Part II [Round-Table Discussion] Centralization of Ethics Committees

*Honorifics omitted

  • Panelists:
    Yoichi Yamamoto, Head of Academic Clinical Research Center, Department of Medical Innovation, Osaka University Hospital
    Sosuke Iwae, Director of Research Ethics Support Department, Clinical Research Support Center, University of Miyazaki Hospital
    Akira Akabayashi, Deputy Director of Office for Human Research Studies, Faculty of Medicine, the University of Tokyo
  • Coordinator:
    Yuzaburo Uetake, Director General of the Ethics Committee, Office for Human Research Studies, Faculty of Medicine, the University of Tokyo
  • Observer:
    Takuya Watanabe, Office for Human Research Studies, Faculty of Medicine, the University of Tokyo

7.Possibilities of Partnerships

Uetake:
Next, I’d like to discuss the sharing of documentation, such as contracts and applications.
We at the University of Tokyo actually do not have our own method and are even okay with utilizing a system developed by Osaka University. What is it like at other institutions?
Yamamoto:
We share the basic system for electronic filing of clinical trial applications with other places but the process in which the medical and administrative staff review and respond to the actual applications is different. Therefore, we have started to slowly customize it so that it becomes easier to share with other institutions. The basis is the same so I think there is so much potential for sharing information.
Uetake:
I agree. Coming up with a standard format for applications is probably not that hard to do. What do you think, Dr. Iwae?
Iwae:

We actually take a fairly customized approach. For example, the data is entered in the system according to subcategories and attributes of the research to make it easier to conduct searches later on. Clinical research extends over a variety of areas so coming up with a universal format may be rather difficult.
Furthermore, with the enactment of the Clinical Research Law* this year (2017) in April, there is the possibility that joint research would become difficult or cannot be carried out smoothly unless we standardize the applications, protocols and informed consent forms. In my opinion, compared to independent clinical research, the administrative offices at each institution are given less discretion in collaborative research.

*Clinical Research Law: Legal regulation of clinical trial enacted in response to the series of scientific misconduct, including what is known as the “Diovan Trial.” The objective was to prevent tampering and recover the public’s trust in clinical research.
Yamamoto:
I agree with you. Under the Clinical Research Law, I think it will be relatively easy to use a standardized form, just like it is with the format for clinical trials.
Iwae:
This is something that needs to be addressed right away! Aiming for standardization in, let’s say, a year would be too late. Each institution may have already come up with its own customized format, making it impossible to work toward standardization.
Uetake:
If we’re going to do it, we need to do it now.
Iwae:
However, unfortunately there is no place where we can discuss governance issues like that.
Yamamoto:
I agree. Japan doesn’t have an organization equivalent to PRIM&R. I strongly think that is the issue with the field of medical research in Japan.

──At this point, coordinator Uetake turns to Takuya Watanabe, staff member from the Office for Human Research Studies at the University of Tokyo.

Uetake:
Mr. Watanabe, since you are here as an observer, do you have anything to add?
Watanabe:
Yes. I do believe research ethics specialists can help contribute to the sound operation of research. However, it is difficult to see how the job is instrumental to the development of research. How can research ethics specialists maintain their motivation?
Yamamoto:

The work by the research ethic specialists may seem like it slows down the progress of research, but their efforts play an integral role in preventing inferior research from making it out into the world. The supportive work is extremely important in that sense.
The research ethic specialists around the world work with great pride. As for organizations in Taiwan and South Korea, there is always someone that flies to the U.S. to attend workshops at PRIM&R once a year. I wish Japanese counterparts also had that much freedom in brushing up their skills.
We have our administrative staff at Osaka University take courses at PRIM&R and also encourage them to attend academic conferences. We make it a requirement for them to present research papers at conferences. I think that makes a good practice, and in turn, leads to raising their level of motivation.

Watanabe:
Also, there are times when I wonder if I’m doing okay or wonder how the work is done at other institutions. In other words, I think I’m looking for a way to exchange information with those in the same line of work, but it’s hard to find places that allow for such exchange….
Yamamoto:
At Osaka University, we have been actively visiting progressive institutions together with office staff for the last 10 years. Of course, that provides the perfect place for information exchange.
Uetake:
Osaka University is very progressive.
Yamamoto:
This may be a surprise to you all, but many people have told us that they had never thought that a place like Osaka University would become the center of clinical research. This is understandable as the institution used to be focused on basic research and it didn’t have the platform for such potential. However, the chief of the research department and the hospital director back then saw the future in clinical research and helped finalize the budget to set up the structure for it. We were very lucky.
Akabayashi:
I think the doctors at Osaka University had a good vision.

8.Summary

Uetake:
We are running out of time, so I’d like each of you to give a comment to wrap up the discussion. Let’s start with you, Dr. Yamamoto.
Yamamoto:
Okay. I think the structure for clinical research in Japan has become well-organized compared to how things were in the past in terms of its position in the international market. The situation will probably improve further if the system allows for more of a site-driven approach that picks up the voices of those working on the frontlines. It is important that we do not depend heavily on the governmentalthough we do need their support for guidance and fundingand build an infrastructure that encourages the initiation at the site level.
Uetake:
Thank you very much.
How about you, Dr. Iwae?
Iwae:
I have a similar opinion. I believe it is necessary to encourage the involvement of support staff at least in policy formation pertaining to clinical research. We must take action to raise issues by creating a forum for discussion beforehand, instead of just sending in a councilor to develop policies.
Uetake:
Dr. Akabayashi, what do you have to add?
Akabayashi:

The discussion today helped us realize that there is so much to prepare in order to proceed with a system for central research ethics committees in Japan. We are not in a place where a single leap would take us to a happy place.
For example, I’ve heard that Europe has a myriad of problems even with the existence of central research ethics committees. As mentioned earlier, a non-profit is utilized in the U.S. I think Japan should proceed with setting up a central research ethics committee system while pursuing its own methodology that draws on the system in the U.S. In doing so, I believe it is crucial to take a site-driven, bottom-up approach. Continuing with our efforts while keeping these two key phrases in mind will hopefully help improve the system in the near future.

Uetake:
I see. Let’s continue to do our best for the research integrity in the future.
Thank you very much everyone.
一同)
Thank you very much.