In November 2015, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. This is the first time the agencies have jointly issued specific guidance on IRB meeting minutes. Read more
TAG ARCHIVES FOR guidance
By Shannon Reynolds, BA, CPIA, RLAT
Shannon Reynolds, regulatory compliance specialist at the Allen Institute for Brain Science, recently shared her experience at the Northwest Association for Biomedical Research (NWABR) 2015 IACUC Conference on NWABR’s official blog, "Thank Research!". We are pleased to share her thoughts and observations about a recent OLAW Notice Number NOT-OD-14-126, which was a topic of discussion at the conference.
The Office of Laboratory Animal Welfare (OLAW) oversees the care and [...] Read more
by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager
Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors. In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the [...] Read more
by Julie Fine, BS, legal specialist, Legal Division, Worldwide Research and Development, Pfizer Inc. (Please note: The views presented here are my own and do not reflect the positions or policies of Pfizer Inc.)
On Thursday, I attended Challenges in Securing Coverage for Research-Related Injury, a session which was presented by my colleague, Marc D. Francis, JD, Pfizer Legal, and Karen E. Moe, PhD, University of Washington. Marc began by [...] Read more
The 2012 Institutional Animal Care and Use Committee (IACUC) Conference hosted several forums that provided insight into complex issues in the field of animal care and use.
One such topic that was discussed at the conference was a webinar, Use of Non-Pharmaceutical-Grade Chemicals and Other Substances in Research with Animals, [...] Read more