Informed consent: process and clinical issues.

PURPOSE/OBJECTIVES: To review the issues related to informed consent in a clinical cancer care setting and suggest strategies to improve the informed consent process.

DATA SOURCES

Published books, journal articles, and clinical research experience.

DATA SYNTHESIS

Clinicians and researchers are ethically obligated to maintain the informed consent process when treating participants in clinical cancer research. Nurse clinicians, clinical trial nurses, and nurse researchers often encounter dilemmas while ensuring proper informed consent. Nurses involved in pediatric cancer care must address specific consent issues relevant to children and youth.

CONCLUSIONS

Informed consent does not end with a patient's signature on a form. Establishing and maintaining informed consent is a multidisciplinary effort in cancer clinical trials. Nurses can improve the informed consent process by ensuring adequate time for patient consideration and understanding and by reassessing consent during the study.

IMPLICATIONS FOR NURSING PRACTICE

Clinical trial nurses and nurse investigators in both adult and pediatric oncology have a duty and obligation to maintain continued informed consent throughout a study and to be involved in all aspects of study planning and implementation.