Table 2.
Guidelines for research on persons who lack capacity to consent
| Ethical code | Criteria for research to be permitted |
|---|---|
| The ethical conduct of research on the mentally incapacitated MRC UK 1993 [www.mrc.ac.ukpdf-ethics-mental.pdf] | Participant does not object |
| Therapeutic research is in the participant's best interests | |
| Non-therapeutic research, no more than negligible risk of harm and not against participant's interests | |
| Research approved by research ethics committee | |
| Independent agreement that the participant's welfare and interests have been properly safeguarded | |
| Medical research involving children. MRC 2004 [www.mrc.ac.uk/pdf-ethics_guide_children.pdf | The relevant information cannot be gained through research with adults |
| Parents can consent to research that has potential benefit for the child | |
| Parents can consent to non-therapeutic research if the risks are sufficiently small to be said not to go against the child's interests | |
| International Ethical Guidelines for Biomedical Research Involving Human Subjects: Council for International Organizations of Medical Sciences (CIOMS) [www.cioms.ch/frame_guidelines_nov_2002.htm] | Applies to children and adults who lack capacity to consent: for non-therapeutic research the risks must not exceed those associated with routine medical or psychological examination of the participants |
| If the risks exceed the above criteria then the ethics review committee must find: (1) that the research is therapeutic; (2) the risks of the research interventions are only slightly greater than those associated with routine care of the participants; (3) the objective of the research is sufficiently important to justify the increased risk, and (4) the interventions are reasonably commensurate with the clinical interventions that the subjects have experienced | |
| Research: The Role and Responsibility of Doctors: General Medical Council 2002 [www.gmc-uk.org/standards/default.htm | Research on adults lacking capacity to consent should only take place if: |
| • it could be of direct benefit to their health; or is of special benefit to the health of people in similar circumstances | |
| • that it will significantly improve the scientific understanding of the adult's incapacity leading to a direct benefit to them or to others with the same incapacity | |
| • the research is ethical and will not cause the participants emotional, physical or psychological harm | |
| • the person does not express objections | |
| National Statement on Ethical Conduct in Research Involving Humans: National health and medical research council of Australia [www.nhmrc.gov.au/publications/synopses/e35syn.htm] | Research on children and young people should only be conducted if the research is important to the well being of this group and cannot be conducted on any other group |
| The research process provides for the physical, emotional and psychological safety of the child | |
| Consent cannot be given for research which is not in the child's best interests | |
| For adults who lack capacity to consent, the research must be in their best interests and their refusal must be respected | |
| Mental Capacity Act. UK 2005 (implementation 2007) [www.opsi.gov.uk/acts/acts2005/20050009.htm] | Research on persons lacking capacity must be connected with an impairing condition affecting that person, and it cannot be carried out on others who can consent. The burden of taking part must not be disproportionate to the potential benefit |
| For non-therapeutic research the risk must be negligible, and that anything done will not be duly restrictive or invasive |