Hispanic research: implications of the National Institutes of Health guidelines on inclusion of women and minorities in clinical research.

Researchers have new opportunities to increase Hispanic health research as a result of the requirements in the March 1994 National Institutes of Health (NIH) guidelines on inclusion of women and minorities (and their subpopulations) as subjects in the biomedical and behavioral research projects that NIH supports. These guidelines are summarized and their implications for research are discussed here. Investigators must include women and minorities in their research involving human subjects and also present outreach plans for recruitment and retention of Hispanic and other participants into this clinical research. When clinical trials are planned, they need to be designed to measure differences in intervention effect in subpopulations when warranted. Investigators are challenged to develop new studies to fill the gaps in our knowledge about how radical/ethnic/cultural factors affect health and disease in Hispanic subgroups. This knowledge is necessary for designing studies that are culturally sensitive, enroll appropriate numbers of Hispanic participants, and ensure that the benefits of the research are made available to the Hispanic community.