IRB Advisor
RSSArticles
-
Self-certification Tool Formalizes Process to Decide Between QI and Research
IRB officials at the University of Wisconsin-Madison realized seven years ago that the IRB was receiving too many requests for review of quality improvement or other projects that did not meet the Common Rule’s definition of human subjects research.
-
Electronic Consent Has a Few Obstacles and Drawbacks
Adoption of electronic consent is a process that will not occur overnight.
-
Future World Without Paper Consent Could Be Here Sooner Than Imagined
Remember when the IRB submission process was entirely on paper? In 2027, someone might ask the same thing of informed consent: “Remember informed consent paper documents?”
-
Using Prisoners as Research Subjects Raises Ethical Concerns
A recent study found a “significant minority” of inmate research participants reported pressure to not participate in trials, both from fellow prisoners and correctional staff.
-
Conduct a QA/QI Research Program Risk Assessment
Human research protection programs (HRPPs) are required to assess their quality, efficiency, and effectiveness if they’re seeking accreditation. HRPPs can do this through ongoing quality assurance/quality improvement (QA/QI) programs. But sometimes the quality improvement program also needs to be assessed for quality.
-
Creating an Optimal Research Training and Mentoring Program
A nine-year IRB chair veteran and a medical school’s associate dean identified gaps in their institution’s human research protection education. They noticed that online training was fine for general information, but came up short when investigators were struggling with specific protocol issues.
-
IRB Has Variety of Self-Assessment, Staff Assessment Tools
An Indiana research compliance program found that IRB staff and board assessments help keep the program on track and running well.
-
Researcher: Human Infection Trials for Zika Could Be Safely Performed
It sounds counterintuitive, but one of the main arguments for getting a Zika virus vaccine into human trials is that as susceptible people become immune through prior infection, it will be harder to test vaccine efficacy in a large population.
-
NIH Ethics Panel Vetoes Zika Human Infection Trials
While there are reports of various Zika vaccine trials proceeding, one the most promising methods to quickly and accurately measure vaccine efficacy has come to a full stop.
-
Student Receives IRB Approval to Collect and Display Comments From Sexual Assault Victims
A Notre Dame student received approval for her design project including the statements of sexual assault victims.