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 German only discussed the approach conceptually. Clinical trials for the evaluation of patient participation in medical Decision making were primarily initiated through the research program of the Federal Ministry of Health.
In 1999, the Conference 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 and patient participation, to modify trials to make them more palatable to clinicians and patients and to assess differences between those patients who agree to participate in trials and those who refuse.
Demographic factors, such as gender, race, age and education level, have been associated in some studies with willingness to participate
www.richardmille.casa says
545550 767060Just added this weblog to my favorites. I enjoy reading your blogs and hope you maintain them coming! 631302