Guide to research with human subjects
Lead author: M.E. Hartnett, MD, FACS, FARVO
This educational module is designed to clarify concepts and provide guidance for investigators when designing, performing and interpreting human subjects research. Considerations include: Conducting ethical research, answering a study question effectively, discussing different types of human subject research, and designing and conducting clinical studies.
Human subjects research is used as a general term throughout the module to refer to both observational clinical studies and interventional clinical trials. “Clinical studies” is a term referring to observational or interventional, prospective or retrospective studies. Clinical trials are a subset of clinical studies that involve the prospective systematic testing of an intervention compared to a comparison or control group.
Members-in-Training ($0.00); Members ($0.00); Nonmembers ($109.00)
Guide to Research with Human Subjects
Description
As in all science, human subjects research evolves. Not only do the scientific questions posed change, but also the designs and analyses, comparators [comparison to placebo, reference or standard], the standard of care and regulatory issues change. Therefore, it is recommended that the investigator use the module as a guideline and consult experts within the scientific community and regulatory organizations. Guidance is provided on whom to include in the teams.
After participating in this program, you will be able to:
- Summarize the ethical requirements involved in human subjects research
- Discuss the role of oversight boards such as institutional review boards and privacy boards
- Determine when there is enough evidence to proceed to a clinical trial
- Read and interpret clinical trial results
- State examples of current research areas in eye and vision science
- Describe the tools necessary to perform clinical research
