Patients would benefit from simplified ethical review and consent procedure

Abstract

In a draft report 1 European Parliament Committee on Civil LibertiesJustice and Home AffairsDraft report on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (general data protection regulation), amendment 27. European Parliament, Brussels2012 Google Scholar about the upcoming European Union Data Protection Directive, the European Parliament Committee on Civil Liberties, Justice and Home Affairs suggests, by contrast with the position of the European Commission, that processing of data for scientific reasons should not be exempt from strict requirements of specific consent by research particpants. 1 European Parliament Committee on Civil LibertiesJustice and Home AffairsDraft report on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (general data protection regulation), amendment 27. European Parliament, Brussels2012 Google Scholar The committee's amendment is an example of how the regulatory framework for the protection of human research participants seems not to keep pace with developments in biomedical research. If the proposed change is implemented, it will have serious consequences for medical research and for patients in need of improved treatment.