(1) Objective of the research and development

Today, a number of research involving human subjects are being carried out. This research and development aims to develop model teaching materials and programs for each of the following groups: 1) members of the research ethics committee (general citizen board members as well as humanities and social sciences professionals), 2) consultants and secretariat staff of the research ethics committee, and 3) researchers who will apply for ethical approval of their research. With regards to model teaching materials and programs targeting the members of research ethics committee, the project also aims to produce modules specialized for legal professional board members.

Furthermore, the project aims to develop brochures for the general public on medical research in order to deepen their understanding and support for the subject.

(2) Background on the research and development

Background 1

In order to carry out research ethics review orderly and promptly, high quality education and training are necessary for a) members of the research ethics committee, b) consultants and secretariat staff of the research ethics committee, and c) researchers applying for ethics approval. This is due in part to some issues raised below:

a) Members of the research ethics committee

It is not easy for board members who are general citizens or those from humanities and social sciences background to fully understand the unique nature of medical research as well as the significance and key points of ethical review. In cases where members take part in the ethical review without fully understanding the key points, opinions questioning the insufficiency of research benefits to the patient or opinions focusing on the effectiveness of the medicine in Phase I trials, where the primary evaluation criteria should be on safety, can be found at the time of the review. Such misunderstandings cause delay in the review process.

b) Consultants and secretariat staff of the research ethics committee

In recent years, secretariat managers and consultants have been increasingly supporting ethical review application process. With an increasingly varying fields of study that call for ethical review, however, it is not uncommon that sufficient and effective support has not been delivered due to a mismatch of the expertise of the secretariat staff and consultants and that of the research context.

c) Researchers applying for ethics approval

It is not unusual that researchers applying for ethical review do not fully understand the points of the review. For this reason, the information necessary for the review may be lacking in the research plan submitted for ethical review, which may result in delay of the review process.

Background 2

In this program, we will aim to develop brochures for the general public on medical research in order to deepen their understanding and support for the subject.

For research that use specimens such as leftover specimens and surgically removed tissues or for research that use clinical data, it is crucial that the research is grounded in broad consent or assuring opportunities to refuse/decline for the research subjects. Having established understanding on the research with the general public is a prerequisite to gain social support.

(3) Future prospect for the R & D

1) Development of effective teaching materials etc.

All of the researchers and developers in this program have extensive experience as committee members of research ethics review and have been involved in the formulation and review of government-related research ethics guidelines. In addition, the members have been involved in research ethics education at affiliated organizations and medical ethics education for practitioners. We believe that we can develop effective model teaching materials based on our deep understanding of issues surrounding research ethics education gained over the years through these experience.

2) Ensuring effectiveness of ethics guidelines

Using the model materials developed in training and educational settings, we aim to (1) improve the understanding of medical research and ethics guidelines among members of the research ethics review committees (general citizen board members, humanities and social sciences professional members), (2) standardize consultants and secretariat members’ ability to respond to varying issues, and (3) improve the quality of research plans created by researchers. By doing so, we believe that we can improve the quality and efficiency of ethical review and contribute to securing the effectiveness of ethical guidelines.

3) Expected indirect outcomes and social impact

With the model materials developed in the program, we can expect improvements in the quality and the efficiency of ethical review, allowing for prompt and proper implementation of medical research. In addition, by disseminating relevant information to the public, we can expect society’s deeper understanding towards medical research, which will facilitate smooth operation of research . Such positive outcomes of the project will contribute to rapid advancement of medicine and has an overall societal significance in Japan.

Moreover, the above effects contribute to securing the effectiveness of research ethics guidelines and ensuring standardized level of ethics in all medical research. This will lead to winning the trust of international community on the quality of medical research from Japan and is thought to have a significance at the international level as well.