by Elisa Hurley, PhD, education director
As many of you may know, the Department of Health and Human Services (DHHS) has extended the public comment period on the advance notice of proposed rulemaking (ANPRM). The revised closing date for submitting comments to DHHS is October 26, 2011.
If you are interested in what others having been saying about the proposed changes to the “Common Rule,” instructions for browsing comments may be found here.
PRIM&R’s ANPRM Task Force is still hard at work drafting and compiling comments. We [...] Read more
It has been more than two months since the 2011 Institutional Animal Care and Use Committee (IACUC) Conference, and yet, I still find myself thinking about one of the sessions I attended on the last day of the conference in March: Strategies for Ensuring your IACUC is a Customer Service-Oriented Organization.
Within the realm of research ethics and animal care and use, it is important to recognize who your customers [...] Read more
We are thrilled to welcome guest blogger Margo Michaels , executive director of ENACCT, to Ampersand. Margo has been in her position at ENACCT for the past six years.
Before a patient or prospective research participant walks in the door, what are the policies and procedures that can create opportunities for more effective discussions with caregivers and optimize understanding among all parties involved?
Over the last five years, my organization has trained hundreds of oncology professionals on strategies to enhance their recruitment and accrual practices, with a strong focus on literacy and language. In the course of this training, we have [...] Read more
by Courtney Jarboe, CIP, PRIM&R Blog Squad member
In November 2010, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) published new continuing review guidance for institutional review boards (IRBs). The new guidance (roughly 40+ pages) is more detailed, and gives IRBs an opportunity to use the [...] Read more
OHRP recently invited public comment on a draft guidance document entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.'' This draft guidance is intended to explain how to interpret the terms “participation” and “discontinuation of participation” in research. The guidance would also clarify that investigators may continue to analyze already collected individually identifiable private information about a subject even when the subject's participation has been discontinued, and that research may continue to involve human subjects even when the participation of all subjects has been completed or discontinued.PRIM&R's Public Policy Committee developed comments that request further clarification about [...] Read more