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

5.Funding and the Administrative Structure

Uetake:
Dr. Yuzaburo Uetake

The question about money inevitably arises when organizations try to do a professional job. Administrative and labor costs are usually covered by the universities’ operating income, public funding and review fees. However, the money is very tight when you consider how much is expected. The Japanese government has suggested substantially raising the review fee to cover the administrative costs. For example, it proposes charging 500,000 to 1,000,000 yen per case for reviews by a certified clinical research review committee, but doubts remain over whether such high price is justifiable.

The bulk of the expenses is accounted for by labor. The cost is significantly different between medical and administrative staff working at the office. I’ve heard that there are more medical workers at the office at Osaka University. Is that true?

Yamamoto:
Osaka University has had more medical staff right from the beginning, but due to cost constraints, we have started to have administrators perform tasks that do not require technical skills. After three to five years of experience, administrative workers become capable of doing work that requires some level of expertise. Most of them can even check the paperwork for observational research.
Iwae:
At our place, administrative workers check the applications for ethics review. As for data management, which falls in the same area of research support but requires more medical expertise, the checks are done by those we refer to as “super administrators.” They have more experience and are more familiar with clinical trials at hospitals. We have one doctor that works as a consultant in research design, but no medical staff at the office.
Uetake:
Why are there fewer medical staff?
Iwae:
We are in the countryside, so it’s hard to find help in this line of work. Of course, there is also the issue with pay….
Yamamoto:
I think it’s difficult even in the city (laughs).
Uetake:
I see. It is important to have the resources. Specifically, what measures are taken by universities to manage financially?
Yamamoto:
Osaka University has set up a billing system, which was the first in Japan. We work with organizations that pay application fees that range from 40,000 to 120,000 yen per research, which includes observational research. This income adds up at the end of the year, enough to cover the costs of labor, such as the payroll for staff working in the research participant protection office. However, once you consider the system management expenses and repair costs, this is not enough so we have other sources, like public funding from AMED (Japan Agency for Medical Research and Development), funding from the Faculty of Medicine and income from clinical trials, to help cover the expenses.
Akabayashi:

I truly think Osaka University had the foresight to have Dr. Yamamoto join soon after the guideline revision to create the Department of Medical Innovation. Also, the fact that the Faculty of Medicine decided to invest with the aim of actively doing more clinical research was huge.

Uetake:
What is it like at University of Miyazaki?
Iwae:
We have an in-house system so unfortunately we cannot charge.
Yamamoto:
Osaka University has set up the first billing system but there is much to be discussed in terms of how much to charge. Of course, it is important to charge a substantial amount from businesses, but what would be the reasonable price tag for doctor-led research? Institutions in Taiwan only charge a few thousand yen at the most and there is no charge in Europe as it is government-run.
Uetake:
What is it like in the U.S.?
Yamamoto:
My impression is that they have a well-balanced system since they receive applications from both businesses and public research institutions.
Uetake:
I see. That way they do not overburden the researchers.
Yamamoto:
That is correct.

6.Importance of Education

Uetake:
In order to enhance the quality of review by ethics committees, I think it is extremely important to educate researchers and specialists about ethically sound research. However, the system for e-learning on this topic seems rather unconsolidated.
Osaka University has its own system called CROCO (Clinical Research Online Professional Certification Program at Osaka University) and the University of Tokyo utilizes a system called CREDITS (Clinical Research Education and Interactive Training System) in collaboration with University Hospital Clinical Trial Alliance. There are many other e-learning platforms available, including CITI (Collaborative Institutional Training Initiative) Japan which is offered by Shinshu University and funded by the Ministry of Education, Culture, Sports, Science and Technology. I’ve heard that AMED (Japan Agency for Medical Research and Development) is also developing a new education system.
Such complexity in the educational system could cause major issues. e-learning may work well with continued education, but I think it is necessary to come up with an integrated web-based training system to teach the basics. Dr. Yamamoto, what do you think?
Yamamoto:
I have a slightly different perspective. The optimal style of education at universities is one that is offered at laboratories and classrooms, providing a place to let students and researchers gather any time, ask questions and attend classes. The purpose of e-learning is to emulate that in a setting outside traditional classrooms. Universities have their own on-site educational structure, so I think it’s reasonable to offer a web-based system in accordance with each structure.
Uetake:
So, you think it’s okay to have multiple options as long as the system is working. Dr. Iwae, what is your take on this?
Iwae:

I think education should be based on OJT (on-the-job training). Training those interested in ethics support should involve inspecting submitted applications and coming up with modifications if necessary. That is the best way to learn the guidelines and become familiar with the basics of research ethics. Also, researchers who wish to be trained can actually learn many things by writing applications. In other words, I think learning at the workplace is the most effective way for both ethics support staff and researchers.
As for e-learning, I think it’s useful to have a comprehensive learning experience, but I’m concerned that it could lose substance by letting students pass after taking a few tests at the end of the session.

Uetake:
I see. Because the work at ethics committees could cover a variety of fields, from observational research to invasive interventional studies and regenerative medicine, there is the question of whether it is appropriate to train everyone under the same curriculum. The same applies for administrative staff.
However, there is the issue of efficiency, so maybe the best way is to learn all the fundamentals through web-based courses and then later follow-up with the technical specifics through individual workshops and conferences.
I believe both the CITI Program and PRIM&R* in the U.S. offer courses in that manner. Am I right?

 
*PRIM&R (Public Responsibility in Medicine and Research): A group that provides accreditation and educational development opportunities with the objective of advancing the highest ethical standards in research.

Yamamoto:
PRIM&R offers about 20 educational sessions that span over a total of four days. Participants can freely select the sessions they are interested in, and there is always an active discussion within each session. In Japan, training tends to be divided into two at the most, so there is no guarantee that the session that you are interested in is offered.
In the U.S., it is customary for a few members from ethics committee to participate in such educational sessions, and the cost of staff training like that is considered as part of necessary expenses. The program fee is at least 100,000 yen per person and the cost of transportation and accommodations are required on top of this, so the total cost adds up. The situation is so different from Japanese organizations that even hesitate to pay for the staff’s traveling expenses from Osaka to Tokyo (laughs).
Uetake:
You are totally right (laughs).
What do you think, Dr. Akabayashi?
Akabayashi:
I believe there are limitations to e-learning and books because they are primarily designed to supplement the classroom experience. That is why I think there is a great need for the Office for Human Research Studies, which helps researchers learn the procedures through our ethics support services. Of course, there is also the issue of training people that teach the courses.
Uetake:

As ethics committees become more and more important, the administrative staff must aim higher to develop their skills. However, providing fundamental education would be difficult with the current budget structure. Therefore, it is important to develop human resources with a bottom-up approach by providing OJT at various institutions, which also gives workers the opportunity for job rotation.

Yamamoto:
We take staff training at our university seriously. We send them to conferences, encourage them to get certifications and urge them to attend any workshop that is held anywhere in the world, however far away it may be from Japan (laughs).
Uetake:
I can see how that can increase the staff’s motivation.