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?

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 … Continue reading

Reporting to NIH on Race and Ethnicity of Clinical Research Participants

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. …. Continue reading