Sop Consent

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CARDIFF UNIVERSITY

STANDARD OPERATING PROCEDURE FOR THE USE ORSTORAGE OF HUMAN TISSUE FOR THE PURPOSES OFRESEARCH OR EDUCATION

OBTAINING INFORMED CONSENT

SOP Number: CU/09/HTA 02/3.0 Effective Date:09 Jan 2013

Version Number & Date: 3.0 & Jan 2013 Review Date:09 Jan 2014

Superseded Version Number and Date: CU/11/HTA 02/2.0July 2011

Author:

Carina Hibbs

Sharon Orton

Position:

HTA Governance

Officer, GOVRN

HTA Co-ordinator,GOVRN

____________________

____________________

Signature Date

Approved by:

Professor Jonathan Bisson

Position:

DILicence No 12422 ____________________

Signature Date

DisclaimerWhen using this document, please ensure that the version you are using is the most up todate either by checking on the GOVRN/HTA website for any new versions or contact theHTA Governance Officer to confirm the current version.

Out of date documents must not be relied upon and should be destroyed.


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VersionNumber

Changes to Document Changesauthored by

Date Approved

1.0 Some wording and formatting throughout.Addition of Consent flowchart and tablesdetailing when consent is/is not required.

Carina Hibbs 14/06/2011

2.0 Contact information updatedReinstated original document numbering(eg CU/09/HTA x/3.0 as opposed theincorrect CU/11/HTA x/2.0 as previouslynumbered)

Carina Hibbs 09/01/2013


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CONTENTS PAGE

1. Background

2. Purpose3. Responsible Personnel4. Definitions5. Procedure

5.1 Flowchart for Key Steps Involved in Taking Consent5.2 When is Consent Required?5.3 Who Can Give Consent for the Living?5.4 Who Can Give Consent for the Deceased?5.5 Who Should Take Consent?5.6 The Process of Consent

5.7 Withdrawal or Refusal to Give Consent5.8 Records of Consent5.9 Photographs and Electronic Images of Human Tissue5.10 Consent and the use of DNA

6. References7. Referenced SOPs8. Contacts

Appendix AHTA Supplementary List of MaterialsAppendix BCardiff University HTA Consent Form Checklist


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1 BACKGROUND

The Human Tissue Act 2004 (HT Act) came fully in to force on 1 September 2006.The aim of the HT Act is to provide a legal framework regulating the storage and useof human tissue from the living and the removal storage and use of tissue from thedeceased. It introduces regulation of other activities likepost mortem examinations,and the storage of human material for education, training and research. It is intendedto achieve a balance between the rights and expectations of individuals and families,and broader considerations, such as the importance of research, education, training,pathology and public health surveillance to the population as a whole.

2 PURPOSE

The purpose of this Standard Operating Procedure (SOP) is to ensure that staffinvolved in research covered by the HT Act understand the need and mechanismsfor gaining informed consent from the research subjects.

3 RESPONSIBLE PERSONNEL

This SOP applies to all Cardiff University and UHB Staff who areresponsible forcollecting, using or storing human tissue for research or teaching purposes. The SOPmust be used in conjunction with the Human Tissue Authority Codes of Practice andall other relevant University and, where appropriate, local University Health Boardpolicies and SOPs.

Principal Investigators/Research Supervisors are responsible for ensuring thatthis SOP is correctly applied in the conduct of research and each researcher also hasindividual responsibility for applying this SOP when required to do so.

Individual Members of Staffare responsible for ensuring that this SOP is correctlyapplied when collecting, using or storing human tissue for teaching purposes.

Governance and Compliance Division, in conjunction with the Research andCommercial Division, is responsible for ensuring that the SOP remains fit forpurpose.

4 DEFINITIONS

Anatomical Examination Macroscopic examination of the body of a deceasedperson, or separated parts of such a body, by dissection for anatomical purposes(teaching or studying, or researching into the gross structure of the human body).

Consent Process by which an individual confirms his/her willingness to participatein a particular procedure. The individual must have been informed of all aspects ofthe procedure/request that are relevant to the decision to participate. The individualmust be competent to take the particular decision, be acting voluntarily and not beacting under duress. Informed consent can be documented by means of a written,signed and dated consent form or may be given non-verbally or orally. In the lattercases, a note of the consent should be made by the person taking it.

Designated Individual (DI) The person who is authorised and who supervisesactivities under a licence issued by the Human Tissue Authority.


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5 PROCEDURE

5.1 Flowchart for Key Steps Involved in Taking Consent


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5.2 When is Consent Required?

Consent under the HT Act relates to the purposes for which material might beremoved, stored or used. The tables below summarise when consent is and is notrequired from tissue from the living and the deceased (see also Fetal Tissue andImported Material below).

Consent IS required

Living Deceased

Obtaining scientific or medicalinformation which may berelevant to any person includinga future person

The continued storage or use oftissue following a coroners postmortem

Research in connection withdisorders, or the functioning, ofthe human body (for exceptionssee below or in HTA Code ofPractice 1: Consent)

For the removal, storage and use ofmaterial from the deceased for thefollowing scheduled purposes:

anatomical examination

determining the cause of death

establishing, after a person'sdeath, the efficacy of any drug orother treatment administered tothem

obtaining scientific or medicalinformation, which may be

relevant to any person including afuture person

public display

research in connection withdisorders, or the functioning, ofthe human body

transplantation

clinical audit

education or training relating tohuman health

performance assessment

public health monitoring and quality assurance

Public Display

Transplantation


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Consent is NOT required

Living Deceased

Clinical audit Carrying out an investigation into

the cause of death under theauthority of a coroner

Education or training relating tohuman health (including trainingfor research into disorders, orthe functioning, of the humanbody)

Retention of material after a postmortem under the authority of acoroner, for a period no longerthan the time needed by thecoroner to discharge theirstatutory functions

Performance assessment Keeping material in connectionwith a criminal investigation orfollowing a criminal conviction

Public health monitoring Quality assurance

Research - Tissue from the living maybe stored or used without consentprovided that:

the researcher is not inpossession, and not likely tocome into possession ofinformation that identifies theperson from whom it has come;an d

the material is used for aspecific research project withNRES ethical approval

Fetal TissueThe law does not distinguish between fetal tissue and other tissue from the livingfetal tissue is regarded as the mothers tissue, however, it is recommendedthatconsent is always gained from the mother for the examination, storage of use of fetaltissue.

It is considered good practice that wherever practicable, consent should also beobtained for the use in research of non-fetal products of conception. ResearchEthics Committee approval is always required for the use of fetal tissue and productsof conception in research.

Imported MaterialIn terms of research, the consent provisions of the HT Act do not apply to importedmaterial. However, the HTA considers it good practice for there to be mechanisms inplace to provide assurance that the tissue has been obtained with valid consent.Guidance for those wishing to import human bodies, body parts and tissue fromabroad into England, Wales and Northern Ireland, is set out in HTA Code of Practice8: Import and export of human bodies, body parts and tissue.

Data Protection Act 1998


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Any health related records which identify the living individual who is the source of thetissue sample may constitute that individuals sensitive personal data and as suchthe Data Protection Act 1998 will require that consent is sought for the processing ofsuch data.

5.3 Who Can Give Consent for the Living?

Competent AdultsIf an adult is competent, only they are permitted to give consent. The MentalCapacity Act 2005 requires that there is a presumption that persons aged 16 andabove have capacity to give consent, unless it is established otherwise.

Adults Lacking CapacityWhere it suspected that a person aged 16 and above lacks capacity the relevantmember of staff must conduct an assessment to establish whether the individual can:

understand the nature and purpose of the proposed procedure

understand and retain information relevant to the decision

weigh the necessary information to arrive at a choice

If the person is capable of the above then he/she is capable of giving informedconsent.

In the absence of explicit consent from an incapable individual, consent may bedeemed to be in place for clinical trials authorised and conducted in accordance withThe Medicines for Human Use (Clinical Trials) Regulations 2004, orwhere it isconsistent with paragraphs 30-34 of the Mental Capacity Act 2005, allowing for thestorage and use of relevant material for research in circumstances provided in thatAct.

ChildrenChildren may be asked to consent to the storage and use of their tissue if they arecompetent to do so. A child who has sufficient intelligence and understanding toenable them fully to understand what is involved is considered to be competent togive consent.

It is recommended as good practice that parents of children who are competent togive consent in their own right are still involved in a supportive role in the decision-making process. See Department of Healths guidance Seeking Consent: workingwith children

Where a child is not competent to give consent a person with parental responsibility(as defined in the Children Act 1989 as amended) may give consent on his/herbehalf.

5.4 Who Can Give Consent for the Deceased?

Competent AdultsWhere a person aged 16 or above has, whilst alive and competent, given consent forthe use or storage of tissue for research or teaching purposes, then that consent issufficient for the activity to be lawful. The consent required for anatomicalexamination of a deceased persons body must be written down and witnessed.

Nominated Representatives


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If a deceased adult has neither consented to nor specifically refused any particulardonation or removal, storage or use of their body or tissue those close to themshould be asked whether a nominated representative was appointed to take thosedecisions.

A nominated representative cannot give consent for anatomical examination, but mayconsent to other teaching or research purposes.

More information on nominated representatives and other persons with qualifyingrelationships and the power to give consent can be found in HTA Code of Practice 1:Consent.

ChildrenAs with adults, where a child (under 16) has, whilst alive and competent, givenconsent for the use or storage of tissue for research or teaching purposes, then thatconsent is sufficient for the activity to be lawful. The consent required for anatomicalexamination of a deceased childs body must be written down and witnessed. It will

however still be essential to discuss this with the childs family and to take their viewsand wishes into account before deciding how to proceed.

If a child did not make a decision, or was not competent to make a decision, the Actmakes it clear that the appropriate consent will be that of the person with parentalresponsibility for the child (as defined by the Children Act 1989 as amended).

For more information on consent from others in respect of deceased children seeHTA Code of Practice 1: Consent.

5.5 Who Should Take Consent?

Training in ConsentAll those involved in seeking consent from patients/research participants for theremoval, storage and use of human tissue should receive training in the implicationsand statutory requirements for consent under the HT Act. Training and support in thetaking of consent should also be received.

Records of such training should be kept locally and a copy supplied to the relevantPD. See Cardiff University Standard Operating Procedures Staff Training andManagement of Records for further information.

Clinical SettingWhen consent for participation is to be sought in a clinical setting, if there is a

University Health Board policy on when and how consent is to be obtained from theirpatients this must be followed.

It is important to decide the most appropriate time and place and whether consentwill be taken by someone on behalf of the research project [usually the donorsclinician] or by someone from the research team. The clinician may delegate takingconsent to another suitably trained and qualified healthcare professional.

Whoever is taking consent must have sufficient knowledge of the proposed researchproject or study, the intended use of the tissue and of the risks to the donor, to beable to brief the donor adequately and deal with any questions that may arise.Responsibility for taking consent must not be delegated to untrained or inexperiencedstaff.


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It is good practice to seek consent well in advance of the proposed procedure. NRESguidance is for 24 hours to be given, unless in an emergency situation. Whereapplicable, the clinician should check before starting the procedure that the donor isstill willing.

Non-Clinical SettingHuman tissue samples may be sought from healthy volunteers in a non-clinicalsetting. In such cases, the Chief Investigator should take the consent or delegate thisto a staff member trained in HTA Code of Practice 1: Consent.

Untrained or inexperienced staff or students should not take consent.

The consent procedures detailed in this SOP should be followed. In particular, theresearcher should ensure that the donor is fully informed of the purpose of the studyand of any risks involved.

The researcher must ensure that valid consent is taken and recorded, either by use

of a duly signed and dated consent form or by a note of any non-verbal or oralconsent.

5.6 The Process of Consent

Consent should be seen as part of a continuing process in which individuals, theirrelatives and friends can discuss the issues fully, ask questions and make aninformed choice.

Valid consent can only be given if proper communication has taken place. Particularconsideration should be given to the needs of individuals and families whose firstlanguage is not English. Where consent forms are used, these should be available in

English and any other relevant language depending on the sample populationslanguage profile. See the Cardiff University HTA Consent Form Checklist forinformation on drafting consent forms (Appendix B).

Individuals should be told whether the consent for research is generic or specific, i.e.whether it is consent for use in any future research project which has ethicalapproval.

Anyone seeking consent in respect of a deceased person must have receivedappropriate training/experience in dealing with the bereaved. The HTA Code ofPractice 3: Post-mortem examination, gives more detail.

Any applicable ethical guidelines relating to the process of gaining consent should befollowed as far as practicable.

5.7 Withdrawal or Refusal to Give Consent

Where consent is a legal requirement for the intended purpose and it is refused thenthat tissue may not be used/stored for that purpose lawfully. No-one should becoerced into giving consent as that consent will not be valid.

Where consent is a legal requirement and is given but later withdrawn then this mustbe respected. No further use may be made of the tissue and the sample must bedestroyed/disposed of or returned to the individual, in accordance with their wishes.

5.8 Records of Consent


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In certain areas of research it is likely that consent records will not be held by or bemade available to the researcher. However, it is important that the researcher issatisfied that informed consent has been obtained. This may be by means of a letteror other documentation from the clinician or tissue bank that is supplying the tissueand is responsible for obtaining consent.

If the consent records are held by the researcher, the appropriate requirementsconcerning data protection and security should be followed. Record keeping anddisposal of documentation should be in accordance with the Cardiff University HTAStandard Operating Procedure for Management of Records.

5.9 Photographs and Electronic Images of Human Tissue

The HT Act does not cover photographs or electronic images of human tissue.However, the General Medical Council provides guidance on this issue. Additionally,such images will constitute personal data if linked to information about a living

identifiable individual or individuals. In such cases the Data Protection Act 1998 willrequire that consent is given by the living individuals for their use for research orteaching purposes.

5.10 Consent and the use of DNA

Qualifying consent is required to analyse DNA, subject to certain exceptions. Thismeans that if consent to use material has been obtained under the HT Act for ascheduled purpose, it is not necessary to obtain separate consent where that usealso involves DNA analysis, but that it should be made clear to the donor that theirbodily material may be used for this purpose, if that is the intention. When discussingconsent, the donor should be made aware if the intended DNA analysis may reveal

significant results e.g. a family genetic condition. Their decision on whether they wishsuch information to be made known to them should be respected in appropriatecases.

In most circumstances, it is an offence to hold material with the intent of analysingDNA without qualifying consent. However, the offence does not apply if the results ofthe analysis are intended to be used for excepted' purposes. See HTA Code ofPractice 1: Consentfor details of these excepted purposes.

6 REFERENCES

Children Act 1989:

http://www.legislation.gov.uk/ukpga/1989/41/contents Department of Health:

Seeking Consent: Working with Childrenhttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007005

General Medical Council:Making and Using Visual and Audio Recordings of Patients [May 2002]http://www.gmc-uk.org/guidance/current/library/making_audiovisual.asp#23

General Medical Council:Research: The Role and Responsibilities of Doctors [Feb 2002]http://www.gmc-

uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdf
http://www.legislation.gov.uk/ukpga/1989/41/contentshttp://www.legislation.gov.uk/ukpga/1989/41/contentshttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007005http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007005http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007005http://www.gmc-uk.org/guidance/current/library/making_audiovisual.asp#23http://www.gmc-uk.org/guidance/current/library/making_audiovisual.asp#23http://www.gmc-uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdfhttp://www.gmc-uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdfhttp://www.gmc-uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdfhttp://www.gmc-uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdfhttp://www.gmc-uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdfhttp://www.gmc-uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdfhttp://www.gmc-uk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_31588009.pdfhttp://www.gmc-uk.org/guidance/current/library/making_audiovisual.asp#23http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007005http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007005http://www.legislation.gov.uk/ukpga/1989/41/contents


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HTA Code of Practice 1: Consent, September 2009http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1consent.cfm

HTA Code of Practice 3: Post Mortem Examination, September 2009http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/c

ode3postmortem.cfm Mental Capacity Act 2005:

http://www.legislation.gov.uk/ukpga/2005/9/contents

NRES guidance on consenthttp://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/

The Medicines for Human Use (Clinical Trials) Regulations 2004:http://www.legislation.gov.uk/uksi/2004/1031/contents/made

7 REFERENCED SOPs

Cardiff University HTA SOP Management of Records [CU/09/ HTA 06/3.0]. Cardiff University HTA SOP Staff Training [CU/09/ HTA 07/3.0].
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1consent.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1consent.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1consent.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code3postmortem.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code3postmortem.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code3postmortem.cfmhttp://www.legislation.gov.uk/ukpga/2005/9/contentshttp://www.legislation.gov.uk/ukpga/2005/9/contentshttp://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/http://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/http://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/http://www.legislation.gov.uk/uksi/2004/1031/contents/madehttp://www.legislation.gov.uk/uksi/2004/1031/contents/madehttp://www.legislation.gov.uk/uksi/2004/1031/contents/madehttp://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/http://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/http://www.legislation.gov.uk/ukpga/2005/9/contentshttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code3postmortem.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code3postmortem.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1consent.cfmhttp://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1consent.cfm


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8 CONTACTS

8.1 DI and PDs

Name

School/

UHB Coverage Email Tel

Prof Jonathan BissonDICU/UHB All areas [email protected] (207)43742

Dr Andrea Longman BIOSI PDARUKBBC [email protected] (208)75419

Mr Bill Edwards BIOSI PD BIOSI [email protected] (208)75136

Prof Phil StephensDENTLLead PD DENTL [email protected] (207)42529

Prof Barbara Chadwick DENTL PD DENTL [email protected] (207)46569

Dr Fiona Gagg DENTL PD DENTL [email protected] (207)42546

Dr Alan Gilmour DENTL PD DENTL [email protected] (207)42617

Prof Bharat JasaniMEDICLead PD PATHY [email protected] (207)42700

Dr Paul White MEDIC PDAML andHAEMY [email protected] (207)44524

Dr Ned Powell MEDIC PDICAGE/GYNON [email protected] (207)44742

Mrs Shelley Idziaszczyk MEDIC PDICAGE/MGENE [email protected] (206)87859

Dr Paul Bowden MEDIC PDINIIM inHWB [email protected] (206)87302

Dr Clive Gregory MEDIC PD IPCPH [email protected] (206)87221Dr Kiran Mantripragada MEDIC PD IPMCN [email protected] (206)87063

Prof Nick Topley MEDIC PD ITIME [email protected] (207)43770

Mr Karl HanzelMEDIC PD(assistant) ITIME [email protected] (207)42050

Prof Colin Dayan MEDIC PD MOLEX [email protected] (207)42182

Dr Wendy PowellMEDIC PD(assistant) MOLEX [email protected] (207)48497

Dr Tracey Martin MEDIC SURGY [email protected] (207)46536

Dr Eddie Wang MEDIC PDTenovusBuilding [email protected] (206)87318

Dr Julie Albon OPTOM PD OPTOM [email protected] (208)75427

Dr James Birchall PHRMY PD PHRMY [email protected] (208)75815

Dr Ian Frayling UHB Med Gen [email protected] (207) 44203

8.2 Human Tissue Act Compliance Team

Name Division Position Email Tel

Mrs Sharon Orton GOVRN HTA Co-ordinator [email protected] (208)74888

Dr Carina Hibbs GOVRN Governance Officer [email protected] (208)70231

Mrs Pat Tamplin UHB Governance Officer [email protected]

(207)45879
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


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when blood is separated)

Cell lines** No

Cells that have divided in culture No

CSF (Cerebrospinal fluid) Yes

Cystic fluid Yes

DNA NoEggs* No

Embryonic stem cells (cells derived from an embryo)** No

Embryos (outside the body)* No

Extracted material from cells, e.g. nucleic acids, cytoplasmic

fraction, cell lysates, organelles, proteins, carbohydrates and

lipids.

No

Faeces Yes

Fetal tissue Yes

Fluid from Cystic lesions Yes

Gametes* NoHair (from deceased person) Yes

Hair (from living person) No

Joint Aspirates Yes

Lysed Cells No

Mucus Yes

Nail (from deceased person) Yes

Nail (from living person) No

Nasal and Bronchial Lavage Yes

Non blood derived stem cells (i.e. derived from the body) Yes

Non fetal products of conception (i.e. the amniotic fluid,

umbilical cord, placenta and membranes)

Yes

Organs Yes

Pericardial fluid Yes

Plasma

(Please note: Depending on how plasma is prepared and

processed, it may contain small numbers of platelets and other

blood cells. If any of the se cells are present then the plasma

must be regarded as relevant material).

No

Platelets Yes

Pieural fluid Yes

Primary cell cultures (whole explant/biopsy present) YesPus Yes

RNA No

Saliva Yes

Serum No

Skin Yes

Sperm* No

Sputum (or Phlegm) Yes

Stomach contents Yes

Teeth Yes

Tumour tissue samples Yes

Umbilical cord blood stem cells Yes

Urine Yes


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* While outside the definition of relevant material for the purposes of the HT Act, these

materials fall under the remit of the Human Fertilisation and Embryology Act 1990, and are

regulated by the Human Fertilisation and Embryology Authority (HFEA).

** Cell lines and embryonic stem cell lines fall within the regulatory remit of the HTA byvirtue of the Human Tissue (Quality and Safety for Human Application) Regulations 2007,

which regulates the processing, storage and distribution of stem cell lines for human

application. Both the HFEA and the Medicines and Healthcare products Regulatory Agency

(MHRA) also have a regulatory remit in respect of cell lines and embryonic stem cells lines.

A joint position statement issued by the HTA, HFEA and MHRA provides guidance on the

relevant regulatory remits.

*** Breast milk does not constitute tissue or cells for human application under the (Quality

and Safety for Human Application) Regulations 2007, but is classified as relevant material

for the purposes of the Human Tissue Act 2004 where stored or used for a scheduled

purposes.


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CARDIFF UNIVERSITY HTA CONSENT FORM CHECKLIST

NOTE: To ensure comp liance with this checkl ist , format and contents o f

cons ent forms wil l be monitored durin g internal audits and via School

Research Ethics Comm ittees.

1 Consent Form Contents

This checklist can be used for both patient and non-patient studies. Theconsent form should comprise basic information for the researcher,statements for the patient/participant to initial demonstratingunderstanding/agreement, and signatures of both patient and researcher.

For NHS patients, the original consent form needs to be kept with the patientsmedical notes and two copies need to be made: one for the participant and

one for the researcher.

See Section 2 for an example of an NRES consent form. For some studies afuller, itemised or hierarchical consent form may be needed to cover importantissues, especially if additional elements are optional for the participant.

1.1 Basic Information

Basic information is usually displayed at the top of the consent form andshould include:

o study number,o title of project,o name of researcher,o patient/participant ID number,o contact details.

1.2 Statements

Initial boxes, provided alongside written statements, ensure that thepatient/participant knows exactly to what they are consenting. They also allowthe patient/participant to consent to certain aspects of the study and notothers if that is their choosing. Mandatory statements need to appear on allconsent forms, with additional statements to be included where necessary.

Mandatory statements ensure the patient/participant:o confirms that the information sheet has been read and understood and that

the patient/participant has had the opportunity to ask questions and thesehave been answered satisfactorily;

o understands that participation is voluntary and they are free to withdraw atany time without giving a reason and, if applicable, without their medical careor legal rights being affected;

o understands that their medical notes may be accessed by individualsassociated with the project (if applicable);

o agrees to their GP being informed of their participation in the study (ifapplicable);

o agrees to take part in the study.


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Additional statements will relate to the specific project and might include:

o additional invasive tests or samples required for study purposes only;o consent to use of audio/video-taping, with possible use of verbatim quotation

or use of photographs;o transfer of data/samples to countries with less data protection;o agreement to receive individual feedback from testing;o agreement to being contacted for future studies;o agreement for their DNA to be extracted.;o given as gift - Some RECs have insisted on including a statement confirming

that the tissue had been given as a gift and the donor would have no right to ashare of any profits that might arise from research using it (e.g. as part of anew medical treatment or test).

1.3 Signatures

The signatories to the consent should be those who are involved in the consentprocess, e.g. the participant, the researcher or a representative of the researcher

delegated to take consent.

An independent witness is not routinely required except in the case of consent by aparticipant who may be blind, illiterate etc.

Further information on drafting consent forms can be found on the NRES website1

1http://nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/


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2 EXAMPLE NRES CONSENT FORM(Form to be on headed paper)

Centre Number:

Study Number:

Patient Identification Number for this trial:

CONSENT FORM

Title of Project:

Name of Researcher:

1. I confirm that I have read and understand the information sheet dated....................

(version............) for the above study. I have had the opportunity to consider the

information, ask questions and have had these answered satisfactorily.

2. I understand that my participation is voluntary and that I am free to withdraw at any

time without giving any reason, without my medical care or legal rights being affected.

3. I understand that relevant sections of my medical notes and data collected during the

study, may be looked at by individuals from [company name], from regulatory

authorities or from the NHS Trust, where it is relevant to my taking part in this

research. I give permission for these individuals to have access to my records.

4. I agree to my GP being informed of my participation in the study.

5. I agree to take part in the above study.

Name of Patient Date Signature

Name of Person Date SignatureTaking Consent

When completed: 1 for participant; 1 for researcher site file; 1 (original) to be kept in medical notes.

Please Initial Box

Documents

Sop Consent