The NIH’s Inclusion Across the Lifespan (IAL) policy will become effective for all grant applications submitted as of January 25, 2019. The policy calls for researchers to justify a higher or lower age requirement for participation in clinical studies. The IAL policy should help ensure that children and older adults are not inappropriately excluded from clinical studies.
According to a presentation at the Society of Gynecologic Oncology, federal funding for medical research shortchanges gynecologic oncology when cancer lethality is taken into account. Among 13 common cancers included in the analysis, gynecologic cancers ranked near the bottom in National Cancer Institute (NCI) funding support, as measured by spending per years of life lost (YLL).
According to a recent study, the number of trials funded annually by the NIH fell from 1,580 to 930 between 2005 and 2015; the NIH budget declined by 20%; and the median size of trials was 64. These numbers suggest that NIH’s mission as a key impartial backer of promising treatments not ready for commercial funding may be threatened. (The Baltimore Sun)
The effective date of the NIH Single IRB Policy is January 25, 2018, and the NIH is taking measures to help organizations make internal changes to facilitate single IRB review. The NIH has provided CTSA (Clinical and Translational Science Awards) Program awardees with funds to develop resources for the research community to be successful in implementing this policy. (National Institutes of Health)
Federal agencies have issued an interim final rule(“IFR”) that delays until July 19, 2018 compliance with changes to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) that were to become effective on January 19. However, the delay did not affect the NIH Single IRB Policy, and all domestic sites participating in NIH funded multi-site studies must use a single Institutional Review Board effective January 25, 2018. (K&L GATES)
On January 25, 2018, the National Institutes of Health (NIH) adopted new rules that will re-classify many federally funded human behavior studies that were considered basic research as clinical trials. This policy change poses new requirements for behavioral scientists and has provoked a backlash from them. (Science)