Protecting human research participants is essential to the clinical research enterprise. When researchers engage in serious and continuing noncompliance with human subjects research regulations, their institutions must develop and implement action plans to address their noncompliance. However, developing appropriate and effective action plans is challenging, and ineffective action plans that do not change researchers' behavior put the researcher and institution at risk that noncompliance will reoccur. We propose an 8-month bioethics supplement that will be relevant to institutional officials charged with addressing human subjects compliance violations and developing action plans in response to these violations. The research team has expertise in researcher professional development, identifying root causes of noncompliance, and responsible behavior in research settings. The research team also has experience developing and conducting a national program intended for researchers referred to the program for noncompliance and research integrity violations. We propose the following aims:
Aim 1. Determine the procedures institutions utilize to develop action plans for serious and continuing noncompliance and identify a comprehensive set of root causes and associated actions and activities. 1A. Conduct in-depth interviews about action plan procedures, content, and perceived effectiveness with 36 institutional officials (IOs) who are experienced with handling cases of human subjects noncompliance to identify root cause-remedial activity linkages and inform the development of the Aim 1B survey. 1B. Administer a survey to institutional officials at all U.S. health science research institutions (n ? 170) to characterize broad action plan development practices, action plan content, and perceived effectiveness.
Aim 2. Convene 6 experts in responsible research to review Aim 1 results, P.I. Program root cause and development activities, and relevant professional development literature to create an action plan tool.
When researchers engage in serious and continuing noncompliance with human subjects research regulations, institutions must develop and implement action plans to address this noncompliance. Complete and accurate identification of the root causes of noncompliance and linking these causes to appropriate actions is central to the effectiveness of these plans. Through interviews and surveys with institutional officials at biomedical research institutions and a review of findings conducted by six experts in research professional development and responsible behavior, we will describe approaches to action plan development and create a resource guide to inform the development of effective action plans.
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