Consulting Services of Ethical, Legal and Social Issues

Introduction
The ELSI group and its three assistant sub-groups are set up under the NRPB for responding to the recognition, identification, research, communication, governance, and regulation of the ethical, legal and social problems and impact arising from the development and application of biopharmaceutical research in the upcoming National Research Programs of Biopharmaceuticals.
 
Structure of ELSI Group
The ELSI group will be in charge of the administrative task and communication with other research groups in NRPB, while the three ELSI assistant sub-groups, which include Ethics and education group, Law and regulation group, and Public engagement group, will be developing practical, responsive, and problem-solving oriented ethical, legal, social research aiming at achieving the following goals.
 
Scopes & Contents
Two major goals of the first year (2011~2012)

  1. Disease/cancer tissue banks: assist to establish standardized sample management procedure in accordance with the Human Biobank Management Act.
  2. Clinical trial consortium: assist members to establish operation process, resolve technical and legal problems during each trial stage, and establish benefit sharing mechanisms related to intellectual property.

 
The following four items can illustrate the mission of the ELSI group and its three assistant sub-groups:

  1. To participate the establishing of the ELSI norm, especially the legal regulatory environment that is required for developing biopharmaceutical research and industry.
  2. To promote societal recognition and rational participation for the biopharmaceutical development and their social application, so as to reinforce communication and trust.
  3. To strengthen the ELSI consultation and education resources concerning national biopharmaceutical development for the policy-making institutions, biomedical industry, general public, and other relevant organization. To assist the governmental and relevant civil organizations to establish education mechanism.
  4. To facilitate international collaboration and communication of ELSI research achievement, and to harmonize international ELSI regulation into domestic legal consideration.
  5. To ensure that the governmental policy concerning biopharmaceutical research and industry development and the national biotechnology ethical framework can fulfill the requirement of UNESCO ethics guidelines.

 
Service Items
The consultation services which ELSI provide include:

  1. Setting up a Q&A database for NRPB related groups and scientists to solve common ethical, legal, and social problems.
  2. Providing consulting services for scientists to solve their ethical, legal, and social issues arising from scientific research and commercialization process. Educating and providing scientists with consultation services in order to realize and identify any potential ethical, legal, and social issues from the beginning of their research design.