Part I Industry and Research Ethics

Introduction

At our Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine, the University of Tokyo, we are studying current situations on the research ethics and examining how future research ethics should be. As a part of our study, we are conducting interviews with industry experts in various fields. We will post the interviews on this website.

Our first guest was a research ethics officer of a private enterprise (A medical equipment manufacturer). Here, we will be sharing the summery of our interview using Q&A format.

1. How is research ethics considered at industries?

Generally speaking, “Ethics” in industries includes “Business Ethics” required for the operation of the business and “Ethics of Technology” required for engineers to follow. Also, if a company has development sectors in medical fields, they must take “Research Ethics” in considerations to protect all people involved in the research and also to carry fair research.

2. How does your company meet the requirements?

At our company, when we run researches in medical fields, we set up an ethics committee following the guidelines stated by the Ministry of Health, Labour and Welfare. The committee will examine if the research and development meets the requirements of ethics and science, and if it is socially accepted or not.

3. Which industries do you think need to follow research ethics at most?

The industries providing the services and products that are directly related to people’s life and health need to pay detailed and careful attention on the method and their attitude towards the research. So, you can see how much responsibilities are required for the pharmaceutical companies and medical device manufacturers. It might not be so obvious, but even for the production of consumer products, if the research is conducted in improper ways, it may cause injuries or health problems to the researchers who involved. So, considering that kind of risks are always possible, even the industries in the area that are not directly related to people’s life and health are included in the elements of research ethics review. One example is gaming consoles’ video viewing research. A long time viewing or certain types of contents may cause health problems.

4. What are the “risks” that companies need to take by not following research ethics?

If a company’s service or product caused the users disadvantages, life-threatening, or health problems because of the company’s lack in research ethics during the development, it may cause the company to face a risk of money loss to compensate for the damages. But not only that, but the event may give negative impacts on their “Corporate Image”. Corporate image and brand are built by years of continual efforts. We don’t want to lose that by only one improper research conduct. One way to think about this is that by following proper research ethics procedures can be a minimum insurance for a company.

5. What type of system is needed to follow proper research ethics procedures?

Companies like pharmaceuticals and medical device manufacturers, which providing the service and products directly related to people’s life and health, must have a system of institutional review board and research ethics committee as a minimum requirement. Recent trend of unconventional and expansion of business increased new companies to enter life/medical/health care businesses. Most likely, soon even those new companies will be required to have systems to follow proper research ethics in the level of pharmaceuticals and medical device manufacturers.

6. What are the advantages and disadvantages for a company to have their own ethics committee?

Having their own ethics committees help the company to handle the research development effectively and to manage the work risk well. But the advantage of having their own committee is not limited to that, but it will be their foundation to build their brand and products’ trust by conducting the highest research ethical standards with future in their mind, and spread that seed to the world.

However, there are disadvantages as well. To keep the fairness and neutrality, the companies should not limit the management by their own, but must become open to the voices and suggestions of the third-party experts. So to speak, they should be careful not to be a self-enclosed corporation.

Also, it is important to set their management system according to the size of the business. They should consider the cost, development speed, and the competitiveness power of the company. It is important to be able to judge the balance of what is needed and proper.

7. What do you think of outsourcing the ethics committee?

In order for a company to manage their ethics committee openly, outsourcing the committee to a third-party expert is one option.
I think there are three main advantages for outsourcing.

The first to mention is the “Diversity”. If a company is specialized in one field, their knowledge could be limited in the specific area. But by welcoming the outsider’s knowledge, they can judge the situations from different sides also. The second advantage is the “Specialty”. Consulting with experts who have advanced knowledge of certain subjects will increase the level of the project. The third advantage is the “Reliability”. If and when an accident occurs, a question of if it was sufficient to have only the internal research ethics committee will arise. Having a third-party committee can be an insurance to assure the project’s reliability.

Having regular checks from the reliable their-party experts can also prevent companies from “cover-up”. We’ve seen that in recent automobile industries’ troubles. They made the problem bigger by covering up the research data that were disadvantageous to them.

Management style of the ethics committee may differ, depending on the history, policy, and the size of the company. However, the knowledge from the third-party expert is a must to have. They may not need to have help of external experts all times, but it can be effective to consider having a third-party ethics committee in certain business situations to fully obtain the three advantages mentioned earlier. A research that requires detailed considerations for the study participants is one example.

8. As an industrial company, are there any concerns about presenting your research contents to the third party?

It is true that we have some kind of hesitations to show company’s important research contents to the third party. We also need to conclude confidentiality agreement. But we do see the possibilities and necessity of outsourcing the ethics committee in the future. We will need to build a well-balanced system that satisfies the necessities of each company to conduct the proper ethics without facing unnecessary concerns and troubles. We’d like to continue working together with people in the involving areas to meet this goal.

おわりに

In this interview, we were able to hear valuable front line stories from an ethics committee management expert of a private enterprise (A medical equipment manufacturer).

We heard that product management problems, improper actions of data falsification, compliance violations and such are happening in not only pharmaceuticals and medical device manufacturers, but in many other industries. This interview reminded us the importance of research ethics from the very start of research development.

We also learnt that in order to establish brand trust, companies need to have and organize ethics committees that are open, neutral, and fair. It is an indication of companies having a strong sense of crisis about the research ethics.