Research with human tissue: legal and ethical considerations. in practice

Transcription

1 Research with human tissue: legal and ethical considerations in practice Dr Jill Shepherd Lecturer in Stem Cell Biology University of Kent School of Biosciences

2 Research with human tissue? Key considerations Legal basis: Human Tissue Act 2004 (the Act) The Act s ethical roots The Act s requirements Licensing Consent In practice Tissue sources Intended use Managing a licence exceptions

3 Retained organs scandal Late 1990 s revealed organ retention without consent going back decades (>100,000 organs) Exposed paternalistic medical culture doctors know best attitude Severely damaged public confidence in medical research Human Tissue Act 2004 (HT Act) The Human Tissue Authority (est. 2005)

4 HTA regulates removal, use, storage and disposal of human tissue. Biosciences Anthropology Forensics medical school / teaching hospitals

5 The HT Act & the HTA Human Tissue Authority (HTA) - regulates activities concerning the removal, storage, use and disposal of human tissue. Research with human tissue? Consider whether an HTA licence is required. Two key areas: Consent Licensing

6 Research & licensing under the HT Act Activity pure research Other legislation - clinical trials, studies involving transplantation Material - contains even one human cell Other legislation - reproductive cells, embryos outside body, (hair/nails from the living)

7 Licensing requirements do not apply if Tissue held pending transfer elsewhere. Time limit - matter of days, no longer than one week Ethical rationale Avoiding burden

8 Licensing requirements do not apply if Tissue is greater than 100 years old and from the deceased. Ethical rationale Drawing the line somewhere Avoid hindering research / unnecessarily burden /#WP6zKZZoSV6EIMRx.99

9 Licensing requirements do not apply if Tissue held pending processing to render acellular Time limit - matter of days, no longer than one week Ethical rationale Aid supply chain management and in doing so avoids unnecessary burden Isolation of DNA Fischer Scientific

10 Licensing requirements do not apply if Approval has been obtained (or is being sought) from an NHS REC Ethical rationale Avoid unnecessary burden of dual approvals NHS REC route preferential closer scrutiny / better knowledge of NHS environment Why preferential for academic researchers? Avoids licence maintenance Lower regulatory burden Lower cost Myth My research does not involve NHS patients directly the tissue is from another establishment. So I should not go through an NHS REC. Why might one consider the HTA licence route instead? Protection of commercial interests i.e. commercial research Freedom to use tissue for other research projects as they develop

11 Case study: Licensing Prof Brains of the University of Kent would like to obtain fresh skin biopsies from living donors, which she plans to use to develop induced pluripotent stem cell lines to use for research. The biopsies will be collected by a collaborator at a local hospital for this specific purpose, anonymised and transferred to Prof Brains on the same day. Prof Brains will use part of each sample immediately for cell line development and store some tissue in her lab. She will also purify and analyse DNA from the tissue. The work has been approved by an NHS REC.

12 Research without consent Best practice Even where consent is not required by law, it is best practice to ensure it is in place. In practice Not always possible or ethically sound to obtain consent

13 a.k.a. existing holdings Ethical rationale Consent provisions of the Act do not apply retrospectively Not always feasible/ethically sound to go back to donor for consent Avoid hindering research In practice If samples were obtained prior to 1 September 2006, then consent is not legally required. Applies to tissue from living or deceased Best practice to ensure consent is in place

14 Ethical rationale Consent provisions of the Act do not apply to imported material Varying international practice rooted in local legislation / culture In practice If samples are imported from outside UK then consent is not legally required. Also includes tissue imported from Scotland as legislation differs. Applies to tissue from living or deceased. Best practice to ensure ethically appropriate consent is in place.

15 Ethical rationale Avoiding hindering research where unable to obtain consent Key donor not identifiable to the researcher In practice Applies only to tissue from the living Best practice to ensure ethically appropriate consent is in place. Grey area - how anonymous is anonymous??? Samples DO NOT have to be permanently unlinked from clinical data. A robust laboratory coding system is sufficient.

16 Potential offense = holding human tissue with the intention to analyse DNA and use the results without specific consent for such analysis Tissue removal from donor Time Intention to analyse DNA Intention to analyse DNA

17 Case study: Consent Prof Brains of the University of Kent would like to obtain fresh skin biopsies from living donors, which she plans to use to develop induced pluripotent stem cell lines to use for research. The biopsies will be collected by a collaborator at a local hospital for this specific purpose, anonymised and transferred to Prof Brains on the same day. Prof Brains will use part of each sample immediately for cell line development and store some tissue in her lab. As part of her work, she will need to purify and analyse DNA from the tissue. The work has been approved by an NHS REC. Any other considerations?

18 Tissue sources The source influences the requirements. Classic fresh tissue obtained directly from donors for the specific research project Colleagues as donors Collaborators Research Tissue Banks Diagnostic archives research without consent

19 Tissue source: Colleagues as donors Same ethical / legal consideration as for any other donor Independent ethical approval required Also Privacy Perceived obligation MRC Guidance:

20 Tissue source: Research Tissue Banks (RTBs) Generic ethical approval: NHS RECs can give generic ethical approval for a research tissue bank's arrangements for collection, storage and release of tissue, providing the tissue in the bank is stored on HTA-licensed premises. In practice Such RTBs can distribute tissue for research and the collaborator is exempt from other licensing / ethical approval, provided the tissue is anonymised. The collaborator s project will instead be reviewed by the RTB to ensure that it is in line with the generic REC approval. The RTB will advise the collaborator about appropriate practice with regard to tissue management.

21 Tissue source: Diagnostic archives Tissue from the living for diagnosis and subsequently stored in a diagnostic/pathology archive Valuable research resource Pure diagnostic archive Occasional release Ad hoc On request RTB Regular release Decision making framework in place Advertising/promoting tissue for research Why? Avoid over-burdening small operations Ethical safeguards Can only release for using in research with appropriate approvals/licensing status

22 Tissue source: Collaborators On no I need some human tissue I ll get some from my mate at the University of X! COLLABORATOR HTA LICENCE REC APPROVAL YOU HTA LICENSE/REC APPROVAL (As above) or to be a NAMED COLLABORATOR

23 When ethical approval expires Storage for future projects what approvals are required? Ethical approval = duration of specific project only. Before the end of the project, you re legally required to: apply for ethical approval of a new project, OR obtain a HTA licence, OR transfer the human tissue to a licensed establishment.

24 Need a licence? Consider Does your establishment hold a licence? If you already hold tissue, under which licence or approval is it held? If you already hold tissue, under which licence or approval is it held?

25 How does an HTA research licence work? Held by establishment not individual Named person Designated Individual legally responsible Application fee = 2, Annual licence fee = 3, Site visit inspections Publicly available inspection reports including shortfalls

26 Proceduralise proceduralise proceduralise Audit provides assurance of what material and information you have Traceability system keeps track of tissue location and information Quality management system ensures policies and procedures are in place and followed Work to Standard Operating Procedures (SOPs) Risk management If it is not documented, it didn t happen

27 Research with human tissue? Legal basis: Human Tissue Act 2004 (the Act) The Act s ethical roots The Act s requirements Licensing Consent exceptions legal and ethical considerations in practice

28 Thank you Dr Jill Shepherd Lecturer in Stem Cell Biology University of Kent School of Biosciences Ph: E: MRC Regulatory: Research using human tissue Cell and tissue therapy development US FDA biologics regulation