Bibliografía Comentada - THE ACADEMY OF MEDICAL SCIENCES, Personal data for public good: using health information in medical research, UK, January 2006.

THE ACADEMY OF MEDICAL SCIENCES, Personal data for public good: using health information in medical research, UK, January 2006.

El propósito de este informe es dar ciertas pautas en la utilización de datos personales en investigación científica, de manera que se concilien los intereses de la sociedad, de los pacientes y de los investigadores. La publicación pretende dar solución a diferentes problemas que se pueden plantear en este ámbito.

Se parte de que la legislación británica a este respecto es muy complicada y deja muchas dudas abiertas.

Reconoce también que es esencial para obtener la confianza, tanto de la sociedad como de los poderes públicos, que se observen ciertas reglas de buena practica en este ámbito. Estas buenas practicas han de referirse a las medidas de seguridad, fundamentalmente.

Las recomendaciones para el uso adecuado de los datos de carácter personal en investigación científica se resumen en las siguientes:

1. Interpreting the legal framework

Identifiable data can be used for medical research without consent, provided that such use is necessary and is proportionate with respect to privacy and public interest benefits. Research governance bodies, including the Patient Information Advisory Group, Information Commissioner’s Office, research ethics committees, NHS research governance offices and General Medical Council should accept this interpretation in their guidance and approval decisions.

2. Improving regulatory processes

The UK Clinical Research Collaboration should lead the bodies involved in governance of research using personal data in developing a simple scheme of assessment for proposals and issue clear guidance on the approval process. There is a continuing need for a body such as the Patient Information Advisory Group with statutory authority in this area. However, PIAG should address the difficulties of approach, process and membership identified in this report and develop an extended and explicit system of class support, whereby its involvement in research proposals becomes the exception, rather than the norm.

3. Developing good practice in research using personal data

The UK Clinical Research Collaboration should lead an initiative involving the regulatory and professional bodies, the medical research community and the public to develop Good Practice Guidance in research using personal data. Such guidance should encompass issues related to data security, anonymisation, consent and the use of health records to identify research participants.

4. Harnessing the opportunities of the NHS National IT programme

Connecting for Health’ should take urgent steps to address the needs of research through the establishment of a Research Advisory Committee. The Care Record Guarantee should be revised to include support for research as an important and legitimate secondary use of Connecting for Health data, while emphasising the appropriate safeguards.

5. Engaging the public

Research funders should encourage and fund research into public awareness and attitudes towards medical research using personal data. The UK Departments of Health, working with the UK Clinical Research Collaboration, should develop public engagement programmes around the purpose and value of using personal data in medical research.



Actualidad en Instituto Roche	Casos clínicos: Metástasis Ováricas de Carcinoma Mamario en Portadora de Mutación en BRCA1	Emilio Muñoz, Biotecnología y Sociedad: Encuentros y Desencuentros	4ª Edición Curso online de Cáncer Hereditario y Consejo Genético