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Informed consent: process and clinical issues

D L Berry1, M J Dodd, P S Hinds

  • 1Department of Biobehavioral Nursing and Health Systems, University of Washington, Seattle, USA.

Oncology Nursing Forum
|April 1, 1996
PubMed
Summary
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Ensuring informed consent in cancer clinical trials is an ongoing, multidisciplinary process. Nurses play a vital role in maintaining patient understanding and assent throughout cancer research.

Area of Science:

  • Oncology
  • Clinical Trials
  • Bioethics

Background:

  • Informed consent is a cornerstone of ethical clinical cancer research.
  • Challenges exist in maintaining the informed consent process, particularly for vulnerable populations.
  • Nurses frequently encounter ethical dilemmas related to informed consent in cancer care.

Purpose of the Study:

  • To review challenges in informed consent within clinical cancer care.
  • To propose strategies for enhancing the informed consent process.
  • To highlight the role of nurses in pediatric and adult oncology trials.

Main Methods:

  • Literature review of published books and journal articles.
  • Synthesis of clinical research experience.
  • Analysis of ethical obligations in cancer research.
Keywords:
Biomedical and Behavioral Research

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Main Results:

  • Clinicians and researchers must uphold informed consent throughout clinical cancer research.
  • Nurse clinicians, trial nurses, and researchers face dilemmas in ensuring proper informed consent.
  • Pediatric cancer care requires specific considerations for consent involving children and youth.

Conclusions:

  • Informed consent is a continuous process, not solely a signed document.
  • Effective informed consent in cancer trials requires a multidisciplinary approach.
  • Nurses can improve consent by allocating sufficient time for patient understanding and reassessment.