ETHICAL ISSUES IN NURSING RESEARCH : ETHICAL ISSUES IN NURSING RESEARCH Issues of ethical behavior are central to health professions. In conducting clinical trials and research projects ethical issues should be taken in to consideration. It is unethical for an investigator not to give patients the best possible treatment. Other way, it is unethical not to discover whether a new treatment is an improvement, since this would deny future patients the possibility of a cure. THE ICN CODE IN GENERAL : THE ICN CODE IN GENERAL The ICN Code of Ethics for Nurses has four principal elements that outline the standards of ethical conduct. 1. NURSES AND PEOPLE 2. NURSES AND PRACTICE 3.NURSES AND THE PROFESSION 4. NURSES AND CO-WORKERS SUGGESTIONS FOR USE OF THE ICN CODE OF ETHICS FOR NURSES: SUGGESTIONS FOR USE OF THE ICN CODE OF ETHICS FOR NURSES The ICN Code of Ethics for Nurses is a guide for action based on social values and needs. It will have meaning only as a living document if applied to the realities of nursing and health care in a changing society. Slide 4: To achieve its purpose the Code must be understood, internalised and used by nurses in all aspects of their work. It must be available to students and nurses throughout their study and work lives. Nurses and nursing students can therefore:: Nurses and nursing students can therefore: Study the standards under each element of the Code. • Reflect on what each standard means to you. Think about how you can apply ethics in your nursing domain: practice, education, research or management. • Discuss the Code with co-workers and others. • Use a specific example from experience to identify ethical dilemmas and standards of conduct as outlined in the Code. Identify how you would resolve the dilemmas. INTERVENTIONS: INTERVENTIONS Work in groups to clarify ethical decision making and reach a consensus on standards of ethical conduct. • Collaborate with your national nurses’ association, co-workers, and others in the continuous application of ethical standards in nursing practice, education, management and research. The role of the nurse in research: The role of the nurse in research The contribution of research to nursing knowledge and competence continues to influence patient care standards. Undoubtedly, there is a continuing need for good research evidence to fuel and support contemporary nursing practice. Accordingly, and similar to other professional groups in the health services,many nurses are now responsible for initiating new and innovative therapies through research in a variety of ways. Student research: Student research Many nurses and other health care professionals undertake small research projects as part of their postqualifying education. If student research involves NHS patients, service users, relatives or carers, staff or NHS premises, it must be reviewed according to the requirements of governance arrangements for research ethics committees Research in developing countries: Research in developing countries Increasing opportunities are arising for nurses to undertake research in developing countries.Whilst some of these countries are developing research policies and procedures, this is a relatively infrequent activity which tends to focus on the conduct of drug trials. Prior to commencing any study it is essential that steps are taken to prevent any research misconduct, poor performance or exploitation of subjects. This is particularly the case when undertaking research with participants who may be considered vulnerable. Safe and ethical research: Safe and ethical research informed consent confidentiality data protection right to withdraw potential benefits potential harms. Behind the seen: Behind the seen It is also unethical to perform bad trials that give misleading results, and there by encourage others not to use a treatment that is beneficial, or to use a treatment that is not beneficial, or may indeed have harmful effects. Slide 13: The issues of ethics in research are often portrayed as taken for granted and the same regardless of the research approach adopted while there tends to be a cornmonality of principles, their translation into practice is diverse. PRIORITIES OF HARYANA RESEARCH: PRIORITIES OF HARYANA RESEARCH 1. SON PREFERANCE-- iq= ykylk 2. MEDICINES in 1 st trimester of pregnancy 3. Pesticides Residual Effects 4. Alcoholism 5. Congress Grass 6. Changing Patterns of Eating Habits 7. Status of women in Haryana 8. Education and Health Myths about Health Clinical trials in India: ethical concerns: Clinical trials in India: ethical concerns Transnational drug companies are moving their clinical trials business to India, giving a new urgency to clinical trials registry reform there. Patralekha Chatterjee reports. Referance: Referance [PDF] ICMR Ethical Guidelines for Biomedical Research File Format: PDF/Adobe Acrobat - Quick View 2006 - Related articles result of the use or application of the contents of this document . .... Thus, the first International Statement on the ethics of medical research using ... www. icmr .nic.in/ethical_guidelines.pdf SCIENCE IS NOT NEUTRAL: SCIENCE IS NOT NEUTRAL According to the Associated Chambers of Commerce and Industry, an influential national industry association, India is set to grab clinical trials business valued at approximately US$ 1 billion by 2010, up from US$ 200 million last year, making the subcontinent one of the world’s preferred destinations for clinical trials . DRUG COMPANIES: DRUG COMPANIES Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system. While good news for India’s economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review. VESTED INTERESTS TO BE TACKLED: VESTED INTERESTS TO BE TACKLED Drugs Controller General of India making it obligatory for all trials to be registered on the Clinical Trials Registry site before permission is granted to co induct them,” “The failure to do so should carry a penalty. In addition, while registering trials, the composition of hospital ethics committees, which approved the trial, should be disclosed 2-IMPORTANT POINTS: 2-IMPORTANT POINTS Two important areas of ethical consideration are rights of human subjects and freedom from harm. Three factors are important regarding the rights of the participants, confidentiality, anonymity and the voluntary participation. It can be ensured through an informed consent which clearly explains the study objectives and states participants’ right to accept or refuse to participate (Fowler & Chevannes, 2002). Research Participants at Risk : Research Participants at Risk Research participants at risk are individuals who may be harmed physically, emotionally, spiritually, economically, socially, or legally through participation in a research study. A basic responsibility of the researcher and those assisting in carrying out the project, is to protect all research participants from harm and while they are participating in an investigation or as a result of the study. Informed Consent : Informed Consent Informed consent is the process of providing an individual with sufficient understandable information regarding his or her participation in a research project. It includes providing potential participants with information about their rights and responsibilities with in the project and documenting the nature of the agreement CONSENT FORMS: CONSENT FORMS All consent forms need to assure potential participants of their right to withdraw from a research study at any time. . Informed consent is the researcher’s conscious and deliberate attempt to clearly and fully provide the potential participant with information about the study. Slide 24: It is a fundamental responsibility of the investigator in human research to ensure research participants understand the nature of the project and the implications of participation and the individual is able to decide freely whether to participate in a project, without fear or reprisal. When the researcher fails to adequately inform potential research participants about full nature of the research, there by preventing them from making an informed decision on their participation is called deception. Confidentiality & Anonymity : Confidentiality & Anonymity Confidentiality refers to the researcher’s responsibility to protect all data gathered within the scope of the project from being divulged to others. Anonymity refers to the act of keeping individuals nameless in relation to their participation in a research project. Regulatory Bodies : Regulatory Bodies The researcher may need to take permission from regulatory bodies for conducting research investigations, mainly when subjects are human beings. There are regulatory bodies in most of the countries which grant permission after considering ethical issues of the study. 'Ethical guidelines: ' Ethical guidelines Indian Council of Medical Research (ICMR) released ' Ethical guidelines for biomedical research in human subjects' in the year 2000, which are similar to Good Clinical Practice (GCP) guidelines and the prevalent international guidelines. These guidelines regulate all biomedical research in human subjects in India. Conclusion: Conclusion The generation of research evidence is crucial to the provision of safe and effective health and social care. If research is based on a robust design and is conducted in a safe and ethical manner, the process and outcome of knowledge generation can be of benefit to everyone involved .