Online ethics training now required for research on human subjects

Any student or faculty member wanting to conduct research involving humans must go through the St. Edward’s University Institutional Review Board (IRB), but now he or she must also go through additional training.

The IRB is requiring all faculty and students who are conducting research on people to complete online ethics training. This requirement went into effect on Oct. 1.

“The distinctions among types of proposal review types of Principal Investigators—faculty, staff, [or] students—determine who should complete the online ethics training,” said Jeannetta Williams, an associate professor in the School of Behavioral and Social Sciences at St. Edward’s and current IRB chair.

The training is offered through the Collaborative Institutional Training Initiative (CITI) program on citiprogram.org.

Once the training is completed, it must be submitted to the IRB. The training is valid for three years.

Students or faculty doing the training must take a number of quizzes and receive a score of at least 80 percent on each one. The training takes four to six hours. The student or faculty member must then submit a completion report to the IRB.

For exempt research projects, only the supervising faculty member must complete the training program.

The purpose of the IRB is to ensure that research involving human subjects is being conducted in an ethical manner as defined by the Office for Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services, according to the IRB Charge website.

The Human Subjects Review Board, which became the IRB in 2008, was formed in 2002. The university’s current IRB serves to make sure the rights of human participants are not violated.

To start the review process, the conductor of the research submits a request for review form, and from there the IRB determines what type of review process it goes through: full, expedited or exempt.

Full review is done for research including an elevated risk for substantial stress or discomfort for the subject. Expedited review includes research with a minimal risk, and exempt review includes research such as observations of public behavior.

“It is rare for a study to be rejected without the possibility of revisions [or] modifications,” said Williams.

The average number of review requests range from 50 to 85 per year, including summer sessions.

Most of the review requests come from the School of Behavioral and Social Sciences, but the number of requests from other departments on campus is growing, Williams said.