As rules, regulations and norms change and shift, many universities consider it an important investment to keep faculty and IRB Members well informed about human research volunteer protections. Toward this end, ORSP hosted a 2-hour workshop on August 4, 2010. Tom Bechert, a nationally recognized consultant, covered the following topics:
A. Overview of Research Ethics and Regulations
B. Criteria for IRB approval of research, including:
--Minimizing risks to volunteers by using procedures consistent with sound research design that do not unnecessarily expose volunteers to risk
--Minimizing risks to volunteers by using procedures already being performed on the volunteers for diagnostic or treatment purposes
--Ensuring that risks to volunteers are reasonable in relation to anticipated benefits
--Equitable selection of volunteers
--Plans for monitoring research data to ensure the safety of volunteers
--Provisions to protect the privacy of volunteers
--Provisions to maintain the confidentiality of data
--Additional safeguards for vulnerable populations
--Informed consent processes
--Documentation of informed consent