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MHRA and HRA Position on who can act as a Chief Investigator

Last updated on 10 Feb 2020

We have produced this guidance with the Medicines & Healthcare products Regulatory Agency (MHRA) on who can act as the Chief Investigator for Clinical Trials of Investigational Medicinal Products (CTIMPS) taking place in the UK. It includes a definition of the term ‘Authorised Health Professional’ and examples of which professions this term applies to.

    2004/1031 defines the following: 

    "Chief investigator" means:

    a) in relation to a clinical trial conducted at a single trial site, the investigator for that site, or 

    b) in relation to a clinical trial conducted at more than one trial site, the authorised health professional, whether or not he is an investigator at any particular site, who takes primary responsibility for the conduct of the trial;

    "Investigator" means:

    in relation to a clinical trial, the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team;

    The SI also distinguishes between "authorised" health professional and health "care" professional. 

    Authorised health professional is defined as: 

    a) Doctor 

    b) Dentist 

    c) Nurse 

    d) Pharmacist 

    Health care professional is defined as:

    a) Doctor

    b) Dentist

    c) Nurse 

    d) Pharmacist 

    e) a person registered in a register of ophthalmic opticians maintained under section 7 of the Opticians Act 1989

    f) a person registered in a register established and maintained under article 5 of Health Professions Order 2001

    g) a registered osteopath as defined by section 41 of the Osteopaths Act 1993, or 

    h) a registered chiropractor as defined by section 43 of the Chiropractors Act 1994

    Therefore, using the definition of ‘authorised’ health professional, only those professions listed (a) to (d) may act as a Chief Investigator (or an investigator).

    The extended list of healthcare professionals is used to determine the membership of the Ethics Committee in relation to a definition of a ‘lay person’ (as per Schedule 2, (3)).

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