CARDIFF UNIVERSITY

STANDARD OPERATING PROCEDURE FOR THE USE OR STORAGE OF HUMAN TISSUE FOR THE PURPOSES OF RESEARCH OR EDUCATION OBTAINING INFORMED CONSENT

SOP Number: CU/09/HTA 02/3.0 Version Number & Date: 3.0 & Jan 2013 Superseded Version Number and Date:

Effective Date: 09 Jan 2013 Review Date: 09 Jan 2014 CU/11/HTA 02/2.0 July 2011

Author: Carina Hibbs

Position: HTA Governance Officer, GOVRN HTA Co-ordinator, GOVRN ____________________

Sharon Orton

____________________ Signature Date

Approved by:

Position:

Professor Jonathan Bisson DI Licence No 12422 ____________________ Signature Date

Disclaimer When using this document, please ensure that the version you are using is the most up to date either by checking on the GOVRN/HTA website for any new versions or contact the HTA Governance Officer to confirm the current version. Out of date documents must not be relied upon and should be destroyed.

CU/09/HTA 02/3.0

Page 1 of 20

Version Number 1.0

Changes to Document

2.0

Changes authored by Some wording and formatting throughout. Carina Hibbs Addition of Consent flowchart and tables detailing when consent is/is not required. Contact information updated Carina Hibbs Reinstated original document numbering (eg CU/09/HTA x/3.0 as opposed the incorrect CU/11/HTA x/2.0 as previously numbered)

Date Approved 14/06/2011

09/01/2013

CU/09/HTA 02/3.0

Page 2 of 20

CONTENTS PAGE 1. 2. 3. 4. 5. Background Purpose Responsible Personnel Definitions Procedure 5.1 Flowchart for Key Steps Involved in Taking Consent 5.2 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 Consent 5.8 Records of Consent 5.9 Photographs and Electronic Images of Human Tissue 5.10 Consent and the use of DNA 6. References 7. Referenced SOPs 8. Contacts Appendix A HTA Supplementary List of Materials Appendix B Cardiff University HTA Consent Form Checklist

CU/09/HTA 02/3.0

Page 3 of 20

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 use of human tissue from the living and the removal storage and use of tissue from the deceased. It introduces regulation of other activities like post mortem examinations, and the storage of human material for education, training and research. It is intended to 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.

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

RESPONSIBLE PERSONNEL This SOP applies to all Cardiff University and UHB Staff who are responsible for collecting, using or storing human tissue for research or teaching purposes. The SOP must be used in conjunction with the Human Tissue Authority Codes of Practice and all other relevant University and, where appropriate, local University Health Board policies and SOPs. Principal Investigators/Research Supervisors are responsible for ensuring that this SOP is correctly applied in the conduct of research and each researcher also has individual responsibility for applying this SOP when required to do so. Individual Members of Staff are responsible for ensuring that this SOP is correctly applied when collecting, using or storing human tissue for teaching purposes. Governance and Compliance Division, in conjunction with the Research and Commercial Division, is responsible for ensuring that the SOP remains fit for purpose.

DEFINITIONS Anatomical Examination Macroscopic examination of the body of a deceased person, 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 participate in a particular procedure. The individual must have been informed of all aspects of the procedure/request that are relevant to the decision to participate. The individual must be competent to take the particular decision, be acting voluntarily and not be acting 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 latter cases, a note of the consent should be made by the person taking it. Designated Individual (DI) The person who is authorised and who supervises activities under a licence issued by the Human Tissue Authority.

CU/09/HTA 02/3.0

Page 4 of 20

Human Tissue Any and all constituent parts of the human body formed by cells. The Human Tissue Authority has issued a Supplementary List of Materials which contains additional information. Human Tissue Authority (HTA) The governing body set up to regulate activities that come under the HT Act. The HTA is a watchdog that supports public confidence by licensing organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions. Informed Consent There is no statutory definition of informed consent although there is extensive literature on the subject and the related field of ethics, see HTA Code of Practice 1: Consent. In relation to consent for use of personal data the Data Protection Act 1998 provides that valid consent must be fully informed and freely given. In terms of consent to participate in clinical trials, section 1.28 of the International Conference for Harmonisation Good Clinical Practice (ICH-GCP) guidelines (1996) states that informed consent is: a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. National Research Ethics Service [NRES] NRES was set up on 1 April 2007 and is part of the National Patient Safety Agency. It incorporated the Central Office for Research Ethics Committee (COREC) and NHS Research Ethics Committee in England. It has a dual mission: to protect the rights, safety, dignity and well-being of research participants, to facilitate and promote ethical research that is of potential benefit to participants, science and society. Person Designate (PD) A person to whom the licence applies and to whom the authority conferred by the licence extends. Each School operating under an HTA Licence should have at least one Person Designate. Principal Investigator (PI) is the appropriately qualified individual at each project site who has responsibility for the conduct of the project at that site. Relevant Material Any material, other than gametes, removed from the body which consists of or includes human cells. In the HT Act references to relevant material from a human body do not include: embryos outside the human body, hair and nail from the body of a living person, cell lines or any other human material created outside the human body, serum, plasma, DNA and RNA, See Appendix A for the HTA Supplementary List of Materials. Standard Operating Procedure [SOP] Detailed, written instructions to achieve uniformity of performance of a specific function.

CU/09/HTA 02/3.0

Page 5 of 20

5 5.1

PROCEDURE Flowchart for Key Steps Involved in Taking Consent

CU/09/HTA 02/3.0

Page 6 of 20

5.2

When is Consent Required? Consent under the HT Act relates to the purposes for which material might be removed, stored or used. The tables below summarise when consent is and is not required from tissue from the living and the deceased (see also Fetal Tissue and Imported Material below).

Consent IS required Living

Obtaining scientific or medical information which may be relevant to any person including a future person Research in connection with disorders, or the functioning, of the human body (for exceptions see below or in HTA Code of Practice 1: Consent)

Deceased
The continued storage or use of tissue following a coroners post mortem

For the removal, storage and use of material from the deceased for the following scheduled purposes: anatomical examination determining the cause of death establishing, after a person's death, the efficacy of any drug or other treatment administered to them obtaining scientific or medical information, which may be relevant to any person including a future person public display research in connection with disorders, or the functioning, of the human body transplantation clinical audit education or training relating to human health performance assessment public health monitoring and quality assurance

Public Display Transplantation

CU/09/HTA 02/3.0

Page 7 of 20

Consent is NOT required Living

Clinical audit

Deceased
Carrying out an investigation into the cause of death under the authority of a coroner Retention of material after a post mortem under the authority of a coroner, for a period no longer than the time needed by the coroner to discharge their statutory functions Keeping material in connection with a criminal investigation or following a criminal conviction

Education or training relating to human health (including training for research into disorders, or the functioning, of the human body) Performance assessment

Public health monitoring Quality assurance Research - Tissue from the living may be stored or used without consent provided that: the researcher is not in possession, and not likely to come into possession of information that identifies the person from whom it has come; and the material is used for a specific research project with NRES ethical approval

Fetal Tissue The law does not distinguish between fetal tissue and other tissue from the living fetal tissue is regarded as the mothers tissue, however, it is recommended that consent is always gained from the mother for the examination, storage of use of fetal tissue. It is considered good practice that wherever practicable, consent should also be obtained for the use in research of non-fetal products of conception. Research Ethics Committee approval is always required for the use of fetal tissue and products of conception in research. Imported Material In terms of research, the consent provisions of the HT Act do not apply to imported material. However, the HTA considers it good practice for there to be mechanisms in place to provide assurance that the tissue has been obtained with valid consent. Guidance for those wishing to import human bodies, body parts and tissue from abroad into England, Wales and Northern Ireland, is set out in HTA Code of Practice 8: Import and export of human bodies, body parts and tissue. Data Protection Act 1998

CU/09/HTA 02/3.0

Page 8 of 20

Any health related records which identify the living individual who is the source of the tissue sample may constitute that individuals sensitive personal data and as such the Data Protection Act 1998 will require that consent is sought for the processing of such data. 5.3 Who Can Give Consent for the Living? Competent Adults If an adult is competent, only they are permitted to give consent. The Mental Capacity Act 2005 requires that there is a presumption that persons aged 16 and above have capacity to give consent, unless it is established otherwise. Adults Lacking Capacity Where it suspected that a person aged 16 and above lacks capacity the relevant member 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 informed consent. In the absence of explicit consent from an incapable individual, consent may be deemed to be in place for clinical trials authorised and conducted in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004, or where it is consistent with paragraphs 30-34 of the Mental Capacity Act 2005, allowing for the storage and use of relevant material for research in circumstances provided in that Act. Children Children may be asked to consent to the storage and use of their tissue if they are competent to do so. A child who has sufficient intelligence and understanding to enable them fully to understand what is involved is considered to be competent to give consent. It is recommended as good practice that parents of children who are competent to give consent in their own right are still involved in a supportive role in the decisionmaking process. See Department of Healths guidance Seeking Consent: working with 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/her behalf. 5.4 Who Can Give Consent for the Deceased? Competent Adults Where a person aged 16 or above has, whilst alive and competent, given consent for the use or storage of tissue for research or teaching purposes, then that consent is sufficient for the activity to be lawful. The consent required for anatomical examination of a deceased persons body must be written down and witnessed. Nominated Representatives

CU/09/HTA 02/3.0

Page 9 of 20

If a deceased adult has neither consented to nor specifically refused any particular donation or removal, storage or use of their body or tissue those close to them should be asked whether a nominated representative was appointed to take those decisions. A nominated representative cannot give consent for anatomical examination, but may consent to other teaching or research purposes. More information on nominated representatives and other persons with qualifying relationships and the power to give consent can be found in HTA Code of Practice 1: Consent. Children As with adults, where a child (under 16) has, whilst alive and competent, given consent for the use or storage of tissue for research or teaching purposes, then that consent is sufficient for the activity to be lawful. The consent required for anatomical examination 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 views and 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 Act makes it clear that the appropriate consent will be that of the person with parental responsibility for the child (as defined by the Children Act 1989 as amended). For more information on consent from others in respect of deceased children see HTA Code of Practice 1: Consent. 5.5 Who Should Take Consent? Training in Consent All those involved in seeking consent from patients/research participants for the removal, storage and use of human tissue should receive training in the implications and statutory requirements for consent under the HT Act. Training and support in the taking of consent should also be received. Records of such training should be kept locally and a copy supplied to the relevant PD. See Cardiff University Standard Operating Procedures Staff Training and Management of Records for further information. Clinical Setting When 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 their patients this must be followed. It is important to decide the most appropriate time and place and whether consent will be taken by someone on behalf of the research project [usually the donors clinician] or by someone from the research team. The clinician may delegate taking consent to another suitably trained and qualified healthcare professional. Whoever is taking consent must have sufficient knowledge of the proposed research project or study, the intended use of the tissue and of the risks to the donor, to be able to brief the donor adequately and deal with any questions that may arise. Responsibility for taking consent must not be delegated to untrained or inexperienced staff.

CU/09/HTA 02/3.0

Page 10 of 20

It is good practice to seek consent well in advance of the proposed procedure. NRES guidance is for 24 hours to be given, unless in an emergency situation. Where applicable, the clinician should check before starting the procedure that the donor is still willing. Non-Clinical Setting Human tissue samples may be sought from healthy volunteers in a non-clinical setting. In such cases, the Chief Investigator should take the consent or delegate this to 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, the researcher should ensure that the donor is fully informed of the purpose of the study and 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 oral consent. 5.6 The Process of Consent Consent should be seen as part of a continuing process in which individuals, their relatives and friends can discuss the issues fully, ask questions and make an informed choice. Valid consent can only be given if proper communication has taken place. Particular consideration should be given to the needs of individuals and families whose first language is not English. Where consent forms are used, these should be available in English and any other relevant language depending on the sample populations language profile. See the Cardiff University HTA Consent Form Checklist for information 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 ethical approval. Anyone seeking consent in respect of a deceased person must have received appropriate training/experience in dealing with the bereaved. The HTA Code of Practice 3: Post-mortem examination, gives more detail. Any applicable ethical guidelines relating to the process of gaining consent should be followed 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 then that tissue may not be used/stored for that purpose lawfully. No-one should be coerced into giving consent as that consent will not be valid. Where consent is a legal requirement and is given but later withdrawn then this must be respected. No further use may be made of the tissue and the sample must be destroyed/disposed of or returned to the individual, in accordance with their wishes. 5.8 Records of Consent

CU/09/HTA 02/3.0

Page 11 of 20

In certain areas of research it is likely that consent records will not be held by or be made available to the researcher. However, it is important that the researcher is satisfied that informed consent has been obtained. This may be by means of a letter or other documentation from the clinician or tissue bank that is supplying the tissue and is responsible for obtaining consent. If the consent records are held by the researcher, the appropriate requirements concerning data protection and security should be followed. Record keeping and disposal of documentation should be in accordance with the Cardiff University HTA Standard 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 will require that consent is given by the living individuals for their use for research or teaching purposes. 5.10 Consent and the use of DNA Qualifying consent is required to analyse DNA, subject to certain exceptions. This means that if consent to use material has been obtained under the HT Act for a scheduled purpose, it is not necessary to obtain separate consent where that use also involves DNA analysis, but that it should be made clear to the donor that their bodily material may be used for this purpose, if that is the intention. When discussing consent, 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 wish such information to be made known to them should be respected in appropriate cases. In most circumstances, it is an offence to hold material with the intent of analysing DNA without qualifying consent. However, the offence does not apply if the results of the analysis are intended to be used for excepted' purposes. See HTA Code of Practice 1: Consent for 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 Children http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPo licyAndGuidance/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.gmcuk.org/Research_the_role_and_responsibilities_of_doctors_2002.pdf_315880 09.pdf

CU/09/HTA 02/3.0

Page 12 of 20

HTA Code of Practice 1: Consent, September 2009 http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/c ode1consent.cfm HTA Code of Practice 3: Post Mortem Examination, September 2009 http://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 consent http://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-andforms/ The Medicines for Human Use (Clinical Trials) Regulations 2004: http://www.legislation.gov.uk/uksi/2004/1031/contents/made

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].

CU/09/HTA 02/3.0

Page 13 of 20

8 8.1

CONTACTS DI and PDs School/ UHB DI CU/UHB BIOSI PD BIOSI PD DENTL Lead PD DENTL PD DENTL PD DENTL PD MEDIC Lead PD MEDIC PD MEDIC PD

Name Prof Jonathan Bisson Dr Andrea Longman Mr Bill Edwards Prof Phil Stephens Prof Barbara Chadwick Dr Fiona Gagg Dr Alan Gilmour Prof Bharat Jasani Dr Paul White Dr Ned Powell

Coverage All areas ARUK BBC BIOSI DENTL DENTL DENTL DENTL PATHY AML and HAEMY ICAGE/ GYNON ICAGE/ MGENE INIIM in HWB IPCPH IPMCN ITIME ITIME MOLEX MOLEX SURGY Tenovus Building OPTOM PHRMY Med Gen

Email BissonJI@cf.ac.uk LongmanAJ1@cf.ac.uk EdwardsWD@cf.ac.uk StephensP@cf.ac.uk ChadwickBL@cf.ac.uk WhiteFS@cf.ac.uk Gilmour@cf.ac.uk Jasani@cf.ac.uk WhitePC@cf.ac.uk PowellNG@cf.ac.uk IdziaszczykSA1@cf.ac.uk Bowden@cf.ac.uk GregoryC1@cf.ac.uk MantripragadaKK@cf.ac.uk Topley@cf.ac.uk HanzelK@cf.ac.uk DayanCM@cf.ac.uk PowellW1@cf.ac.uk MartinTA1@cf.ac.uk WangEC@cf.ac.uk AlbonJ@cf.ac.uk BirchallJC@cf.ac.uk Ian.Frayling@wales.nhs.uk

Tel (207)43742 (208)75419 (208)75136 (207)42529 (207)46569 (207)42546 (207)42617 (207)42700 (207)44524 (207)44742 (206)87859 (206)87302 (206)87221 (206)87063 (207)43770 (207)42050 (207)42182 (207)48497 (207)46536 (206)87318 (208)75427 (208)75815 (207) 44203

Mrs Shelley Idziaszczyk MEDIC PD Dr Paul Bowden Dr Clive Gregory Dr Kiran Mantripragada Prof Nick Topley Mr Karl Hanzel Prof Colin Dayan Dr Wendy Powell Dr Tracey Martin Dr Eddie Wang Dr Julie Albon Dr James Birchall Dr Ian Frayling 8.2 Name Mrs Sharon Orton Dr Carina Hibbs Mrs Pat Tamplin MEDIC PD MEDIC PD MEDIC PD MEDIC PD MEDIC PD (assistant) MEDIC PD MEDIC PD (assistant) MEDIC MEDIC PD OPTOM PD PHRMY PD UHB

Human Tissue Act Compliance Team Division GOVRN GOVRN UHB Position HTA Co-ordinator Email HTA@cf.ac.uk Tel (208)74888 (208)70231 (207)45879

Governance Officer HTA@cf.ac.uk Governance Officer Pat.Tamplin@wales.nhs.uk

CU/09/HTA 02/3.0

Page 14 of 20

APPENDIX A

Supplementary list of materials This list is intended to provide supplementary guidance to the HTAs broader policy framework on relevant material. The list is not intended as exhaustive or exclusive, but is intended to provide guidance to stakeholders in respect of a number of materials that guidance on the status of, as relevant material or otherwise, has previously been sought. The HTA will review and update the list periodically. The list currently refers solely to which human body parts, tissues and cells are defined as relevant materials for the purposes of the Human Tissue Act 2004, in line with the statutory definition above. The HTA intends to expand the list in the future to also provide guidance to the human application sector on which tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Where a material is not included within the following list stakeholders should refer to the policy framework to formulate their own assessment of the materials status in line with the guidance provided in the framework. Materials classified in the following list as relevant material are done so subject to the following general caveat that they are relevant material except where: They have divided or been created outside the human body They have been treated, processed or lysed through a process intended to render them acellular. This would include the freezing or thawing of cells only where that process is intended to render the material acellular. Relevant materials for the purposes of the Human Tissue Act 2004? No No Yes Yes Yes Yes Yes Yes No Yes

Material

Antibodies Artificially created stem cells* Bile Blood Bone Marrow Bones/Skeletons Brain Breast Milk*** Breath Condensates and exhaled gases Buffy coat layer (interface layer between plasma and blood cells

CU/09/HTA 02/3.0

Page 15 of 20

when blood is separated) Cell lines** Cells that have divided in culture CSF (Cerebrospinal fluid) Cystic fluid DNA Eggs* Embryonic stem cells (cells derived from an embryo)** Embryos (outside the body)* Extracted material from cells, e.g. nucleic acids, cytoplasmic fraction, cell lysates, organelles, proteins, carbohydrates and lipids. Faeces Fetal tissue Fluid from Cystic lesions Gametes* Hair (from deceased person) Hair (from living person) Joint Aspirates Lysed Cells Mucus Nail (from deceased person) Nail (from living person) Nasal and Bronchial Lavage Non blood derived stem cells (i.e. derived from the body) Non fetal products of conception (i.e. the amniotic fluid, umbilical cord, placenta and membranes) Organs Pericardial fluid 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). Platelets Pieural fluid Primary cell cultures (whole explant/biopsy present) Pus RNA Saliva Serum Skin Sperm* Sputum (or Phlegm) Stomach contents Teeth Tumour tissue samples Umbilical cord blood stem cells Urine
CU/09/HTA 02/3.0

No No Yes Yes No No No No No

Yes Yes Yes No Yes No Yes No Yes Yes No Yes Yes Yes Yes Yes No

Yes Yes Yes Yes No Yes No Yes No Yes Yes Yes Yes Yes Yes
Page 16 of 20

* 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 by virtue 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.

CU/09/HTA 02/3.0

Page 17 of 20

CARDIFF UNIVERSITY HTA CONSENT FORM CHECKLIST

NOTE: To ensure compliance with this checklist, format and contents of consent forms will be monitored during internal audits and via School Research Ethics Committees. 1 Consent Form Contents

This checklist can be used for both patient and non-patient studies. The consent form should comprise basic information for the researcher, statements for the patient/participant to initial demonstrating understanding/agreement, and signatures of both patient and researcher. For NHS patients, the original consent form needs to be kept with the patients medical 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 a fuller, itemised or hierarchical consent form may be needed to cover important issues, 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 and should include:
o o o o o 1.2 study number, title of project, name of researcher, patient/participant ID number, contact details.

Statements

Initial boxes, provided alongside written statements, ensure that the patient/participant knows exactly to what they are consenting. They also allow the patient/participant to consent to certain aspects of the study and not others if that is their choosing. Mandatory statements need to appear on all consent forms, with additional statements to be included where necessary. Mandatory statements ensure the patient/participant:
o o o o o confirms that the information sheet has been read and understood and that the patient/participant has had the opportunity to ask questions and these have been answered satisfactorily; understands that participation is voluntary and they are free to withdraw at any time without giving a reason and, if applicable, without their medical care or legal rights being affected; understands that their medical notes may be accessed by individuals associated with the project (if applicable); agrees to their GP being informed of their participation in the study (if applicable); agrees to take part in the study.

CU/09/HTA 02/3.0

Page 18 of 20

Additional statements will relate to the specific project and might include: o o o o o o o additional invasive tests or samples required for study purposes only; consent to use of audio/video-taping, with possible use of verbatim quotation or use of photographs; transfer of data/samples to countries with less data protection; agreement to receive individual feedback from testing; agreement to being contacted for future studies; agreement for their DNA to be extracted.; 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 a share of any profits that might arise from research using it (e.g. as part of a new medical treatment or test).

1.3

Signatures The signatories to the consent should be those who are involved in the consent process, 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 a participant who may be blind, illiterate etc.

Further information on drafting consent forms can be found on the NRES website 1

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

CU/09/HTA 02/3.0

Page 19 of 20

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: Please Initial Box

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 Taking Consent

Date

Signature

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

CU/09/HTA 02/3.0

Page 20 of 20