Research use of an existing collection of human samples
A research project aims to use an existing collection of human samples that is held by an NHS Pathology Department. The project does not involve any genetic/DNA analysis.
This scenario details the relevant requirements of the human tissue legislation, and the approvals required in order to begin the study.
In England, Wales and Northern Ireland
To ascertain if the Human Tissue Act 2004 is relevant and if so, to determine its specific impact, the following needs to be considered:
Although there are legal exemptions that enable tissue to be used without consent, investigators should also consider the ethical implications of such use before deciding on their course of action (see Using diagnostic archives without consent).
Were the samples collected prior to 1st September 2006? If so, the consent requirements of the Act are not applicable. However, it is considered best practice to ensure that consent is in place before samples are used for research, whenever this is possible. There are further legal exemptions to allow the use of such samples without consent, which are explored below. The NHS Pathology department must also ensure that patient confidentiality is protected in the proposed research use. The best way to do this is to ensure samples are robustly coded before they leave the department.
If samples were collected on or after 1st September 2006, then the following should be considered in turn:
- Were the samples removed from the living or from the deceased (i.e. removed after death)?
- If from the living, the next question to ask is: Will the samples be identifiable to the research team?
- If not identifiable (i.e. anonymous to the researcher), provided the research team obtains NHS Research Ethics Committee (NHS REC) approval, consent is not legally required for research use. This approval must be project-specific and must include the use of the samples without consent.
- If samples are identifiable to the research team, consent for research is required. In this situation, if consent is not feasible, it is advisable to ask a member of the Pathology department to code the samples so that identifiable information is not seen by the research team, and ensure that the research has been approved by an NHS REC.
An HTA licence is required whenever relevant material is held for research purposes, unless the following apply:
- NHS REC approval exemption: this relies on the research having (or pending) project-specific NHS REC approval. In these situations, a licence is not required. Be aware that ethics approval from a non-NHS REC does not qualify under this exemption, here a licence would be needed. Research tissue banks must also hold an HTA licence even if broad NHS REC approval is in place for their operations. This broad approval arrangement confers ethical approval for projects receiving tissue from the bank within the conditions agreed by the NHS REC. This means that researchers receiving material from a Research tissue bank that has a broad NHS REC approval, do not themselves need a licence to store the material for this research or to apply for project specific REC approval.
- Where samples are to be processed in order to render them acellular in hours, days but no more than a week, a licence is not required.
- Where samples are being held pending transport elsewhere for hours, days and no more than a week then a licence is not required.
If none of the above exemptions apply then an HTA licence will be required.
The samples continue to be stored in the Pathology Department
If the samples will continue to be stored in Pathology, the research group and the Designated Individual of the existing licence should discuss any implications of the proposed research activity, to ensure that licensing standards are not compromised, e.g. it should be checked whether the existing licence includes storage of relevant material for a scheduled purpose, unless the NHS REC approval exemption applies (see above).
Samples will be transferred to different premises
If the samples are to be transferred to different premises for research and storage, a licence may be required at those premises.
The Principal Investigator (recipient of the samples) should make sure that they hold material under an appropriate licence or that a licensing exemption applies (e.g. if the existing licence relates to the hospital as a whole, rather than just to a specific department or project-specific NHS REC approval is in place). Relevant material that does not fall under any of the exemptions mentioned above and is stored for the purposes of research must be stored on licensed premises.
If the research is carried out on premises under the same governing body as the Pathology Department, but at a substantially different site (e.g. different campus, postcode or the original licence is very narrow in its definition of the licensed premises, i.e. Pathology Department 5th floor) it may be possible to designate the site where the research is being carried out as a satellite site. This should be done in conjunction with the Designated Individual of the original licence. To qualify as a satellite, the site must be under the same governance arrangements as the main site, but smaller (for further detail see the Human Tissue Authority website).
If the samples are to be stored on different premises for the duration of the research project only, and the project has or is pending approval from an NHS Research Ethics Committee, a licence is not required (see above). At the end of the project the exemption from licensing that the NHS REC approval provides no longer holds. If the premises do not already have an HTA licence, then the samples should be transferred to licensed premises (e.g. back to Pathology), or further NHS REC approval or an HTA licence should be obtained. To avoid the need for a licence for a single collection of samples, it is recommended that the samples be transferred to licensed premises.
To ascertain if consent must / should be in place before samples can be used for research the following questions need to be asked:
- Is the research likely to involve DNA or genetic analysis?
- If yes, then there is a legal requirement for explicit consent to be in place for DNA analysis. There are exemptions to this; for detailed guidance see In England, Wales and Northern Ireland above.
- If no, were the samples collected from the living or from the deceased (i.e. removed after death)?
- If they were taken from the living, then there is no legal requirement for consent in Scotland, however it is considered best practice to ensure that consent is in place for the research use of samples taken from the living, whenever this is possible. Legal guidance given for England, Wales and Northern Ireland constitutes what is considered best practice in Scotland, even though there is no legal compulsion to comply.
- If they were taken from the deceased, were they removed post mortem?
- If prior to 1st September 2006, the collection is an Existing Holding and the requirements of the Human Tissue (Scotland) Act 2006 do not apply for research. However, as mentioned above it is still important to adhere to best practice guidelines and ensure that consent is in place whenever this is possible.
- If 1st September 2006 or afterwards, then authorisation is required to use the samples for research. There is no exemption to this requirement.
There is no licence scheme in Scotland for establishments that hold human tissue for research or for diagnostic purposes, so an HTA licence is not required to store samples in Scotland for research. That said, NHS Scotland is currently piloting an accreditation scheme which will apply to tissue (as per the HTA definition) for which NHS Scotland is responsible. Where tissue is transferred to a third party a Material Transfer Agreement (MTA) must be in place to ensure that the standards set by NHS Scotland are adhered to. The accreditation scheme will follow a 3 year cycle with the first cycle commencing on the 1st of April 2012. This means that NHS Boards will need to have certain standards in place by the 31st March 2012. For more information please see the Scottish Health Department letter SGHD/CMO(2011)7
Please note that this accreditation scheme should not to be confused with UKAS Accreditation (which is replacing the Clinical Pathology Accreditation scheme). UKAS accreditation is a voluntary, government recognised scheme which applies UK wide and provides a means to accredit Clinical Pathology Services and External Quality Assessment Schemes (EQA). For further information on this scheme please visit the UKAS website.
Approvals (UK wide)
In addition to the need for NHS REC approval (discussed above in terms of the legal consent and licensing requirements in each of the devolved administrations in the UK), further research approvals may be required. The detail of which approvals are required will depend on the project and implementation of local policies:
- NHS R&D permission. In order to obtain NHS R&D permission, sign off from the Head of the Pathology Department will be required. It is recommended that discussions with the department be conducted early in the project planning stages, as highlighted in the Planning & Funding Route Map (see Consult R&D).
- If using samples from more than one NHS Pathology Department, permission from each NHS organisation and sign-off from each Pathology Department is required.
- Any prospective collection of tissue from patients for research will require approval from an NHS REC.