IRB stakeholders: Protecting human research participants through a culture of conscience in a community based participatory research model: An exploratory study

Institutional Review Boards (IRBs) have emerged as arbiters of ethical research with human participants during the past 35 years. Researchers and IRBs charged with protecting research participants must assure that consent is given with full understanding of their choices. Ethical issues regarding experimental projects involving vulnerable adults (especially those with cognitive decline) are difficult to resolve, particularly when lines of communication among stakeholders - researchers, other IRB members and human participants - have been ill defined and poorly negotiated. This dissertation explores and describes current problems and proposes ways to improve communications.;Using a Community Based Participatory Research (CBPR) model, this study focused on the interactions and strategies of three primary research stakeholders. CBPR involves representatives of participants in the design and implementation of research. Data were gathered from online surveys with 161 participants. SPSS 17 was utilized for analysis. Responses from two focus groups and individual interviews were coded for themes.;Three aims drove the analysis. The first aim was to identify methodologies currently recommended by IRB members and used by researchers to assess consent capacity. The second aim was to explore communication between Institutional Review Boards and researchers about the nature and key issues of the research. The third aim was to explore communication between researchers and potential participants about the nature and key issues of the research. Lines of communication are inadequate for protecting participants.;This exploratory study can serve as a basis for further studies regarding the most effective methods for communication among stakeholders. It may inform policies which govern research and inform practice for social workers among other professionals, as we honor principles of respecting the dignity and autonomy of the individual.;Protection of human subjects has occurred within a culture of compliance. Rules are duly processed but they offer little direction about how to assess consent capacity. Reformers wish to institute a culture of conscience, as articulated by Greg Koski, first Director of the Office of Human Research Protection (OHRP). This would shift the focus of research from satisfying regulations to deciding what is right and just in each research context.