Consent and Participant Information Sheet
Preparation Guidance

Glossary

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

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Adult lacking capacity / adult with incapacity

In England and Wales – Capacity is absent if, at the time of decision making:

  • The person in question has impaired functioning of their mind or brain.
  • This impairment makes the person unable to decide whether to participate in this particular research.

A person is deemed unable to decide whether to take part in research if they cannot:

  • Understand the information relevant to the decision (information should be given in a way that is appropriate to the particular person; this might include use of simplified information sheets, pictures or sign language).
  • Retain that information for long enough to make the decision (this may be for a relatively short time, but still long enough to enable decision making to occur).
  • Use or weigh that information as part of the process of making the decision (they need to understand the consequences of each option and of not making the decision).
  • Communicate their decision (whether by talking, using sign language or any other means).

In Scotland – Adults with incapacity 'Incapable' means unable to:

  • Act; or
  • Make decisions;
  • Or communicate decisions;
  • Or understand decisions; or
  • Retain the memory of decisions by reason of mental disorder or of inability to communicate because of physical disability.

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Adverse event (AE)

Any untoward or undesirable occurrence on a particular study.

In relation to a study participant, it can be described as any unfavourable and unintended sign, symptom or disease temporally associated with participation in the research project.

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Anonymisation

The process of rendering data into a form which does not identify individuals and where identification is not likely to take place.

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ABPI

The Association of the British Pharmaceutical Industry

www.abpi.org.uk

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Authorisation

The Human Tissue (Scotland) Act is based on the principle of 'authorisation', an expression which is intended to convey that people have the right to express, during their lifetime, their wishes about what should happen to their bodies after death, in the expectation that those wishes will be respected.

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Caldicott principles

In 1997, the Review of the Uses of Patient-Identifiable Information, chaired by Dame Fiona Caldicott, devised six general principles for information (the Caldicott principles):

  1. Justify the purpose(s)
  2. Every proposed use or transfer of patient identifiable information within or from an organisation should be clearly defined and scrutinised, with continuing uses regularly reviewed, by an appropriate guardian.
  3. Don't use patient identifiable information unless it is absolutely necessary
  4. Patient identifiable information items should not be included unless it is essential for the specified purpose(s) of that flow. The need for patients to be identified should be considered at each stage of satisfying the purpose(s).
  5. Use the minimum necessary patient-identifiable information
  6. Where use of patient identifiable information is considered to be essential, the inclusion of each individual item of information should be considered and justified so that the minimum amount of identifiable information is transferred or accessible as is necessary for a given function to be carried out.
  7. Access to patient identifiable information should be on a strict need-to-know basis
  8. Only those individuals who need access to patient identifiable information should have access to it, and they should only have access to the information items that they need to see. This may mean introducing access controls or splitting information flows where one information flow is used for several purposes.
  9. Everyone with access to patient identifiable information should be aware of their responsibilities
  10. Action should be taken to ensure that those handling patient identifiable information — both clinical and non-clinical staff – are made fully aware of their responsibilities and obligations to respect patient confidentiality.
  11. Understand and comply with the law
  12. Every use of patient identifiable information must be lawful. Someone in each organisation handling patient information should be responsible for ensuring that the organisation complies with legal requirements.

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Capacity / competence

Mental Capacity Act (England and Wales) and Adults with Incapacity (Scotland) Act define incapacity in slightly different ways. Here we give the converse definitions, those for competence or capacity.

In England and Wales – A person has capacity if they:

  • Understand the information relevant to the decision (information should be given in a way that is appropriate to the particular person, this might include use of simplified information sheets, pictures or sign language).
  • Retain that information for long enough to make the decision (this may be for a relatively short time, but still long enough to enable decision making to occur).
  • Use or weigh that information as part of the process of making the decision (they need to understand the consequences of each option and of not making the decision).
  • Communicate their decision (whether by talking, using sign language or any other means).

In Scotland – Adults are considered to have capacity if they are able to:

  • Act; and
  • Make decisions;
  • And communicate decisions;
  • And understand decisions; and
  • Retain the memory of decisions.

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CTIMP

Clinical Trial of an Investigational Medicinal Product (CTIMP)

A Clinical Trial of an Investigational Medicinal Product is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies.

Visit the MHRA algorithm - Is it a clinical trial of a medicinal product?

Visit the MHRA pages on clinical trials for medicines legislation.

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Consultee

Under the Mental Capacity Act (enforced in England and Wales) before an adult who lacks capacity to give consent can be included in research, the researcher must take reasonable steps to identify someone to consult (a consultee), to determine if participation in research is appropriate.

The consultee must be involved in the person's care, interested in their welfare and must be willing to help. They must not be a professional or paid care worker. They will probably be a family member, but could be another person.

A person is not prevented from being a consultee if they are an attorney authorised under a registered Lasting Power of Attorney or are a deputy appointed by the Court of Protection; but that person must not be acting in a professional or paid capacity (for example, person's solicitor).

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Council of Europe

Europe's leading human rights organisation. It includes 47 member states, 28 of which are members of the European Union. All Council of Europe member states have signed up to the European Convention on Human Rights, a treaty designed to protect human rights, democracy and the rule of law.

www.coe.int

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Data controller

'Data controller' means the person who decides the purposes for which, and the manner in which, personal data are to be processed. This may be an individual or an organisation and they must be registered with the Information Commissioner's Office.

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Duty of confidence

You owe a duty of confidence, in common law, when information is given to you and:

  • It is not in the public domain,
  • It has a degree of sensitivity associated with it, and
  • It has been communicated for a limited purpose and in circumstances where the individual is likely to assume an obligation of confidence; for example in the doctor patient relationship.

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Emergency research

Research conducted involving people who are incapacitated and:

  • Who require treatment to be given urgently, and
  • Where it is necessary to take urgent action for the purposes of the study.

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EEA

The European Economic Area is comprised of the 28 member states of the European Union and Iceland, Liechtenstein and Norway.

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GP

General Practitioner (GP)

A medical practitioner who specialises in general practice (i.e. works in the community, usually in a primary healthcare centre). The term General Practitioner or GP is common in the UK and several Commonwealth countries, whilst in North America the nearest equivalent is a family physician.

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Gillick competence

The term used to describe a young person's ability to make a decision regarding consent. Although statute (in England, Wales and Northern Ireland) does not govern the rights of those under the age of 16 to give consent for medical treatment or research, case law provides the example of the Gillick case with respect to treatment. This case determined that where a young person has sufficient understanding and intelligence to understand fully what is proposed, and use and weigh this information in reaching a decision, he or she can consent to treatment themselves and consent from parents is not legally necessary – although parental involvement should always be encouraged.

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GROS

The General Register Office for Scotland (GROS) merged with National Archives of Scotland to form the National Records of Scotland (NRS) in April 2011.

www.nrscotland.gov.uk

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HRA

HTA

Independent / impartial witness

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the consent form and any other written information supplied to the subject.

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ISD

Information Services Division: ISD Scotland

www.isdscotland.org

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ICH GCP

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to achieve greater harmonisation. ICH aims to ensure safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

GCP or Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. GCP aims to deliver safe and ethical trials ensuring valid data is collected.

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Intrusive research

In the context of the Mental Capacity Act (enforced in England and Wales) intrusive research is where "if a person taking part had capacity, the researcher would need to get consent to involve them". It specifically excludes research that falls under the definition of Clinical Trial of an Investigational Medicinal Product (CTIMP).

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IMP

Investigational Medicinal Product.

For further details please visit CTIMP above.

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Ionising Radiation

Procedures involving ionising radiation include:

Diagnostic X-rays, CT scans or DXA scans. Radiotherapy (including brachytherapy and therapy using unsealed sources). Radionuclide imaging (including diagnostic imaging and in vitro measurements).

Magnetic Resonance Imaging (MRI) or ultrasound investigations do not involve ionising radiation.

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Legal representative

This is someone who can legally give consent on behalf of a child / young person or an adult unable by virtue of physical or mental incapacity to give informed consent themselves.

Clinical Trials of Investigational Medicinal Products (CTIMPs)

Legal representative is defined in the Medicines for Human Use (Clinical Trials) Regulations 2004 and relates to a child / young person (or minor) or an adult unable to consent for themselves, and who is, or is being considered as, a subject for a Clinical Trial of an Investigational Medicinal Product (CTIMP):

  • (a) In relation to adults and minors in England, Wales and Northern Ireland, and minors in Scotland, the legal representative can be:
    • (i) A person, other than a person involved in the conduct of the trial, who:
      • (aa) By virtue of their relationship with that adult or that minor, is suitable to act as their legal representative for the purposes of that trial, and
      • (bb) Is available and willing to so act for those purposes, or
    • (ii) If there is no such person, a person, other than a person connected with the conduct of the clinical trial, who is:
      • (aa) The doctor primarily responsible for the medical treatment provided to that adult, or
      • (bb) A person nominated by the relevant health care provider; and
  • (b) In relation to adults in Scotland, the legal representative can be:
    • (i) Any guardian or welfare attorney who has power to consent to the adult's participation in research, or
    • (ii) If there is no such guardian or welfare attorney, the adult's nearest relative, or
    • (iii) If it is not reasonably practicable to contact a guardian or welfare attorney or the adult's nearest relative before the decision to enter the adult as a subject of the clinical trial (i.e. CTIMP) is made, a person, other than a person connected with the conduct of the clinical trial, who is:
      • (aa) The doctor primarily responsible for the medical treatment provided to that adult, or
      • (bb) A person nominated by the relevant health care provider.

Children and young people in non-CTIMPs

In cases across the UK where a child/young person is not deemed competent to give consent themselves, consent can be sought from a parent or someone else with parental responsibility for the child/young person. Consent is valid if it is given by only one person with parental responsibility, provided they are competent, they have been adequately informed and are able to make a voluntary decision.

Adults lacking capacity in non-CTIMPs

In Scotland, an adult may be involved in non-CTIMP research if consent is sought from their legal representative, in this case the legal representative can be:

  • (i) Any guardian or welfare attorney who has power to consent to the adult's participation in research, or
  • (ii) If there is no such guardian or welfare attorney, the adult's nearest relative

In England and Wales no-one is specifically empowered to act as an adult's legal representative in cases where the adult lacks capacity to give consent themselves. Instead the Mental Capacity Act requires that someone is consulted about whether or not the adult should be included in non-CTIMP research. They are asked to give advice rather than to formally give consent. (For further guidance on this role, please refer to the definition of Consultee).

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NHS

National Health Service (England, Wales and Scotland)

www.nhs.uk

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NHS Central Register

In England and Wales

The National Health Service Central Register (NHSCR) compiles and maintains for the Department of Health a computerised record of NHS patients (i.e. those registered with an NHS general practitioner (GP) in England, Wales or the Isle of Man). Further details are available from the Office for National Statistics (ONS) website - The role of the NHS Central Register

In Scotland

The National Health Service Central Register (NHSCR) contains basic demographic details of everyone who was born, or has died, in Scotland plus anyone else who is (or has been) on the list of a general practitioner in Scotland. Further details are available from the National Records of Scotland (NRS) website - National Health Service Central Register: About the register

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NHS Digital

NHS Digital

digital.nhs.uk

Formerly Health and Social Care Information Centre (HSCIC)

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NRS

The National Records of Scotland (NRS) was formed on 1 April 2011 by the merger of the General Register Office for Scotland (GROS) and the National Archives of Scotland.

www.nrscotland.gov.uk

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Nearest relative

Nearest relative is used in Scotland in both the Adults with Incapacity (Scotland) Act and the Human Tissue (Scotland) Act.

The Adults with Incapacity (Scotland) Act uses the hierarchy of relationships defined in the Mental Health (Scotland) Act 1984 as the definition of nearest relative. In decreasing order of closeness, these are:

  • a) Spouse;
  • b) Child;
  • c) Father or mother;
  • d) Brother or sister;
  • e) Grandparent;
  • f) Grandchild;
  • g) Uncle or aunt;
  • h) Nephew or niece

For more detailed information you can access Section 53 of the Mental Health (Scotland) Act

In the Human Tissue (Scotland) Act, nearest relative means (in order from highest to lowest):

  • a) The adult's spouse or civil partner;
  • b) Living with the adult as husband or wife or in a relationship which had the characteristics of the relationship between civil partners and had been so living for a period of not less than 6 months (or if the adult was in hospital immediately before death had been so living for such period when the adult was admitted to hospital);
  • c) The adult's child;
  • d) The adult's parent;
  • e) The adult's brother or sister;
  • f) The adult's grandparent;
  • g) The adult's grandchild;
  • h) The adult's uncle or aunt;
  • i) The adult's cousin;
  • j) The adult's niece or nephew;
  • k) A friend of longstanding of the adult.

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Nominated representative/ nominee

In England, Wales and Northern Ireland

Under the Human Tissue Act, an adult may appoint one or more persons to represent him after his death in relation to consent. Appointment can be made in writing or orally (the latter to be witnessed by at least two adults). The nominated representative's consent cannot be overridden by other individuals, including family members.

In Scotland

Under the Human Tissue (Scotland) Act, a person (aged 12 and over) can, before death, nominate a person or persons to represent them after their death. Nominees can authorise a post mortem examination, the removal of organs or tissues for research and/or the retention of organs or tissue for research. Authorisation by a nominee must be in writing and must be witnessed (for nominees of children over 12, authorisation must be witnessed by two witnesses).

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ONS

Office for National Statistics

www.ons.gov.uk

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Personal legal representative

This is a term used in the Medicines for Human Use (Clinical Trials) Regulations and as such only applies to Clinical Trials of Investigational Medicinal Products (CTIMPs). In this case the personal legal representative is someone who can legally give consent on behalf of a child / young person (or minor) or an adult unable by virtue of physical or mental incapacity, to give informed consent themselves:

  • (a) In relation to adults and minors in England, Wales and Northern Ireland, and minors in Scotland, the legal representative can be:
    • (i) A person, other than a person involved in the conduct of the trial, who:
      • (aa) By virtue of their relationship with that adult or that minor, is suitable to act as their legal representative for the purposes of that trial, and
      • (bb) Is available and willing to so act for those purposes, or
  • (b) In relation to adults in Scotland, the legal representative can be:
    • (i) Any guardian or welfare attorney who has power to consent to the adult's participation in research, or
    • (ii) The adult's nearest relative,

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Professional legal representative

This is someone who can legally give consent on behalf of a child / young person (or minor) or an adult unable by virtue of physical or mental incapacity to give informed consent themselves; in relation to adults and minors in England, Wales and Northern Ireland, and Scotland, where no personal legal representative is available.

It is a person, other than a person connected with the conduct of the clinical trial (i.e. CTIMP), who is:
(aa) The doctor primarily responsible for the medical treatment provided to that adult / minor, or
(bb) A person nominated by the relevant health care provider.

Across the UK a professional legal representative can give consent on behalf of adults and children / young people to take part in Clinical Trials of Investigational Medicinal Products (CTIMPs). However, for all other research, the option of approaching a professional legal representative, if no personal legal representative is available, is only an option in England and Wales.

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Qualifying relationship

In England, Wales and Northern Ireland

Under the Human Tissue Act, if a deceased person has not indicated their consent (or refusal) to post-mortem removal, storage or use of their body or tissue for scheduled purposes (including research), and has not appointed a nominated representative, then appropriate consent may be given by someone who was in a 'qualifying relationship' with the deceased person immediately before their death. The hierarchy of qualifying relationships is as follows (highest first):

  1. Spouse or partner (including civil or same sex partner). The Human Tissue Act States that, for these purposes, a person is another person's partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship.
  2. Parent or child (in this context a child may be of any age and means a biological or adopted child)
  3. Brother or sister
  4. Grandparent or grandchild
  5. Niece or nephew
  6. Stepfather or stepmother
  7. Half-brother or half-sister
  8. Friend of long standing

For a full definition of 'qualifying relationship' you should visit paragraphs 83 to 87 in the HTA Code of Practice on Consent.

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Research

The primary aim of research is to derive generalisable new knowledge. A clear definition and clarification of how research differs from audit and service evaluation can be found in the HRA Defining Research leaflet.

To help you decide if your study is defined as research, the HRA have a web-based decision making tool: Is my study research?

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R&D

Research and Development (R&D)

This term is used generically to describe Research and Development offices or departments within either NHS organisations or universities.

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Research Database

The HRA define a 'research database' as:

A collection of data, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending.

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Research Ethics Committee (REC)

A research ethics committee is a group of people appointed to review research proposals to assess formally if the research is ethical. This means the research must conform to recognised ethical standards, which includes respecting the dignity, rights, safety and well-being of the people who take part.

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Research Tissue Bank

The HRA define a 'research tissue bank' (or 'biobank') as:

A collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending

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Sponsor

The Medicines for Human Use (Clinical Trials) Regulations define the sponsor of a clinical trial as "the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial".

Note: The Clinical Trials Regulations allow for two or more persons to take responsibility for the functions of the sponsor. Where this applies, they require that one of the sponsors should take responsibility for each of the following functions:

(a) Communications relating to substantial amendments, modified amendments and the conclusion of the trial
(b) Communications relating to urgent safety measures
(c) Pharmacovigilance reporting.

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STRATUM

Strategic Tissue Repository Alliances Through Unified Methods (STRATUM)

www.stratumbiobanking.org

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Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. We have used the term participant rather than subject throughout this guidance.

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Welfare Attorney

In Scotland:

A power of attorney is an authority given by an individual (known as the Granter) to another person(s) (known as the Attorney/s) to deal with aspects of the Granter's affairs, under the Adult with Incapacity (Scotland) Act. In the case of Welfare Attorney, the Granter gives authority to deal with their personal welfare.

Welfare powers cannot be exercised until such time as the Granter has lost the capacity to make these decisions. A Welfare Attorney can be anyone the granter trusts: a relative, a friend or a professional person.

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Welfare Guardian

In Scotland:

A Welfare Guardian is a person who is appointed by court to take action and make decisions on behalf of an adult with incapacity, in relation to that adult's personal welfare; under the Adults with Incapacity (Scotland) Act.

Guardianship is likely to be more suitable where the adult has long-term needs in relation to these matters. The standard term for a guardianship appointment is 3 years, although the Sheriff has the discretion to make the appointment for a longer or shorter period. Welfare Guardians are supervised by local authorities.

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