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Establishing a framework for Consent

Establishing a framework for Consent. Ruth Musson Pathology Specialist Nurse . Overview. The right environment Corporate responsibilities Individual accountability – Person taking consent Pathologist Clinician . Requirements of consent.

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Establishing a framework for Consent

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  1. Establishing a framework for Consent Ruth Musson Pathology Specialist Nurse

  2. Overview • The right environment • Corporate responsibilities • Individual accountability – • Person taking consent • Pathologist • Clinician

  3. Requirements of consent • To ensure that the removal, storage or use of any tissue is lawful, it is important to establish clearly that consent has been given. • Consent may be expressed in various ways, and does not necessarily need to be in writing, • Obtaining valid consent presupposes that there is a process in which individuals, including their families where appropriate, may discuss the issue fully, ask questions and make an informed choice.

  4. Environment • Corporate environment • Policies and procedures • Ethos of organisation • Physical environment • Where consent takes place • Personal environment • Preparedness of mind, knowledge and understanding

  5. Consent policy • Who, When, where • Information and consent forms • Feedback • Photographs and x-rays • Research consents • Cultural requirements

  6. Pathologist accountability Has to reasonably believe that : • Consent has been given by the correct person • A full explanation has been given (available for consultation) • Disadvantages of any limitations have been explained • Additional requirements – infection control • Organs to be retained have been explained

  7. Consent must be given • voluntarily • by an appropriately informed person • with the capacity to agree to the activity in question. • by the appropriate person

  8. Those consenting require: • An explanation that they can understand • To be in a comfortable area free from distractions • Confidence in the person taking consent • TIME • Sensitivity • Understanding

  9. The process begins The Clinician: • Raises possibility with patient/ appropriate family member • Explains why • Coroners pm – reason for referral THIS CAN ALL START BEFORE THE DEATH OCCURS

  10. Who can obtain consent? • A PERSON WHO IS SUFFICIENTLY TRAINED • Clinician in charge of care – if updated • A person who can perform the procedure • A suitably qualified person who has been trained – • The procedure • Communication • Death and bereavement

  11. Person obtaining consent • Only operates within published procedures for their organisation • Is equipped with relevant knowledge • Basic medical knowledge • Minimum and maximum procedure required – ability to consult beforehand • Any special requirements • Implications for family • Likelihood of usage of tissues for research

  12. Training • Human Tissue Act • Overview of procedure • Policies and procedures of the organisation • Methods of individual pathologists • Coroners requirements • Implications of additional processes agreed to • Other research studies

  13. Ongoing Training • Maintain CPD in this area • See a post mortem examination and a range of procedures • See laboratory practice • Regularly take consent • Prove competence

  14. Implications of Consent – person consenting • Acting in accordance with deceased’s wishes • Signing that they are the correct person • Consent is not irreversible • Something will happen • If they have not been asked about something, it will not happen • Anything that they have refused – will not happen • Something will come out of the event

  15. Feedback • Clinician - copy of the report • Framework for feeding back results • Agreement with Coroner

  16. Conclusion • Consent is a process that needs to be integrated into the fabric of an organisation • Consent is not taken in isolation • Those taking consent need to be well informed, trained and regularly updated

  17. And finally …… • Post mortem consent policy • Clear standard procedures • Training programme/records • Standard consent forms • Standard information • Agreements with local Coroners • Risk Management framework

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