title: Nurse awareness of clinical research: a survey in a Japanese University Hospital.
abstract: BACKGROUND
  Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research.
  
  
  METHODS
  As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed.
  
  
  RESULTS
  Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse.
  
  
  CONCLUSIONS
  These findings suggest that clinical nurses have only limited knowledge on clinical research and the importance to have chances to make nurses aware of clinical research-related issues is suggested to establish an extended research team. Because of the study limitations, further study is warranted to determine the role of clinical nurses in establishing a suitable infrastructure for ethical pursuit of clinical research.
authors.affiliation: Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima 770-8503, Japan. niseko@tokushima-u.ac.jp.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yanagawa
authors.forename: Shigemi
authors.initials: S
authors.lastname: Takai
authors.forename: Michiko
authors.initials: M
authors.lastname: Yoshimaru
authors.forename: Toshiko
authors.initials: T
authors.lastname: Miyamoto
authors.forename: Rumi
authors.initials: R
authors.lastname: Katashima
authors.forename: Kikue
authors.initials: K
authors.lastname: Kida
mesh_terms: D000328:Adult; D001291:Attitude of Health Personnel; D035843:Biomedical Research / Q000379:methods*; D003625:Data Collection; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006785:Hospitals, University; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009726:Nurses; D009741:Nursing Staff, Hospital; D011795:Surveys and Questionnaires; D055815:Young Adult