Research and Ethics in Pediatric Oncology

and Daniela Cristina Stefan2



(1)
Université Mohammed VI des Sciences de la Santé Cheikh Khalifa Hospital, Casablanca, Morocco

(2)
South African Medical Research Council, Cape Town, South Africa

 



Keywords
Respect for persons and informed consentEthical issue of end-of-life careEthical principlesRiskResearch



Case Presentation


An 11-year-old girl presents with a distal metaphyseal osteosarcoma of the left femur, and lung metastases. Chemotherapy allowed a complete response of lung metastases and a slight volume reduction of the tumor of the thigh. The surgeon proposed an amputation, which was denied by the teenager and her parents. After 3 months of treatment abandonment, she returned to the hospital because of pain. Chest X-rays showed lung metastases. Treatment with second-line chemotherapy and radiotherapy is proposed on an experimental basis.


  1. 1.


    Would it would be ethical to proceed with this program?

     

  2. 2.


    Should it be discussed with the parents, who are illiterate?

     

  3. 3.


    Should the patient be informed?

     

Research on diagnostic and therapeutic approaches has been the main tool to improve the quality of care of childhood cancer in developed countries. Besides diagnostic and therapeutic approaches, the research may also involve epidemiology, organization, funding, and organization of care or the sociocultural aspects of pediatric oncology. Even though this group of diseases is rarely encountered compared to adult cancer, appropriately organized international teams made a great impact. This is now considered as a model in medical practice. In well-organized pediatric oncology units, up to 70 % of patients are included in prospective research programs. Patients enrolled in international network programs have also show to have a better outcome. Hence, among the competences that a team should have to support children with cancer, the ability to conduct research and participate with other teams in national and international programs, is of great added value.

However, research must respect the principles of ethics. The team should respect the basic principles of human rights, and pay attention to possible exploitation of vulnerable patients and families for commercial purposes. In most countries, regulation to protect patients is implemented. One of the most effective ways of protection of persons is the use of a review by independent ethics committees.

Furthermore, the authors and editors of scientific publications have ethical obligations. For the publication of study results, investigators have to ensure the accuracy of their results. Negative as well as positive results should be published or made available. Funding, and any potential conflicts of interest must be clearly outlined in the publications.

In developing countries, searching for the best diagnostic and therapeutic approaches adapted to local settings is one of the best research fields. The rights of the child and their parents to get best possible care must always be respected.


Informed Consent


This is one of the fundamental ethical principles. Indeed, respect for the dignity and autonomy of subjects are at the basis of ethics. Children, their parents or their legal representatives must give their informed consent without any constraint or influence. Consent must be voluntary and reversible.

The information given to parents must enable them to understand the rationale for the study, the type of investigations, the expected results and potential risks (Table 31.1). They should also be informed of available alternatives and about the measures taken to protect confidentiality of their personal information. The process of consent must take into account the sociocultural context.


Table 31.1
Rules of informed consent









• The information must be given in an understandable manner

• Explanations of the benefits and potential risks should be included

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Jun 26, 2017 | Posted by in PEDIATRICS | Comments Off on Research and Ethics in Pediatric Oncology

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