ke your comments and suggestions heard as NIH plans the follow-up to the 2017 Inclusion Across the Lifespan workshop, the Inclusion Across the Lifespan II (IAL-II) workshop that will focus on the recruitment and retention of pediatric, geriatric, and other underrepresented participants in clinical studies.
Wondering where to go for information on NIH’s Inclusion policies? Visit the new Inclusion Policies for Research Involving Human Subjects landing page, where you can navigate to learn more about NIH policies on the inclusion of women and minorities and the inclusion of individuals across the lifespan.
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For over two decades, NIH has required researchers to include women, members of racial and ethnic minority groups, and children in their work absent an acceptable scientific or ethical rationale for their exclusion. Now, for the first time, selected inclusion data on sex/gender and race/ethnicity are publicly available disaggregated for various research, condition, and disease areas.
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Applicants should include a rationale for the age range of study participants and justification for age-based exclusion in the Inclusion of Women, Minorities, and Children section of the PHS Human Subjects and Clinical Trials Information Form (Section 2.4). This section will continue to have the heading “Inclusion of Women, Minorities, and Children” until the next forms update. See the instructions under Inclusion of Children in the application guide for additional information.
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Effective for due dates January 25, 2019 or later, keep in mind the following changes to your applications and progress reports.
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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.
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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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