1. Application package

1.1 IRAS application completed correctly

Introduction

The completion of the project filter/clinical dataset tailors the application information for the type of research study, by enabling only those questions and sections that are relevant to the study. The accurate completion of the IRAS project filter/clinical dataset is crucial to each study application. The integrated dataset for the study will be created from the answers given to the questions in the IRAS project filter/clinical dataset. The system will generate only those questions and sections that (a) apply to the study type and (b) are required by the bodies reviewing the study. In addition, certain questions are enabled in response to questions in the form itself.

Studies that meet the criteria for study-wide review but that have incorrectly completed project filters will be asked to submit a corrected IRAS form/project study information form if the error has a material effect on the content of the application. Studies that do not meet the criteria will be given appropriate advice on applying through alternative systems (e.g. research outside of the NHS/HSC or non-Research activities).

Particular care should be taken where studies involve:

Ionising radiation and, specifically, research exposures

Procedures involving ionising radiation include:

• diagnostic X-rays, CT scans or DXA scans
• radiotherapy (including brachytherapy and therapy using unsealed sources; or
• radionuclide imaging (including diagnostic imaging and in vivo measurements)

Magnetic Resonance Imaging or ultrasound investigations do not involve ionising radiation

Human biological samples

• new human biological samples are those where the research will involve collecting samples from participants primarily for research purposes
• existing human biological samples are those where the research will involve the use of residual material left over from routine clinical or diagnostic procedures, left over from other research studies or existing stored samples from an archived collection or tissue bank. If the research team will conduct additional analysis on samples taken as per standard care, then they should indicate that they are making use of existing samples

Participants who are children

Research studies with participants who are under 16 years of age are considered to have children as participants. This also includes the use of samples or data from participants who are under 16 years of age.

Participants who are adults lacking capacity to consent for themselves

This includes research studies (both CTIMP and non-CTIMP) where the research could at any stage include adults (aged 16 and over) who are unable to consent for themselves due to physical or mental incapacity (including temporary incapacity). Particular care should be given to the potential for the research study to include further research procedures on or in relation to such participants (including collection of new samples or data) following loss of capacity to consent during the study.

Students undertaking research as part of an educational qualification

Student research means studies which are primarily for the purpose of obtaining an educational qualification. Studies where the main purpose is to undertake specific research – and the educational qualification is secondary – do not fall into this category. Group research (a programme of research designed by academic supervisor to support the attainment of a qualification for a group of students) is not subject to the student research eligibility criteria.

Student eligibility criteria

Undergraduate level

Standalone research health and social care research cannot be carried out by undergraduate students.

Masters’ level

Health and care professionals or trainees on health and care courses studying at health and care research active universities are able carry out research in NHS that requires a full REC review. Masters’ students on health and care courses at health and care research active universities, who are not health and care professionals or trainees, can carry out research in the NHS, but only if it is suitable for Proportionate REC Review and/or non-REC applications (those requiring HRA and HCRW Approval and equivalent in Scotland and Northern Ireland only).

Students studying on other types of courses or where the university is not active in health and care research cannot carry out health and care research in the NHS.

Doctorate level

Doctorate students are eligible to complete standalone health and social care research.

If you have any questions on the eligibility of a specific study, please contact your line manager in the first instance for advice.

Students should not normally take the role of chief investigator at any level of study, as this function should be undertaken by supervisors or course leaders. Exception is made for an experienced care practitioner or manager undertaking an educational qualification for continuing professional development or a doctoral-level study while employed by a health or social care provider or a university, or for a researcher undertaking a doctoral-level study in receipt of a fellowship.

In the case of a clinical trial of an investigational medicinal product, the Chief Investigator must be an authorised health care professional as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended. This can be a doctor, a dentist a nurse or a pharmacist [1]; each role is defined in the regulations. For non-CTIMPs involving significant clinical risk, it may be inappropriate for the Chief Investigator to not be medically qualified.

Students conducting research in the NHS should have on-site supervision from NHS staff (which may include staff with honorary or clinical academic contracts). Universities and colleges should accept the role of sponsor for all educational research conducted by their own students for the purpose of fulfilling the academic requirements of the course. Sponsors of educational research should ensure that their supervisors can and do carry out the activities involved in fulfilling this role.

Identification of participating NHS organisations, nations and ‘site types’

Participating nations should be selected in the IRAS project filter/clinical dataset where the research team expect research sites will be located. A research site is defined as the single organisation responsible for conducting the research at a particular locality. Study wide reviewers should note that the number and definition of site types may vary in different participating nations due to differences in how health services are structured.

The research site is not necessarily the location where research activities will actually take place. For example, in a research project by practice nurses from GP practices, interviews with participants may take place in the participant’s home, but the research site would be the GP practice, because the GP practice would be responsible for the research activity.

Organisations where clinicians or clinical units refer potential participants to the research team for assessment and possible recruitment are not considered to be research sites.

Different participating site types may arise in one of two different contexts.

1. Because of the involvement of different categories of participating organisations, e.g. some NHS organisations may participate as ‘Investigator Sites’ and others as ‘PICs’
2. Where a study where different organisations conduct different activities, and are therefore of different types, but where each of these different groups meets the definition of an ‘Investigator site’

Where the study will involve Participant Identification Centres (PICs) the inclusion of PIC activity can be identified at the outset of a study even if no PICs have yet been identified but any PIC activities must be detailed.

Where NHS organisations are providing data as per routine practice only (e.g. routine monthly returns to the surveillance unit) they are not considered to be research sites. Where the central unit is an NHS organisation, we would expect this to come for governance review to provide assurances to that central organisation as a single centre study. Where NHS/HSC organisations need to undertake additional activities (e.g. provide data from notes, samples, approach patients etc.) to the routine monthly returns, then study wide reviewers should consider if that additional activity is significant enough to constitute a ‘research’ study, or just an extension of the standard surveillance programme.

Study-wide considerations

Consider the study, using the study information provided by the applicant

• is the project research? The HRA decision tool is available for sponsor organisations to inform their decision making process
• have the IRAS project filter/clinical dataset questions been answered correctly?
• have the correct participating nations been identified, with one or more site(s) listed in Part C/Section G for each named nation and, where relevant. have nation specific documents been provided, for example to account for national legislative differences in relation to Adults Lacking Capacity and Minors?
• have the researchers correctly identified the site 'types' that will participate in the research (and provided relevant documents for each site type)