Table 8.
Opportunities for improvement and possible interventions to address them in clinical research processes.
| Identified opportunity | Potential intervention |
|---|---|
| Motivation | |
| • Altruism as motivation for participation Compensation as second order motivation for participation Free healthcare as motivation | • Consider role of altruism in planning recruitment, retention, and conduct Moderate the emphasis on compensation in recruitment Guard against undue influence; facilitate access to available alternatives |
| Informed consent | |
| • Some participants under estimate risk Participants do not understand the research study plan “Diagnostic Misconception” that screening tests equal a clean bill of health | • Develop means to test and enhance understanding of study risks and requirements of participating Reconstruct informed consent to address the limitations of study‐related testing |
| Study conduct and retention | |
| • Participants desire, but do not receive their clinical results | • Implement standardized procedures to share clinical results with participants |
| • Participants desire, but are not informed of the results of the research study in which they participated | • Evaluate ethical issues relative to sharing overall research results Where appropriate, develop and test standard procedures for sharing overall research results with participants |
| • Positive impact of professional and organized conduct by staff • Negative impact of unprofessional or disorganized conduct by staff | • Educate research teams on the impact of professionalism on participants’ experiences and willingness to continue in studies. • Develop metrics for quality review and improvements on key items such as courtesy, respect, timeliness, and organizational workflow |
| • Under‐appreciated value of “research partnership” to participants | • Explicitly acknowledge and respect role of participant as essential partner in research process |