Research Ethics and Regulation. 1.5 -

Catalog description

This course will introduce students to key ethical requirements and issues that arise in the design and implementation of scientific research. Historical developments leading to the establishment of national and international guidelines for ethical conduct in research with human subjects will be addressed. Specific international and national guidelines for ethically responsible research will be explored with attention to their merits and limitations in the conduct of research. Informed consent, a fundamental requirement for ethical research will be examined. The function and role of institutional review boards (IRBs) will be described with attention to challenges faced by investigators in adhering to regulatory requirements. Ethical issues associated with risk assessment and recruitment strategies will be examined. Ethical issues that arise in the implementation of biobanks and stem cell research will be discussed. Challenges associated with the development and production of pharmaceuticals will be assessed. The importance of scientific integrity in the conduct of research will be examined with special attention to conflicts of interest and scientific misconduct such as research fraud. The role of advocacy in promoting research will be addressed. Research ethics and human rights will be explored. The course will end with a discussion of emerging issues in research ethics. Case examples will be used to illustrate ethical complexities surrounding the topics discussed. Offered as BETH 503 , CRSP 603 and LAWS 5225 .