Part II [Round-Table Discussion] 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

3.Pros and Cons of Central Research Ethics Committees

Uetake:
How about the advantages and disadvantages of centralization?
Yamamoto:
The greatest disadvantage would be the fact that it could highlight the disparity in terms of readiness. It would not be an issue if each institution is prepared but if ill-equipped institutions are asked to be part of a central committee, could they perform up to the standard? Some may think that there should be no problem as long as the researchers demonstrate a level of excellence. However, researchers are humans, not super heroes. That’s why I believe institutions should support and oversee the research. I think it’s very dangerous to proceed with centralization without considering such argument.
Iwae:

The advantages include increased efficiency and reducing the overall workload. The disadvantage is decline in quality, which is basically the same as what Dr. Yamamoto said. Could institutions that are poorly equipped in terms of staff and competencewhich holds true for University of Miyazaki still ensure the same high quality after suddenly being the subject of centralization…?

Akabayashi:
There hasn’t been much talk regarding how much to follow-up after approval by an ethics committee. We cannot ignore the fact that there may be organizations that find a loophole in the system and take advantage of the central ethics committee’s seal of approval to proceed with an unreasonable experiment on patients.
Uetake:
We can say that another disadvantage is that the central organization could end up with a huge administrative burden. The success of this system heavily relies on the operational improvement of research institutions regardless of size and scale. Therefore, unless the research institutions are well qualified, the central review board playing the key role might be left with the extra work of overseeing the research itself in addition to providing the ethics review.
Yamamoto:
I think that depends on the division of responsibility. However, even if the review is conducted by a central committee, there is still the question of whether the research implementing entities are performing up to the standards….
Akabayashi:
I think the foundation is yet to be built.
Uetake:
You think it is too soon?
Akabayashi:
I’m just saying that there are necessary steps that need to be taken beforehand.
Iwae:
The fact is, central ethics committees are expected to perform too many roles. There are numbers of issues at hand, but the unspoken agreement is that things will take care of themselves once it gets going.
Akabayashi:
That is definitely an illusion (laughs). The government guidelines specify that a case gets approved as long as the head of the institution gives a go-ahead, but it does not go that smoothly on site.
Iwae:
It is just the entrance.
Akabayashi:
Yes, just getting one foot into the entrance.

4.International Trends

Uetake:
What is it like around the world? Dr. Yamamoto, you have visited many international sites. Would you care to comment?
Yamamoto:
In Europe, neutral RECs play the central role in the review system. However, their quality is not necessarily first rate. Perhaps centralization could hinder access to information from the sites.
In the U.S., a non-profit accrediting body named AAHRPP* leads the way in the field of research ethics. Their accreditation process involves checking the ethics committee, organization and the research staff. The evaluation is very thorough, and they even randomly conduct interviews with the researchers. They do a respectable job in the sense that they take on an educational approach that helps institutions do better, instead of punishing them for things that need improvement. They are committed to ensure the protection of human research participants without relying on the government.

 
 *AAHRPP (Association for the Accreditation of Human Research Protection Programs, Inc.): An independent association that works with clinical research organizations to promote the protection of research participants through the accreditation of institutions with human research programs that meet the standards required by the American government.

Uetake:
What is it like in other parts of Asia?
Yamamoto:
Taiwan has been tinkering with the idea of a central ethics committee for quite some time. They have settled on a balanced system which is not entirely centralized but incorporates reviews from various institutions. We can refer to it as a hybrid system.
Uetake:
In what areas do you think Japan can learn from other countries?
Yamamoto:

In other countries, people working at the administrative level are exemplary. This is not to say that Japanese administrative workers need to work harder. However, I have the impression that their counterparts in other countries have more of a professional mannerism and a strong sense of aspiration. In Japan, the tendency is to look at administrative positions as non-specialists and unfortunately it is difficult to find those that actively work with strong professionalism.

Iwae:
I agree. The ethics review process in Japan entails compliance checks more so than a professional review, making it more of a clerical task. For institutions, being ethical means you do not deviate from what the guidelines say. I think it is more important to protect the research participants than scrutinizing whether the guidelines are followed strictly.
Akabayashi:
Guidelines are just guidelines, not the law.
However, you cannot get funding unless you follow the guidelines, so it is an important element for researchers. That’s probably why the reviews are more focused on adhering to the guidelines instead of ensuring a high level of protection for research participants for which the review process was originally intended.