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Ethics, human rights and justice in clinical research of drugs in developing countries

Ethics, human rights and justice in clinical research of drugs in developing countries

UNICRI and AIFA collaborate to protect human rights and promote ethical and legal standards for clinical drug trials in developing countries

UNICRI has recently received a contribution from the Italian Medicines Agency (AIFA) to implement a new training and technical cooperation project aimed at the promotion of ethics, law and the human rights of participants in clinical research of drugs in developing countries.

The aim of this project is to carry out the recommendations of a 2008 study conducted by UNICRI and AIFA, as the responsible agency in Italy for pharmaceutical control, to verify that the ethical and scientific principles of Good Clinical Practice (GCP) are being applied in clinical research trials in developing countries, particularly in sub-Saharan Africa.

The previous research study culminated with an international Round Table event, during which the need for urgent intervention to attain adequate ethical and legal standards throughout the developing world was reaffirmed.

With the economic, political and social links between different regions of the world becoming ever more important, AIFA would like to contribute to the implementation of a project to establish ethical standards in clinical trials in countries which lack any specific legislation or guidelines.

The United Nations strongly supports initiatives aimed at establishing a reliable base of knowledge and strengthening the capabilities of local professionals. It is only through the sharing of data and expertise that the disparities and inequalities between different regions can be overcome. Providing training, improving knowledge, and sharing information are at the core of UNICRI’s mandate. Since its establishment in 1968, the Institute has conducted training programmes for government officials around the world to guarantee the correct application of relevant international legal instruments on crime prevention and justice.

UNICRI and AIFA will work closely together to provide strong support to countries that are still far from reaching minimum standards of ethical and legal protection for patients enrolled in clinical trials. The two institutions will organize practical and theoretical courses for the training of health professionals in a Sub-Saharan country.

In order to ensure the long-term sustainability of the project, the training courses will assist in the development of a best practice model. This will be made available for those responsible for the rights and well-being of patients in other countries and regions.

UNICRI and AIFA aim to establish a permanent network of professionals in Africa who are trained in the standards of ethics and law regarding clinical drug research. By combining this knowledge with an understanding of local social, economic and health issues, this network will have the potential to become an international model for promoting and applying Good Clinical Practice.

UNICRI, in collaboration with the Tanzanian National Institute for Medical Research (NIMR), AIFA and the Bambino Gesù Pediatric Hospital organized the training course “Good Clinical Practice: the promotion of international harmonization for the respect of ethical principles, human rights, and justice.

The course, held in Tanzania, from 11-14 June 2012, aimed at increasing the expertise of officers and professionals working in the field of pharmaceutical clinical research with human participants and strengthening knowledge of ethical, scientific, and regulatory aspects of Good Clinical Practice Guidelines. The course has laid the groundwork for establishing an African-European network of professionals trained in the international standards of clinical trials. Further action will include the delivery of the training modules to other professionals in Tanzania and eventually to other countries in the Region.

 

For further information please contact cteunicri.org

Building capacity to enhance ethics and human rights protection of participants in biomedical research

Building capacity to enhance ethics and human rights protection of participants in biomedical research

 

UNICRI
United Nations
Interregional Crime and Justice Research Institute

Italian Medicines Agency
GCP Promotion Unit, GCP and
Pharmacovigilance Inspectorate

In the era of globalization, the spread of biomedical research with human subjects poses challenges at various various levels. The growing number of clinical trials conducted in developing settings,in Latin America, Africa and Asia requires total commitment from all stakeholders to ensure the correct application of internationally recognized Good Clinical Practices and adherence to the internationally recognized principles of ethics, human rights and justice.

In recent years, UNICRI, in collaboration with AIFA - the Italian Medicines Agency - has investigated the ethical and legal issues surrounding the conduct of clinical trials with human participants in developing countries, with particular regard to its criminal implications, such as the risks of fraudulent behavior, non compliance with the standards of ethical reviews and the lack of control on the quality of drugs and/or of the established protocols. In order to contribute to the creation of effective control mechanisms in this field, UNICRI and AIFA conducted a survey on the legislative framework related to the protection of participants in biomedical research. They also investigated the training, educational and capacity building activities carried out in the 53 African States which support the work of Ethical Review Boards and Inspectorates.

Deeply rooted in the Millennium Development Goals core objectives, UNICRI's policy of action-oriented research supports governments and the international community at large in strengthening human rights protection and the rule of law and tackling the threats that posed by crime to development and stability.

UNICRI believes that a proper legislative framework; its correct application; and adequate ethics training for professionals involved in research with human beings, are all key factors to ensuring the protection and promotion of human rights, safety and the well being of research participants all around the world.

Contacts

For further information please contact cteunicri.org

Publications

Publications

The Centre disseminates UNICRI publications, provides information on the Institute scope of activities, offers worldwide experts a resource for the development and implementation of technical interventions and research, supports training activities.

Click here to access the UNICRI Publications list and related full-text.

Probation and Parole Database

Probation and Parole Database

Through the IPPW Directory you can find the address of relevant Institutions dedicated to Probation.

The IPPW on-line publications offers a collection of specialized data and documents from public and private institutions (in Word and/or PDF formats) as well as links to specialized libraries and documentation centres.

Bibliographies

Bibliographies

The Documentation/Information Centre produces the Bibliography on Trafficking in Human Beings, the Bibliography on Organized Crime and Corruption and the Bibliography on Environmental Crimes.

The documents are available in hard copy and may be consulted at the Institute. The databases enable many of the documents to be consulted via the relevant electronic link as well.

The Centre also produces the UNICRI Bibliography series that includes a selection of publications acquired by the UNICRI Library.

About the Centre and the Library

About the Centre and the Library

Through its major online library, with more than 19.000 monographs, 1.250 journals and yearbooks, tens of thousands documents by the United Nations System, the Centre is an asset to research, training and field activities.

The rich collections of print and electronic resources are continuously updated and expanded to ensure access to the latest data, research and analysis.

Click here to consult the UNICRI Libray catalogue.

Documentation and Information Centre

Documentation and Information Centre

Since its establishment in 1969, the Documentation Centre has built a comprehensive collection of data to contribute to the global sharing of criminal justice information and to assist the international community in formulating and implementing improved policies on crime and justice.

The activities of the Centre include the collection, analysis and dissemination of legislative, statistical and bibliographic documents that form the library holdings.

The Library holds more than 20.000 monographs, 1.250 journals and yearbooks, tens of thousands documents by the United Nations System, other international and regional organizations, national institutions and NGOs, multimedia material, grey literature on crime prevention and criminal justice issues.

The Centre offers on-line access to all its services, such as the library catalogue and criminological thesaurus, electronic resources, bibliographies, directories, tables of contents, full-text articles and publications, abstracts of monographs and personalized alerts targeted to the needs of its users.

The UNICRI Library is part of a strong network of United Nations and UN system libraries, that share expertise, best practices and resources, and cooperate to ensure the best quality of products and services for their users.

The Centre offers worldwide experts a resource for the development and implementation of technical interventions and research, supports training activities, produces and disseminates UNICRI publications, provides information on the Institute mandate, scope of activities, past and current programmes.

The flyer entitled "A Library Network" is available for distribution.

 

 

 

UNICRI Liaison Office in Rome

UNICRI Liaison Office in Rome

UNICRI Liaison Office in Rome

In 2000, while UNICRI HQs moved to Turin, a Memorandum of Understanding was signed with the Italian Ministry of Foreign Affairs and FAO to keep a UNICRI Liaison Office in Rome.

The UNICRI Liaison Office in Rome became operational from 1 May 2000. Since January 2004, following an agreement with the UN Department of Public Information and the Italian Government, the UNICRI Liaison Office in Rome also backstops the Brussels-based UN Regional Information Centre for Europe (UNRIC).

The UNICRI Liaison Office promotes UN objectives and activities at national level, in constant coordination with Brussels. To this end, the Office supports UNRIC in the relations with public and private institutions, the civil society and the media.

The UNICRI Rome Office is open to the public for the consultation of UN documents and information materials, including most recent releases.

The Liaison Office also closely collaborates with SIOI (Italian U.N. Association) in the organization of events, seminars and press conferences.

Post-Graduate Education Section Banner

Post-Graduate Education

Post-Graduate Education Section Banner

Post-Graduate Education

 

UNICRI is constantly expanding its activities in the field of post-graduate education, offering a wide range of on-campus and decentralised training to provide for a variety of professional needs. UNICRI’s work draws on an extensive network with high level universities and research institutions around the world.

Along with a series of post-graduate short-courses on topics which fall within the scope of UNICRI’s mandate on crime prevention and criminal justice.

 

 

Capacity building - Professional Training Section Banner

Capacity building - Professional Training

Capacity building - Professional Training Section Banner

Capacity building - Professional Training

 

UNICRI provides sustainable and tailored capacity-building support to Member States, partners, and communities, with the objective of strengthening institutions and civil society. Rooted in an evidence-based and interdisciplinary approach, these efforts enhance national and local capacities in the areas of crime prevention, justice, and security.

Drawing on a broad network of experts and strategic partners, the Institute delivers both rapid-response training to address urgent needs and longer-term support to build resilience and lasting competence. This dual approach enables flexible, context-specific interventions that are responsive to evolving priorities and threats.

UNICRI offers a wide portfolio of educational and capacity-building programmes for criminal justice practitioners, law enforcement officials, policymakers, and post-graduate students. These include:
– tailored and specialised training courses;
– simulation-based exercises and Training of Trainers (TTT);
– workshops at national, regional, and international levels;
– Master’s programmes, hybrid learning opportunities, and e-learning modules.

Over the years, UNICRI has strengthened its training capabilities by developing national and regional curricula, modular content, and manuals for both trainers and trainees. Pilot courses have targeted law enforcement officers, prosecutors, judges, and social workers, covering both foundational and advanced topics relevant to their professional roles.

UNICRI’s thematic areas reflect the complexity of today’s security landscape and the need for specialised, forward-looking responses. Its capacity-building activities address:
– justice reform;
– anti-corruption and asset recovery;
– the responsible use of artificial intelligence and emerging technologies;
– mitigation of chemical, biological, radiological, and nuclear (CBRN) risks;
– cybercrime and cybersecurity, including online child abuse;
– counter-terrorism and violent extremism;
– the nexus between organised crime and terrorism;
– community-level resilience and the protection of vulnerable groups, including migrants;
– trafficking in persons and smuggling of migrants;
– crimes against the environment and illicit exploitation of natural resources;
– protection of cultural heritage;
– counterfeiting and the trafficking of cultural goods;
– reform of penitentiary systems, including crisis management, probation, and green and digital prisons.

UNICRI’s models are participatory, practice-oriented, and adapted to local realities. Training initiatives are co-designed with stakeholders, grounded in real-world scenarios, and aimed at delivering scalable, impact-driven solutions.

Working in close collaboration with Member States, UN entities, nationa, regional and international organisations, civil society, academia, and the private sector, UNICRI fosters integrated, multi-stakeholder ecosystems. These partnerships promote shared ownership, strengthen institutional coordination, and improve cross-border cooperation, while reducing duplication and optimising the cost-effectiveness of interventions.

As a trusted provider of technical assistance, training, and policy guidance, UNICRI contributes to the development of effective, evidence-based strategies that support justice, enhance institutional resilience, and advance peace, security, and development.