Office of Human Research

Origin

Taipei Medical University Office of Human Research (TMU OHR) was established on August 1, 2013, with the goal of integrating human research-related activities and resources across Taipei Medical University, Taipei Medical University Hospital (Managed by Taipei Medical University), Taipei Municipal Wanfang Hospital, and Taipei Medical University Shuang Ho Hospital, Ministry of Health and Welfare. The OHR supports researchers and institutions in bringing research outcomes and innovations to clinical validation, enhancing the efficiency and digital transformation of clinical trials, and promoting the integration and alliance of the biotech and pharmaceutical industry chain, thereby creating clinical application value for biomedical research outcomes.

The core activities of the Office of Human Research include:

Promoting clinical trial activities within the Taipei Medical University system and managing trial cases.
Ensuring that the design of human research adheres to ethical considerations and relevant regulations to protect the rights of participants.
Auditing and managing risk for non-compliance events in human research cases.
Managing the storage and retrieval of various disease specimens to advance translational medical research.

Organization Chart

OHR is consists of four departments.

JIRB Administration Section
Data Safety Managing Section
Joint Clinical Research Center
Joint Biobank

Mission

Enhance the efficiency of clinical trials and complete the integration and alliance of the industry chain

By coordinating and supporting relevant industries, effectively enhance the efficiency of clinical trials, reduce obstacles and delays in the trial process, and promote cooperation and alliance among various relevant units and institutions, thereby forming an efficiently operating industry chain.

Promote decentralized clinical trials to achieve digital transformation

Promote decentralized clinical trials, use digital technology to make clinical trials more flexible and efficient, thereby reducing geographical and time constraints, and improving the coverage and quality of research.

Assist in the development of emerging trial targets to promote the diversified development of clinical validation

Support and assist in the development of emerging trial targets, encourage innovation and diversification of clinical validation, thereby promoting the continuous development of the medical and biotech industries to meet the needs of more patients and medical needs.

Strengthen quality control (QC/QA) and audit framework for clinical trials

Implement QC/QA and audit frameworks for clinical trials to ensure that each stage of the trial meets the highest standards. Establish sound quality control processes, conduct regular audits to ensure the accuracy and reliability of clinical trials, and enhance the credibility and integrity of trial data.