• Caldicott Guardian

    The Department of Health defines a Caldicott Guardian as "a senior person responsible for protecting the confidentiality of patient and service-user information and enabling appropriate information-sharing. The Guardian plays a key role in ensuring that the NHS, Councils with Social Services responsibilities and partner organisations satisfy the highest practicable standards for handling patient identifiable information".

  • Chief Investigator (CI)

    The Investigator with overall responsibility for the research, who is accountable to their employer, and through them to the sponsor. In a multi-site study the CI has responsibility for design, management and reporting of the study and coordinating investigators who take the lead at each site (i.e. the PIs or Principal Investigators).

    All applications for ethical review should be submitted by the CI.


  • Child

    There are different and confusing definitions of 'child' that affect consent issues in medical research. The situation is best explained in the Children station.


  • Clinical trial

    With the advent of the Clinical Trial Regulations, the term clinical trial is used to describe a trial that tests the safety or efficacy of an investigational medicinal product, i.e. a clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. To avoid confusion we recommend that the term Clinical Trial of an Investigational Medicinal Product or CTIMP be used for this definition.

    In the academic sector the term clinical trial is commonly used more loosely to describe:

    Any prospective evaluation of a health care intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle advice (e.g. dietary advice).


  • Clinical Trial of an Investigational Medicinal Product (CTIMP)

    A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, i.e. a trial that tests the safety or efficacy of an investigational medicinal product. For more information, please see the Clinical Trials Toolkit, Is the trial within the scope of the UK Regulations? station.


  • Clinical Trial Regulations

    The Medicines for Human Use (Clinical Trials) Regulations (2004) is the law within the UK that applies to research into the safety and/or efficacy of investigational medicinal products. These Regulations are how the EU Clinical Trials Directive was transposed into UK legislation. Further information can be found in the Clinical Trials Toolkit.


  • Coded

    Coded samples or data contain identifiable personal information in which the details that could identify people are concealed in a code, but which can be readily decoded by those using it.


  • Competence

    The ability of a person, given the necessary information, to understand the nature and the consequences of the proposed procedure or treatment, and to use that information to make a valid choice in accordance with their own fundamental values.

    In relation to research this would impact upon the person's ability to fully participate within the consent process - i.e. their ability to understand the research project and their proposed role within it and to then make a decision as to whether they would like to participate in the project or not, based on this information.


  • Confidential information

    Any information obtained by a person on the understanding that they will not disclose it to others, or obtained in circumstances where it is expected that they will not disclose it. The law assumes that whenever people give personal information to health professionals caring for them, it is confidential as long as it remains personally identifiable. See also 'Personal data'.


  • Confidentiality

    The duty of persons to whom personal information has been given, not to disclose it without consent or other strong justification (see Duty of Confidentiality/Confidence).


  • Confidentiality Advisory Group (CAG)

    The Confidentiality Advisory Group (CAG) of the Health Research Authority (HRA) provides independent expert advice to the HRA (for research applications) and the Secretary of State for Health (for non-research applications) on whether research applications to access patient information without consent should be approved.  The key purpose of the CAG is to promote and protect the interests of the patient whilst at the same time facilitating appropriate use of confidential patient information for purposes beyond direct patient care.


  • Consent

    An agreement to participate in research, based upon the participant's understanding of the information which has been provided through the course of the consent process.

    Consent is only considered valid when it is:

        -  Voluntarily given;
        -  By a competent person;
        -  Once they have been appropriately informed; and
        -  In practice, indicated (e.g. verbally or signed consent form)


  • Consent form

    A written record of the participant's decision to take part in a research study.


  • Custodian

    The custodian is responsible for the safekeeping of data and/or tissue samples and control of their use, and eventual disposal (if required), all in accordance with legislation and the terms of the consent given by the donor.

    Custodianship implies some rights to decide how the data/samples are used and by whom, and also responsibility for safeguarding the interests of the donors.