Clinical Research

Clinical Research

This system for commissioned research deals exclusively with research on human subjects. Reports are later provided to commissioning organizations.
Unlike the other commissioned research undertaken by the faculty members of this institution on behalf of private companies and other organizations, this system deals exclusively with research on human subjects (including collaborative research). Clinical Research includes areas such as methods of disease prevention, improvement of diagnostic and treatment methods, understanding disease causes and pathology, and medical research conducted in order to improve the quality of life for patients (this includes the fields of dentistry, pharmacology, nursing science, rehabilitation studies, preventive medicine and health sciences). The results of this research will be reported to the commissioning organization, which will be covering research expenses.

Related Information (Application and Contract Forms)


1. Application

Commissioning organizations that wish to apply for Clinical Research (excluding Clinical Trials) must input the required information on the Commissioned Research Application Form and attach any necessary materials for implementing clinical research. These include the Implementation Planning Sheet for Clinical Research and the Summary of Clinical Research. Documents should be submitted to the clerical counter (Clerical Department Institute of Research Innovation). The application must also be approved by the person-in-charge of the area of research to which the principle researcher belongs, as well as the relevant department head (who oversees principle researcher).

2. Determination of Acceptance

  1. Must be approved by related committees (Ethics Review Committee and Committee on Conflicts of Interests in Clinical Research) at the facility where the clinical research will be implemented.
  2. Participating researchers cannot one-sidedly terminate Clinical Research projects.
  3. Intellectual Property Rights related to inventions and discoveries made through clinical research essentially belongs to this institution.
  4. Facilities and equipment acquired for Clinical Research through the provision of expenses shall be retained by the institution.
  5. When Clinical Research is terminated for an unavoidable reason, or when an extension of duration becomes necessary, this institution will not be held responsible.
  6. When implementing research using pharmaceuticals or medical instruments, participating researchers must take necessary protective actions, including but not limited to purchase of insurance, provision of compensation related to health hazards (include ones caused by the operations of this institution) that may occur to a subject during the implementation of Clinical Research.
  7. If a third party suffers damage or injury caused by the implementation of Clinical Research, and if this institution is held responsible for reparations, with the exception of a situation where participating researchers are held responsible for damages, all reparation must be covered by the commissioning organization.
  8. Other items deemed necessary by this institution.

3. Determination of Acceptance Procedures

  1. When an Application for Clinical Research is submitted, the feasibility of its implementation is examined by investigation committees related to clinical research (Ethics Review Committee and Committee on Conflicts of Interests in Clinical Research), based on materials necessary for implementation of said clinical research.
  2. Upon examination by said investigation committees, approval or disapproval will be determined based on a comprehensive judgment. In addition to considering whether or not the proposed Clinical Research can actually be implemented, criteria includes the significance of the educational research and whether it might interfere with other operations.
  3. The approval process detailed above includes acceptance by the collaborative researchers who will cooperate on the Clinical Research.

4. Clinical Research Expenses, Etc. (Expenses covered by consignor)

Clinical Research Expenses refers to the sum total amount of direct expenses necessary for the research staff to conduct Clinical Research (awards, travel expenses, and research expenses - including equipment, supplies, communication and transportation costs, rent and hiring,  Etc.). It also includes equivalent indirect expenses necessary for the management of the institution.
  1. Indirect Expenses are equivalent to 30% of the Direct Expenses. If the Clinical Research is contracted by the National Government or organization such as a local public entity and is difficult to quantify, exclusions will be made.

The payment of expenses must be delivered to the designated bank account of the institution by the deadline set on the Commissioned Research Contract Form, based on the invoice sent from the institution following the finalization of the Clinical Research Contract.

5. Implementation of Research

Implementation of Clinical Research shall be carried out in accordance with the Ethical Principles outlined in the Helsinki Declaration, Ethics Policy regarding Clinical Research (Ministry of Health, Labor and Welfare announcement No. 255, effective as of July 30th, 2003, completely revised on December 28th, 2004 and July 31st, 2008), Act on the Protection of Personal Information (Article 57 of the Act, 2003) and other related announcements.

6. Contract Duration

Essentially, Contract Duration of Commissioned Research ranges from three months to five years.

For Inquiries regarding Clinical Research

Clerical Department, Institute of Research Innovation

Tel: 03-5803-4823