Announcer: From the National Institutes of Health in Bethesda, Maryland this is All About Grants.

Megan Columbus (MC):

Welcome to All About Grants.  This is Megan Columbus from NIH's Office of Extramural Research, here today with Dr. Meredith Temple-O'Connor to talk about how grantees and applicants should be reporting race and ethnicity to the NIH in their clinical research grants.  Welcome.

Dr. Meredith Temple-O'Connor (MTO): Thank you.

MC: So, Meredith, you're our NIH Inclusion Policy Officer, right? So, what does that mean?

MTO: So, that means that I, ensure that women, minorities and children are properly included in our clinical research studies that we conduct at NIH, or that we support through grants and other mechanisms.

MC: Great.  So, we have a podcast on the inclusion policy, and, so there's going to be a URL at the end of this podcast that can get you there.   Can you tell me the distinction between race and ethnicity for the purposes of reporting?

MTO: So, for the purposes of reporting we have five racial categories.  And they include several different categories: American Indian, Alaskan Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African-American, and White.  Then, we also have two ethnic categories: Hispanic or Latino and not Hispanic or Latino.  So, these standards are set by the Office of Management and Budget, and they're handled for government-wide collection ofracial and ethnic information, for government purposes.  And, one of the reasons we're here today is there has been ongoing confusion in our communities about the distinct nature of race and ethnicity.  So, we want to have individuals who are participants in our clinical projects asked both their ethnicity and their race.  Not an either/or.

MC:   So, that would mean somebody who's Hispanic, who's also black, would be able to choose both of those categories, the race and ethnicity.

MTO: Correct.

MC: And, and while we all understand, you know, I'm sure that there's lots of other combinations that could be there.  This is a standard set by the Office of Management and Budget.  It's the same thing used by the Census and by all the other federal agencies. And so, this is what NIH is also obliged to use.

MTO: Correct.

MC: All applicants and grantees must be reporting on this.  How is that information actually collected by them and given to the NIH?

MTO: We have tables that we provide in the competing application forms, as well as in the, annual progress reporting from investigators to provide this information.  In general, the planned enrollment is what's provided when they submit their initial application.  And, then, each year, they report to us, for continuation, how many individuals they've actually enrolled in the clinical study. 

MC: So, the forms that we're collecting this data on, those are forms that are purely supposed to be used for sending information to NIH, right?

MTO: Right.  These should not be what investigators use to collect the information from their participants. They need to develop an appropriate collection tool for this type of demographic information from their patients using these categories to present to their participants, but not using this form per se.

MC: I know that these forms are undergoing a few changes in order to allow us to collect the information in a way that will be more usable to us and for the grantee community. So, what's going on with that?

MTO: Exactly.  So, we want these forms to be useful and helpful to, to individuals and not be confusing.  The main thing that has changed is the layout of the forms. It's the same data collection that we had before. The standards for race and ethnicity are the same.  A couple of key things to highlight:  We did add the "more than one race" category to the plan enrollment report -- that was previously not available there, but was on the actual enrollment report.  In addition, as I mentioned, we've re-organized the layout of the forms to try to make it more clear to our investigators that we need to collect the information on race and ethnicity, not an either/or.  So hopefully now, the layout is more conducive to understanding what we're trying to get from our investigators.

MC: And so applicants should begin seeing the new layouts in the fall of 2013 and grantees probably the year after.

MTO: Exactly.  So, it's going to start with the application packages that roll out in September 2013.

MC: The inclusion policy is fairly detailed.  And the new forms will certainly help, provide some clarity, I think.  I think you have resources available on your websites. 

MTO: Yes.

MC: Do you want to talk a little bit about those?

MTO: Sure. We have a website that is dedicated to discussing the policy on the inclusion of women and minorities in clinical research.  It has policy statements as well as links to the OMB discussions about the race and ethnic standards.  In addition, we also have some FAQs and slide decks, including some narrated slide decks that can also help individuals who are looking to sort through this.  We also have a list of contacts, both at the individual institutes and centers at NIH as well as my contact information, if individuals have more broad-based questions.  So, I encourage people to use the resources and to contact either me or the institute or center that they plan to apply for funding through.

MC: And I am sure some of those slide decks may be useful to the people at the institutions who actually do training.

MTO: Absolutely.

MC: Wonderful. Is there anything else you'd like to add, Meredith?

MTO: Just that we hope that this new form, the new layout to the form, will help make things clearer in terms of collecting this information. I guess, one other point to make is that individuals always have the right not to identify.  This is based on self-identification of the participants.  So, if they do not feel that they fit these categories, and this is not how they identify, they always have the option of selecting 'Unknown' and not-reporting.  And that's both for race and ethnicity.  So I just wanted to stress that, that individuals always have that option if these categories are not how they consider themselves.

MC: But they choose 'Unknown' and not 'decline to respond'?

MTO: Well, I think from an investigator's perspective, they would probably put 'declined to respond.'  What the investigators would then fill out on our table is 'Unknown', not reported.

MC: Thank you so much for your insights today. 

MTO: Thank you.

MC: For NIH and OER, this is Megan Columbus. 

Announcer:    For more about the NIH Inclusion Policy, visit the NIH OER home page at and search for "Inclusion of women and minorities". To listen to the podcast on the NIH inclusion policy, visit