# Appropriate Implementation of Epidemiologic Studies

## Overview

## Appropriate Implementation of Epidemiologic Studies

Epidemiologic studies investigate the frequency and the distribution of health phenomenon, including the morbidity of diseases, and clarifies the factors associated with it. Epidemiologic studies are considered essential in investigating the causes of diseases, verifying the effectiveness of prevention/treatment methods used with diseases, or clarifying the relationship between environment/life styles and health, and thus play a significant role in the progress of medicine and the maintenance and improvement of public health. In recent years, however, providing research subjects with explanations and obtaining their agreement has been considered important. Furthermore, an increased awareness on the rights to privacy and social trends in private information protection has necessitated clarification of legally binding standards.

Because of the above reasons the Ministry of Health, Labour and Welfare (MHLW), in cooperation with the Ministry of Education, Culture, Sports, Science and Technology (MECSST), formulated “Ethical Guidelines for Epidemiologic Studies” (MECSST/MHLW Notification No. 2 of 2002) in June 2002. The Guidelines prescribe that, when conducting epidemiologic studies, informed consent shall be obtained from the research subjects, in principle, study plans reviewed by an Ethical Review Committee established at the pertinent research institute, and a personal information protection system established, etc., while also requiring researchers, etc. engaged in epidemiologic studies to observe the promotion of the appropriate implementation of epidemiologic studies.

In addition, and for the purpose of responding to the smooth implementation of the Act on Protection of Personal Information (Act No. 57 of 2003), the MHLW, in cooperation with MECSST, revised the Guidelines in December 2004 from the point of view of protecting personal information by ensuring all personal information protection measures prescribed in the said Act, in principle, were included (MECSST/MHLW Notification No. 1 of 2004).

Furthermore, provisions regarding the obligations of the directors of research institutions and protection of research subjects, etc. were established in August 2009 (MECSST/MHLW Notification No. 1 of 2009).

## Appropriate Implementation of Clinical Trials

## Overview

## Appropriate Implementation of Clinical Trials

Clinical trials are conducted on humans for the purpose of preventing diseases, improving diagnostic/treatment methods, improving understanding of the causes and pathologies of diseases, and improving the quality of life of patients. With the progress being made in science and technology in recent years their importance is further increasing.

In addition, medical advances will ultimately and inevitably depend on clinical trials, and therefore appropriate implementation of clinical trials needs to be promoted through obtaining social understanding and cooperation and with human dignity and human rights fully respected.

Because of the above reasons the Ministry of Health, Labour and Welfare (MHLW) formulated the “Ethical Guidelines for Clinical Trials” (MHLW Notification No. 255 in 2003) in July 2003, which cover all clinical trials, in thus promoting their appropriate implementation. The Guidelines prescribe that, when conducting clinical trials, sufficient explanations shall be provided to the research subjects before obtaining their consent, consideration be given to the protection of the personal information of the research subjects, and the appropriateness and consistency of any clinical trials reviewed by an Ethical Review Committee established at the pertinent research institute, etc. In addition, the Guidelines were revised in December 2004 to include the necessary provisions to ensure the appropriate handling of personal information in clinical trials. Furthermore, an overall review of the Guidelines took place in July 2008 in further improving research ethics and protecting the research subjects. All relevant parties involved in clinical trials are requested to observe the said Guidelines in thus promoting the appropriate implementation of clinical trials.

An Expert Committee was established under the Committee on Sciences Council in December 2012 to discuss revisions of both the said Guidelines and the “Ethical Guidelines for Epidemiologic Trials” in a unified manner. “Ethical Guidelines for Medical Research on Humans” that integrated both Guidelines was compiled at a joint session between the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare in May 2014.

## Appropriate Implementation of Clinical Trials involving Human Stem Cells

## Overview Appropriate Implementation of Clinical Trials involving Human Stem Cells

Clinical trials on human stem cells play an important role in maintaining public health and preventing, diagnosing, and treating diseases through organ function regeneration, etc.

Because of the above reasons the Ministry of Health, Labour and Welfare (MHLW) formulated “Guidelines for Clinical Trials using Human Stem Cells” (MHLW Notification No. 425 in 2006) in July 2006 in thereby ensuring that all clinical trials involving human stem cells are appropriately implemented/promoted through obtaining the understanding of society and get implemented with human dignity and human rights fully respected, and effectiveness and safety secured based on scientific knowledge.

Since enforcement of the Guidelines, anyone engaging in clinical trials involving human stem cells has been requested to observe the aforementioned guidelines. However, revisions have been made to the relevant laws and ordinances, as well as new stem cell technologies developed, which include human embryonic stem cells (human ES cells) and human-induced pluripotent stem cells (human iPS cells), etc., with progress also having been made in basic research, etc. In order to respond to these changes in environment surrounding clinical studies on human stem cells, discussion on reviewing the Guidelines took place at "Expert Committee on Reviewing the Guidelines for Clinical Trials using Human Stem Cells". Human ES cells and human iPS cells, etc. were newly covered by the Guidelines in addition to somatic stem cells in November 2010 (2010 revision), and some clinical trials using human ES cells were allowed in October 2013 (2013 revision).

In addition, “Expert Committee on Securing Safety and Promotion of Regenerative Medicine” was established in September 2012 to discuss a system to promote practical application of regenerative medicine provided as medical care while securing sufficient safety, etc., and the “Draft Act on the Safety of Regenerative Medicine” based on the report of the said Expert Committee was submitted to the Diet in May 2013. The “Act on the Safety of Regenerative Medicine” (Act No. 85 of 2013) was established in November of the same year. Since the said Act applies to clinical trials covered by the conventional Guidelines, the Guidelines for Clinical Trials using Human Stem Cells is scheduled to be abolished when the said Act is enforced in November 2014.