2 Comments
Investigators need to include information on research participant sex/gender, race, and ethnicity when submitting new applications, competing renewal applications, and progress reports (non-competing renewals.)
When submitting a new or competing renewal application to the NIH, investigators should address plans for research participant inclusion on the basis of sex/gender, race, and ethnicity in the Human Subjects Section of the application and will also usually complete the Planned Enrollment Report. Additionally, investigators submitting a competing renewal application should also complete a Cumulative Inclusion Enrollment Report(s) to describe inclusion in the previous funding period. You’ll notice that the layout of the enrollment forms has been simplified and you can now provide information on participants who identify with more than one race.
When submitting progress reports, investigators describe progress in enrolling individuals on the basis of by sex/gender, race, and ethnicity, by completing an Inclusion Enrollment Report for each study in progress.
Additional instructions for completing these forms are available in the application form packages.
For more information on NIH Inclusion Policy, including additional details on reporting race and ethnicity visit the inclusion policy implementation page on grants.nih.gov.
I understand the need for clinical trials to include people of diverse ethnicity and both genders. For far too long, our human trials research has been limited to white males. However, it seems an unnecessary burden to ask the investigator to fill out all of these forms, including those for predicted enrollment when one is not able to control who is enrolled in the trial because the disease process hat qualifies subjects for the trial determines this enrollment. I include the predicted statistics in my grant proposals, but do I really need to then make up predicted numbers of how many people who are diagnosed at my institution at my institution in the next year will be female hispanics? I will be wrong a high percentage of the time. Who is this helping?
NIH is required by the Public Health Service Act (sec. 492B, 42 U.S.C. sec 289a-2) to ensure that funded clinical research involves the appropriate distribution of study participants by sex/gender, race, and ethnicity to accomplish the scientific goals of the study. Providing proposed plans in your competing application allows review panels to evaluate this important element of study design and assess its appropriateness relative to the science proposed. After an application is funded, providing the actual enrollment by sex/gender, race, and ethnicity in the progress report allows NIH program staff to evaluate progress in meeting the proposed inclusion plans and assess if the science is progressing satisfactorily. Investigators are strongly encouraged to conduct outreach during recruitment to ensure that study populations closely reflect the distribution of sex/gender, race, and ethnicity proposed in their applications. We have additional information and resources related to the NIH Inclusion Policy here that you mind find useful.