The NRES Standard Operating Procedures for Research Ethics Committees (version 4.0, April 2009) states the following:
"1.33 Any application potentially involving research participants who lack capacity, i.e. they are physically or mentally unable to consent for themselves, should be allocated through Central Allocation System to a flagged REC. Detailed guidance on allocation and review procedures for research involving adults lacking capacity is set out in Section 12", and
"12.6 Where the trial is to be conducted at one or more sites in Scotland, and the Chief Investigator is professionally based in Scotland, it should be allocated to “the Ethics Committee” constituted by Scottish Ministers under the Adults with Incapacity (Scotland) Act 2000. This committee is currently the Scotland A REC. If the Chief Investigator is based outside Scotland, the application may be allocated to any other REC, which is both recognised and flagged for the purpose of reviewing research involving adults unable to consent for themselves."

A flagged REC being one of a panel of RECs established to review research involving adults unable to consent for themselves.

According to this guidance, the adults with incapacity REC in Scotland does not need to approve the trial as the Chief Investigator is professionally based outside Scotland.

Applications for Clinical Trials of Investigational Medicinal Products (CTIMPs) require a EudraCT number which is a unique reference number and the main identifier for clinical trials with at least one site in the European Community. The EudraCT database is a European clinical trials database which provides all international competent authorities with a common set of information about all CTIMPs conducted in the European Community.

As stated in the Research Governance Framework, "Chief investigators must have suitable experience and expertise in the design and conduct of research" .  Also for clinical trials of IMPs, the CI and other investigators must be authorised health professionals as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004.

The NRES Standard Operating Procedures for Research Ethics Committees (NRES SOPs) confirm that a change to the CI is a 'substantial amendment', the same definition of a 'substantial amendment' applies to clinical trials and other research, and a favourable opinion from the main REC is always required before implementation.

For clinical trials of IMPs  it is the responsibility of the Sponsor to decide whether a substantial amendment requires authorisation from the relevant CA and/or an ethical opinion.  However, Sponsors may wish to take account of the following general guidance: amendments normally requiring a favourable ethical opinion only include a change to the CI, as agreed between NRES and the MHRA and as detailed in Annex E of the NRES SOPs.  However, the Sponsor of a clinical trial must notify the MHRA of a substantial amendment for change of CI for information only.

Amendments to clinical investigations being carried out under the provisions of the Medical Devices Regulations must be notified in all cases to the MHRA (Devices).

Section 5 of the NRES SOPs sets out how substantial amendments to clinical trials of IMPS should be notified using the European Commission notice of amendment form and for other research the NRES form should be used.  

For the appointment of a new CI, a copy of their CV and the Declaration sheet in part D of IRAS (signed by the new CI) should be submitted In addition to the notice of amendment.

If the New CI is also a new Principal Investigator (PI) for a research site, this should be described in the notification.

For NHS sites, all amendments should be discussed with the R&D office immediately; the notice of amendment should be provided to R&D offices in parallel with ethical and regulatory review.  Please refer to the IRAS Amendment Guidance for further details.

For non-NHS sites requiring site-specific assessment(SSA), the SSA REC should also be notified.

The Medicines for Human Use (Clinical Trials) Regulations 2004 define an investigator brochure (IB) as a document containing "a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects".

Its purpose as defined in the ICH E6 Guideline for Good Clinical Practice is "to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures."

An IB is required as part of the supporting data for a clinical trial authorisation for a medicinal product for human use in Phase I, II, and III trials and must be reviewed at least once a year and revised as appropriate (refer to section 7 of the ICH E6 Guideline).  The sponsor is responsible for ensuring that an up-to-date IB is made available to the investigator(s).

A Summary of Product Characteristics (SmPC) can be used in place of an IB where a marketed product is being used within the terms of its marketing authorisation (refer to Schedule 3, Part 2, paragraph 11 of The Medicines for Human Use (Clinical Trials) Regulations 2004), as in the case of many non-commercial trials which involve IMPs that are already marketed in the UK (or other EU countries)). The MHRA have confirmed that the requirement to review at least once a year applies to the IB and not the SmPC that replaces it.  However, the drug manufacturer should notify any updates to the SmPC to the MHRA/relevant Competent Authority.

The Research Governance Frameworks confirm that for any research that takes place within the scope of the NHS (or HPSS in Northern Ireland) there must be a Sponsor.  This Sponsor must be based in the UK or have a legal representative in the UK, with the exception of clinical trials of medicinal products.  The Medicines for Human Use (Clinical Trials) Regulations 2004 require a Sponsor to be, or have a legal representative, established in an EEA (European Economic Area) State.

England, Wales and Northern Ireland

The consent provisions of the Human Tissue Act 2004 will apply. Please see the MRC Regulatory Support Centre's Consent Summary for information on when consent is required for research purposes.

This summarises the provisions of the Act and the Human Tissue Authority's Code of Practice on Consent (updated Sept 2009) [2].

Scotland

There are two pieces of legislation that apply to research involving human tissue in Scotland:

• Human Tissue Scotland Act 2006
• Human Tissue Act 2004 - Section 45: Non-consensual DNA analysis

For more information on applicable human tissue legislation in Scotland, please see the MRC Regulatory Support Centre's Scotland Summary [3].

Consent
The Human Tissue Act 2004 states that it is an offence to hold bodily material with the intent to analyse its DNA without ‘qualifying consent’. This is subject to certain exceptions. This offence applies throughout the UK.

For more information please see the Human Tissue Authority (HTA) Code of practice for Consent (Section 152-156). It is worth noting that the guidance in these sections of the code of practice also apply to RNA analysis where it is used to provide information about DNA.  Please also see the Q&A under Relevant & Bodily Material.

Further detail regarding the offence of non-consensual DNA analysis can be found in the HTA Code of Practice for Research (section 49-54), and the HTA web page on non-consensual DNA analysis provides further exceptions.

Licensing
Storage of relevant material for research requires a licence. This is subject to certain exemptions. Relevant material is defined as material that consists of or includes human cells. Therefore the storage of extracted DNA or RNA (where no whole cells remain) does not require a licence.

Supply of tissue to research projects

According to the Human Tissue Authority (HTA), it is not a requirement of a licence that tissue banks supply tissue only to ethically approved projects. It may be a requirement of the ethical approval of the tissue bank, as the information sheet may well say that samples will only be used in future ethically approved projects, and consent is given by the donors on that basis. If this is the case, to comply with these consent terms, all projects aiming to use the banked tissue should have ethical approval. It is advisable to check the wording of the information sheets and approved ethics submission, to see if this is the case.

If the person receiving the tissue was storing it in England, Wales or Northern Ireland and they did not have NHS REC approval then they would need a licence to store this material. However, the situation is different when you are exporting tissue outside of England / Wales / Northern Ireland. A licence would not be required to store the tissue in Scotland.  Please also be aware that there are requirements for the import and export of tissue, please see the HTA Code of Practice on import and export of tissue for more information.
 
Ethical approval of research tissue banks

In July 2009, the HTA and National Research Ethics Service (NRES) agreed a position whereby NHS research ethics committees (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. This approval can extend to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises; individual ethical review of the specific project is not required as this is deemed to be in place as long as it is within the terms of the bank’s ethical approval. Generic ethical review of research tissue banks and all projects receiving non-identifiable tissue from the bank is voluntary.
Applications for ethical review may be made by diagnostic archives planning to operate as research tissue banks. Such diagnostic archives are subject for licensing by the HTA in the same way as for other research tissue banks.  If the archive does not gain generic research tissue bank approval for all projects receiving non-identifiable tissue, the tissue can only be released as follows:

• to another HTA-licensed establishment, or
• for use in a specific project with ethical approval by a REC; therefore exempting it from the need to be stored under an HTA storage licence.

For further information about ethical review of research tissue banks, see the NRES website.

England, Wales and Northern Ireland

The licensing provisions of the Human Tissue Act 2004 apply to establishments storing tissue for research purposes in England, Wales and Northern Ireland. For a summary of when a licence is required and the exemptions to the need for a licence, please see the MRC Regulatory Support Centre's Licensing Summary.

The main exemption to the need for a research licence that is likely to apply is if the relevant material is being stored for research that has, or is pending, approval from an NHS Research Ethics Committee (REC). If samples are going to be stored for uses that are not covered by an NHS REC approval, then a licence will be needed. Alternatively they could be transferred to a licensed establishment, or if appropriate, rendered acellular or disposed of.

The Human Tissue Authority website has a host of accessible information on licensing.  Under the EU Tissues and Cells Directive, the HTA also issues licences for storage of human cells for human application. This may be relevant for some research projects.

Scotland

There is no requirement for a licence to store human tissue for research in Scotland, unless the research involves storage of human cells for human application (as the HTA issues licences for human application in Scotland as well as the rest of the UK).

England, Wales and Northern Ireland
A licence is not required for the storage of relevant material* which has come from the body of a living person, where the person storing it is intending to use it for education or training relating to human health.

There are different licence exemptions for samples that have come from the deceased; please see the HTA guidance.

*For a definition of relevant material, please see the Relevant & Bodily Material Q&A and the Human Tissue Authority guidance.

Scotland
There is no requirement for a licence for the storage of human tissue from the living or deceased for education or training.

Samples collected prior to commencement of the Human Tissue Act 2004 and Human Tissues (Scotland) Act 2006 (1st September 2006) are considered ‘existing holdings’ and as such are exempt from the consent provisions of the HT Act 2004 and exempt from all research provisions in the Scottish Act.

However in England, Wales and Northern Ireland, these samples (if they are “relevant material”, i.e. they consist of or include cells) do need to be stored on licensed premises, or with/pending ethical approval of the project in which the samples will be used. If the samples are being stored for as yet unspecified research purposes, a licence is required from the Human Tissue Authority.

‘Generic Ethical Approval’ is an arrangement that has been set up by National Research Ethics Service.  This is available to all collections of human material within the UK, which is being stored for potential research (described as by NRES as Research Tissue Banks). In England, Wales and Northern Ireland, tissues being stored for use in unspecified research must obtain a licence from the Human Tissue Authority. So only in Scotland is generic ethical review available for collections of tissues in un-licensed premises. 

 ‘Generic Ethical Review’ is voluntary and offered in one of two ways:

1. Ethical review of arrangements for collection and storage of samples only. Each research project utilising the tissue samples requires separate ethical review.
2. Ethical review of arrangements for collection, storage and future use of samples. In this case the end users of non-identifiable samples do not require their projects to undergo separate ethical review, provided the research is carried out within the conditions of the overarching approval.

For more information, please see NRES Standard Operating Procedures sections 11.19-11.34 [2].

Relevant Material
For most of the Human Tissue Act, the term Relevant Material is used (these sections of the Act do not apply to Scotland).

Relevant material is defined as material, other than gametes, which consists of or includes human cells. It specifically excludes embryos outside the body; and hair and nail from a living person.
 
The Human Tissue Authority has produced some comprehensive guidance on how to apply this in practice. Examples typically relevant to research include the following:

• Primary cell cultures that contain original human cells are considered relevant material; whereas established cell lines are not relevant material, as no original cells remain. 
• Samples that are processed to render them acellular, such as plasma are not generally considered relevant material.
• Bodily secretions and excretions are considered relevant material.
• Extracted material from cells (e.g. nucleic acids, cytoplansmic fractions, cell lysates, organells, protein, carbohydrates and lipids) is not relevant material.

Please visit the Human Tissues Authority web pages for more information and examples on the status of specific materials.

Bodily Material
For the section of the Human Tissue Act 2004 (section 45) on Non-consensual DNA analysis (which also applies to Scotland), the term ‘bodily material’ is used. Bodily material is defined as material that has come from the human body (living or deceased) and which consists of or includes human cells. Unlike relevant material, this includes gametes, and hair and nails from the body of a living person. Embryos outside the human body are specifically excepted from Section 45 of the Act. Please note that extracted DNA is not bodily material.

There are other exemptions to this, which include the following:

• where the bodily material is an existing holding (obtained before 1 September 2006) and used for research;
• material that has been manufactured outside the body e.g. cell lines;
• where the results of DNA analysis are used for research, provided the bodily material comes from a living person, the person carrying out the analysis is not in, and not likely to come into, possession of identifying information (samples can be coded) and the research is approved by an NHS (or other committee recognised by the UK Ethics Committee Authority) Research Ethics Committee.

The section, Consent and the use of DNA (sections 152-156), of the Human Tissue Authority's Code of Practice on Consent gives a comprehensive list of ‘excepted material’ and ‘excepted purposes’ (i.e. where the results of the DNA analysis are used for particular ‘excepted’ purposes an offence will not be committed if consent is not in place). Further information can also be found in the HTA Code of practice on Research (sections 49-54).

England, Wales and Northern Ireland

The consent provisions of the Human Tissue Act 2004 will apply. Please see the MRC Regulatory Support Centre's Consent Summary for information on when consent is required for research purposes.

This summarises the provisions of the Act and the Human Tissue Authority's Code of Practice on Consent (updated Sept 2009) [2].

Scotland

There are two pieces of legislation that apply to research involving human tissue in Scotland:

• Human Tissue Scotland Act 2006
• Human Tissue Act 2004 - Section 45: Non-consensual DNA analysis

For more information on applicable human tissue legislation in Scotland, please see the MRC Regulatory Support Centre's Scotland Summary [3].

Supply of tissue to research projects

According to the Human Tissue Authority (HTA), it is not a requirement of a licence that tissue banks supply tissue only to ethically approved projects. It may be a requirement of the ethical approval of the tissue bank, as the information sheet may well say that samples will only be used in future ethically approved projects, and consent is given by the donors on that basis. If this is the case, to comply with these consent terms, all projects aiming to use the banked tissue should have ethical approval. It is advisable to check the wording of the information sheets and approved ethics submission, to see if this is the case.

If the person receiving the tissue was storing it in England, Wales or Northern Ireland and they did not have NHS REC approval then they would need a licence to store this material. However, the situation is different when you are exporting tissue outside of England / Wales / Northern Ireland. A licence would not be required to store the tissue in Scotland.  Please also be aware that there are requirements for the import and export of tissue, please see the HTA Code of Practice on import and export of tissue for more information.
 
Ethical approval of research tissue banks

In July 2009, the HTA and National Research Ethics Service (NRES) agreed a position whereby NHS research ethics committees (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. This approval can extend to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises; individual ethical review of the specific project is not required as this is deemed to be in place as long as it is within the terms of the bank’s ethical approval. Generic ethical review of research tissue banks and all projects receiving non-identifiable tissue from the bank is voluntary.
Applications for ethical review may be made by diagnostic archives planning to operate as research tissue banks. Such diagnostic archives are subject for licensing by the HTA in the same way as for other research tissue banks.  If the archive does not gain generic research tissue bank approval for all projects receiving non-identifiable tissue, the tissue can only be released as follows:

• to another HTA-licensed establishment, or
• for use in a specific project with ethical approval by a REC; therefore exempting it from the need to be stored under an HTA storage licence.

For further information about ethical review of research tissue banks, see the NRES website.

England, Wales and Northern Ireland

The licensing provisions of the Human Tissue Act 2004 apply to establishments storing tissue for research purposes in England, Wales and Northern Ireland. For a summary of when a licence is required and the exemptions to the need for a licence, please see the MRC Regulatory Support Centre's Licensing Summary.

The main exemption to the need for a research licence that is likely to apply is if the relevant material is being stored for research that has, or is pending, approval from an NHS Research Ethics Committee (REC). If samples are going to be stored for uses that are not covered by an NHS REC approval, then a licence will be needed. Alternatively they could be transferred to a licensed establishment, or if appropriate, rendered acellular or disposed of.

The Human Tissue Authority website has a host of accessible information on licensing.  Under the EU Tissues and Cells Directive, the HTA also issues licences for storage of human cells for human application. This may be relevant for some research projects.

Scotland

There is no requirement for a licence to store human tissue for research in Scotland, unless the research involves storage of human cells for human application (as the HTA issues licences for human application in Scotland as well as the rest of the UK).

England, Wales and Northern Ireland
A licence is not required for the storage of relevant material* which has come from the body of a living person, where the person storing it is intending to use it for education or training relating to human health.

There are different licence exemptions for samples that have come from the deceased; please see the HTA guidance.

*For a definition of relevant material, please see the Relevant & Bodily Material Q&A and the Human Tissue Authority guidance.

Scotland
There is no requirement for a licence for the storage of human tissue from the living or deceased for education or training.

Relevant Material
For most of the Human Tissue Act, the term Relevant Material is used (these sections of the Act do not apply to Scotland).

Relevant material is defined as material, other than gametes, which consists of or includes human cells. It specifically excludes embryos outside the body; and hair and nail from a living person.
 
The Human Tissue Authority has produced some comprehensive guidance on how to apply this in practice. Examples typically relevant to research include the following:

• Primary cell cultures that contain original human cells are considered relevant material; whereas established cell lines are not relevant material, as no original cells remain. 
• Samples that are processed to render them acellular, such as plasma are not generally considered relevant material.
• Bodily secretions and excretions are considered relevant material.
• Extracted material from cells (e.g. nucleic acids, cytoplansmic fractions, cell lysates, organells, protein, carbohydrates and lipids) is not relevant material.

Please visit the Human Tissues Authority web pages for more information and examples on the status of specific materials.

Bodily Material
For the section of the Human Tissue Act 2004 (section 45) on Non-consensual DNA analysis (which also applies to Scotland), the term ‘bodily material’ is used. Bodily material is defined as material that has come from the human body (living or deceased) and which consists of or includes human cells. Unlike relevant material, this includes gametes, and hair and nails from the body of a living person. Embryos outside the human body are specifically excepted from Section 45 of the Act. Please note that extracted DNA is not bodily material.

There are other exemptions to this, which include the following:

• where the bodily material is an existing holding (obtained before 1 September 2006) and used for research;
• material that has been manufactured outside the body e.g. cell lines;
• where the results of DNA analysis are used for research, provided the bodily material comes from a living person, the person carrying out the analysis is not in, and not likely to come into, possession of identifying information (samples can be coded) and the research is approved by an NHS (or other committee recognised by the UK Ethics Committee Authority) Research Ethics Committee.

The section, Consent and the use of DNA (sections 152-156), of the Human Tissue Authority's Code of Practice on Consent gives a comprehensive list of ‘excepted material’ and ‘excepted purposes’ (i.e. where the results of the DNA analysis are used for particular ‘excepted’ purposes an offence will not be committed if consent is not in place). Further information can also be found in the HTA Code of practice on Research (sections 49-54).

NHS Research Ethics Committee review

NRES have published a general policy on expedited review of ethical applications in their Standard Operating Procedures for Research Ethics Committees (version 4.0, April 2009, Section 8).

In summary, there is no statutory provision for the expedited review of applications but NRES recognises there may be circumstances whereby an application should be reviewed urgently e.g. where there is a threat to public health.  In these cases, the Chief Investigator (CI) or Sponsor should contact the Operations Director at NRES directly for advice (individual RECs have no authority to expedite applications) and they will consult with the necessary parties before making a decision on whether the application can be submitted for expedited review.

NHS R&D review - NIHR Portfolio studies

The National Institute for Health Research (NIHR) Clinical Research Network (CRN) records the details of research studies which meet specific eligibility criteria in a database known as the NIHR CRN Portfolio.  The following guidance applies to those studies included on this portfolio:

The NIHR Coordinated System for gaining NHS Permission (CSP) standardises and streamlines the process for gaining NHS permission for clinical research studies in England. The system is designed specifically to facilitate NHS permission for multi-centre research but is also applicable to single centre research. In exceptional circumstances where the Department of Health has identified the need to ensure that urgent public health research gains NHS permission as quickly as possible, such studies will be given priority within NIHR CSP. It is the responsibility of the Chief Investigator and their team to work closely with their Comprehensive Local Research Network (CLRN) so that the study is identified for prioritisation.

NHS R&D review – Non-portfolio studies

There is no national system for NHS R&D expedited review. It is local agreement to set up the appropriate arrangements. R&D offices are expected to handle requests for R&D review appropriately and should ensure that they are able to consider such requests and make necessary arrangements. 

In the case of a single centre study, it would be reasonable for the CI to liaise directly with the relevant R&D office to request an expedited review. It would usually be the responsibility of the R&D Director to agree to conduct an expedited review.

In the case of multi-centre studies it could potentially be more difficult to arrange.  In such cases, the Department of Health have stated that NHS organisations should take a pragmatic approach to reviewing these projects.

NHS R&D review - Multi-centre research in Scotland

NHS Research Scotland (NRS) is an initiative developed to streamline the process of obtaining R&D approval for multicentre research studies in Scotland. The process is managed by the NRS coordinating centre (NRSCC), which is the main point of contact for applicants undertaking such studies, and is responsible for liaising with NHS Board R&D offices to facilitate Board and management approval prior to study initiation.

This response applies to England only. Responses for other countries in the UK will be posted on this site in due course.

Negligent Harm

NHS indemnity, in England through the Clinical Negligence Scheme for Trusts (CNST), covers clinical negligence and negligent harm to patients and volunteers in research that involves NHS staff and/or NHS patients1,2

The relevant NHS body will take financial responsibility for compensation for negligent harm unless the study were covered by such other indemnity as may have been agreed between the NHS body and those responsible for the trial i.e. the Sponsor.

The following are examples of potential events/risks which might be considered as negligent harm resulting from a research study:

For all NHS research activity (commercial or non-commercial) liability for clinical negligence on the part of NHS staff lies with the health-care professional’s NHS or honorary NHS employer.

In the event of harm arising out of the design of the study, the employer of the Chief Investigator would be vicariously liable. If the employer is an NHS organisation, the NHS indemnity schemes would need to be consulted to check if this type of cover is provided3.

Non-negligent harm

Apart from liability for defective products, legal liability does not arise where a person is harmed but no one has acted negligently. In some circumstances, an ex-gratia payment may be considered. Even if non-negligent harm is unlikely to occur in a research study, participants should be made aware if there are no insurance arrangements for non-negligent cover.

Source(s)

It is advised by the NHS R & D Forum that “when patient data is disclosed to a third party outside the NHS, or patient tissue or organs are transferred to a third party outside the NHS, the originating NHS organisation should document in writing that the responsibility for actions of that third party in relation to the data, tissues or organs rests with the third party.”
 
“It is important that NHS organisations are aware of the transfer of patient data or tissue samples to third parties and that they ensure that anonymisation is in place or, if this is not possible, that appropriate explicit consent is in place to permit such transfer. It would therefore be appropriate for NHS organisations to receive a copy of the ethics application and approval for the project/ databank in order to receive assurances about these arrangements. However, because the NHS organisation would not wish to retain liability for the use of the data or tissue samples by the third party, it is not appropriate for the NHS organisation to provide permission for the research itself or to extend indemnity. It would, however, be appropriate for the NHS organisation to confirm in writing that it agrees to the arrangements for provision of data or tissue samples.”
 
The MRC also provides guidance on the transfer of data and tissues on the new Data and Tissues Tool Kit.

The National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP isa streamlined system for gaining R&D permission to begin a NIHR Portfolio study at NHS sites in England. The UK Clinical Research Network(UKCRN)Coordinating Centre is leading on the development of NIHR CSP on behalf of the National Institue for Health Research(NIHR)and in collaboration with key partners such as the UK Clinical Research Collaboration, the NHS R&D Forum, industry and researchers.

Information relating to NIHR CSP processes can be accessed from the UKCRN website at http://csp.ukcrn.org.uk/or by emailing the CSP unit at csp@ukcrn.org.uk.

It is advised by the NHS R & D Forum that “when patient data is disclosed to a third party outside the NHS, or patient tissue or organs are transferred to a third party outside the NHS, the originating NHS organisation should document in writing that the responsibility for actions of that third party in relation to the data, tissues or organs rests with the third party.”
 
“It is important that NHS organisations are aware of the transfer of patient data or tissue samples to third parties and that they ensure that anonymisation is in place or, if this is not possible, that appropriate explicit consent is in place to permit such transfer. It would therefore be appropriate for NHS organisations to receive a copy of the ethics application and approval for the project/ databank in order to receive assurances about these arrangements. However, because the NHS organisation would not wish to retain liability for the use of the data or tissue samples by the third party, it is not appropriate for the NHS organisation to provide permission for the research itself or to extend indemnity. It would, however, be appropriate for the NHS organisation to confirm in writing that it agrees to the arrangements for provision of data or tissue samples.”
 
The MRC also provides guidance on the transfer of data and tissues on the new Data and Tissues Tool Kit.

The research passport system provides a mechanism by which researchers can provide NHS R & D offices with details of the pre-engagement checks that have been undertaken by their substantive employer. The aim is to reduce the need for duplicate checks to be carried out on researchers whilst providing robust assurances to NHS organisations regarding the pre-engagement checks the substantive employer has undertaken. It is particularly useful where researchers are conducting research at more than one NHS site.

The research passport system should be used for researchers who conduct research in the NHS, but who have no contractual arrangements with the NHS  e.g. researchers with substantive university employment contracts, students.

A research passport differs from an honorary research contract (HRC) in that it is simply a mechanism for sharing information about pre-engagement checks that have been undertaken. The research passport does not remove the requirement to have an HRC or letter of access and the requirement for these will be determined by the research activity an individual will be undertaking.

An HRC, or a letter accepting the terms of an existing HRC, is required where the individual researcher’s activity could have a foreseeable and direct impact on the quality of care. HRCs ensure that the researcher is accountable to the NHS organisation for their activities that impact on patient care. In addition, HRCs ensure that the substantive employer understands the research activities, the risks involved, and has undertaken all necessary checks.

Further information is available on the NIHR website or from your local CLRN.