Guidance on patient consent
this section contains mrc guidance on planning or conducting studies involving people who lack the mental capacity to give informed consent about taking part in research. it also covers the use of personal information by medical researchers, including patient data for which consent has not or will not be obtained.
Research involving children
medical research involving children leads to innovations in healthcare that can substantially improve the health and quality of life of all children. the mrc therefore believes that research involving children should be supported, encouraged, and conducted in an ethical manner. to ensure that the research participants, their parents and the general public can be confident that mrc researchers work ethically with children, we provide guidelines outlining the practical, legal and ethical issues that they must consider when carrying out studies involving children.
Adults who lack the capacity to consent
our guidance for studies involving adults who lack the capacity to consent was developed in 1991 to ensure that such research is conducted ethically and is sensitive to the needs of the individuals involved. it is currently being updated to reflect the mental capacity act 2005 which comes into force in april 2007, but remains valid in england, wales and northern ireland.
体育直播站the mental capacity act 2005 governs decision-making on behalf of adults who lack mental capacity, both where they lose capacity at some point in their lives, and where the incapacitating condition has been present since birth. the mrc has welcomed the act, as it has clarified and enshrined in law the statutory requirements for when adults who lack the capacity to consent are included in medical research studies.
Use of personal information
when studying specific health problems, medical researchers sometimes need to use information about people drawn from surveys, medical records, scientific tests and interviews. most of this information is confidential and inappropriate use of it could harm a person’s sense of security and autonomy, damage the doctor-patient relationship or lead to unfair discrimination.
体育直播站the mrc provides guidance on how such information should be used, which the researchers we fund must follow. it reflects developments in law, changing public attitudes and medical researchers’ increasingly sophisticated information needs. the guidance also sets out procedures that must be followed by those undertaking or planning research that involves the use of patient data where consent from the individuals concerned has not or will not be obtained.
our guidance on the use of personal information in medical research 2000 also contains guidance on section 60 of the health and social care act 2001 added in 2003.
Contact: Dr Catherine Elliott
Telephone: 020 7636 5422