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

Fujita M, Hayashi Y, Tashiro S, Takashima K, Nakazawa E, Akabayashi A - Health Res Policy Syst (2014)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: 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. misao-fujita@cira.kyoto-u.ac.jp.

ABSTRACT

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.

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Related in: MedlinePlus

Comparison of actual and ideal treatments of incidental findings. Calculations were based on data obtained from the 14 principal investigators who conduct human research using imaging devices.
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Fig1: Comparison of actual and ideal treatments of incidental findings. Calculations were based on data obtained from the 14 principal investigators who conduct human research using imaging devices.

Mentions: We mailed questionnaires to 31 PIs and obtained responses from 23 (response rate, 74.1%; Table 2). Of the 14 PIs who were conducting human research using imaging devices at their research facilities, 6 (42.9%) reported prior experience with IFs. These findings included brain tumors, cerebrovascular disorders, cerebral aneurysms, arachnoid cysts, and sinusitis. Figure 1 shows the current and ideal approaches for handling IFs according to the answers provided by the 14 PIs. Six (42.9%) answered that they were unsure of whether institutional guidelines exist, and 5 (35.7%) selected option 3 (Table 1) as the current institutional policy. However, half of the PIs indicated that specialist involvement would be appropriate (option 4 or higher) if resources were available. None of them currently adopted option 1 or option 2, or considered these options ideal. A comparison of responses concerning the current approach and those concerning the ideal approach using the Wilcoxon signed rank sum test revealed a significant difference (P =0.0156).Table 2


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

Fujita M, Hayashi Y, Tashiro S, Takashima K, Nakazawa E, Akabayashi A - Health Res Policy Syst (2014)

Comparison of actual and ideal treatments of incidental findings. Calculations were based on data obtained from the 14 principal investigators who conduct human research using imaging devices.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4195876&req=5

Fig1: Comparison of actual and ideal treatments of incidental findings. Calculations were based on data obtained from the 14 principal investigators who conduct human research using imaging devices.
Mentions: We mailed questionnaires to 31 PIs and obtained responses from 23 (response rate, 74.1%; Table 2). Of the 14 PIs who were conducting human research using imaging devices at their research facilities, 6 (42.9%) reported prior experience with IFs. These findings included brain tumors, cerebrovascular disorders, cerebral aneurysms, arachnoid cysts, and sinusitis. Figure 1 shows the current and ideal approaches for handling IFs according to the answers provided by the 14 PIs. Six (42.9%) answered that they were unsure of whether institutional guidelines exist, and 5 (35.7%) selected option 3 (Table 1) as the current institutional policy. However, half of the PIs indicated that specialist involvement would be appropriate (option 4 or higher) if resources were available. None of them currently adopted option 1 or option 2, or considered these options ideal. A comparison of responses concerning the current approach and those concerning the ideal approach using the Wilcoxon signed rank sum test revealed a significant difference (P =0.0156).Table 2

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: 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. misao-fujita@cira.kyoto-u.ac.jp.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus