Handling incidental findings in neuroimaging research in Japan: current state of research facilities and attitudes of investigators and the general population

详细信息    查看全文

• 作者：Misao Fujita (1)
  Yoshinori Hayashi (2)
  Shimon Tashiro (3)
  Kyoko Takashima (4)
  Eisuke Nakazawa (4)
  Akira Akabayashi (4)
  
  1. Uehiro Research Division for iPS Cell Ethics ; Center for iPS Cell Research and Application (CiRA) ; Kyoto University ; The Kyoto Technoscience Center #3 ; 14 ; Yoshidakawara-cho ; Sakyo-ku ; Kyoto ; 606-8305 ; Japan
  2. College of Letters ; Human Studies Program ; Ritsumeikan University ; 56-1 Toji-in Kitamachi ; Kita-ku ; Kyoto ; 603-8577 ; Japan
  3. Office for Promoting Medical Research ; Showa University ; 1-5-8 Hatanodai ; Shinagawa-ku ; Tokyo ; 142-8555 ; Japan
  4. Department of Biomedical Ethics ; The University of Tokyo Graduate School of Medicine ; 7-3-1 Hongo ; Bunkyo-ku ; Tokyo ; 113-0033 ; Japan
  
• 关键词：General population ; Incidental findings ; Investigators ; Japan ; Neuroimaging ; Questionnaires
• 刊名：Health Research Policy and Systems
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：12
• 期：1
• 全文大小：445 KB
• 参考文献：1. Wolf, SM, Lawrenz, FP, Nelson, CA, Kahn, JP, Cho, MK, Clayton, EW, Fletcher, JG, Georgieff, MK, Hammerschmidt, D, Hudson, K, Illes, J, Kapur, V, Keane, MA, Koenig, BA, Leroy, BS, McFarland, EG, Paradise, J, Parker, LS, Terry, SF, Van Ness, B, Wilfond, BS (2008) Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 36: pp. 219-248 CrossRef
  2. Illes, J, Chin, VN (2008) Bridging philosophical and practical implications of incidental findings in brain research. J Law Med Ethics 36: pp. 298-304 CrossRef
  3. Illes, J, Kirschen, MP, Edwards, E, Stanford, LR, Bandettini, P, Cho, MK, Ford, PJ, Glover, GH, Kulynych, J, Macklin, R, Michael, DB, Wolf, SM (2006) Ethics. Incidental findings in brain imaging research. Science 311: pp. 783-784 CrossRef
  4. Kirschen, MP, Jaworska, A, Illes, J (2006) Subjects鈥?expectations in neuroimaging research. J Magn Reson Imaging 23: pp. 205-209 CrossRef
  5. Kumra, S, Ashtari, M, Anderson, B, Cervellione, KL, Kan, L (2006) Ethical and practical considerations in the management of incidental findings in pediatric MRI studies. J Am Acad Child Adolesc Psychiatry 45: pp. 1000-1006 CrossRef
  6. Wolf, SM, Paradise, J, Caga-anan, C (2008) The law of incidental findings in human subjects research: establishing researchers鈥?duties. J Law Med Ethics 36: pp. 361-383 CrossRef
  7. Hayashi, Y (2010) Ethical issues of handling incidental findings in neuroimaging research: clarifying and discussing some points. Appl Ethics 4: pp. 29-43
  8. Lawrenz, F, Sobotka, S (2008) Empirical analysis of current approaches to incidental findings. J Law Med Ethics 36: pp. 249-255 CrossRef
  9. Illes, J, Kirschen, MP, Karetsky, K, Kelly, M, Saha, A, Desmond, JE, Raffin, TA, Glover, GH, Atlas, SW (2004) Discovery and disclosure of incidental findings in neuroimaging research. J Magn Reson Imaging 20: pp. 743-747 CrossRef
  10. Royal, JM, Peterson, BS (2008) The risks and benefits of searching for incidental findings in MRI research scans. J Law Med Ethics 36: pp. 305-314 CrossRef
  11. Richardson, HS (2008) Incidental findings and ancillary-care obligations. J Law Med Ethics 36: pp. 256-270 CrossRef
  12. Miller, FG, Mello, MM, Joffe, S (2008) Incidental findings in human subjects research: what do investigators owe research participants?. J Law Med Ethics 36: pp. 271-279 CrossRef
  13. Milstein, AC (2008) Research malpractice and the issue of incidental findings. J Law Med Ethics 36: pp. 356-360 CrossRef
  14. Illes, J, Kirschen, MP, Edwards, E, Bandettini, P, Cho, MK, Ford, PJ, Glover, GH, Kulynych, J, Macklin, R, Michael, DB, Wolf, SM, Grabowski, T, Seto, B (2008) Practical approaches to incidental findings in brain imaging research. Neurology 70: pp. 384-390 CrossRef
  15. Underwood, E (2012) When a brain scan bears bad news. Science 338: pp. 455 CrossRef
  16. The National Core for Neuroethics: / New Documentation for the Management of Incidental Findings. [http://neuroethics.med.ubc.ca/new-documentation-for-the-management-of-incidental-findings/]
  17. The Ministry of Education, Culture, Sports, Science and Technology: / The Strategic Research Program for Brain Sciences. [http://brainprogram.mext.go.jp/] (In Japanese)
  18. The Japan Neuroscience Society: / Guidelines for Ethical Issues of Non-Invasive Research on Human Brain Function. [http://www.jnss.org/wp-content/uploads/2012/02/rinri.pdf] (In Japanese)
  19. Sakura, O, Fukushi, T (2007) Neuroethics: towards communicative relation among neuroscience and public. J Jpn Assoc Bioethics 17: pp. 18-27
  20. Fujita, M Views among researchers, and the position of institutions, regarding the handling of incidental findings in research using brain images. In: Akabayashi, A eds. (2011) Brain Science Research and Ethics; Collection. The University of Tokyo, Tokyo, pp. 46-61
  21. Deslauriers, C, Bell, E, Palmour, N, Pike, B, Doyon, J, Racine, E (2010) Perspectives of Canadian researchers on ethics review of neuroimaging research. J Empir Res Hum Res Ethics 5: pp. 49-66 CrossRef
  22. Cooke, R, Peel, E, Shaw, RL, Senior, C (2007) The neuroimaging research process from the participants鈥?perspective. Int J Psychophysiol 63: pp. 152-158 CrossRef
  23. Shaw, RL, Senior, C, Peel, E, Cooke, R, Donnelly, LS (2008) Ethical issues in neuroimaging health research: an IPA study with research participants. J Health Psychol 13: pp. 1051-1059 CrossRef
  24. JMA Research Institute Inc [http://www.jmar.co.jp/] (In Japanese)
  25. Mamourian, A (2004) Incidental findings on research functional MR images: should we look. AJNR Am J Neuroradiol 25: pp. 520-522
  26. Booth, TC, Jackson, A, Wardlaw, JM, Taylor, SA, Waldman, AD (2010) Incidental findings found in 鈥榟ealthy鈥?volunteers during imaging performed for research: current legal and ethical implications. Br J Radiol 83: pp. 456-465 CrossRef
  27. Pickard, JD, Gillard, JH (2005) Guidelines reduce the risk of brain-scan shock. Nature 435: pp. 17 CrossRef
  28. Ulmer, S, Jensen, UR, Jansen, O, Mehdorn, HM, Schaub, J, Deuschl, G, Siebner, HR (2009) Impact of incidental findings on neuroimaging research using functional MR imaging. AJNR Am J Neuroradiol 30: pp. E55 CrossRef
  29. Shoemaker, JM, Holdsworth, MT, Aine, C (2011) A practical approach to incidental findings in neuroimaging research. Neurology 77: pp. 2123-2127 CrossRef
  30. Ross, K (2005) When volunteers are not healthy. EMBO Rep 6: pp. 1116-1119 CrossRef
  31. Hayashi, Y (2010) Researcher鈥檚 obligations to handle incidental findings and their implications. J Jpn Assoc Bioethics 21: pp. 22-29
  32. Illes, J, Rosen, AC, Huang, L, Goldstein, RA, Raffin, TA, Swan, G, Atlas, SW (2004) Ethical consideration of incidental findings on adult brain MRI in research. Neurology 62: pp. 888-890 CrossRef
  33. Illes, J (2006) 鈥楶andora鈥檚 box鈥?of incidental findings in brain imaging research. Nat Clin Pract Neurol 2: pp. 60-61 CrossRef
  34. Appelbaum, PS, Roth, LH, Lidz, C (1982) The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 5: pp. 319-329 CrossRef
  35. Appelbaum, PS, Lidz, CW (2008) Twenty-five years of therapeutic misconception. Hastings Cent Rep 38: pp. 5-6 CrossRef
  36. Rangel, EK (2010) The management of incidental findings in neuro-imaging research: framework and recommendations. J Law Med Ethics 38: pp. 117-126 CrossRef
  37. Hayashi, Y, Fujita, M, Takashima, K, Tashiro, S, Akabayashi, A Recommendations. In: Akabayashi, A eds. (2012) The Management of Incidental Findings in Neuroimaging Research. The University of Tokyo, Tokyo, pp. 1-27
  
• 刊物主题：Health Administration; Social Policy; Quality of Life Research;
• 出版者：BioMed Central
• ISSN：1478-4505

文摘

Background To establish appropriate measures that deal with incidental findings (IFs), the neuroscience community needs to address various ethical issues. The current state of research facilities regarding IFs and investigator attitudes as well as potentially eligible research participants must be assessed prior to future discussions and before the development of policies and guidelines. To this end, we conducted two questionnaire surveys to clarify i) how IFs are addressed at neuroimaging research facilities in Japan and ii) the views of investigators and potential research participants regarding the handling of IFs. Methods Thirty-one principal investigators (PIs) involved in the Strategic Research Program for Brain Sciences (SRPBS), a government-funded project, were asked to fill out a questionnaire regarding ways IFs were handled at the facility. A total of 110 investigators engaged in SRPBS tasks, including 31 PIs who participated in the research facility survey and researchers conducting studies under the management of the PIs, and 500 individuals from the general public (i.e., general population) were asked to select the most appropriate way to deal with IFs in two scenarios, namely the medical school and humanities and social sciences department scenarios. Results More than 40% of PIs responded that they did not know or were unsure of what type of approach was employed to handle IFs at their research facilities. Nevertheless, they were willing to improve the current status if sufficient resources were provided. With regard to specialist involvement, 37.7% of investigators responded that it was appropriate to have a specialist check all images in the medical school scenario, whereas 13.3% responded that such involvement was appropriate in the humanities and social sciences department scenario. In contrast, 76.1% and 61.0% of the general population indicated that specialist involvement was appropriate in the medical school and humanities and social sciences department scenarios, respectively. These results show that expectations of the general population exceed those of investigators regarding measures to address IFs. Both investigators and the general population demanded more responsibility from PIs at medical institutions, compared to PIs at non-medical institutions. Conclusions Based on our preliminary results, we recommended that a licensed physician perform a screening test to appropriately examine clear abnormalities. These recommendations were implemented by the SRPBS as guidelines for handling IFs in national research projects in Japan.