080115L - ETHICO-LEGAL ISSUES IN RESEARCH 2

Background material by Professor Omar Hasan Kasule Sr. for Year 3 Semester 2 PPSD Session on January 15, 2008

EMBRYO OR FETAL RESEARCH

1. Describe 2 sources of embryos for research and explain the difference in ethical consideration between them (embryos can be surplus from IVF procedures or can be created specifically for research. Creation of embryos for the sole purpose of research is a more serious issue).

2. List research that requires use of embryos (emphasis on conception, contraception, infertility, inherited diseases).

3. Explain ethical guidelines on research on fetal tissue (emphasis: fetal tissue from spontaneous abortion creates few problems. Fetal tissue from induced abortion created the appearance that the abortion was for purposes of obtaining the tissue, consent is needed, no financial inducements, the timing, place, and type of termination procedure must not be related to the requirements of research).

RESEARCH USING HUMAN MATERIAL

1. Describe ethico-legal guidelines on genetic testing of biological samples obtained from individuals (emphasis on: informed consent must be obtained if the test is not anonymized).

2. Describe ethico-legal guidelines on research on material from living donors (emphasis on: approval by ethics committee, information on the how long the material will be stored and the benefits and risks of the research, informed consent is needed to take more material than is needed for therapeutic purposes and specific consent to a specific research, rules of confidentiality. There is no need for consent to test surplus anonymized material). 

3. Describe ethico-legal guidelines on research on material from deceased donors (emphasis on: consent by family after full information: what tissues to retain, the purpose and nature of the research, confidentiality).

PROBLEMS OF FRAUD IN RESEARCH:

1. Describe various forms of fraud in research (emphasis on: failure to follow standards GCP, failure to get consent, data falsification, plagiarism, including as researchers senior professor who did not actually participate in the research, researchers not trained in ethics, falsifying authorship).

2. Describe methods of avoiding research malpractices (emphasis on: training researchers in GCP and ethics, ethical and scientific review of the research proposal, detailed recording of all research activities, the principal researcher should be personally involved in the research activities, quality assurance and audit programs, whistleblowers on fraud).