JSCO2016: International Session 20 Ethics for Clinical Research

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The 54th Annual Meeting of Japan Society of Clinical Oncology (JSCO2016)

"Renovation of Cancer Medicine in the Mature Society"



International Session 1: Lung Cancer
International Session 2: Colorectal Cancer
International Session 3: Gastric Cancer
International Session 4: Urological Cancer (Prostate and Renal Cancer)
International Session 5: Supportive Care for Adverse Events
International Session 6: Gynecological Cancer (Uterine Body Cancer and Ovarian Cancer)
International Session 7: Central Nervous System Tumor
International Session 8: New Development of Particle Beam Therapy for Cancer
International Session 9: International Cooperation in Radiation Medicine
International Session 10: Recent Advances In Cancer Immunotherapy
International Session 11: Breast Cancer
International Session 12: Pharmacology of Antitumor Agents: New Drug Application (NDA)
International Session 13: Malignant Lymphoma
International Session 14: Palliative Care
International Session 15: Radiation Therapy
International Session 16: Head and Neck Cancer
International Session 17: Skin Cancer (Malignant Melanoma)
International Session 18: Hepato-Biliary and Pancreas Cancers
International Session 19: Leukemia
International Session 20: Ethics for Clinical Research
International Session 21: Esophageal Cancer
International Session 22: Bone and Soft Tissue Tumor
FACO/JSCO Joint Symposium

Abstract Archives (in Japanese)


International Session 20: Ethics for Clinical Research


Ethical guidelines for clinical research in Japan
Atsushi Asai (Tohoku University Graduate School of Medicine)
Clinical research is a clinical investigation or observation involving human participants, performed in accordance with a protocol designed to yield generalizable scientific knowledge and it is essential to modern medicine (Jonsen, AR, et al., 2015). However, historically, the risks of harm to human subjects have often been placed heavily on the economically disadvantaged, the very sick, and the vulnerable and the unjustified overutilization of them has long been a matter of deep moral concern (Beauchamp, TL and Childress, JF, 2013). It is pointed out that patients were often unwilling and unknowing subjects of clinical research in the past. In addition, it is commonly recognized that research itself involves many conflicts of interest (Jonsen, et al., 2015). Furthermore, administration of a chemical or biological compound to a human being is never without risk(Bresalier RS, et al., 2005).
A good research question must be ethical (Cummings SR, et al., 2001). Research had been heavily regulated because it has been thought to place subjects at risk for the benefit of others and to investigate unconfirmed hypotheses about diagnoses and treatments (Beauchamp and Childress, 2013). Unfortunately, research misconduct has recently become more prominent in Japan. In addition, medical researchers at a top medical school in Japan were found to have conducted invasive tissue sampling solely for research purposes during a surgical operation, even though the patient was under general anesthesia and had not provided informed consent (Asai, et al., 2016). Under these circumstances, Japanese government has just recently issued Ethical Guidelines for Medical and Health Research Involving Human Subjects (December 22, 2014). This presentation discusses its structure, contents, and implications.


Ethical guidelines for clinical research in the United States
Takefumi Komiya (Division of Medical Oncology, Department of Internal Medicine, University of Kansas Medical Center, USA)
In 1995, International Conference on Harmonization - Good Clinical Practice (ICH-GCP) was established in order to assist researchers and regulatory agencies in sharing common ethical ground for clinical research. The United States Department of Human and Health Services (HHS) and the Food and Drug Administration (FDA) responded by creating regulations in order to comply with ICH-GCP guideline.

HHS Title 45 Part 46 is the lead federal regulation in the US regarding protection of human subjects. It applies to all research involving human subjects, and defines federal rule to cover all aspects of clinical research, including requirements of institutional review board (IRB) and informed consent (IC).

In addition to international and national guidelines/regulations, there are some routine measures in the US to further safeguard clinical research. These include registration of IRB and additional review committees in each institution. Large cancer centers in the US are expected to develop scientific review system which is independent of ethical reviews. The University of Kansas Cancer Center, the 67th NCI-designated Cancer Center, provides such infrastructure to meet expectations as a state-of-the-art cancer center. Establishment of these independent committees requires additional administrative effort and higher cost. Overall approval process becomes lengthier as a result of complex review system. Development of novel agents with complicated study design further creates challenges to institutions.

In this international session, we will identify differences across nations in various topics related to clinical research. This session will hopefully provide all the stakeholders with useful discussion for international harmonization.


Year in review from Asia, ethical guidelines for clinical research
Sun Young Rha (Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Korea)
Not Received


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