TABLE 2.
Oncology Nursing Competencies for Clinical Trials in the Era of Precision Medicine
| Functional Area | Competencies |
|---|---|
| Protocol compliance | Facilitates compliance with research protocol and good clinical practice* |
| Demonstrates an understanding of the relationship of genetics/genomics to a clinical trial† | |
| Trial-related communication | Utilizes multiple communication methods to facilitate implementation of clinical trials* |
| Facilitates referrals for specialized genetic/genomic services for clients as needed and as allowed per protocol† | |
| Informed consent process | Demonstrates leadership in ensuring patient comprehension and safety during initial and ongoing clinical trial informed consent discussions* |
| Advocates for the rights of clients for autonomous, informed genetic/genomic related decision-making and voluntary action† | |
| Management of research subjects | Uses a variety of resources and strategies to manage the care of study participants, ensuring compliance with protocol procedures, assessments, and reporting requirements, as well as management of symptoms* |
| Identifies credible, accurate, appropriate, and current genetic/genomic information, resources, services, and/or technologies, per protocol† | |
| Demonstrate importance of tailoring genetic/genomic information and services to clients based on their culture, religion, knowledge level, literacy, and preferred language† | |
| Documentation | Ensures collection of source data and completion of documentation that validates the integrity of the study* |
| Collects personal, health, and developmental histories that consider genetic, environmental, and genomic influences and risks, per protocol† | |
| Subject recruitment | Utilizes a variety of recruitment strategies to enhance recruitment while being mindful of the needs of the study populations* |
| Assesses potential study subjects’ knowledge, perceptions, and responses to genetic/genomic information† | |
| Identifies study subjects who may benefit from specific genetic/genomic information and/or services based on assessment data, per protocol† | |
| Ethical issues | Demonstrates leadership in ensuring adherence to ethical practices during the trial in order to protect the rights, well-being, and privacy of participants and the collection of quality data* |
| Identifies ethical/ancestral, religious, legal, fiscal, and societal issues related to genetic/genomic information and technologies† | |
| Defines issues that undermine the rights of all clients for autonomous, informed genetic and genomic-related decision-making and voluntary action† | |
| Professional development | Assumes responsibility for identifying ongoing professional development needs and seeks resources and opportunities to meet need, ie, membership in nursing, oncology or research organizations* |
| Examines competency of practice regularly, identifying areas of strength, as well as areas in which professional development related to genetics/genomics would be beneficial† | |
| Incorporate genetic and genomic technologies/information into professional practice† | |
| Recognizes when one’s own attitude and values related to genetic/genomic science may affect care provided to clients† |