Ethics of Research

1. Ethics of Research

2. Objectives • Importance of Research. • Informed consent and research necessity. • Human Genetic Research. • Risks and benefits of research. • Economic aspects of Health care Ethics.

3. Research and Ethics • Well-known to all countries as an essential tool for development. • Developing countries devoted about 1% of gross national product to research and development. • Research is conducted in all countries (developing and developed ) on human subjects and animals too. • Biomedical research on human should be in a compliance of respect of persons, beneficence and distributive justice.

4. Research involving human subjects • A declaration on the subject was necessary according to Nuremberg trials. Subsequently, the council of international organization of Medical sciences (COIMS) with WHO elaborated a code of ethics for clinical research that was named” The Helsinki declaration”. • Basic principles of Helsinki declaration: • Respect for the individual (Article 8). • Their right to self-determination and the right to make informed decisions (Articles 20, 21 and 22). • The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18). • Allowance should be considered for surrogate consent by an individual acting in the subject's best interest, although their consent should still be obtained if at all possible (Article 25).

5. Informed Consent • Freely informed given declaration and the liberty to withdrawal at any stage of research or experiment. • Informed Consent difficulties: • Rural people in developing countries unable to grasp the experiment or risks. • Volunteers usually coming from poorer sections of population and suffer from sever pain and potential damage for small payments. • Medical students, prison inmates, and other groups used in medical experiments configuring different favors and advantages. • Children and mental defective persons should be excluded . • Pregnant women may be included for clinical trials. Despite many ethicists advise that fetus may be included until being visible. This is not a final agreement but a large section of physicians advised to exclude pregnant and nursing women for any risk on fetus or neonates or any intended problems on pregnancy or lactation.

6. Human genetic research • Discussed internationally to map the human genome in order to yield extremely useful information about 4000 genetic diseases that almost single –gene diseases like ( Thalassemia, Sickle Cell Anemia, Cystic fibrosis) and other diseases with genetic initials like ( Coronary Heart Disease, Hypertension, Diabetes, certain cancers and mental disorders). This will make an accurate diagnosis at the presymptomatic stage and even prenatally with further understanding and prevention or treatment in combination with gene therapy.

7. Risks and benefits of research. • Physical harm from a procedure performed on the participant. • Illness from a medication. • Emotional trauma from interactions with the researchers. • Loss of a relationship or a job because the researchers failed to keep confidential information given to them. • Social stigma or embarrassment from loss of privacy.

8. Institutional review board (Irb) • It’s the onset tool aimed to confirm if researchers follow ethical principles of research on human subjects. Roles of IRB: • Review study proposals. • Inform investigators when their study protocols fall short of conventional ethical standards. • Approve ethically sound protocols. • Monitor studies over their duration to ensure that ethical standards are adhered to throughout the course of the study.

9. To be continued • Assessment of the risks surrounding the confidentiality of participants' information. • Ensure that appropriate care and treatment is provided to participants in the case of medical interventions. • Investigate deeply the outcomes of the study via a comparison of participant’s medical case before and after to elucidate whether being due to a normal development of previous disease or study influences.

10. NB. • For an institution, such as a university, to receive funding for research from most funding agencies, it must have an IRB registered with the federal Office for Human Research Protections (OHRP). • Many professional journals require that a manuscript submitted for publication indicate that an IRB approved the study.

11. Economic aspects of Health care ethics • Patients is the key player and consumer who need the permission from someone else to obtain medical services and ethics related to medical practice play an economic role. • Health care practicionairs are the main decision-maker in health and the excessive prescription by physicians and reliance on the fees for cost services mode of reimbursement are the main causes of cost escalation in several care systems. • Providers of Health services may join together to form Heath maintenance organizations (HMOs) dependent on the power of professional ethics in heath care. HMOs are established or purchased by insurance companies .

12. Be continued • Some times the owners of private hospitals exerted a pressure on physicians and other health care professionals leading to ethical dilemma. • In many African countries that suffer from unfavorable economic conditions leads to deterioration of health status than a decade ago. • Economists assure that justice and equity in resource allocation and distribution in heath services are the important bioethics needed for the development of health care systems.