With the launch of the new Human Subjects System (HSS), there is now a new two-step submission process for any Research Performance Progress Reports (RPPR) reporting inclusion enrollment updates.
For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019.
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Last December, NIH announced a revision to its Inclusion of Children Policy to expand the policy to individuals of all ages. The revised policy, now called the Inclusion Across the Lifespan policy, requires individuals of all ages (including children and older adults) be included in clinical research studies unless there are scientific or ethical reasons to exclude them.
A recent Viewpoint Essay published in the Journal of the American Medical Association (JAMA), co-authored by Drs. Marie Bernard (National Institute on Aging), Janine Clayton (NIH Office of Research on Women’s Health), and Michael Lauer, highlights the need for such a policy. The essay summarizes efforts by NIH to implement 21st Century Cures requirements to publish data on the age of research participants, to convene a workshop on age grouping and exclusions, and to make a determination on whether to revise inclusion guidelines on age.
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Starting January 29, 2019, NIH will begin implementing the Inclusion Across the Lifespan policy, which requires the consideration of age, along with sex/gender and race/ethnicity, in applications that involve human participants. What does this policy mean for you and your study?
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If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited. The existing dataset sample can be provided on the Cumulative Inclusion Enrollment Report. You should provide the sex/gender, race, and … Continue reading “What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?”
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If the study is considered human subjects’ research and meets the NIH definition of clinical research, then it is subject to the NIH inclusion policy.
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Much has been learned about how sex and race may contribute to differences in health outcomes and physiologic conditions (Clayton, 2014). We know that, for example, a specific drug used to treat insomnia requires different dosing for women and men. African Americans with hypertension are more susceptible to stroke than whites with the same blood pressure levels (Howard, 2013). But in many cases, findings from potentially informative stratified analyses may not be widely available. Less than a third of NIH studies required to analyze sex/gender and race/ethnicity have been found to publish sex-stratified results in peer-reviewed journals (Foulkes, 2011).
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The inclusion of women, different racial and ethnic groups, and children is extremely important in clinical research to understand who is affected by a given disease or condition and to develop the appropriate treatments. …. I’m bringing this topic to your attention because there has been some confusion about the distinction between race and ethnicity and how to report this information to the NIH. ….
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