Annual Plan

Overview of the Research and Development

1) Plan for FY2016 (created January 2017)

In fiscal year 2016, we will create a first draft of model teaching materials for research ethics targeting members of the research ethics review committees (general citizens board members, humanities and social sciences professional members), secretariat staff, consultants, and researchers. In order to obtain the base information for this development, we will consult pre-existing teaching materials and ethical guidelines. Also, in order to assess the current issues related to ethical review and secretariat operations, we will conduct substantive research (interview and questionnaire surveys) on ethics review committees and secretariats of medical and dental schools.

  1. Create a draft of model teaching material on research ethics for members of the ethics review committee, secretariat staff, and researchers
  2. Field survey on issues related to ethics review and secretariat operations ( ethics review committees in schools of medicine and dentistry)
    1) Interview survey
    2) Questionnaire survey

As for the achievement indicators of this research and development, with the limited timeframe of two months to carry out the research this fiscal year (February, March) in practice, an objective indicator will be the implementation of the situational survey.

2) Plan for FY2017 (created March 2017)

In fiscal year 2017, we will prepare trial edition of model teaching materials on research ethics for research ethics review committee members, secretariat staff, consultants, and researchers. We will also conduct trial trainings using the material (in-person classroom courses as well as online courses).

In order to develop the material, we will first need to understand the issues at hand related to ethical review and secretariat work. We will therefore conduct field surveys (interview and questionnaire surveys) targeting ethical review committees of the following institutions: a) clinical training hospitals, b) faculty of life science (non-medical system departments), c) schools of public health , d) faculty of health sciences (nursing departments, etc).

For the achievement indicators of R & D, we will assume the following: (1) implementation of field surveys (questionnaire survey, interview survey), (2) development of trial version model teaching materials and programs, (3) trainings (in-person classroom courses as well as online courses)

(1) Basic research: field survey (questionnaire survey, interview survey)

In order to understand the issues at hand related to ethical review and secretariat work., we will conduct field surveys (interview and questionnaire surveys) targeting ethical review committees of the following institutions: a) clinical training hospitals, b) faculty of life science (non-medical system departments), c) public health graduate schools, d) faculty of health sciences (nursing departments, etc).

We conducted a field survey targeting the ethics review committee and secretariat of medical and dental schools in FY2016 as a means of a pilot study. For the FY2017, we will improve the content of the questionnaire based on the results from the FY2016 survey and conduct the survey among the four varying types of institutions.

As described above, we will carry out the survey not only to medical and dental schools but also widely to non-clinical training hospitals and non-medical universities in this basic research. The reason for this is to understand the current status of the legal professional board members (attributes, contribution to the ethical review), tasks, and roles expected. Furthermore, by classifying the issues based on factors (for example, by the department, or by comparing hospitals and school departments, by area) and comparing them, we can examine the contents of model teaching materials and programs for legal professional board members and the contents and methods of simulated education.

(2) Development of trial version model teaching materials and programs (creation of textbooks and of videos)

We will create trial version model teaching materials (textbooks and videos).

In this research and development, we are planning to provide modules specialized for legal professional members. For this reason, if necessary, the contents specific for legal professional members may be added onto the contents of model teaching materials and programs for non-legal professional members . As for the scope and contents of R & D, there is a possibility of change as it requires coordination with other research groups.

(3) Trial educational training: in person education and release of teaching materials online

Using the trial version model teaching material, we will conduct educational training (in person classroom course and online teaching materials ). In the process, we will identify points for improvement and brush up the material. During the trial , training specialized for the legal professional members will also be conducted.

In-person training is planned to be conducted in the four areas of Japan: Hokkaido, Kanto, Kansai and Kyushu. Materials will be made available online through this homepage and of AMED’s. As for the scope and contents of R & D, there is a possibility of change as it requires coordination with other research groups.

3) Plans for FY 2018 (planned to be uploaded around March 2018)

Based on the findings obtained in the field survey (FY2016 - FY2017) and feedback from the participants in the trial educational training (FY2017 - FY2018), we will brush-up our educational materials and finalize the model teaching material and program in FY2018. In addition, we will compile the results of the questionnaire survey, create a feedback material for the survey cooperators, and develop a supplementary teaching material to be attached to the model teaching material. We will also prepare publicity materials for the general public that will layout various points of research ethics.

Our milestones of R & D are (1) development of model teaching materials / programs (preparation of the final version), (2) preparation of feedback material for cooperators of the questionnaire survey / development of supplementary teaching materials, (3) development of publicity materials on clinical research.

(1) Development of model teaching materials / programs

In the previous fiscal year, we conducted a number of trial educational training 1) for ethics committee officials and researchers nationwide (at Keio University and Waseda University for a total of 6 times) and 2) for lawyers (Kanagawa Prefecture Bar Association Hall and Osaka Prefectural Bar Association Hall), 3) for university ethics committees (The University of Tokyo and Hokkaido University). From these trial trainings, we received a feedback from participants on ways to improve the trial educational materials.

In 1) trial trainings for ethics committee officials and researchers nationwide, we asked for volunteers and conducted focus group interviews at the end of each session to receive feedback on ways to improve the trial educational materials. In addition, we conducted a field survey (questionnaire survey / interview survey) to understand the issues and concerns surrounding research ethics review.

Based on the materials mentioned above, we will further improve our educational materials and use them in our trial trainings (in person training and online materials). We will revise our teaching materials as necessary and develop the final version of model training materials / programs.

(2) Preparation of feedback material for questionnaire survey cooperators / development of supplementary teaching materials

In order to get a quantitatively understanding of the issues relating to the research ethics review (e.g.: In order to examine the contents of training materials and programs targeting legal professional committee members, we asked about the roles expected by legal professional committee members, the realities of education and training, tasks, etc.), we conducted a questionnaire survey targeting the ethics committees of medical and dental departments in universities throughout the country in FY 2016 and 2017. We will summarize the results of these surveys and create feedback material for the survey cooperators. We will also develop a supplementary teaching material.

(3) Preparation of publicity materials on clinical research

We will prepare publicity materials (poster, pamphlets) on clinical research, which will layout various points of research ethics (acquisition of informed consent, protection of personal information, approval by ethics committee, etc).