17
Oct2022

Circling back to the 3Rs, if 90% or more of most research studies are already using mice, should we expand the 3Rs and ask the IACUC to interpret the use of mice more judiciously for research?  Reproducibility, repeatability, rigor, relevance and rationalization all start with ‘R’ and in today’s world may potentially be more important factors to consider than replacement, reduction, or refinement.  As an animal resources director, IACUC Chair and research investigator, I fully recognize these questions are ‘hot button topics’ that are both sensitive and often controversial.  This is especially true if the science using mice isn’t peer-reviewed by an external agency and the IACUC is also charged with (in some manner) evaluating the science behind the use of animals.  Smaller institutions, which have fewer resources and scientists conducting large-scale experiments with mice, are probably at an even bigger disadvantage when faced with expanding the 3Rs to determine if the use of animals is justified in an unfunded scientific proposal.  Read more

14
Oct2022

The concept of Decentralized Clinical Trials means bringing the activities of the trial to non-centralized places, such as away from a doctor’s office or clinic, so that participants have better access to the interventions and measures needed to conduct a trial.  A few ways researchers are decentralizing clinical trials include engaging home health groups to come to the home to collect or administer study tasks. These trials seem to be the wave of the future and have many advantages for participants. For more information on this topic register for PRIM&R 2022 Annual Conference session, PRIM&R Service Award Presentation, and Plenary IX: Decentralized Clinical Trials (DCTs): Considerations of and for IRB review (Location: Livestreamed) Thursday, December 15, 2022, 10 AM - 11:30 AM. Read more

11
Oct2022

This blog summarizes the major provisions of the second NPRM, which is focused primarily on harmonizing language, definitions, and informed consent requirements in 21 CFR 50—Protection of Human Subjects, and on harmonizing provisions around continuing review, IRB review generally, and IRB membership, in 21 CFR 56—Institutional Review Boards.   Read more

29
Sep2022

It has been eleven years since the NIH last updated their federal regulations on financial conflict of interest. But, during that time, and especially over the past four years, a lot has been discussed about conflict of interest. What started out as concerns over the loss of intellectual property has now morphed into overall requirements for research security, with conflict of interest as the lynchpin. Read more

27
Sep2022

Research participants who discuss their research participation online may unintentionally disclose information that increases the risks of the research to themselves or others. These risks include unblinding study participants or the research team, communicating incorrect information, or inadvertently licensing participant behaviors that conflict with study requirements, each of which may potentially threaten study integrity and/or participant safety. Read more