Bridging the Need for Advancing Prevention Research and Assuring the Protection of Human Subjects

Evaluations of prevention interventions that target behaviors associated with morbidity and mortality and/or negative social sanctions such as substance use, risky sexual behaviors, suicide ideation/behavior, and delinquency, are often fraught with human subject protection challenges.  Although these challenges affect all age groups, for minor children/adolescents they become more complex and involve balancing interests of adults, public institutions and minors' own right to privacy and protection.  Primary among these other individuals are, of course, the parents/guardians but often others concerned about the protection of minors are involved as a result of the setting for the intervention such as school administrators and the leaders of faith- or community-based organizations.  Human subjects protection procedures can have a major impact on (a) who participates in these studies, particularly when these studies depend on data collection across several data points, (b) types of information collected, and, (c) how individuals at risk are identified for analyses that linking data across time.

This roundtable discussion will focus on four 'real world' situations:

(1) To understand the processes of the prevention process particularly the influence of the social contexts of the interventions and of the lives of the targeted groups, prevention science is moving towards more intricate mixed methods designs.  An example is provided of human subjects issues in a substance abuse prevention trial using mixed methods.

(2) Evaluating large population-based interventions often require measuring population-based rates of behaviors, rather than a focus on enrolled individuals.  An example is presented from an RCT of a universal school-based suicide prevention program that required surveillance of suicidal behavior at a population level.

 (3) While the NIH policy of data sharing has begun to open up opportunities for synthesizing findings across studies, special concerns are raised regarding confidentiality at individual level and within and between trials, and review of findings by those who collected the data.  An example is discussed in the context of a large synthesis project funded by NIMH to illustrate how a collaborative synthesis project can facilitate integration of research projects.

(4)  Researchers who conduct effectiveness and implementation studies are faced with challenges when making data available for researchers at different institutions.  While the original data may be approved for use by a local IRB such approval does not confer access to colleagues at different sites.  An example of the “trusted party”, a neutral third party, is presented to discuss how datasets are merged and passed along as deidentified versions to investigators

5) A second example of how a “trusted party” can enable cross-institution data sharing involves a situation where text information such as names was automatically scrubbed by a computer program.  An example is presented where individual names from text messages can be replaced automatically so that they do not violate IRB restrictions.