 Let's move along then. The next is the inclusion report. This is every three years NHGRI is required to present to council. What we call the inclusion report is report describes the demographics of race and ethnicity of all the participants that are recruited to NHGRI sponsored research projects. So Christine Chang program director in the division of generally Edison will give the report and then we'll take questions and comments from council. When the discussion is concluded, we will take a vote asking the council to accept the report. So Christine we can see your slides. Why don't you go ahead. Thank you. So, I will be presenting this trial advisory report on human subjects participation and NHGRI sponsored research for the fiscal years 2019 to 2021 and the NHGRI extramural inclusion officers are myself and Dr. And our intramural counterpart is Ms. Mindy Perilla. So inclusion monitoring is required by the Public Health Service Act which mandates that there be inclusion of women and minority groups in all NIH funded clinical research in a manner that is appropriate to the scientific question. The research findings be generalizable to the entire population, and that clinical trials be designed to provide information about differences by sex, gender, race, and or ethnicity. Inclusion monitoring applies to all clinical research. So this includes patient oriented research that is research that's conducted with human subjects or on material human origin. And the definition from this definition would be in vitro studies that utilize human tissues that cannot be linked to a living individual. So that includes studies of mechanisms of human disease, therapeutic interventions, clinical trials and development of new technologies, clinical research also encompasses epidemiological and behavioral studies, outcomes research and health services research. So inclusion coding and information is initially collected on the grant application using the human subjects and clinical trials information form. This form requires an inclusion enrollment report or IER for each study and in the grant application. So a sample table is shown here. The IER table contains the plan distribution of subjects by sex, gender, race, and ethnicity. Opkins also describe the rationale for selection of sex, gender, racial and ethnic group members in terms of scientific objectives and proposed study design, as well as they propose outreach for recruitment. And over the course of the grant as progress reports are submitted, the grantee submits IERs containing cumulative enrollment data, which is based on the actual number of participants recruited and examined in the course of the study. Because a single grant or project can have multiple studies and each study can have multiple IERs, there can be multiple IERs per grant or project. For example, an extramural multi-center project will have multiple studies for different sites and then each study can also have multiple IERs to separate participant groups. The data presented in this report show only IERs labeled as prospective data, so in other words the IERs that contain existing data are excluded from analysis. On a triennial basis, each NIH institutional advisory council is required to review the aggregate data on the cumulative enrollment of participants to ensure that, one, it isn't compliance with the mandate for appropriate sex, gender and minority inclusion, and two, has in place adequate procedures to ensure these inclusion levels are monitored and maintained. The link to the report is in the electronic council book and the report describes NHGRI's intramural and extramural processes for monitoring inclusion and ensuring compliance in detail. And in this presentation, we're going to highlight some of the data from that report. Looking at the total number of IERs, about a third of them did not have enrollment because of delayed onset of recruitment or were active studies that completed enrollment in previous years, so they no longer need to recruit participants in that reporting period. Among the IERs with enrollment, the majority associated with U.S. sites, IERs with non-U.S. sites included countries like Botswana, Cameroon, Ghana, just to name a few. These include only female participants because of the nature of the studies, so for example, pregnant women's views on prenatal sequencing. Looking at participant enrollment and the number of IERs across the reporting period, we see that extramural makes the bulk of clinical research, whereas enrollment and intramural was pretty steady across the reporting period. The extramural enrollment fell markedly, and this decrease can largely be attributed to the end of the emergency, merge three consortium, as well as the onset of the COVID-19 pandemic in spring of 2020. And this is consistent with many grantees reporting difficulty and recruitment and reaching target enrollment numbers. Even after academic research and health centers resume business, understandably patients were hesitant to participate in research and low recruitment rates continued. NIH uses sex gender to indicate that either sex or gender may be reported for inclusion enrollment purposes. The NIH encourages investigators to design their data collection instruments in a way that allows the participants to self-identify their sex or gender in a way that is meaningful within the studies context. Overall, over the reporting period, the sex gender distribution was balanced. The slightly higher proportion of females, again, is largely due to having some female-only studies, but no male-only studies. The distribution is shown here using a census that's needed race categories, which include white, black, African American, unknown not reported, Asian, more than one race, American Indian, Alaska Native, and Native Hawaiian Pacific Islander. When enrolling research participants, researchers ask participants to self-identify both their ethnicity and their race with the option to select more than one racial category or to decline providing race and ethnicity. So in this reporting period, there was a study increase in black, African American participant enrollment shown here in orange. This is due to continued efforts by NHGRI to increase the number of studies with diverse participants. Through programs such as the Human Heredity and Health in Africa program or H3Africa, the clinical sequencing evidence-generating research program or CSER, and the implementing genomics and practice consortia or NITE. In addition, there's language encouraging applications that include diverse participants, which is standard for all applicable NHGRI funding opportunity announcements. Now looking at enrollment by ethnicity defined as Hispanic-Latino versus not Hispanic-Latino. Following the U.S. Office of Management and Budget definition, Hispanic and Latino participants can be of any race. The proportion identifying as Hispanic-Latino was generally study across FY 19 to FY 21 at about 5%. So although the goal of NIH's inclusion policy is not to endorse or enforce quotas for proportional representation based on census data, I think we will note that comparisons show that Hispanic-Latino enrollment at NHGRI is much lower than the U.S. 2021 population estimates of about 18% and lower than the overall NIH Hispanic-Latino enrollment level of about 10%. And it's possible that some of the strategies used to increase enrollment of Black African-American participants could be applied to increase the enrollment of Hispanic-Latino participants in NHGRI studies. And similarly, successful strategies for enrolling Hispanic-Latino participants and studies at other NIH institutes and centers could be adapted for NHGRI studies. So taking this all together, minority enrollment in this report includes all races except white and unknown race plus Hispanic-Latino participants that already, not already identified in another race category that fits the minority definition. And in this reporting period, we see that the total proportion of minority enrollment gradually increased from 28.3% in 2019 up to 35.6% in 2021. And this is a modest increase over the previous reporting years, which was 25% in 2017 and 26.6% in 2018. The NIH revised its inclusion of children policy in 2017. And the revised policy, which is now called the NIH policy and guidelines on the inclusion of individuals across the lifespan applies to individuals of all ages and requires reporting of participant age at enrollment and annual progress reports. The policy became effective for applications submitted on or after January 25 of 2019, as well as intramural studies initiated after this date. So the table shown here shows the age distribution for enrolled participants for studies falling under this policy. And it should be noted that the data should be interpreted with caution given the very low enrollment numbers overall. And the numbers are low because the policy applies only to the very small portion of studies recently funded, and most of NHGRI research does not fall under this policy yet. So in summary, the deleterious effect of COVID-19 on NHGRI participant enrollment was substantial, while academic research centers and other study sites quickly adapted and resumed recruitment efforts. There are residual delays in difficulty in reaching initial target enrollment numbers. There was also a successful strategy as an increasing overall minority participant enrollment, but improvements are still needed in certain participant groups, most notably the Hispanic Latino participant group. So with that, my colleagues and I would be happy to take questions and comments. That was really informative and it was great to see the progress that's being made, albeit slow. One is I realized the term human subjects has legal definitions, but I would love to see us move away from the word subjects as much as possible, including in the title of these reports, and certainly in the contents. Secondly, you know, we there's a lot of data that people on the LGBTQ community are underrepresented in research and that doesn't seem to be something we're measuring. And I wonder if that's something we should be measuring. I think that's a good point for the first point about moving away from human subjects I think increasingly we're using the word participant. So that's definitely the right step for underrepresented LGBTQ community and like making sure that is captured in the reports. I don't think that has quite made it to serve official official census categories. But that's definitely a well, a good point taken I know that we have representation on the sexual and gender minority working groups, I don't know if someone from that working group wants to chime in as well. This is Terry not not on the on the section general minority working group but but Gail just so that you know these reports are actually mandated centrally so we follow a central template will certainly raise the issue that it would be very helpful to have information on sexual and gender minorities. I suspect it's coming it's just that it hadn't been reported in the past three years, but excellent point thanks. Additionally, the Office of sexual gender minority is across an age for a better collection that will be reported on. Excuse me other questions or comments from Council. All right, that's long enough to have found mute button if you wanted to speak up. So can I ask for a motion to accept the report. I'll take one of those extra hands as a second all in favor. Thank you. Anyone opposed. Anyone abstaining. All right, thank you very much. Thank you Christine. Wonderful job.