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

Introduction

At the Office for Human Research Studies, Faculty of Medicine, the University of Tokyo, we study the latest trend revolving around research ethics and conduct interviews with specialists from various industries to examine the future of research ethics.
As Part II of the series, we gathered a panel of experts involved in research ethics committees at Japanese universities to discuss the centralization of ethics committees.

<Participants> *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

1.Why the Debate for Centralization Now?

Objective of the Round-Table Discussion

Uetake:
In Japan, there are somewhere between 2,000 and 3,000 ethics committees. This number is twice as many as in the U.S., seven to eight times more than in South Korea and roughly 40 times more than in France. The overwhelming number of committees in the country has already posed some problems, as seen in the inconsistency in the quality of review and the complexity of the review procedures.
The Japanese government has recognized the need to mitigate the situation, and to seek quality improvement, standardization and centralization. This is why the Certified Ethics Committee System was established in 2014. Today, there are 42 certified ethics committees in Japan. Although this number may seem quite satisfactory, the situation is still far from ideal.
Today, we will have doctors active in the field of research ethics in Japan discuss the significance of central ethics committees, which may hold the key to the future of research ethics.

Historical Background

Uetake:
Why is there a growing debate over central ethics committees now in the first place?
Akabayashi:
Dr. Akira Akabayashi

I had worked as the chairman of the ethics committee at Kyoto University Hospital for a few years since 2000. There was already the concept of central ethics committees at that time.
Central ethics committees play a central role among ethics committees that are set up at research institutions. Centralizing the control can deliver a variety of advantages, including improving the quality of review and expediting the start of joint research projects by preventing delays caused by multiple reviews by multiple committees.
This trend has accelerated in the last few years, most likely in direct response to academic research misconduct extensively covered by the media. What is your take on this, Dr. Yamamoto?

Yamamoto:
I think it all started with the revised ethical guidelines for clinical research* that was put into effect about 10 years ago.
Osaka University set up a department supporting clinical research around that time. I think Japan as a country has started to steer in the direction to actively and carefully reflect on the importance of research ethics.
*Revised ethical guidelines for clinical research: Refers to the amendments made in 2008 (announced in July 2008, enforced in April 2009) to the “Ethical Guidelines for Clinical Research” that were implemented in 2003. The revision took place with the objective of further improving research ethics and protecting the participants. Detailed guidelines were added to cover five areas, such as reinforcing ethics committees and securing a suitable enforcement system.
Akabayashi:
I agree. The debate regarding central ethics committees has also intensified around that time.
Uetake:
What do you think, Dr. Iwae?
Iwae:
Dr. Sosuke Iwae

I didn’t get involved in what I do now until a few years later, around 2015, so I am not familiar with how things were when it started. However, my impression is that the system for central ethics committees mentioned in the “Guidelines for Clinical Research” and “Guidelines for Epidemiological Research” that were put into effect around 2015 focused on efficiency rather than improving the quality of review. It was designed so that national universities such as the University of Tokyo, Osaka University and University of Miyazaki could act as a collective review board that operated on behalf of small institutions without ethics committees or research entities with poorly functioning ethics committees.

Uetake:
I see. Adding to what Dr. Iwae just said about “collective reviews,” I think it is often unclear whether the centralization is for conducting a collective review for multiple institutions or for improving the quality in terms of ensuring impartiality, integrity and neutrality.
The University of Tokyo maintains the stance to stay detached from hospitals for the sake of being fair, neutral and impartial. It will be interesting to see in which direction Japan as a country will be heading. Dr. Akabayashi, what do you think?

2.Future of Central Ethics Committees

Akabayashi:
First of all, I agree with what Dr. Iwae said earlier and believe the primary interest for a collective review system is to improve efficiency.
To maintain integrity, neutrality and impartiality as Dr. Uetake mentioned, some countries such as United Kingdom have set up ethics committees outside the hospitals. Even in cases in which medical institutions have their own review boards, it is possible to ensure impartiality, integrity and neutrality by keeping the system transparent through the participation of external board members, including people without scientific expertise.
Yamamoto:
Dr. Yoichi Yamamoto

In other words, they are either IRBs (Institutional Review Boards) located within institutions or independent RECs (Research Ethics Committees). Even with IRBs, it is possible to maintain neutrality by bringing in third parties. However, there are limitations, in my opinion. For example, for high-risk intervention research, I think it would be useful to have an external organization conduct the review to maximize neutrality.

※IRB=Institutional Review Board 施設内審査委員会
※REC= Research Ethics Committee 倫理審査委員会
Uetake:
Dr. Iwae, what is your take on this?
Iwae:
I think it is sufficient to utilize internal committees for low-risk studies such as observational research that only involves data analysis and cases in which the investigator can assume the responsibility. However, there are limitations with IRBs in research that goes beyond the scope of the investigator’s responsibility, as in intervention research like Dr. Yamamoto mentioned, where the possibilities of causing direct harm to subjects cannot be totally eliminated.
Uetake:
It seems like the general consensus is that high-risk studies such as those done by corporations should be reviewed by third parties.

Part I Industry and Research Ethics