Influence of Subject Eligibility Criteria on Compliance With National Institutes of Health Guidelines for Inclusion of Women, Minorities, and Children in Treatment ResearchAlcoholism: Clinical and Experimental Research 31 (6), 988–995. - June 2007
Many alcohol treatment outcome studies exclude some patients with particular problems, such as psychiatric disorders, noncompliance, and homelessness. Such criteria may increase the likelihood of a study being successfully conducted, but may also have the unintended consequence of reducing a study's ability to comply with National Institutes of Health guidelines for inclusion of racial minorities, women, and children in treatment research.
Under several eligibility criteria, most notably those for drug use and social/residential instability, women and African-American patients are substantially more likely to be excluded than are men and non–African-American patients, respectively.
In designing treatment studies with many eligibility criteria, researchers may therefore inadvertently be thwarting their own good faith efforts to ensure that a range of vulnerable populations are able to participate in research.
We analyze the implications of this dilemma for the generalizability of treatment results and for research design, and provide data that may help researchers working in different treatment systems estimate the impact of various eligibility criteria.
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