ABSTRACT
INTRODUCTION
Research is
very important in finding solution to contemporary problems. The importance of
research cannot be overemphasized as very many discoveries have been made via
research and through this same important tool, many more breakthrough will be
made in all human endeavor, the health system inclusive as there are still many
diseases that defy cure currently and are at best, managed. But the
participation of patients in the above exercise is no less important. The aim
of this study was evaluation of patients’ willingness to participate in
research in both the University of Benin Teaching Hospital (UBTH) and Central
Hospital, Benin City (CHB). It also to compare factors that encouraged and
discouraged patients’ participation in medical research.
SAMPLING METHODOLOGY
The study design was a
descriptive cross-sectional study where data was obtained via interviewer
administered questionnaires. A total of 855 questionnaires were analysed using
statistical package for scientific solutions (SPSS 20.0). Appropriate measures
of statistical significance were utilized were p-value was set at p= 0.05.
RESULTS
A total of 855(65%) had heard
about medical research.47.1% of respondents who have heard about medical
research had participated.91.7% of the respondents were willing to consent to
clinical research. Among the 65% of respondents who knew about medical
research, 188 (33.9%) were influenced by trust in the
researcher,158(28.4%) by aim and
objective of research,125(22.5%),when given by doctor,159(24.6%),when there are
no adverse effect and 146(26.3%) for other reasons. Also among the 65% of
respondents who knew about research,273 (50.1%) were discouraged when it
involved serious adverse effect,251(45.1%) when it is time consuming,127(22.9%)
by mistrust of the researcher and 146(26.3%) by other reasons.
CONCLUSION
Majority of the respondents were willing
to consent to research in both UBTH and Central Hospital, Benin City. The
factors that influenced patient willingness to participate in medical research
were the aims and objective of the research, less time requirement, absence of
adverse effects, researchers trust, when it is given by doctor and
transportation fare. The discouraging factors were mistrust of researchers,
time consuming research, adverse effect, uninteresting research topic and
absence of monetary reward.
TABLE
OF CONTENTS
TITLE
PAGE……………………………………………………………………………...i
DEDICATION………………………………………………………………………...........ii
DECLARATION……………………………………………………………………..........iii
CERTIFICATION….............................................................................................................iv
ACKNOWLEDGEMENT………………………………………………………….............v
TABLE OF
CONTENTS…………………………………………………………………..vi
LIST OF
TABLES………………………………………………………………………...ix
LIST OF
FIGURES…………………………………………………………………...........x
ABSTRACT…………………………………………………………………………........xiii
CHAPTER ONE:
INTRODUTION………………………………………………………...1
CHAPTER TWO:
LITERATURE REVIEW………………………………………………7
CHAPTER THREE:
MATERIALS AND METHODS…………………………………...17
CHAPTER FOUR:
RESULTS……………………………………………………….........23
CHAPTER FIVE:
DISCUSSION, CONCLUSION, RECOMMENDATIONS…………..43
REFERENCES……………………………………………………………………….........50
APPENDIX…………………………………………………………………………..........57
LIST
OF TABLES
Table
1: Socio-demographic characteristics of respondents................................................24
Table 2: Respondents’
awareness of and willingness to participate in research……………29
Table
3: Respondents’ participation in research and respondents
who will take part in research when fully
informed…………………………………………………....31
Table
4: Factors That Militate Against
Respondents’ Participation In Research……….. 33
Table
5: Factors That Promote Respondents’
Participation In Research…………………35
Table
6: Information Required By Respondents Before Participating In Research………..37
Table
7: Benefit expected by respondents while participating in research…………………39
Table
8: Respondents’ Opinion On Payment Of Patients For Participating In Research…..41
LIST
OF FIGURES
Figure ( ii): Bar
chart showing the skill level of respondents………………………….25
Figure (i): pie
chart of respondents who have heard about research …………………..27
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.
1.4. AIM AND OBJECTIVES
General objective:
To
evaluate thewillingness of patients to participate in research and the
associated factorsin both the University of Benin Teaching Hospital (UBTH) and
Central hospital Benin(CHB).
Specific objective:
1. To assess patients awareness of medical research.
2. To evaluate factors that
encouragepatients’ willingness to participate in research
3.
To evaluate factors that discourage patients’ willingness to be
involved in research.
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