The Importance of Full and Informed Consent (Authorisation)

Transcription

1 The Importance of Full and Informed Consent (Authorisation) 20 th November 2009 Tracey Millar University of Edinburgh

2 Why are Brains needed for Research? To progress our knowledge of different diseases (Alzheimer s, Parkinson s, CJD and vcjd) BUT Investigation of brain abnormalities requires control (normal) tissue for comparison

3 Current Sources of Brain Tissue for Research Hospital post mortem examinations (but numbers are declining) Neurosurgical biopsies i (but amount of tissue is restricted) Donor programmes (but they tend to concentrate on specific diseases) Medico-legal post mortem examinations (but they are not consented for research)

4 What are the Problems with Obtaining Control Brain Tissue for Research? Declining number of hospital consented post mortem examinations (PME) The public perception that t brain examination is only important in disease cases New legislation and increasingly complex ethical restrictions What is a control (normal) brain? Usually those that have no history of psychiatric, psychological or neurological disorder and have no indication of any neuropathological abnormality at post mortem examination

5 Causes of Death in Medico-legal Post Mortem Examinations Cardiovascular and respiratory Trauma, RTAs Drug and alcohol l related Acute psychiatric disorders and suicide Acute CNS events SUDI/SIDS and other child deaths Other maternal deaths, epilepsy, diabetes The medico-legal system is a source of control (normal) brain tissue and of other CNS disorders not otherwise obtainable

6 Potential Problems with the Medico-legal System Approach to the family depends on Procurator Fiscal (Coroner) approval Concerns over approaching relatives at such a distressing time inappropriate? Insensitive? Medico-legal PMEs fall into 3 groups: * non suspicious deaths (majority) in our experience, usually no objection to approaching the family * sudden deaths in which criminality is suspected approach to the family often prohibited * sudden deaths as a result of criminal activity leading to prosecution prohibited Removal of research samples cannot interfere with defence PME or chain of evidence procedures

7 MRC Sudden Death Brain and Tissue Bank Set up in Edinburgh with the approval of the Scottish Executive, Crown Office, Procurators Fiscal and Police Deaths Unit Approved by Lothian Ethics of Research Committee Main remit is to collect control (normal) brain tissue Telephone authorisation is obtained from families prior to PME Signed authorisation subsequently obtained to confirm verbal agreement and specifically for access to medical records, genetic research and commercial research

8 Governance and Management of the MRC Sudden Death Brain and Tissue Bank 2 levels of managerial committees: Local Management Group - all staff associated with the bank and local academic staff including the forensic pathologists and Procurator Fiscal Service. Steering Group - Comprising of all members of the Management Group, an independent Chair and expert professionals including an ethicist, lay members and an MRC representative Tissue requests approved by the Management Group although those which require further discussion are reviewed by the Steering Group Ethical review of all changing paperwork Clear and transparent information at All case details and information stored in a secure database

9 Aims: - To establish a mechanism for seeking explicit authorisation - To determine whether recently and suddenly bereaved families would be willing to donate tissue samples for research - To retrieve tissue samples for research from medico-legal PMEs with the full authorisation of relatives - To audit the families experience of the authorisation process - To achieve a sufficient success rate to support the establishment of Sudden Death Brain and Tissue Bank Challenges: - To develop an empathetic method for approaching bereaved families - To provide adequate and appropriate information to allow families to make an informed decision - To establish good working relationships and a communication network with police, procurator fiscal and mortuary staff

10 The Authorisation Process Report of all sudden deaths received from police Identification of potential cases of interest Full report from Procurator Fiscal Establish NOK and make telephone call Explanation and information given Letter confirming conversation sent Authorisation forms sent out for signing 3-4 weeks later Final letter of thanks

11 Provision of Information to Enable an Informed Decision Get past the gatekeeper (if necessary) to the established NOK Initial introduction and gentle reminder of need for PM Act as a source of help/information Establish a rapport Provide information about the procedure following a sudden death Explain the necessity for PME Answer any questions or concerns Explain the procedure of PME Bridge into the explanation of the research project and provide adequate information for a decision to be made

12 Answer any questions or concerns How do you feel about that? t? What questions or concerns do you have? Repeat what NOK has agreed to Extend thanks Send written confirmation Obtain signed authorisation Finally audit questionnaire

13 Variations in the Conversation Some families have many questions Others have none Some circumstances of death, for example suicide, which might be perceived as the most difficult in respect of approaching the family have nearly always initiated a very positive ii response

14 Examples of Questions asked by Families Will the body be disfigured? What do you mean by tissue samples? Where will they be taken from? What size are the tissue samples? Will the funeral be delayed? Can I view the body after the post mortem examination? and how will it look?

15 Results to Date 200 families approached 191 (96%) agreed to make a donation for research No families have subsequently withdrawn Results from Audit Questionnaire (54% response) are positive and all respondents remain satisfied with their decision 102 tissue requests fulfilled

16 Comments from Families It would be a waste to bury the body with the brain if there is the opportunity of it being useful in helping others in the future It was empowering to receive your telephone call offering this opportunity at such a desperate time If this helps only one person then it has been worthwhile I want to help with research and do something which may help others

17 Conclusion and Findings Despite the distressing circumstances of sudden bereavement, with appropriate information and explanation, the vast majority of families are willing to authorise research activities We can be open and honest about the PME The audit suggests that families are not further distressed by the request The act of donation for research may provide some comfort and meaning to unexpected death Comments and letters received from families confirm that the need for medical research is well understood Some families have voiced an interest in making a research donation in the future

18 Acknowledgements Principal Investigators; Dr Colin Smith, Emeritus Professor Jeanne Bell Neuropathologists; Dr Colin Smith, Emeritus Professor Jeanne Bell, Professor James Ironside Forensic Pathologists; Dr Gerhard Kernbach-Wighton, Dr Ralph Bouhaidar Head of Division of Pathology; Professor David Harrison Brain Bank Manager, Dr Robert Walker Psychiatric review; Professor Douglas Blackwood, Dr Donald McIntyre Procurators Fiscal (Legal Authority) and Lothian Police Deaths Unit Mortuary staff Research Funding; UK Medical Research Council The bereaved families