IRB Advisor – June 1, 2003
June 1, 2003
View Issues
-
Students and research protection: Student volunteers don’t give up their right to human subject protections
Recruiting students for research at universities and colleges is no longer as simple as having professors offer extra credit in exchange for participation. It has become an area that has created controversy within institutions and IRBs. -
Students and research protection: Student recruiting raises issues, concerns for IRBs
College student populations may offer a plentiful and accessible source for human subjects research, but IRB and university research officials say that a variety of issues arise when students are used. -
Students and research protection: IRB monitoring varies for student researchers
IRBs located in universities might find themselves inundated with low-risk protocols if they reviewed every single study proposed by college students working on their graduate papers. On the other hand, it would be poor policy and possibly provide risk to human subjects if these studies were routinely ignored. -
IRBs have a new charge: Authorization waivers
It started out a simple premise: protect patients privacy by securing their health information. But the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) is raising some concerns, not just among primary caregivers and treatment facilities. -
HHS guidance on financial conflicts puzzles some
The draft guidance on financial conflicts of interest and research published March 31, 2003, in the Federal Register offers more questions to be considered than specifics to be followed. -
Conflict of interest questions in a nutshell
The Stanford (CA) University protocol application form includes a section that examines potential conflict of interest through seven questions. -
Spotlight on Compliance: False advertising laws apply in clinical arena
One of the challenges in clinical trial operations is to recruit patients to participate. The Food and Drug Administration notes that recruitment methods and material also should be reviewed as a part of the IRB oversight function. -
IRBs’ lay members want more education, respect
Nonaffiliated and nonscientist members of IRBs the so-called lay or community members say they need more introductory education and ongoing training to better meet the challenges of their roles.