Ethical issues in research to improve the management of malignant bowel obstruction: challenges and recommendations.
Research to improve the care of patients with malignant bowel obstruction (MBO) is urgently needed. In particular, there is an urgent need for high-quality descriptive research, including prospective cohort studies, as well as randomized controlled trials to define optimal management strategies. However, investigators and clinicians face numerous barriers in conducting high-quality research in this patient population. These barriers include lack of funding, difficulties in identifying eligible patients, and a variety of practical and methodological challenges of designing these studies. In addition, there are a variety of ethical challenges that arise in the design and conduct of studies of MBO and particularly in the conduct of clinical trials. In this article, we address four categories of ethical issues: study design, recruitment, informed consent, and Institutional Review Board review. For each, we outline salient issues and suggest recommendations for enhancing the ethics of MBO studies, including interventional trials.
Laneader
Alice
A
Research Compliance and Quality Improvement, University of Pennsylvania, Philadelphia, Pennsylvania 10104, USA.
Angelos
Peter
P
Ferrell
Betty R
BR
Kolker
Ann
A
Miner
Thomas
T
Padilla
Geraldine
G
Swaney
Julie
J
Krouse
Robert S
RS
Casarett
David
D
D006801:Humans; D007258:Informed Consent; D007414:Intestinal Neoplasms / Q000150:complications / Q000628:therapy*; D007415:Intestinal Obstruction / Q000209:etiology / Q000628:therapy*; D010166:Palliative Care / Q000941:ethics* / Q000379:methods; D017410:Practice Guidelines as Topic