1. A critical reflection on the Development of a Biobanking Governance Framework
In Argentina
Ana Palmero
Legal and Research Ethics Advisor
Directorate of Research for Health
National Ministry of Health,
Argentina

2. Research governance framework in Argentina
The Ethical Guidelines in Biomedical Research Involving Human Subjects
National Ministry of Health
Ethical oversight of biomedical research involving human subjects
Good Clinical Practices for Clinical Trial
National Administration of Drugs, Food and Medical Technology (ANMAT)
Mandatory for any clinical trial.
Prescribed in accordance with the ICH-GCP

3. Ethical guidelines address the use of biological material
Use of biological material collected for a specific study
Consent Essential Information
Secondary use of biological material
Consent Essential Information
the possible research uses: direct or secondary;
final disposition of samples: if specimens will be destroyed or details about their storage for future use;
whether commercial products may be developed from biological specimens; and
a statement that biological specimens will not give rise to direct financial gain.
An ethics committee may authorize it if original consent specifies:
whether there will be any secondary use;
type of study that may be performed;
the conditions under which investigators will be required to contact the research subjects for authorization for secondary use; and
the rights of subjects to request destruction or anonymization of biological specimens

4. However, there is no legislation or guidelines in relation to biobanking, as well as data-sharing­­­­­­­ for research purposes

5. Risks
Different standards being applied and inadequate safeguards for the rights and welfare of donors

6. National Ministry of Health convened a Technical Commision
Context
The National Research Ethics Advisory Committee recommends convening a technical commission to clearer guidance on biobanking and data sharing
Purpose
To develop a governance framework that includes legal and ethical oversight for biobanks with research purposes, as well as samples and data sharing.
Composition
Experts of biobanks, bioethicists, lawyers, genomic researchers.
Representatives of the National Institute of Cancer (INC), the National Institute for Ablation and Implantation (INCUCAI), and the National Ministry of Science and Technology.

7. National Ministry of Health technical commission
Principal concerns
National Ministry of Health technical commission
Different meanings of “biobanking”
Public and private biobanks; and private collections without legal and ethical oversight
Improper governance system
Biobanks do not have a proper governance system to ensure donors rights
No requirements for MTA
Local researchers with no possibility of negotiating favorable terms related to confidentiality, intellectual property rights and return of results. 7

8. Key points of future regulation
The term “biobank”
Broad consent-taking process
It will include all existing biological material collection
For unspecified future uses and review of future research by a research ethics committee
Biobanks as custodians
MTA to regulate the transfer of material and data
Responsible for the quality of the materials and data, and for ensuring donors’ rights
To allow researchers and institutions negotiate fair terms relating to secondary uses, return of results and benefits
Governance system
Governance mechanisms to protect donors’ rights and achieve harmonization

9. Aspects to improve Resources Researchers Ethics committees
It is necessary to identify
1) research infrastructure required
2) the specialized personnel and their training needs
Researchers are reluctant to share their results and samples due to absence of regulation about ownership, responsibilities, and donors' protection
Ethics committees
Community engagement
Committees are cautious in approving studies:
1) Broad consent may conflict with current guidance
2) Mistrust from a history of exploitation of LMICs
Research is required to better understand public views. Strategies such as community consultation, surveys and interviews, are required. Also educational material.

10. Resources and training needs
Infrastructure and specialized personnel
Training for researchers
Training for members of ethics committees
Community engagement
To achieve responsible data and sample management
To promote the benefits of data and sample sharing and ethical requirements
To ensure ethical review of studies using stored material or data, and broad consent procedure
To promote public trust in biobanking and data sharing

11. Capacity building for research and review
Recommendation
Capacity building for research and review
These issues could be expected as benefits from international research collaboration in terms of contributions to capacity building for research and review.

12. Thank you!