Yes Ma’am!
A Perspective on Women in Research Compliance As a consultant I’ve had the opportunity to work with a number of Research Compliance (IRB and IACUC) offices across the country as…
Tags: HS
Wait…What? IRB Budgets Are Up?
I noticed a peculiarity in AAHRPP’s 2012 Metrics on Human Research Protection Program Performance updated in July. IRB budgets were… wait for it… UP! Budgets are returning to levels not…
On the winds of Change…Opportunity
I recall several years ago getting ready to work on my first InfoEd implementation. I was hired to be this Regulatory Compliance /IT/Accreditation “Guy;” later affectionately dubbed the “InfoEd Guru.”…
Introspective Reporting and Building a Smarter eIRB
One of my favorite things to do when I worked in the IRB was reporting. Not simply the “How many Protocols do we have and sort that into Full, Expedited…
Reviewer Guide
How do you make sure that your scientific/assigned reviewers are really reviewing their assigned protocols? Do you ask that your assigned reviewers answer questions or think about certain regulations for…
Improving Response to Change in Research
InfoEd Global was represented at the 2011 PRIM&R Advancing Ethical Research Conference by Becca DuBose and Kelsey Rosell. InfoEd Global was a Bronze Supporter of this year’s conference, which offered…
New Draft Guidance on Exculpatory Language in Informed Consent Documents
The Office for Human Research Protections (OHRP) is collaborating with the Food and Drug Administration (FDA) to produce a new joint guidance on exculpatory language in consent documents for research.…
Common Rule Proposed Changes
The DHHS issued a News Release in July regarding proposed changes to the “Common Rule”, and is welcoming all comments regarding changes that would affect biomedical and social/behavioral research. Highlights…