The Interim Report released in March 2016 by the Oversight Committee for Fukushima Health Management Survey called for the need to establish the rules of management and provision of the data so it can be widely utilized by domestic and international experts. Accordingly, the Subcommittee to Review Provision of Data for the Purpose of Academic Research met in Fukushima City, Fukushima, for the first time on May 31, 2016. Subcommittee members were selected by the Fukushima prefectural government in order to address the role of the subcommittee in establishing technical rules in provision of data and include specialists in epidemiology, information technology, law, and legal sociology. Also included are members of the Oversight Committee for Fukushima Health Management Survey, Shoichiro Tsugane and Hokuto Hoshi, and the Health Survey Support Department Head and the Department of Epidemiology Chair at Fukushima Medical University, Tetsuya Ohira, representing the Fukushima Health Management Survey. Noteworthy was the absence of a medical ethicist.
The subcommittee meeting, streamed live online by independent journalists, revealed important facts that warrant sharing with the English-speaking community.
First, even those of us who have been following activities of the Fukushima Health Management Survey from the beginning did not realize Fukushima Prefecture has actually commissioned academic presentation and paper publication of the data to Fukushima Medical University in addition to collection of data. Apparently, data analysis is one of the commissioned tasks assigned to Fukushima Medical University, and as a result, end products of data analysis such as presentations and published papers are considered part of the commissioned tasks.
(Note: It is a public knowledge that Fukushima Medical University is commissioned by Fukushima Prefecture to conduct the Fukushima Health Management Survey using the 78.2 billion yen "Fukushima Resident Health Fund" established in late 2011 by the Japanese government. However, it might not be as well known that the 78.2 billion yen came from the Ministry of Economy, Trade and Industry, whose Agency for Natural Resources and Energy is tasked with promoting construction of nuclear power plant facilities in Japan via its Nuclear Facilities Development and Nuclear Fuel Cycle Industry Division of the Electricity and Gas Industry Development Department).
Second, it became apparent that the Fukushima Medical University has such strict management guidelines for the Fukushima Health Management Survey data that there is tight control over presentation and publication of the analyzed data via an internal peer review process which approves or disapproves the work.
For information, the purposes of the Fukushima Health Management Survey are stated on the website of the Radiation Health Science Center:
"The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects."
According to Ohira's statements, summarized below and shown in the video recording of the subcommittee meeting (from 25 minutes 57 seconds, in Japanese), this is what Fukushima Medical University researchers have to go through:
Those interested in analyzing data would have to submit a request for data analysis specifying the type and purpose of the analysis. The request is then examined by the review committee. If the review committee deems appropriate, the data is provided to the applicant who signs an agreement on data handling. Thus the data is strictly managed. When it comes to presenting the analysis at an academic meeting or publishing the analysis, another request for presentation must be filed with the review committee. The presentation or publication of the analysis can only proceed if the review committee approves it as appropriate.
A question was posed by a Fukushima University professor and legal sociologist, Hiroyasu Shioya,
"For the third party use, would the review be a matter of formality or more substantial?"
"At the Radiation Medical Science Center for the Fukushima Health Management Survey at Fukushima Medical University, the content (substance) of the analysis itself is examined. In the case of publication of a paper, we conduct what is called an internal peer review, where the paper is distributed to reviewers for examination of the content. Then it is further discussed at the review committee and approved if it is determined appropriate."
Chair of the Subcommittee to Review Provision of Data for the Purpose of Academic Research, Shoichiro Tsugane, wondered how the third-party use review might actually proceed, indicating that would be a future topic of the subcommittee.
A question arose to the viewers' mind as to what is considered "appropriate" by the review committee and who constituted such committee. Answers were found in a document distributed at the February 15, 2016 Oversight Committee Meeting by the Prefectural Department of Fukushima Health Management Survey describing the details of the review committee.
In summary, any research conducted at Fukushima Medical University must be approved by the Ethics Review Committee as well as the Conflict of Interest Committee. Then, within the Radiation Medical Science Center for the Fukushima Health Management Survey, there is a special review committee, the Review Committee for the Use and Analysis of the Fukushima Health Management Survey Data (referred to as "the Review Committee" hereafter). Below is a translation of page 4 of the document.
Review procedures for research at Fukushima Medical University
Procedures within Fukushima Medical University
1. Ethics Review Committee (description not translated)
2. Conflict of Interest Committee (description not translated)
Procedures within the Radiation Medical Science Center for the Fukushima Health Management Survey
3. Review Committee for the Use and Analysis of the Fukushima Health Management Survey Data
Reviews appropriateness in the use, analysis, and report of the Fukushima Health Management Survey data.
(1) Eligibility for application
a. Fukushima Health Management Survey expert committee members
b. Equivalent to the above, with approval by the expert committee
(2) Items to be reviewed
a. Study title, applicant name
b. Type and range of data to be used
c. Purpose of data use
d. Plan for analysis
e. How the analytical result will be publicized
f. Items regarding the use and storage of data
(3) Review criteria
a. Whether the use and report of data will be appropriate according to the Report of Review Committee Regarding Handling of Research and Development Results (Ministry of Education, Culture, Sports and Technology, May 20, 2002).
b. Whether the use follows one of the purposes of the Fukushima Health Management Survey, "to monitor the long-term health of residents."
c. Whether there is any problem if data is used, analyzed and reported according to the review application.
d. Whether there is any problem with qualifications and credentials of the person handling data.
e. Whether data is properly handled.
f. Any other issues with data use.
(4) Review Committee members
Chair: Executive Director of the Radiation Health Science Center
Members: Deputy Directors, Department Heads, Division Chiefs, Deputy Administrative Director (in charge of reconstruction) of the Radiation Health Science Center; others considered necessary by the Review Committee
According to the information provided on the Japanese website and English website of the Radiation Medical Science Center, Chair of the Review Committee is Masafumi Abe, executive director of the Radiation Medical Science Center for the Fukushima Health Management Survey, and a vice president of Fukushima Medical University.
Below are the Review Committee members whose names and titles are publicly available on the Japanese website.
Vice Directors: Koichi Tanigawa, Shunichi Yamashita, Kenji Kamiya.
Department Heads: Akira Ohtsuru (Thyroid Examination Department), Masaharu Maeda (Health Survey Department), and Tetsuya Ohira (Health Survey Support Department)
(Note: Names of the above individuals often appear as co-authors of papers published using the Fukushima Health Management Survey data, such as this, this, and this.
Page 3 of the document shows a flow chart of the review procedures at Fukushima Medical University. Use of any data outside the Fukushima Health Management Survey, including the clinical data, only goes through steps 1 and 2, ethics review and conflict of interest review. Use of the Fukushima Health Management Survey data additionally goes through step 3, with details outlined above, except that the review process is different for the publicized data and the unpublicized data.
Use of the publicized data can be requested through the Review Committee in three ways: use, use and academic presentation, or use and academic paper writing. A request for use alone is simply approved or disapproved. If a request for an academic presentation using the publicized data is approved by the Review Committee, the applicant must report back to the Review Committee whether the presentation was accepted at the academic meeting or not. If a request for writing an academic paper using the publicized data is approved by the Review Committee, the completed paper must go through an internal peer review followed by examination of the content at the Review Committee before the paper is approved to be published.
The review process for use of the unpublicized data is more rigorous. After the application to use and analyze the unpublicized data is approved by the Review Committee, another request must be filed for the result of the analysis to be presented at an academic meeting. If the Review Committee approves the request, the applicant must report back whether the presentation was accepted or not. If the applicant wishes to write a paper using the analyzed result of the unpublicized data, a request must be filed before writing the paper. If the Review Committee approves the request, the paper can be written. Once complete, the paper goes through an internal peer review followed by examination of the content at the Review Committee before the paper is approved to be published (just as in the case of the paper using the publicized data).
Comment: The extent that the data use is "managed" seems extraordinary. Specifically, one of the review criteria regarding whether the use follows the purpose of the Fukushima Health Management Survey, "to monitor the long-term health of residents," is unique to this review process. However, exactly how this is determined and applies as a criterion is unclear. During the Subcommittee meeting, "promotion of health and the well-being of residents" was mentioned multiple times by various committee members as the primary purpose of the Fukushima Health Management Survey and as the reason to guard the data so closely. Certainly, one could imagine the "misuse" of data, as internally determined by the Review Committee, might be detrimental to the well-being of someone--whoever that might be.
This unusually strict management of data raises questions such as: neutrality of the internal review of academic papers which list the Review Committee members as co-authors; potential biases in the conclusion of the academic presentation or paper; and missed opportunities in pursuing scientific knowledge of health effects of radiation exposure in Fukushima residents.
What the Subcommittee decides on the third-party use of the data is to be closely followed.