Different kinds of research need different levels of peer review. In general, the greater the burden or potential risk to which the participants are exposed, the more robust and independent the review should be.
In order to help researchers identify the level of review needed for individual projects, the Peer Review service has developed a framework. This should act as guidance for you as to the level that will be required for your project.
The minimum requirements for peer review at each level are as follows:
Level 1 No peer review required
Level 2 Review by project supervisor or departmental colleague
Level 3 Independent internal review
Level 4 External review
Level 5 (NIHR) External review - Two reviews both of which are by experts external to the host institute
A set of examples can be found in the RGIT_SOP_040_Peer Review.pdf
Projects at Levels 3 and 4 should be processed through the PRO, the office can also provide the necessary support for levels 1 and 2 if needed.
Peer review
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
Minimum level of peer review required: No peer review required
Projects in this category:
Studies that have been specifically peer reviewed by 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 RGI team that the relevant grant-giving body had conducted formal peer review of the particular piece of research proposed.
The exemption does include projects that have been reviewed by the Imperial Healthcare Charity and which would otherwise have been considered at Level 2 or 3.
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:
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Routine history taking
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Non-intimate physical examination e.g. joint examination, blood pressure measurement
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Histological studies on existing/historical specimens
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Projects using existing stored data
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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
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Venesection involving a single skin puncture: up to 50mls total from healthy volunteers, 20 mls total from patients (or pro rata for children)
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Taking of blood via existing cannula or at same time as venesection which is part
of normal patient cars: in single or multiple samples, total volumes as above
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Spirometry
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The obtaining or analysis of non-invasive samples, e.g. urine, saliva, faeces.
Examples of projects not included in this category:
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Intimate physical examination
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Histological studies on newly acquired specimens
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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
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Taking of blood: more than 50mls total from healthy volunteers and 20mls total from patients (pro rata for children)
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Physiological experiments on students or healthy volunteers involving an element of risk e.g. hypoxia.
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Administration of drug or device to participants
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:
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Intimate physical examination when appropriate to clinical context
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Taking of up to two blood samples total volume of 100mls for healthy volunteers or total volume of 20mls for patients over the whole project or pro rata for children
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Taking of extra biopsies during biopsy procedure that is part of normal care
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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
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Investigation that involves a minimal risk procedure (e.g. arterial blood gas analysis)
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New acquisition of personal data that are not part of the normal clinical history
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Administration of questionnaires involving "sensitive" information outside of normal clinical practice
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Single-arm study of a drug or device not affecting patient care decisions
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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:
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Intimate physical examination outside of appropriate clinical context
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Use of radiation
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Randomized trials of drugs or devices within their licensed use
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Withdrawal of existing/standard therapy
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:
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Phase I, II and III drug or device trials.
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Randomized trials of drugs or devices within their licensed use
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Intimate physical examination outside of appropriate clinical context
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Use of radiation
Minimum level of peer review required:
NIHR adoption criteria state that two individual experts who are independent of the investigator's host institution and not involved in the study in any way should provide peer review of the research. These reviewers should have been approached independently, i.e. not by the researchers or their team, but only by a third party for instance the Peer Review Office. For portfolio adoption, you must therefore have these reviews in place and RGIT confirmation that they meet the NIHR criteria.
Projects in this category: Projects applying for NIHR portfolio adoption
Examples of projects or procedures in this category:
- Projects eligible for NIHR portfolio adoption.