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HCW/PRO – April 2012 PEER REVIEW LEVELS; REQUIREMENTS FOR PROJECTS Level 1a Minimum level of peer review required: No peer review required Projects in this category: Studies that involve minimal risk to participants Examples of projects or procedures in this category: Short questionnaire studies for use among hospital staff or GPs Questionnaires asking participants about the quality of hospital services, or requesting other non-personal data, taking up to 10 minutes for a patient, or 20 minutes for a healthy volunteer Use of data from medical notes by clinician looking after patient Examples of projects or procedures not included in this category: Acquisition of new personal or laboratory data about patients Lengthy questionnaires that represent a significant burden to the participant (e.g. taking more than 10 minutes for a patient, or 20 minutes for a healthy volunteer) Histological studies on existing/historical specimens Questionnaires involving personal data History taking Non-intimate examination techniques, e.g. blood pressure measurement Spirometry Urinalysis Level 1b Minimum level of peer review required: No peer review required Projects in this category: Studies that have been specifically peer reviewed by either: i)a major grant-giving body or similar organisation. These include the following: UK Research Councils (including the Medical Research Council); the National Institute for Health Research; and Members of the Association of Medical Charities (including the Wellcome Trust and a large number of specialist or disease-specific charities). This exemption does not include projects that are part of a programme grant but which have not been specifically considered by the grant-giving body. Applicants need to be able to demonstrate to the REC and to the IC Joint Research Office that the relevant grant-giving body had conducted formal peer review of the particular piece of research proposed. or ii) a pharmacutical company that has initiated and designed the study. Investigator-led projects that are merely supported by pharmaceutical or other external funding will generally require review through the PRO. 1 HCW/PRO – April 2012 Level 2 Minimum level of peer review required: Departmental colleague or student project supervisor Projects in this category: Low-risk projects with minimal patient involvement Student projects that involve either no patient/participant involvement or only minor involvement Examples of projects or procedures in this category: Routine history taking Non-intimate physical examination e.g. joint examination, blood pressure measurement Non-intimate photography or video recording (where the participant is neither recognizable nor identifiable from the image) Histological studies on existing/historical specimens Projects using existing stored data Administration of simple questionnaires that do not involve “sensitive” (e.g. psychiatric, sexual, drug or end of life-related) information, unless that information is part of normal clinical practice for the condition under study Venesection involving a single skin puncture: up to 50mls from healthy volunteers, 20 mls from patients (or pro rata for children) Taking of blood via existing cannula or at same time as venesection which is part of normal patient care: in single or multiple samples, total volumes as above Spirometry The obtaining or analysis of non-invasive samples, e.g. urine, saliva, faeces. Examples of projects not included in this category: Intimate physical examination Histological studies on newly acquired specimens Questionnaires involving “sensitive” (e.g. psychiatric, sexual, drug or end of life-related) information that is outside normal clinical practice for the condition under study Intimate photography or video recording Taking of blood: more than 50mls from healthy volunteers and 20mls from patients (pro rata for children) Physiological experiments on students or healthy volunteers involving an element of risk e.g. hypoxia. Administration of drug or device to participants Level 3 Minimum level of peer review required: Individual within Imperial College or the applicant’s hospital trust Projects in this category: Projects with minor patient or participant risk Examples of projects or procedures in this category: Intimate physical examination, photography, or video recording when appropriate to clinical context and where the participant is neither recognizable nor identifiable from the image Taking of up to two blood samples of no more than 25mls each from healthy volunteers, 10mls from patients (or pro rata for children) 2 HCW/PRO – April 2012 Taking of extra biopsies during biopsy procedure that is part of normal care A minor lengthening of an invasive procedure (such as less than 5 minutes or 10% added to a procedure that is part of patient care, whichever is the shorter), with little or no extra risk associated with either the investigation or the lengthening of the procedure Investigation that involves a minimal risk procedure (e.g. arterial blood gas analysis) New acquisition of personal data that are not part of the normal clinical history Projects working with genetic material researching a condition known to the patient Administration of questionnaires involving “sensitive” information outside of normal clinical practice Single-arm study of a drug or device not affecting patient care decisions Clinical intervention study or controlled trial with low risk to participants (e.g. a study of an oral nutritional supplement, low vitamin doses, or dietary intervention) Examples of projects or procedures not included in this category: Intimate physical examination, photography, or video recording outside of appropriate clinical context or where the participant is recognizable or identifiable from the image Use of radiation Research involving embryos Projects with the potential for diagnosis of new genetic conditions Randomized trials of drugs or devices within their licensed use Withdrawal of existing/standard therapy Level 4 Minimum level of peer review required: Two reviewers, including one individual outside IC or the applicant’s hospital trust Projects in this category: Projects with greater than minor risk to participants Examples of projects or procedures in this category Phase I, II and III drug or device trials. Randomized trials of drugs or devices within their licensed use Intimate physical examination photography or video recording outside of appropriate clinical context or where the participant is recognizable or identifiable from the image Use of radiation Research involving embryos Projects with the potential for diagnosis of new genetic conditions Additional Considerations Vulnerable Adults In the case of adults who are unable to give consent in situations where consent is deemed to be appropriate, the project should receive review at one Level higher than the project is graded without this condition. 3