Why Do We Have Mandatory Training

The following training and education modules are designed for personnel proposing to conduct, or those reviewing research involving human subjects. Research using human subjects is heavily regulated by the federal government and requires targeted training and documentation of that training.

The following is an excerpt of a message about education and training from Jeffery Cohen, Office for Human Research Protection (OHRP), the federal office responsible for oversight and compliance with human subjects research regulations and guidelines (May 1999)

"There are two basic features of an education program that OHRP looks for - that it is ongoing and that it reaches everyone involved in human subjects research at an institution. The necessity to train IRB members is obvious, as without proper training the IRB cannot make informed decisions. Equally important is the necessity to train the individuals who actually conduct the human subjects research. Unless the IRB can be sure that these individuals understand the issues involved in human subjects research (informed consent, risk/benefit, confidentiality, etc.) it cannot be sure that the subjects in the research are being adequately protected."

Consequently, it is the responsibility of the institution and the IRB to adequately train and educate researchers and IRB members in topics pertinent to the programs ongoing at that institution. The following training and education modules provide that material. Each module targets a different aspect of human subjects research. The OHRP has mandated that training be "ongoing." Consequently, formal training will be required at a minimum of every 3 years. There is some redundancy between modules, but the information that is found to be in common among the modules is important to the overall understanding of the critical issues involved.

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