Human Tissue Research at UWE: Operating Procedures

Version3 April 2014

Human Tissue Research at UWE: Operating Procedures Guidance for staff and students

Contents:

1) Introduction 2) What is the Human Tissue Act? 3) What is human tissue? What are relevant materials? 4) Storage of Human Tissue at UWE: Regulatory compliance and ethical approval. i. Ethics approval ii. UWE Register of Research using Human Tissue 5) What is good practice? i. Consent ii. Samples sourced from outside the UK iii. Governance and quality systems iv. Safe and secure storage. v. Using the storage ledger. vi. Transportation and transfer of samples. vii. Disposal

Glossary of terms

Appendix 1 – Ethics Application Form for Research Using Human Tissue Appendix A – Request to register a new research project using human tissue Appendix B – Request to register a research project using imported human tissue Appendix C – Request to register a research project using acellular human tissue

1 Version3 April 2014

1. Introduction. This document aims to set out the University’s policy relating to Research using Human Tissue (HTR). It also outlines the operating procedures related to the ethical review, oversight and management of HTR. The University is committed to high quality research and to promoting high standards of scientific conduct and research practice. As part of the Research Governance Framework the University aims to ensure that researchers are compliant with the law in this area, that research is ethical and of the highest scientific quality.

This is not a guide covering all aspects of the Human Tissue Act as it relates to HTR. Researchers working on human tissue are expected to follow best practice on handling, transport and storage and consent as described by the Human Tissue Authority. Detailed guidelines on the regulatory requirements and codes of practice are available from the Human Tissue Authority website at: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.c fm

2. What is the Human Tissue Act?

The Human Tissue Act 2004 makes consent the fundamental principle underpinning the lawful storage and use of body parts, organs and tissue from the living or the deceased for specified health-related purposes and public display. It also covers the removal of such material from the deceased and lists the purposes for which consent is required which includes research as a ‘scheduled purpose’. The Human Tissue Act 2004 made it an offence to store human tissue without a licence and/or recognised Research Ethics Committee approval.

The key points of the Human Tissue Act 2004

 The Human Tissue Act 2004 regulates the removal, storage and use of human tissue. This is defined as material that has come from a human body and consists of, or includes, human cells.  The Human Tissue Act 2004 creates a new offence of DNA ‘theft’. It is unlawful to have human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came.  The Human Tissue Act 2004 makes it lawful to take minimum steps to preserve the organs of a deceased person for use in transplantation while steps are taken to determine the wishes of the deceased, or, in

the absence of their known wishes, obtaining consent from someone in a qualifying relationship.

Offences under the Human Tissue Act 2004

 Removing, storing or using human tissue for Scheduled Purposes without appropriate consent.  Storing or using human tissue donated for a Scheduled Purpose for another purpose.  Trafficking in human tissue for transplantation purposes.  Carrying out licensable activities without holding a licence from the HTA (with lower penalties for related lesser offences such as failing to produce records or obstructing the HTA in carrying out its power or responsibilities).  Having human tissue, including hair, nail, and gametes (i.e. cells connected with sexual reproduction), with the intention of its DNA being analysed without the consent of the person from whom the tissue came or of those close to them if they have died. (Medical diagnosis and treatment, criminal investigations, etc., are excluded).

The Human Tissue Act (HT Act) is currently regulated by the Human Tissue Authority (HTA), which issues licences for the storage and use of human tissue, carries out inspections on licensed premises and promotes good practice on all aspects of the handling, use, storage and disposal of human tissue. The Human Fertilisation Embryology Authority regulates research using human embryos and gametes (see http://www.hfea.gov.uk/ ). A new ‘Health Research Authority ’ was established in December 2011 and is expected to take on responsibilities relating to human tissue research soon (see http://www.nres.nhs.uk/hra/).

3. What is human tissue and what is ‘relevant material’?

The HT Act defines human tissue as ‘material that has come from a human body and consists of or includes human cells’ and is frequently referred to in the Act as ‘relevant material’. The Act defines relevant material as human tissue, other than gametes, which consists of, or includes cells. Only relevant material is covered by the HT Act.

There are a number of categories of relevant material: 1) Specifically identified relevant material: . Bodily organs and tissues consisting largely or entirely of cells and clearly identifiable and regarded as such. Includes human bodies, internal organs & tissues, skin and bone.

2) Processed material: . Where a processing technique is generally agreed to leave the material either always cellular or acellular, the resulting material should be regarded as such. e.g. the plastinisation of tissues and body parts retains cellular structure and would therefore be considered relevant material, whereas plasma or serum separated from whole blood, generally, would not (however, depending on the process used, plasma may contain small numbers of platelets or blood cells which would be considered relevant material). 3) Bodily waste products: . Bodily waste should normally be considered relevant material as even a single cell may be subject to research. However, there may be cases where a researcher believes a particular material to be acellular. In such cases the researcher should consult the HTA for advice who would refer the case to a member’s panel if necessary. 4) Cell deposits and tissue section on microscope slides: . In general, cell deposits and tissue sections are considered relevant material.

A list of relevant material can be found on the HTA website at: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofreleva ntmaterial.cfm

See also the MRC Regulatory Support Centre e-learning module on Human Tissue at http://www.rsclearn.mrc.ac.uk/ and

MRC Data and Tissues Toolkit: http://www.dt-toolkit.ac.uk/e-learning.cfm

It is the responsibility of the Principal Investigator/Project Leader to understand and be familiar with the requirements of the HTA.

4. Storage of Human at UWE : Regulatory Compliance and Ethical Approval.

UWE does not currently hold an HTA licence for storage of human tissue.

There are a number of conditions under which an institution is exempt from HTA licensing:

 Where a research project using relevant material has been approved by a recognised research ethics committee (e.g. NRES) and the researcher cannot identify the individual from whom the material has come, the relevant material may be stored without a license for the duration of the project. At the end of the project, the relevant material must either be destroyed or returned to the licensed premises.

 Relevant material which has been processed to render the material acellular may be stored without a licence providing that the processing takes a matter of hours or days and certainly no longer than a week.

 Existing holdings of relevant material (those held prior September 1st 2006) are exempt from licensing. However, there may still issues of consent which prevent the free use of such material for research purposes.

4.1 Ethical Approval for research

All Research using Human Tissue requires ethical approval.

Researchers are expected to familiarise themselves with the current guidance provided by NRES on Human Tissue Research to be found at:

NRES Guidance on Human Tissue Research: http://www.nres.npsa.nhs.uk/applications/guidance/research-guidance/

The University’s policy relating to ethical review aligns with NRES Guidance:

1. If your research involves NHS patients (including tissue or organs obtained from them), you will need to obtain NRES approval.

2. If you intend to collect any relevant material and store it for more than 5days then you will need NRES approval (this includes research outside the NHS).

3. If you wish to collect human blood from healthy volunteers to analyse intact cells you will need to apply for NRES approval even if you intend to use it within a short period of time (this includes research outside the NHS).

4. If you wish to collect human blood from healthy volunteers as control groups for a study that also uses materials collected from NHS patients then you should apply for approval to do this at the same time as you submit your NRES application.

5. If you wish to collect human blood or any other relevant material and render it acellular before analysis within 5 days you may apply for ethical review and approval from FREC.

6. If you wish to import human tissue for your research you may apply for ethical review and approval from FREC.

It is the responsibility of the Principal Investigator/Supervisor/Project Manager to obtain appropriate ethical approval for the research.

Applications to NRES using the IRAS system should be sent to Research Administration before submission; Applications will be checked by the Chair of FREC before the sponsor letter is prepared and authorisation given for it to be submitted; Research can only proceed when NRES permission has been received and this permission has been registered with Research Administration in RBI (see below);

Supervisors of students are responsible for checking and approving a student application to NRES before sending it to Research Administration.

Applications to FREC should be submitted using the application form at Appendix 1.

Student applications need prior approval by a supervisor before an application is sent to Research Administration.

External Review If you obtain human tissue samples from a licensed Research Tissue Bank which has generic ethical approval you will need to register your research at UWE but you may not need to submit your project for further ethical review.

See: http://www.nres.npsa.nhs.uk/applications/guidance/research- guidance/#useofhumantissue

If you are a collaborator on a project using human tissue being led by another institution and for which UWE is not a sponsor, it is essential that you are aware of the content of any ethics application submitted to an external REC. It is your responsibility to ensure that your research has appropriate ethical approval. You should lodge a copy of the ethics application with Research Administration.

If you are a collaborator on a project which has received ethical approval and you wish to transfer human tissue samples to UWE you will need to register your research at UWE and submit a copy of any Material Transfer Agreement, the ethics application and approval to FREC. (see section 6 below)

M Level Students Where M Level students will be working on staff projects they may be named as co-researchers on the application form when the initial project is reviewed. If M level students are to be added to a project at a later date an application to the module leader will need to be completed.

4.2 UWE Register of Research Using Human Tissue

From 1st November 2011 all research using human tissue must be registered on the UWE Register of Research using Human Tissue. To do this the PI/Supervisor/Project Manager must complete a registration form:

 Registration of a new research project using Human tissue (Appendix A)  Registration of research project using Human Tissue (Imported tissue). (Appendix B)  Registration of a research project using Human tissue (Acellular materials) (Appendix C)

a) Research which has NRES approval can only proceed when the project has been registered with Research Administration and a copy of the approval submitted;

b) All Research using Human Tissue which has been approved by FREC will also need to be registered;

c) Research with samples brought in from outside the UK can only proceed with permission from FREC and must be registered;

d) Research on human tissue and relevant materials rendered acellular requires FREC approval and must also be registered.

5. What is good practice? The HT Act includes provisions for codes of practice to be made by the HTA on a number of issues. The codes are intended to form part of the regulatory system under the HT Act. Their purpose is to provide guidance to persons carrying out activities within the HTA’s remit and to lay down the standards expected in the carrying out of such activities. The codes provide detailed advice on the matters that they cover and include an explanation of requirements under the HT Act and the Regulations.

The Codes of practice have been divided into nine documents available to download from the HTA website at: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.c fm

Of the nine codes of practice, those of most relevance to the work carried out at UWE are:

Consent, Disposal, Import/Export Research

All researchers using human tissue are expected to familiarise themselves with these codes.

(i) Consent

The HT Act makes consent the fundamental principle underpinning the lawful storage and use of relevant material. However, where the relevant material is from a living person, but the researcher cannot come into possession of information which identifies the persons donating the material and where the material is to be used for a specific research project approved by a recognised research ethics committee (e.g. NRES), specific consent is not required. Researchers should note that 8 Version3 April 2014

material sourced under the above conditions can only be used for the particular research project for which it was obtained. At the end of the project, the material must either be destroyed or consent for further research use obtained from the donors.

Therefore, to facilitate the use of valuable human tissue in research, the HTA advises, in line with the MRC and NRES that consent should be generic because this avoids the need to obtain further consents. It is still important however that consent is valid. If the intention is to store the tissue for an as yet unknown research purpose or as part of a tissue bank for research then this should be explained, setting out the types of research that may be involved, any wider implications and the arrangements for disposal of the tissue.

Source: http://www.hta.gov.uk

See also ‘Good practice in research and consent to research’ guidance document published by the Medical Research Council.

(ii) Samples sourced from outside the UK.

The consent provisions of the HT Act do not apply to relevant material which has been imported into the UK. Nonetheless, the HTA considers it good practice to ensure mechanisms are in place in the source country for obtaining consent as part of the process by which the material is obtained.

(iii) Governance and quality systems. In order to obtain a HTA licence, a facility must demonstrate that it meets a number of core standards for governance & quality systems, suitable premises, storage and disposal facilities. Even where a licence is not being sought, facilities using relevant material in research should strive to meet the core standards in order to follow good practice.  Institutional processes and systems are in place to support and monitor good practice  Regular procedural reviews  Clear lines of reporting and responsibility, documented roles and responsibility, systems of staff training, appraisal and development.  Documented policies and procedures covering all aspects of the storage and use of relevant material in research.  Records must be kept which document consent and allow traceability to tissue stored for research. This should include, names of the principal researcher responsible for the samples use in the project, sample receipt dates, specific storage locations, scope of consent, transfer of material to another project (if permitted) and date and means of disposal.

A key element of adherence to good practice is the maintenance of an appropriate and functional inventory of relevant material used in research projects. Additionally, samples should be logged as they arrive in the laboratory and accurate records kept of storage locations, processing dates and disposal dates. It should be possible to track an individual sample from the point at which it entered the University to the day and means of its’ disposal.

Where ethical approval from a recognised ethics committee is not in place, material can only be stored under the governance of a HTA licence. However, a licence should not be viewed as an alternative to ethical approval

(iv) Safe and secure storage. Premises and facilities for storage must be ‘fit for purpose’. This means that areas used for storage of human tissue for use in research must provide an environment that is safe and secure. for those working under the licence and preserves the integrity of the tissue. The establishment must have contingency arrangements in place should there be an emergency situation that renders the premises unusable for the storage of human tissue for research. Consideration should be given to protecting workers from infection and sample security.

(v) Using the storage ledger. It is also vital the samples be stored in such a way that they can be readily identified and retrieved by a third party using information in the sample ledger. In cases where a researcher has anonymised samples using a coding system, documentation containing the codes and donor information must be kept in a locked cupboard, away from the storage facility. The ledger is intended to hold all the information required to follow good practice on sample documentation and traceability. Details should be entered as soon as the relevant material arrives on site and when the material is processed or disposed of as appropriate. Storage locations must be recorded in sufficient detail to enable a third party to locate the sample should the need arise. The ledger is project specific and should contain the relevant information for that particular project (NRES number, lead worker, etc.). Where a researcher is involved in two or more different projects, a separate ledger must be maintained for each project. The ledger may be in a paper or electronic form – whichever is most convenient for the researcher to allow them to update records as samples arrive, are processed or disposed of. Ledgers are available from Research Administration and the Laboratory Manager.

All Principal Investigators are responsible for ensuring that a storage ledger is used. The ledger may be called in at the end of a project by the Research Administration for audit purposes.

(vi) Transportation and transfer of samples between UWE and other sites or organisations.

A system must be in place which ensures that the traceability of tissue is maintained during transport and delivery. Records should be kept to cover details of: transport and delivery; material transfer agreements with recipients of tissue; SLAs with courier or transport companies. The traceability system should follow the operation of a donor ID system which assigns a unique code to each sample and to each of the products associated with it. When human bodies, body parts and tissue are carried by post or courier, the packaging should conform to the international standards for the transport of hazardous clinical material.

Under the terms of the Human tissue Act, the giving of consent for the use of relevant material in research does not automatically permit the transfer of the material to researchers or projects outside those for which the consent was originally given.

NRES recommends that wherever possible, researchers should seek generic consent (i.e. not limited to the scope of the original project) which also permits the use of the material in future research projects. However, researchers receiving samples from collaborators or other institutions must never assume that such generic consent is in place and in all cases, must obtain documented evidence that consent has been given for the transfer and use of the relevant material in question.

In order to maintain good practice as defined by the Human Tissue Authority, it is important that where collaborating researchers wish to share or transfer 12 Version3 April 2014 any relevant material, they must ensure that the following is in place before the transfer of any material takes place:

 Contact UWE Contracts and Legal Team in the Finance Department [email protected] or [email protected] to arrange a Material Transfer Agreement (MTA).

 Check the terms of the consent given by the research participants, to confirm consent has been given for their donated sample to be sent to collaborators or other institutions in the UK and/or abroad; and if appropriate, if they consented for use in future ethically approved projects. If samples are being transferred to UWE from an external collaborator, it is the responsibility of the recipient principal investigator (PI) to obtain the relevant documentation confirming the terms of consent.

 Where the recipient is to use the samples in a different project (i.e. not the one that they were collected for) and generic consent has not been given, the recipient must seek NHS Research Ethics Committee approval for the use of the samples for their project. The recipient must give written assurance to the sender that ethical approval is in place for the recipient's project.

 If the appropriate consent for transfer is in place, the recipient should be informed in writing, including the terms of that consent. The sender should also agree, in writing, the terms of what the recipient is permitted to do with the samples and stipulate in the agreement that only the agreed analyses should be performed on the samples.

 Samples must in all cases be sent in a coded form, so that no identifiable information is sent with them, unless there is explicit consent for transferring identifiable information from the research

participant and this has been approved by an NHS Research Ethics Committee. If identifiable information is sent subject to these requirements, the recipient must confirm that these data will be treated The relevant material storage ledger must be updated to show when, where and to whom the samples are being transferred.

 The sender should inform the recipient of what should happen to the samples following recipient use (i.e. disposal or return). If disposal, the agreement should stipulate how they should be disposed of. Arrangements for disposal must also be outlined in the participant information sheet.

 In all cases, stipulate that the recipient is not at liberty to use the samples for their own commercial gain, or to send the samples to any other third party.

 Records of all correspondence must be retained and lodged in the UWE Register of Research using Human Tissue held by Research Administration in RBI.

(vii) Disposal. Researchers should consider the issue of disposal at the consent stage. The normal method of disposal is by incineration, but this may not be appropriate for some cultures or religions. Researchers should be aware of this and offer alternatives wherever possible, bearing in mind that the choices regarding disposal are for the individual donor or relative to make. Where practical, relevant material should be bagged separately from other clinical waste but does not need to be separately incinerated. The date and method of disposal must be recorded in the sample ledger.

Source: http://www.hta.gov.uk

Professor Julie Kent Chair of HLS Faculty Research Ethics Committee On behalf of the UWE Human Tissue Working Group February 2012

6. Glossary of Terms.

Appropriate consent: Defined in the HT Act by reference to the person who may give consent. This is broadly either the consent of the person concerned, their nominated representative or (in the absence of either of these) that of a person in a qualifying relationship to them immediately before they died.

Cells: Individual human cells or a collection of human cells when not bound by any form of connective tissue. For establishments licensed for human application this includes cell lines grown outside the human body but not gametes, embryos outside the human body, or blood and blood components.

Designated Individual (DI): The individual designated on the licence to supervise the licensable activities being carried out. DIs are trained by the HTA to carry out this important role and they have statutory responsibilities they must fulfil.

Donor: Every human source, whether living or deceased, of tissue, cells, organs or part organs.

Existing holdings: The body of a deceased person, or any relevant material which has come from the human body, held immediately prior to 1 September 2006.

Licensing: A number of activities can only be carried out where the establishment is licensed under the HT Act by the HTA. Organisations whose activities involve the removal, storage or use of relevant material may need to work under an HTA licence. All establishments working under an HTA licence must work to specified standards set by the HTA.

Licensed premises: Where the licensed activity takes place. If the licensed activity will take place at more than one place, a separate licence will be issued for each place. Premises in different streets or with different postal codes are considered as being in different places. In contrast, different buildings on a hospital site could be regarded as the same place.

NRES: National Research Ethics Service – the body with oversight of NHS based research in the UK that oversees the promotion of ethical research with a view to protecting those that agree to take part in research studies.

Processing: All operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human application.

Relevant material: Defined by the HT Act as material other than gametes, which consists of, or includes, human cells. In the HT Act, references to relevant material from a human body do not include: (a) embryos outside the

16 Version3 April 2014 human body, or (b) hair and nail from the body of a living person. See policy guidance on how to apply this definition on the HTA’s website [ www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_materia l.cfm ].

Research: A study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications of new knowledge.

Recognised Research Ethics Committee: A Research Ethics Committee (REC) established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments [www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyA ndGuidance/DH_4005727 ]; or an ethics committee recognised by United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004 [ www.opsi.gov.uk/si/si2004/20041031.htm ].

Tissue: Any and all constituent part/s of the human body formed by cells.

Valid consent: Consent which has been given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question.

APPENDIX 1

APPLICATION FOR ETHICAL REVIEW (using Human Tissue)

This form should be submitted electronically to Leigh Taylor, Secretary of the Faculty Research Ethics Sub-Committee, ([email protected]) together with all supporting documentation (see below). A paper copy with signatures should be sent to Leigh Taylor, Secretary of the Faculty Research Ethics Sub-Committee,Faculty Research Office Frenchay Campus, within 5 working days of the electronic version.

You are advised to read the guidance notes attached to this form.

Please provide all the information requested and justify where appropriate – the spaces will expand to provide additional space.

For further guidance please contact your AHOD RKE, Dept Ethics Lead, Academic Supervisor or Leigh Taylor ([email protected]) or telephone 0117 328 1170.

Project Details:

Project title

Project funder Proposed project start date

Anticipated project end date

Applicant Details:

Name of Principal Investigator (applicant) Faculty and School Status (Staff/ Postgraduate Student/ Undergraduate Student) Email address Contact postal address

Contact telephone number Name of co-researchers (where applicable)

(for completion by SRESC) Date received: SRESC reference number:

Scrutiny – Cttee/CA Outcome: Applicant informed:

Applicant Details continued:

For student applicants only: Name of Supervisor (for PG and UG student applicants)¹ Supervisor’s email address Supervisor’s telephone number Details of course/degree for which research is being undertaken

¹For student applications supervisors should ensure that all of the following are satisfied before the study begins:

The topic merits further research The student has the skills to carry out the research The participant information sheet or leaflet is appropriate The procedures for recruitment of research participants/donors and obtaining informed consent are appropriate Appropriate arrangements have been made for the processing, storage and disposal of human tissue samples.

Supervisor comments:

Details of the proposed work:

1 Aims and objectives of, and background to the research:

2 Research methodology to be used (include an explanation of why donated human tissue is required for your research and describe any information you intend to collect about the research participants/donors.):

3 Selection of participants/donors: Will the participants be from any of the following groups?(Tick as appropriate)

Children under 18 Adults who are unable to consent for themselves² Adults who are unconscious, very severely ill or have a terminal illness Adults in emergency situations Adults with mental illness (particularly if detained under Mental Health Legislation) Prisoners Young Offenders Healthy Volunteers Those who could be considered to have a particularly dependent relationship with the investigator, e.g. those in care homes, medical students Other vulnerable groups

(² Please note, the Mental Capacity Act requires all intrusive research involving adults who are unable to consent for themselves to be scrutinised by an NHS Local Research Ethics Committee – Please consult the Chair of your Faculty Research Ethics Sub-Committee or Ros Rouse (UWE Research Governance Manager) for advice: [email protected]).

If any of the above applies, please justify their inclusion in this research

Note: If you are proposing to undertake research which involves contact with children or vulnerable adults you will generally need to hold a valid Criminal Records Bureau check. Please provide evidence of the check with your application.

4 Please explain how you will determine your sample size, and identify, approach and recruit your participants/donors:

5 Please describe how you propose to collect, process, store and dispose of the human biological samples.

6 What risks, if any, do the participants/donors face in taking part in this research and how will you minimise these risks?

7 How will you seek informed consent from the participants/donors (include copies of participant information sheets and consent forms)?

8 Please explain how confidentiality will be maintained, and if samples will be anonymised:

9 How have you addressed the health and safety concerns of the participants/donors, researchers and any other people impacted by this study?:

10 Please describe how you will maintain data protection:

11 How will the results of the research be reported and disseminated? (Select all that apply)

Peer reviewed journal Conference presentation Internal report Dissertation/Thesis Other publication Written feedback to research participants Presentation to participants or relevant community groups Other (Please specify below)

12. Other ethical issues: (please describe and address any ethical issues not already covered in your application for example relating to the importation or export of human biological samples, any material transfer agreements.)

Checklist Please complete before submitting form (insert N/A if not applicable)

Yes/No Is a copy of the research proposal attached? - If you have already obtained other external ethics approval is a copy attached? - Will the human blood or other relevant material be rendered acellular within 5 - days? Have you explained how you will select the participants/donors? -

Have you described how you will collect, process, store and dispose of the human - tissue samples? Have you described the ethical issues related to the well-being of - participants/donors? Have you considered health and safety issues for the participants/donors and - researchers? Have you included details of data protection including data storage? - Have you described fully how you will maintain confidentiality? - Is a participant/donor consent form attached? - Is a participant/donor information sheet attached? - Is a copy of any questionnaire/interview or personal data sheet attached? -

Declaration

Principal Investigator

Signed

Supervisor or module leader (where appropriate)

Signed

The form should be emailed to Leigh Taylor, Secretary to the HLS Faculty Research Ethics Committee at [email protected]. A paper copy with signatures should be sent to Leigh Taylor, Secretary of the Faculty Research Ethics Sub-Committee, Faculty Research Office, Frenchay Campus, within 5 working days of the electronic version.

APPLICATION FOR ETHICAL REVIEW OF HUMAN TISSUE RESEARCH USING ‘RELEVANT MATERIAL’: GUIDANCE NOTES

These notes are intended to be read when completing the application form for ethical review of human tissue research using ‘relevant material’. For a definition of what is meant by ‘relevant material’ see: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm

You should familiarise yourself with the Human Tissue Authority (HTA) Codes of Practice on Research; Consent; Disposal, Import and Export which can be found at: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm

Please note that UWE does not currently hold an HTA License for storage of human tissue.

Please ensure that you have considered whether you need approval for your research from a ‘recognised REC’ via the NRES system. If you are uncertain please seek advice from your Dept Ethics Lead, AHoD RKE or Centre Director in the first instance or contact NRES at http://www.nres.nhs.uk/.

1. If your research involves NHS patients (including tissue or organs obtained from them), you will need to obtain NRES approval. 2. If you intend to collect any relevant material and store it for more than 5days then you will need NRES approval. 3. If you wish to collect human blood from healthy volunteers to analyse intact cells you will need to apply for NRES approval even if you intend to use it within a short period of time. 4. If you wish to collect human blood from healthy volunteers as control groups for a study that also uses materials collected from NHS patients then you should apply for approval to do this at the same time as you submit your NRES application. 5. If you wish to collect human blood or any other relevant material and render it acellular within 5 days you may apply for ethical review and approval from FREC using this form. 6. If you wish to import human tissue for your research you may apply for ethical review and approval from FREC using this form.

If your project is approved you will need to complete a registration form to register your research on the UWE Human Tissue Research Register. The registration form may be obtained from Dr Lynne Lawrance [email protected] or Emma Youde, UWE Research Governance: [email protected].

External ethics approval

Where the work has already been subjected to ethical scrutiny, for example by an NHS Local Research Ethics Committee through the National Research Ethics Service (NRES) you should indicate this on the form.

If your research involves NHS patients (including tissue or organs), or NHS Data you will need to get NRES approval. The UWE procedures recognise the burden placed on the researcher in applying for NRES approval. In order to assist PIs in this as far as possible, you should apply for NRES ethics approval first (using the IRAS form) and submit a copy of the application and the letter of approval to your FREC or to UREC (as applicable). This approach has been designed to retain the right of ultimate ‘sign off’ by the University without having to go through a separate protracted University process. UREC has established a panel of volunteers to assist staff and students in making applications to the NRES, by supporting applicants on a one-to-one basis, please contact Leigh Taylor ([email protected] ) for details. However it is important that PIs conducting research in the NHS appreciate that both UWE and NHS Ethics clearance will be needed and are separate. Achievement of the one does not guarantee success with the other.

If you have already received ethical approval from an external research ethics committee you should provide evidence of this with your application to UREC/FREC. You will need to register your research on the UWE Human Tissue Research Register after you obtain NRES and UWE approval to proceed.

If you obtain human tissue samples from a licensed Research Tissue Bank which has generic ethical approval you will need to register your research at UWE but you may not need to submit your project for further ethical review. See: http://www.nres.npsa.nhs.uk/applications/guidance/research-guidance/#useofhumantissue

If you are a collaborator on a project which has received ethical approval and you wish to transfer human tissue samples to UWE you will need to register your research at UWE and submit a copy of any Material Transfer Agreement, the ethics application and approval to FREC.

Doctoral and M Level student applications

For student applications the PI is usually the supervisor who should ensure that all the following are satisfied before the study begins: . The topic merits further research . The student has the skills to carry out the research . The participant/donor information sheet or leaflet is appropriate . The procedures for recruitment of research participants and obtaining informed consent are appropriate. . Appropriate arrangements have been made for the processing, storage and disposal of human tissue samples.

Declaration This should be completed once all the following questions have been answered. Where the application is from a student, a counter-signature from the supervisor is also necessary.

Question 1: Details of the proposed research – Aims and objectives of the research

This should provide the reviewer of the application with sufficient detail to allow him/her to understand the nature of the project and its rationale, in terms which are clear to a lay reader. Do not assume that the reader knows you or your area of work. It may be appropriate to provide a copy of your research proposal.

Question 2: Details of the proposed research – Research methodology to be used

You should explain how you plan to undertake your research. Explain why donated human material is required for your research and describe any information you intend to collect about the participants/donors. Where applicable a copy of any interview schedule/questionnaire/personal data sheet should be attached.

Question 3: Participant details – Participants from vulnerable groups

You must indicate if any of the participants in your sample group are in the categories listed. Any Department of Health funded research involving participants who might not have the capacity to consent may need to go through the new Social Care Research Ethics Committee, unless it is already being reviewed through NRES. If your research subjects fall into any of the specified groups you will need to justify their inclusion in the study, and find out whether you will require a Criminal Records Bureau check.

Members of staff requiring CRB checks should contact Claire Holmes ([email protected]) in Human Resources. CRB checks for students will usually be organised through the student's faculty, but students in faculties without a CRB countersignatory should contact John Rushforth the University's lead countersignatory.

Please note: Evidence of a CRB check should take the form of an email from the relevant CRB countersignatory confirming the researcher has a valid CRB check for working with children and/or vulnerable adults. It will be the responsibility of the applicant to provide this confirmation.

Question 4: Participant details – Determination of sample size, identification and recruitment of participants

In this section you should explain the rationale for your sample size and describe how you will identify and approach potential participants/donors and recruit them to your study.

Question 5: Collection, processing, storage and disposal of human biological samples

You should explain what samples will be collected, who will collect them and how they will be collected. Describe the arrangements for processing the samples (eg rendering them acellular), storing and disposing of them.

Question 6: Risk and risk management – Risks faced by participants/donors

Describe ethical issues related to the physical, psychological and emotional well being of the participants, and what you will do to protect their wellbeing. If you do not envisage there being any risks to the participants/donors please make it clear that you have considered the possibility and justify your approach.

Question 7: Informed consent and withdrawal

Informed consent is an ethical requirement of the research process. Applicants should demonstrate that they are conversant with and have given due consideration to the need for informed consent and that any consent forms prepared for the study ensure that potential research participants/donors are given sufficient information about a study, in a format they understand, to enable them to exercise their right to make an informed decision whether or not to participate in a research study. You should make clear whether consent being sought is project specific or generic.

Consent must be freely given with sufficient detail to indicate what donating human tissue for the study will involve. Withdrawal from future participation in research is always at the discretion of the participant. There should be no penalty for withdrawing and the participant is not required to provide any reason. You should explain how you will deal with the human tissue samples if the donor wishes to withdraw from the study.

You should describe how you will obtain informed consent from the participants/donors and, where this is written consent, include copies of participant/donor information sheets and consent forms. Where other forms of consent are obtained (eg verbal, recorded) you should explain the processes you intend to use. (See also Data access, storage and security below).

Question 8: Confidentiality/anonymity

You should explain what measures you plan to take to ensure that the information provided by research participants is anonymised and how it will be kept confidential. In the event that the data are not to be anonymised, please provide a justification.

Question 9: Risk and risk management – Potential risks to researchers

Describe any health and safety issues including risks and dangers for both the participants and yourself (if appropriate) and what you will do about them. This might include, for instance, arrangements to ensure that a supervisor or co-researcher has details of your whereabouts and a means of contacting you when you conduct interviews away from your base; or ensuring that a ‘chaperone’ is available if necessary for one-to-one interviews.

Question 10 : Data access, storage and security

Describe how you will store the data, who will have access to it, and what happens to it at the end of the project. If your research is externally funded the research sponsors may have specific requirements for retention of records. You should consult the terms and conditions of grant awards for details. For all research the University has recently agreed a policy on research data management (http://info.uwe.ac.uk/secretariat click on records management, then guidance) which you are advised to read before completing your application.

It may be appropriate for the research data to be offered to a data archive. If this is the case it is important that consent for this is included in the participant consent form. For guidance on ensuring that consent for archiving of data is acquired see [new webpage – under construction].

The Data Protection Act 1998 requires individuals to be made aware of how information about them will be managed. For further guidance on the collection of personal data for research purposes and compliance with the Data Protection Act see http://www.uwe.ac.uk/finance/sec/dp/intranet/docs/F29.pdf

Question 11: Publication and dissemination of research results

Please indicate in which forms and formats the results of the research will be communicated.

Question 12: Other ethical issues

This gives the researcher the opportunity to raise any other ethical issues considered in planning the research or which the researcher feels need raising with the Committee. This might include a description and explanation of the import or export of samples. Please describe and attach copies of any material transfer agreements.

Please address any enquiries about the application process which are not covered in these notes either to the contact (named below) for the Faculty Research Ethics Sub-committee to which you are submitting your application or to Leigh Taylor at [email protected] .

APPENDIX A

REQUEST TO REGISTER A (NEW OR EXISTING) RESEARCH PROJECT USING HUMAN TISSUE ‘RELEVANT MATERIALS’

Name of Applicant1: Name of PhD Student (if a PhD project): Title of the Project: Type of ‘relevant material’ being used in the study: NRES Reference Number2 (if applicable): Start Date of Project: End Date of Project: Expiry Date for use of stored samples: HLS Reference Number: Date of Application: Signed by: Print Name:

CHECKLIST Please tick  if relevant Have you submitted a completed ethics application form to the Faculty Research Office?3  Is a copy of the Information Sheet for research participants attached?  Is the Consent Form for research participants attached?  Is a copy of the Approval Letter attached?  Have you notified the laboratory manager of your intention to use imported human tissue samples in your research?  Have you submitted any relevant Material Transfer Agreement for samples obtained from another source?  Have you set up a ledger to record the collection, storage and disposal of human tissue samples?  Have you made appropriate arrangements for the storage and disposal of these samples? 

To be completed by a member of staff from the Faculty Research Office: Date received by Faculty Research Office (FRO):

APPENDIX B

REQUEST TO REGISTER A RESEARCH PROJECT USING (IMPORTED) HUMAN TISSUE ‘RELEVANT MATERIALS’

Name of Applicant1: Name of PhD Student (if a PhD project): Title of the Project: Type of ‘relevant material’ being used in the study: Source of imported materials: NRES Reference Number (if applicable): Start Date of Project: End Date of Project: Expiry Date for use of stored samples: HLS Reference Number: Date of Application: Signed by: Print Name:

CHECKLIST Please tick  if relevant Have you submitted a completed ethics application form (if applicable) to the Faculty Research Office?2  Is a copy of the approval letter attached (if applicable)?  Are you satisfied that the imported samples were obtained in accordance with good ethical practice?  Is a copy of the Materials Transfer Agreement attached?  Have you notified the laboratory manager of your intention to use imported human tissue samples in your research?  Have you set up a ledger to record the storage and disposal of these imported human tissue samples?  Have you made appropriate arrangements for the storage and disposal of these samples? 

APPENDIX C

REQUEST TO REGISTER A RESEARCH PROJECT USING (ACELLULAR) MATERIAL DERIVED FROM HUMAN TISSUE

Name of Applicant1: Name of PhD Student (if a PhD project): Title of the Project: Type of ‘acellular material’ being used in the study: Source of material: NRES Reference Number (if applicable): Start Date of Project: End Date of Project: Expiry Date for use of stored samples: HLS Reference Number: Date of Application: Signed by: Print Name:

CHECKLIST Please tick  if relevant Have you submitted a completed ethics application form (if applicable) to the Faculty Research Office?2  Is a copy of the approval letter attached (if applicable)?  Are you satisfied that the samples were obtained in accordance with good ethical practice?  Have you notified the laboratory manager of your intention to use acellular materials in your research?  Have you set up a ledger to record the storage and disposal of these materials?  Have you made appropriate arrangements for the storage and disposal of these materials? 