Table 2.

Key Tasks and Participants in the Norm Implementation Process

Normative Stage	Example	Stage Specific Tasks	Key Experts and Participants
Identify Ethical Challenge	The informed consent process for clinical research often fails to sufficiently inform potential participants, thus impairing their ability to provide meaningful informed consent.	Interaction between scholars and stakeholders to understand ethical issues	Scholars in philosophy, bioethics, and religious studies Stakeholder group representatives
Normative Ethics	Respect for Persons: “Individuals should be treated as autonomous agents who are capable of deliberation about personal goals and of acting under the direction of such deliberation.” (Adapted from Belmont Report section B.1.)	Identify ethical norm and justify through dialectic argument among scholars Reality check with stakeholders to ensure ethical deliberation is reflective of frontline reality	Scholars in philosophy, bioethics, and religious studies Stakeholder group representatives
Applied Ethics	“Researchers ought to optimize participant understanding by using plain language, graphics, and simple formatting in consent documents.”	Further specify norm to guide actions Apply implementation principles to ensure that specific norm is feasible If norm is not feasible, reformulate Evaluate for intended and unintended consequences	Scholars in philosophy, bioethics, and religious studies Bioethicists with social science research skills Implementation scientists Key stakeholders and frontline staff
Intervention Development	Pilot testing of plain language forms with graphics, appropriate language, and simple formatting during informed consent conferences.	Develop intervention to enact specific norm Engage implementation principles in designing intervention Identify outcome measures Reality check intervention with frontline stakeholders Evaluate for intended and unintended consequences	Bioethicists with social science research skills Implementation scientists Clinical trialists Key stakeholders and frontline staff
Dissemination +/− Policy Development	If pilot testing shows positive results, refine intervention and disseminate to multiple institutions. Support this dissemination with changes to federal policy (common rule revisions).	If intervention is successful, develop plan for dissemination and outcome measurement In some cases, craft policy to mandate changes in practice and support dissemination Evaluate for intended and unintended consequences	Implementation scientists Lawyers Advocates Funding agencies