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OUR RESPONSIBILITIES & DUTIES

Ethics will be given the highest priority in the BIRDY project. In particular, the project will comply with the relevant rules and recommendations for investigation: (i) in developing countriesDeveloping country
This term is generally used to describe a nation with a low level of material well-being. Since no single definition of the term developing country is recognized internationally, the levels of development may vary widely within so-called developing countries. Some developing countries have high average standards of living.

The World Bank classifies all low- and middle-income countries as developing but notes, "The use of the term is convenient; it is not intended to imply that all economies in the group are experiencing similar development or that other economies have reached a preferred or final stage of development. Classification by income does not necessarily reflect development status".
and (ii) in children. These sensitive populations create unique and important responsibilities for the researcher and partner organisations:

1. The research project is scientifically sound and responsive to the health needs of the children, the population, and the country where it will be carried-out. Study issues include:

  • Severe childhood infections from birth to 2 years when children are the most susceptible, and where the highest mortality is observed; and
  • Bacterial resistance to antibiotics, which represents an increasingly important global health issue.

2. All appropriate measures will be taken to ensure that: the best interest of the child will be the primary consideration over the interests of the study;

3. Legally authorised children's representatives are able to provide a genuine informed consent. Local investigators will convey the information, whether orally or in writing, in language that suits the individual's level of understanding, ensuring the information has been adequately understood. Children's representatives may stop their participation at any time without penalty.

4. The direct benefits for children and stakeholders to participate in the BIRDY project will be maximised while the associated risk and burden will be minimised.

  • The BIRDY project provides free medical treatment for bacterial infections contracted by the participating children within the course of the study. Every child entering into the study will be assured of access to the optimal standard of care
  • The project aims also to strengthen local capacities by: (i) funding equipment and materials for the partner hospitals / health centers and (ii) enhancing medical expertise. This equipment and knowledge will remain with partners even after the end of the project and is expected to sustainably improve, at the local scale, the care and welfare for children and, more widely, the community.


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The results of the project will benefit developing countriesDeveloping country
This term is generally used to describe a nation with a low level of material well-being. Since no single definition of the term developing country is recognized internationally, the levels of development may vary widely within so-called developing countries. Some developing countries have high average standards of living.

The World Bank classifies all low- and middle-income countries as developing but notes, "The use of the term is convenient; it is not intended to imply that all economies in the group are experiencing similar development or that other economies have reached a preferred or final stage of development. Classification by income does not necessarily reflect development status".
by contributing to an improvement in the scientific understanding of antibiotic resistanceAntibiotic resistance
Infections caused by antibiotic-resistant bacteria are increasing steadily worldwide in hospitals as well as in the community. These infections often have more severe outcomes than those caused by so called "sensitive" bacteria. As a consequence, they also require more expensive second-line treatments as well as a more careful and costly follow-up care for patients.
in these settings and conferring future benefits for the individual and population (through capacity building and improved health care practices). The estimated proportion of morbidity and mortality of children attributable to resistance will be communicated to the national and international health authorities in order to make all stakeholders aware of this potential threat and convince them to invest in prevention measures which will ultimately enhance public health.

5. Biological samples will be collected in compliance with the given informed consent and will be used for research purpose only. Standard Operating Procedures as well as quality criteria defined by international Good Laboratory Practice and confidentiality rules shall be applied to the biomedical laboratory techniques, collection, storage, and use of these biological samples.

6. Effective and appropriate mechanisms for data handling, privacy, and protection are being implemented in order to avoid any potential family or social discrimination or prejudice resulting from participant identification.

7. The BIRDY project abides by the relevant international ethical guidelines. It also must be approved by each host country which will judge the ethical acceptability of the research in accord with its own laws, customs, and traditions.









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SOME USEFUL REFERENCES

- Declaration of Helsinki 2000 (Clause 5)


- Declaration of Helsinki of the World Medical Association. Ethics principles applicable to medical research involving human beings, last revised in October 2008 in Seoul


- Universal Declaration of Human Rights (1948)


- The Universal Declaration on Bioethics and Human Rights (2005).


- Convention for the protection of human rights and the dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine


- International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organisations of Medical Sciences (CIOMS). Adopted in 1993, revised in 2002


- UN Convention on the Rights of the Child (1989)


- The ethics charter of the Institut Pasteur


- Ethical aspects of Clinical Research in Developing Countries. Opinion of the European Group on Ethics in Science and New Technologies to the European Commission, 2003.

- Wendler D, Emanuel EJ, Lie RK (2004). The standard of care debate: can research in developing countriesDeveloping country
This term is generally used to describe a nation with a low level of material well-being. Since no single definition of the term developing country is recognized internationally, the levels of development may vary widely within so-called developing countries. Some developing countries have high average standards of living.

The World Bank classifies all low- and middle-income countries as developing but notes, "The use of the term is convenient; it is not intended to imply that all economies in the group are experiencing similar development or that other economies have reached a preferred or final stage of development. Classification by income does not necessarily reflect development status".
be both ethical and responsive to those countries' health needs. Am J Public Health. 94-6:923-928.