P

• Parent / Guardian

  Describes those with legal responsibility for a child. The term, person with parental responsibility is used by the Human Tissue Authority.

   

• Participant

  A person who takes part in a research study or allows their tissue samples or information to be used in research, following appropriate consent, e.g. a patient or a healthy volunteer.

   

• Participant / Patient information sheet (PIS)

  The participant information sheet, in a form appropriate for the study population, explains what the research involves and how the research study will affect the participant. It is usually accompanied by a consent form.

   

• Peer review

  A system whereby research, or research proposals, are reviewed by independent experts to assure the quality of the research (e.g. can the research design answer the question? Does the research add to existing knowledge?).

   

• Personal data

  In the context of the Data Protection Act 1998 personal data comprise information about living people who can be identified from that data, or from combinations of data and other information which the person in control of the data has, or is likely to have in future.

  This includes written and electronic records, opinions, images, recordings and information obtained from samples, from which the person can be identified.

  The terms: confidential personal/patient data/information; identifiable personal/patient information/data; or identifiable confidential information, are used interchangeably and mean the same as personal data.

   

• PI (Principal Investigator)

  The Research Governance Framework defines the Principal Investigator as the leader responsible for a team of individuals conducting a study at a site. In a single site study the PI and the CI are likely to be the same person. (To avoid confusion the term Principal Applicant is being increasingly used to describe the lead investigator on a funding application.)

   

• PIAG (Patient Information Advisory Group) (see NIGB)

  PIAG was established to provide advice on issues of national significance involving the use of patient information and to oversee arrangements created under Section 60 of the Health and Social Care Act 2001. Its membership is drawn from patient groups, healthcare professionals and regulatory bodies.  This has been replaced by the National Information Governance Board (NIGB).

   

• Proposal

  A proposal details the scientific and ethical reasons for research and should demonstrate conceptual innovation, methodological rigor and substantive content. The term is used to refer to a document produced to apply for funding.

   

• Protocol

  A research protocol is a written document demonstrating the necessity and feasibility of a particular study, as well as giving a detailed plan of how the study will be conducted, analysed and disseminated.

   

• Pseudonymised data / information

  Described under the Data Protection Act 1998 to mean where the normal personal identifiers have been replaced by an artificially-created identifier so as to conceal the identity of the patient. The links between the artificial and normal identifiers are stored separately and securely, and so the data may still qualify under the Data Protection Act as personal data. Also referred to as linked anonymous data or coded data.