Consent; Roles and Responsibilities

1. Consent; Roles and Responsibilities 21 October 2010 Emyr Harries, Regulation Manager

2. Content • Legislative framework • HTA standards and Codes of practice • Obtaining consent • Examples

3. The HTA’s regulatory aim • To create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence • Consent under the Human Tissue Act 2004 relates to the purposes for which material might be removed, stored or used

4. Relevant Legislation • Human Tissue Act 2004 • Quality and Safety (for Human Application) Regulations 2007 • HTA Directions

5. Consent requirements under the Human Tissue Act 2004

6. Article 13 (European Union Tissue and Cells Directives) • The procurement of human tissues or cells shall be authorised only after mandatory consent or authorisation requirements in force in the Member state concerned have been met • Member States shall, in keeping with their national legislation, take all necessary measures to ensure that donors, their relatives or any persons granting authorisation on behalf of the donors are provided with all appropriate information

7. HTA Directions ‘The establishment shall not procure any human tissues and cells unless and until they have satisfied themselves that the necessary consent has been properly obtained.’

8. C1 Consent is obtained in accordance with the requirements of the HT Act 2004, the Human Tissue Regulations 2007 and as set out in the HTA’s Codes of Practice • If the establishment acts as a procurer of tissues and / or cells, there is an established process for acquiring donor consent which meets the requirements of the HT Act 2004, the Human Tissue Regulations 2007 and the HTA’s Codes of Practice • If there is a third party procuring tissues and / or cells on behalf of the establishment the third party agreement ensures that consent is obtained in accordance with the requirements of the HT Act 2004, the Human Tissue Regulations 2007 and the HTA’s Codes of Practice • The establishment or the third party’s procedure on obtaining donor consent includes how potential donors are identified and who is able to take consent • Consent forms comply with the HTA Codes of Practice • Completed consent forms are included in records and are made accessible to those using or releasing tissue and / or cells for a Scheduled Purpose

9. C2 Information about the consent process is provided and in a variety of formats • The procedure on obtaining consent details what information will be provided to donors. As a minimum, the information specified by Directions 001/2006 is included • If third parties act as procurers of tissues and / or cells, the third party agreement details what information will be provided to donors. As a minimum, the information specified by Directions 001/2006 is included • Information is available in suitable formats and there is access to independent interpreters when required • There are procedures to ensure that information is provided to the donor or donor‘s family by trained personnel

10. C3 Staff involved in seeking consent receive training and support in the implications and essential requirements of taking consent • Staff involved in obtaining consent are provided with training on how to take informed consent in accordance with the requirements of the HT Act 2004 and Code of Practice on Consent • Training records are kept demonstrating attendance at training on consent

11. Obtaining Consent • Valid consent • Positive act • Given voluntarily • Appropriately informed • Understand what the activity involves • Capacity to agree • Respect consent given

12. Obtaining Consent • Consent may be specific or generic (research) • Duration of consent • Withdrawal of consent • Confidentiality • Living and deceased donors • Format of consent

13. Who can give Consent • Person concerned • Their nominated representative • Consent of a person in a ‘qualifying relationship’

14. Qualifying Relationship hierarchy • Spouse or partner (including civil or same sex partner) • Parent or child (in this context a child may be of any age and means a biological or adopted child) • Brother or sister • Grandparent or grandchild • Niece or nephew • Stepfather or stepmother • Half-brother or half-sister • Friend of long standing

15. Deceased Donors • Options discussed with deceased person’s family • Honest, clear, objective information • Opportunity for questions • Reasonable time to reach decisions, privacy for discussion between family members • Support if they need and want it

16. Deceased donation example - Corneas • Eye bank has formal agreement in place with transplant coordinators for obtaining consent • Responsibilities of parties • Documents the procedure • Valid consent • Trained staff

17. Living donor example – Unrelated allogeneic PBSC donor • Information to the donor • Options • Benefits • Process • Risks • Fully informed choice

18. Example of obtaining verbal consent • Verbal consent via the telephone • Information provided • Opportunity to ask questions • Documented in donor’s records • Audio recording of the consent conversation • Letter of confirmation

19. Summary • Consent under the Human Tissue Act 2004 relates to the purposes for which material might be removed, stored or used • Legislation • Assess compliance • HTA Code of Practice on Consent

20. www.hta.gov.uk