RESEARCH METHODOLOGY Research Ethics Dr. Amira Yahia CASE STUDY 1: ZAINAB’S STORY Zainab is a 14-year-old girl. One day she was at her neighbour Asha’s house for a birthday party. At the party, Asha’s family took lots of photographs. Recently, Zainab and her family found out that Asha’s family has given copies of Zainab’s photograph to numerous families for prospective marriage proposals without their knowledge. Zainab and her parents are very upset. A) Why do you think Zainab and her parents are upset? B) Do you think Asha’s family should have circulated Zainab’s photograph? Why or why not? CASE STUDY 2: RABAB’S STORY Rabab is an 18-year-old married girl. One day, a journalist comes to her house, and asks if she would like to be interviewed for an article on married life. Before Rabab can answer, her mother in law says, “Yes, Rabab will participate.” a) How would you feel if you were Rabab ? b) Do you think the journalist should continue with the interview and take this as consent on Rabab’s part? c) What do you think the journalist should have done to ensure that Rabab is willing to participate in the interview? FUNDAMENTAL PRINCIPLES ETHICS Respect for persons Beneficence Justice Respect for communities OF RESEARCH People should not be only a way to achieve the research objectives. RESPECT FOR PERSONS Respect the dignity of research participants Ensure their independence (autonomy). Should be protected from any abuse that results due to their vulnerability. Each individual: Is unique and free Has the right and capacity to decide Has value and dignity Has the right to informed consent VULNERABLE PARTICIPANTS Minors, pregnant women, prisoners Persons with mental disabilities Persons who are illiterate or have limited formal education Persons with limited access to health services Women in some settings BENEFICENCE The principle of beneficence makes the researcher responsible for the physical, mental, and social well-being of the research participant Researcher must: Minimize the risks associated with research, including psychological and social risks Maximizing the benefits that accrue to research participants. JUSTICE Researchers must: Ensure a fair distribution of risks and benefits Conduct equitable recruitment of research participants Provide special protection for vulnerable groups RESPECT FOR COMMUNITIES Respect for communities means that researchers must respect the values of the community involved in the research and protect the community from harm. This is very important in research which requires community-wide knowledge, values, and relationships and, thus, the community may be impacted by the research process or its outcomes. GENERAL ETHICAL GUIDELINES FOR RESEARCH Confidentiality Informed voluntary consent Right to refuse or withdraw at any time Reporting back Special consideration for vulnerable groups ELEMENTS 1. 2. 3. 4. 5. 6. 7. 8. OF INFORMED Purpose of Research Risks and Discomforts Benefits Alternatives Confidentiality Compensation for Injury Research Questions Voluntary Participation CONSENT: BASIC RESEARCH ETHICS DOCUMENTS Nuremberg Belmont CIOMS Helsinki The illegal experiments performed on concentration camp prisoners by Nazi doctors during World War II and the subsequent Nuremberg Trials in 1946 gave birth to the Nuremberg Code, that states that “voluntary informed consent is absolutely necessary.” The Declaration of Helsinki of 1964 stressed the importance of written consent forms. The 1974 Belmont Report highlighted the 3 fundamental principles of respect for persons, beneficence, and justice. In 1993, CIOMS issued guidelines to apply the Declaration of Helsinki in developing countries. HIGH ALTITUDE EXPERIMENTS HIGH ALTITUDE EXPERIMENTS The purpose was to investigate how much a human being could resist high altitudes without the use of oxygen. The victims were locked in the chamber, whose pressure was then lowered to a level corresponding to very high altitudes. The pressure could be very quickly altered, allowing Researcher to simulate the conditions which would be experienced by a pilot freefalling from altitude without oxygen FREEZING EXPERIMENTS FREEZING EXPERIMENTS The purpose was to determine the best way of warming German pilots who had been forced down in the North Sea and suffered hypothermia. The victims were forced to remain out of doors naked in freezing weather for up to 14 hours, or kept in a tank of ice water for 3 hours, their pulse and internal temperature measured through a series of electrodes. Warming of the victims was then attempted by different methods, most usually and successfully by immersion in very hot water. BLOOD COAGULATION EXPERIMENTS Researcher predicted that the preventative use of Polygal tablets would reduce bleeding from gunshot wounds sustained during combat or during surgery. Subjects were given a Polygal tablet, and shot through the neck or chest, or their limbs amputated without anaesthesia. THE DECLARATION OF HELSINKI “The well-being of the human subject should take precedence over the interests of science and society” Consent should be in writing Use caution if participant is in dependent relationship with researcher Limit use of placebo Participants benefit from research COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES (CIOMS) GUIDELINES • Role of ethics committees Nuremberg • Informed consent • Access to benefits Helsinki • Provision of health care services • Distribution of burdens and benefits CIOMS RESOURCES Sadaf Shallwani and Shama Mohammed. Community-Based Participatory Research. A Training Manual for Community-Based Researchers, 2007. Roberto Rivera,David Borasky, Florence Carayon, Robert Rice, Stella Kirkendale, Wayne L. Wilson, and Cynthia Woodsong. Research Ethics Training Curriculum for Community Representatives. 2004 by Family Health International. Health Research Library http://sites.google.com/site/healthresearchlibrary/home