بسم الله الرحمن الرحيم

THE TITLE

“INTRODUCTION”

ETHICS IN BIOMEDICAL RESEARCH Biomedical Research is the area of science devoted to the study of the processes of life, the prevention and treatment of disease and the genetic and environmental factors related to disease and health.

ETHICS IN BIOMEDICAL RESEARCH What is research ethics? The field of research ethics is devoted to the systematic analysis of such questions to ensure that study participants are protected and, ultimately, that clinical research is conducted in a way that serves the needs of such participants and of society as a whole.

ETHICS IN BIOMEDICAL RESEARCH Ethical issues in research must not be addressed by researchers as an afterthought. Ethical issues permeate research and must guide research design.

ETHICS IN BIOMEDICAL RESEARCH A study must address a question of sufficient value to justify the risk posed to participants. Exposing subjects even to low risk to answer a trivial question is unacceptable.

ETHICS IN BIOMEDICAL RESEARCH A study must be conducted honestly. It should be carried out as stated in the approved protocol, and research ethics boards have an obligation to ensure that this is case.

ETHICS IN BIOMEDICAL RESEARCH Study findings must be reported accurately and promptly. Methods, results and conclusions must be reported completely and without exaggerating to allow practising clinicians to draw reasonable conclusions.

ETHICS IN BIOMEDICAL RESEARCH The study to ensure confidentiality is founded in the physician patient contract, physicians disclose information about a patient only in the patient’s best interests and they avoid any conflict of interest in the disclosure of patient information.

ETHICS IN BIOMEDICAL RESEARCH What are the main ethical principles that govern research with human subjects? There are three primary principles that are traditionally cited when discussing ethical concerns in human subjects research: 1.Autonomy 2.Beneficence 3.Justice

ETHICS IN BIOMEDICAL RESEARCH THE WORLD MEDICAL ASSOCIATION Declaration of Helsinki World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects

ETHICS IN BIOMEDICAL RESEARCH Any research using the human beings as subjects of medical or scientific research or experimentation shall bear in mind the following principles:

ETHICS IN BIOMEDICAL RESEARCH Principles of essentiality whereby, the research entailing the use of human subjects is considered to be absolutely after a due consideration of all alternatives; in the light of the existing knowledge in the proposed area of research and after the proposed research has been duly vetted and considered by an appropriate and responsible body of persons who are external to the research and who, after careful consideration, come to the conclusion that the said research is necessary for the advancement of knowledge and for the benefit of all members of the human species and for the ecological and environmental well being of the planet.

ETHICS IN BIOMEDICAL RESEARCH Principle of Institutional Arrangements whereby, there shall be a duty on all persons conducted with the research to ensure that all the proceedures required to be complied with and all institutional arrangements required to be made in respect of the research and its subsequent use or application are duly made in a bonafide and transparent manner.

ETHICS IN BIOMEDICAL RESEARCH Principle of the maximisation of the public interest and of distributive justice whereby, the research or experiment and its subsequent applicative use are conducted and used to benefit all human kind.

ETHICS IN BIOMEDICAL RESEARCH Principles of accountability and transparency whereby, the research or experiment will be conducted in a fair, honest impartial and transparent manner after a full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist:

ETHICS IN BIOMEDICAL RESEARCH Principles of professional competence whereby, the research is conducted at all times by competent and qualified persons who act with total integrity and impartiality and who have been made aware of, and are mindful of, the ethical considerations.

ETHICS IN BIOMEDICAL RESEARCH Principles of voluntariness, informed consent and community agreement whereby, research subjects are fully apprised of the research and the impact and risk of such research on the research subject retain the right to abstain from further participation in the research irrespective of any legal or other obligation that may have been entered into by such human subjects or someone on their behalf.

ETHICS IN BIOMEDICAL RESEARCH Principles of privacy and confidentiality whereby, the identity and records of the human subjects of the research or experiment are as far as possible kept confidential; and, that no details about identity of said human subjects, which would result in the disclosure of their identity, are disclosed, without sound scientific reasons.

ETHICS IN BIOMEDICAL RESEARCH Principles of precaution and risk minimisation whereby, due care and caution is taken at all stages of the research and experiment to ensure that the research subject and those affected by it are put to the minimum risk.

ETHICS IN BIOMEDICAL RESEARCH Principle of non-exploration whereby, as a general rule, research subjects are renumerated for their involvement in the research or experiment; and, irrespective of the social and economic condition or status, of literacy or educational levels attained by the research subjects kept fully apprised of all the dangers arising in and out of the research.

ETHICS IN BIOMEDICAL RESEARCH The scientific investigator must obtain informed consent from each research participant. This should be obtained in writing (although oral consents are sometimes acceptable ) after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions. Informed consent should be seen as an ongoing process, not a singular event or a mere formality.

ETHICS IN BIOMEDICAL RESEARCH What are the components of an ethically valid informed consent for research? Disclosure : The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits risks, stresses, and discomforts.

ETHICS IN BIOMEDICAL RESEARCH Understanding: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the investigators.

ETHICS IN BIOMEDICAL RESEARCH Voluntariness: The participant’s consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation.

ETHICS IN BIOMEDICAL RESEARCH Competence: The participant must be competent to give consent. A designated surrogate may provide consent if it is in the participant’s best interest to participate.

ETHICS IN BIOMEDICAL RESEARCH Consent: The potential human subject must authorize his/her participation in the research study, preferably in writing, although at times an oral consent or assent may be more appropriate.

ETHICS IN BIOMEDICAL RESEARCH The scientific community supports the highest quality of care and treatment for research animals because their use in research remains a necessity. These animals help to unlock the mysteries of disease and deserve our respect and the best possible care.