treatment efficacy.Recruitment
into clinical trials, however, is notoriously difficult in general5, and surgical trials in particular face further obstacles to recruitment 6.
Low recruitment leads to poor statistical power to detect meaningful
differences, subjecting participants to potentially risky interventions
with no guarantee that their participation will lead to results of
scientific value7. Investigators planning a Randomized
controlled clinical trial mustensure that recruitment of subjects
intothetrialwill be sufficient to achieve the study aims.
In addressing issues of trial recruitment, investigators have tried to Identify barriers to clinician andpatient participation8, to modify trialsto make them more palatable to clinicians and patients 9and to assess differences between those patients who agree to participate in trialsand those who refuse10.
Demographic factors, such as gender,
race, age and education level, have been associated in some studies with
willingness to participate5.
1.2.PROBLEM STATEMENT
Research withhuman subjects can
occasionally result in a dilemma for investigators. When the goals of
the research are designed to make major contributions to a field, such
asimprovingthe understanding of a disease process or determining the
efficacy of an intervention, investigators may perceive the outcomes
of their studies to be more important than providing protections for
individual participants in the research2.
Although it is understandable to focus
on goals, our society values the rights and welfare of individuals. It
is not considered ethical behaviour to use individuals solely as means
to an end. The importance of demonstrating respect for
research participants is reflected in the principles used to define
ethical research and the regulations, policies, and guidance that
describe the implementation of thoseprinciples2.us
It is becoming increasingly recognised that patients can make Valuable contributions to their health care safety11.
However, while these interventions are well intentioned, a key issue is
the lack of evidence on patients’ preferences to adhere to the advice
and recommendations, namely how willing patients really are to take on
such an active role12. Patients were more willing to ask
factual (eg, ‘How long will I be in hospital for?’)as opposed to
challenging questions(eghave you washed your hands?’) particularly when
interacting with a doctor .The research also highlighted the potential
facilitating role of doctors: patients reported they would be more
willing to ask challenging questions if they were instructed to by a
doctor.In addition, previous research solely examined the potential
effect that doctors could have on increasing patients’ willingness to
participate. However, given patient involvement in safety is largely a
function of patients’ interactions with different health care
professionals12.
1.3 JUSTIFICATION
Available studies have showed that
patients value safety, convenience, oversight and open communication
in research. However they were put off by some aspects that are valued
by health care professionals. Educating the public about research may
improve participation.
This study was conducted in order to
evaluate factors that will improve Patients’ willingness to participate
in research and to assess patients’ awareness of medical research. Also
to educate and encourage patients that they are essential to the conduct
of research intended to improve human health in UBTH. As such,the
relationship between investigators and human subjects is critical and
should be based on honesty, trust andrespect.