IRBs often struggle with determining risks of social and behavioral research studies. Its easy to be both too cautious and too complacent.
There are no industry standards for handling incidental findings (IFs) in research.
As technology in genetic and genomic research expands, most if not all IRBs will face the issue of incidental findings, including how to manage them, and whether researchers have a duty to report them to study participants, experts say.
The Cincinnati Childrens Hospital Medical Center IRB and a special task force developed guidance and a template for improving and simplifying informed consent forms.
The exponential increase in smartphones and social networking sites has led to concerns from some patients regarding the possible unlawful distribution of images outside the realms of their care.
An IRB member and human research protection expert learned firsthand how complicated informed consent (IC) forms could be when her granddaughter was seriously ill.
While the informational quality of internationally registered trials has increased, theres still room for improvement, according to a recent study.
One chief hurdle in human research protection program (HRPP) accreditation is the mindset that its all about the IRB, an expert says.
The IRB at Grand Valley State University in Allendale, MI, uses a matrix that clarifies how IRB members and staff might describe various potential harms at four levels, from no more than minimal risk to high risk.
Technology advances have driven increased interest in molecular studies involving tissue analyses. As a result, biotech firms increasingly are asking scientists to sell human tissues for study by outside enterprises.