With finalization of the revised Common Rule postponed for at least six months — and possibly one year — IRBs should continue preparing to comply with the regulation as they await additional clarification and guidance.
Many see the single IRB requirement in the revised Common Rule as a necessary sword to sever the Gordian knot of regulatory overlap and unnecessary delay of multisite review. Suzanne M. Rivera, PhD, is not one of them.
Most research informed consent forms are written at a high school reading level when many people who are being recruited for studies might need language nearer to a fifth-grade level, according to a new study.
Low health numeracy is a problem that could affect how well trials recruit and provide informed consent to potential participants. It’s defined by how well people access, process, interpret, communicate, and act on numerical, biostatistical, and other numbers-related health information.
Educating and onboarding IRB members should include more than perfunctory online human subjects research training. The goal could be to provide new members with comprehensive information in a well-organized training program.
As we leave the analog age and enter the vast expanse of digital “big data,” the potential benefits and risks for social science research are uncharted. However, this bright future casts a shadow as big data raises the specter of ethical breaches of informed consent and violated privacy.
It is well-established that incarcerated people suffer disproportionately from low literacy and health-related conditions that can affect cognition. Despite this, modified informed consent processes are not required by federal guidelines.