Integrated Research Application System (IRAS)

Question-specific guidance

Site-specific information form (NHS sites)

This version of the guidance on the Site-Specific Information Form (SSIF) applies to NHS sites only. Separate guidance is available for non-NHS sites.

  • This document includes guidance for all questions relating to NHS sites. The initial filter question must be completed in order to generate the appropriate dataset.

Identifying the research site

  • Whether a site is defined as NHS or non-NHS is not related to the physical location of research activities, but to the organisation that is responsible for the research activity. If a NHS organisation is accountable for the care of participants or the governance of tissue and data then NHS site should be selected when creating the SSI Form.
  • If a study is exempt from Site-Specific Assessment (“SSA-exempt”) for the purposes of ethical review, you should still create SSI Forms that can be used for application to the NHS R&D offices responsible for each site.
  • A research site is defined as the single organisation responsible for conducting the research at a particular locality. Where the research will be conducted at more than one location within the same organisation (for example, where the departments or clinics involved are dispersed at different hospitals within an acute Trust or Health Board), this should normally be considered as a single site.
  • Research sites are organisations responsible for participant-related research procedures specified in the protocol - including recruitment and informed consent. Referral of a patient for assessment and possible recruitment is not part of the conduct of the study. The following are not considered to be research sites:

Clinicians or clinical units making referrals to the research team.

Research units undertaking support functions, e.g. project management, site monitoring, data analysis or report writing.

  • Where “shared care” arrangements are in place between two or more organisations, each of which is responsible for the conduct of some protocol procedures, each organisation should be treated as a separate research site. A SSI Form should be completed for each site. Where facilities or equipment at a different location from the site are used, but the participant remains under the responsibility of the main site, then only one SSI Form needs to be completed. Details of protocol procedures conducted at other locations should be described in the SSI Form for the main site.
  • For further guidance on research sites, see Section 4 of the NRES Standard Operating Procedures

General guidance on the SSI form

  • The Site-Specific Information Form (SSI) Form is a combined form to apply for:

(i)NHS permission for research. NHS permission is required for all researchconducted at NHS sites. Permission is required from each NHS organisationat which research procedures will be conducted.

and, if required,

(ii)Site-specific assessment (SSA ). SSA is a local assessment of the suitabilityof the site and investigator to support the ethical review. It is required forcertain types of research only (see guidance below).

  • The SSI Form should only be completed after Parts A–D of the REC application form have been completed by the Chief Investigator and validated for ethical review by the main REC. The CI will then transfer Parts A-D of the R&D application to the PI to assist in completion of the SSI Form.
  • Some of the answers in the SSI Form will appear automatically and will be identical to the answers the Chief Investigator gave to questions in Parts A and B.

Applying for NHS permission

  • For NHS research sites, NHS permission must be sought from the relevant NHS care organisation before the project starts at the NHS site.
  • NHS permission is always required for a research site, even where the study or the individual site is “SSA-exempt” for the purposes of the ethical review (see below).
  • For information on the documents to submit in an R&D application, please select the checklist and submission tabs. There are different arrangements developing in different parts of the UK for R&D applications and the tabs will provide the appropriate information for your study and site.

Applying for site-specific assessment (SSA)

What is site-specific assessment?

  • SSA is a local assessment of the suitability of each research site and local Principal Investigator to support the ethical review.
  • The outcome of SSA is advice from the local assessor to the main Research Ethics Committee for the research. The main REC considers this advice and decides whether or not to approve the research site as part of the ethical opinion. Confirmation of ethical approval is sent in writing to the Chief Investigator.

Who undertakes site-specific assessment?

  • For NHS sites, the assessment may be undertaken either by the local REC (“SSA REC”) or a NHS R&D office. Responsibility for SSA is in the process of being transferred from RECs to R&D offices, but the timescales for transfer vary across the UK. Local investigators are therefore advised to check the local arrangements before submitting applications.

Is site-specific assessment required for my research?

  • SSA is only required for research involving certain types of research procedure involving more than minimal risk of harm to participants.
  • The NRES Standard Operating Procedures give guidance on procedures at research sites that should normally be regarded by RECs as either requiring SSA or as SSA-exempt. These are summarised in the table below:

Procedures requiring SSA / SSA-exempt procedures
Novel clinical interventions (e.g. IMPs, surgery, radiotherapy, mental health interventions)
Novel clinical assessments (not within routine professional competence of local collaborators)
Clinical use of non-CE marked medical device, or a CE marked device that has been modified or is to be used outside its intended purpose
Additional clinical monitoring under study protocol (outside normal clinical responsibilities)
Taking of informed consent by local collaborators / Investigations or assessments within the routine professional competence of local collaborators (e.g. blood/urine samples, scans, mental health assessments)
Routine clinical monitoring
Questionnaires and surveys
Qualitative research methods
Collection of data or human tissue
Performance evaluation of in vitro diagnostic device (using data/tissue only)
Laboratory tests and analysis
Facilitating participant recruitment
  • RECs will normally treat the following types of research (as identified in the Project Filter) as requiring SSA:

Clinical trials of investigational medicinal products (CTIMPs)

Clinical investigations of medical devices

Combined CTIMP and device investigation

Other clinical trials and investigations

Research involving adults unable to consent for themselves.

  • Other types of research will normally be SSA-exempt except where responsibility forinformed consent is delegated to local collaborators and there is more than minimalrisk of harm to participants. More detailed guidance can be found at paragraphs4.19–4.32 of the NRES SOPs.

How do I find out whether to apply for SSA?

  • The Co-ordinator of the main REC will inform the Chief Investigator whether thestudy appears to require SSA when it validates the application for ethical review. Theadvice will be based on the guidance in the NRES SOPs (see above). The CI mayinstigate applications for SSA as soon as it receives the validation letter.
  • The requirement for SSA will be confirmed by the main REC when it carries out themain review. The main REC will normally confirm the advice given on validation.

What does SSA exemption mean?

  • If a study is “SSA-exempt”, this means that:
  • It is not necessary to submit a Site-Specific Information Form to local RECsat any site, including the “lead site” in a single- or multi-site study.
  • There is no requirement for individual research sites to be approved by themain REC as part of the ethical review.
  • Research with a favourable opinion can be extended to other sites anywherein the UK without requiring SSA or approval by the main REC or other RECs.
  • Policy on SSA exemption applies to single- and multi-site studies in the same way.

Whether or not the study is SSA-exempt, R&D approval must be sought from theNHS R&D office (e.g. NHS Trust or PCT) before the project starts at a NHS site.This is a requirement of the Research Governance Framework. SSA exemptionrelates only to the process of ethical review. Applications for R&D approval inEngland, Wales and Scotland should be made using the Site-Specific InformationForm.

How do I apply for SSA?

  • If SSAs are required, the CI should arrange for the lead investigator or collaborator ateach research site to be designated as local Principal Investigator (PI).
  • The Site-Specific Information Form should then be completed by each PI andsubmitted to the relevant local assessor. The PI should check the localarrangements for SSA before submitting the application.
  • Where the local REC is still responsible for the SSA process (including where it stillreceives applications prior to transfer to R&D), the PI should send a signed versionof the SSI Form to the REC office together with the following documents:

A current CV for the PI (see template in IRAS under “My account”)

A copy of Parts A and B of the main application for ethical review.

  • Once the R&D office has taken on full responsibility for the SSA process in aparticular area of the UK, there will be no need to send any documentation to thelocal REC. All the necessary documentation for SSA purposes will be included in thesubmission to the R&D office for NHS permission.

Question 1-1Study site

  • The name of the NHS organisation responsible for the research site should be identified.
  • For hospital sites, the organisation responsible is normally the name of the NHS Trust (England and Wales), Health Board (Scotland), or HPSS Trust (Northern Ireland).
  • Where the research site is a primary care site, indicate this at question 1-3. Give the name of the primary care organisation for which the site provides contractual services. This is the Primary Care Trust (England), Health Board (Scotland), Local Health Board (Wales) or HPSS Trust (Northern Ireland).
  • The Primary Care Trust (England), Health Board (Scotland), Local Health Board (Wales) or Central Services Agency (Northern Ireland) may itself be the research site in the case of research being conducted into primary, community or social care services that it manages directly. However, in England, Wales and Northern Ireland, if the investigator is employed by the primary care organisation but provides services to an acute Trust on its premises, the research site will normally be the acute Trust. In Scotland, both primary and acute care services are managed by Health Boards.

Question 1-3Primary care sites

  • Selecting primary care site in this question affects which sub-questions appear at questions 2 and 5. Give the name of the research site, which may be a GP practice, general dental practice or other primary care organisation.

Question 2Principal Investigator/ Local Collaborator

  • Where the activities at the site are minimal and the CI will undertake most activities, a PI may not be required but a Local Collaborator based at the site must be identified. The Local Collaborator will normally be the individual with whom the CI has negotiated access to the site or the head of the department where the research will take place, e.g. Head of Pharmacy for research involving questionnaires to pharmacy staff.
  • Where possible, give details of time involvement in Whole Time Equivalents. A PI who will work half-time on this project would be 0.5 WTE, or four hours per week would be about 0.1 WTE based on a 37 hour week. If the involvement in the project is on one occasion rather than a regular input then give the total number of hours.
  • NHS organisations are required to ensure that anyone who has no contractual relationship with any NHS organisation, who will interact with individuals in a way that has direct bearing on the care of NHS patients, holds an NHS honorary research contract. The contract should cover the appropriate time period or have arrangements for extension if required. Where such a contract does not exist, this should be arranged with NHS R&D after submitting the form. A Research Passport system is being implemented during 2008/9 to support issuing of honorary research contracts. For more information see
  • In primary care, anyone who does not hold an honorary or employment contract with the NHS care organisation, who will interact with individuals in a way that has direct bearing on the care of NHS patients, must either:

be contracted to provide NHS services to the NHS care organisation, e.g. many GPs, or

have a substantive or honorary employment contract with someone contracted to provide NHS services to the NHS care organisation, e.g. staff employed by a GP practice.

  • The PI should also submit a summary CV with the application. It is recommended that applicants use the CV template available in IRAS or, if not, the CV should include the areas of information in this template. For example, it should give evidence of previous research in the same field of study, and other relevant experience and training. The length should be a maximum of 2 pages of A4. The CV should be signed and dated prior to submission. Local Collaborators do not need to submit a CV.
  • The SSA will include assessment of whether the local PI has the necessary training and experience to undertake the research described in the proposal.

Question 3Research locations

  • The information supplied in this question should be in sufficient detail to allow the location(s) and scale of the research to be assessed. Explain which parts of the research will take place in each location, and give details of any major equipment or facilities that will be used.
  • NHS R&D will use this information for:

financial assessment

resource assessment

co-ordination of relevant internal authorisations.

  • The SSA will review:

availability of necessary facilities and support services (also taking into account information given in question 19)

the capacity of the PI to supervise the research effectively across all locations

whether research participants will have easy and safe access.

Subsidiary sites

  • Where “shared care” arrangements are in place between two or more organisations, each of which is responsible for the conduct of some protocol procedures, each organisation should be treated as a separate research site.
  • If the procedures conducted at “subsidiary sites” are routine procedures within the normal clinical competence of healthcare professionals at the subsidiary site, that site will be exempt from site-specific assessment and an SSI Form will not need to be submitted to the REC. However, the main REC application should make clear that such arrangements are planned. Where the procedures at subsidiary sites are minimal, e.g. taking a blood sample or performing a routine scan, a copy of the SSI Form for the main site should be submitted to the R&D office for the subsidiary site. The R&D office for the subsidiary site must give permission for the activity at its site and may need to liaise with the R&D office for the main research site. It should be made clear to the subsidiary site, exactly what activities will be undertaken at the site, and which main site is responsible for the research.
  • Where protocol procedures are shared between two or more sites and the involvement is more than minimal, an SSI Form should be submitted to the R&D office for each site, even if the site would still be exempt from site-specific assessment.
  • Where facilities or equipment at a different location from the site are used, but the participant remains under the responsibility of the main site, then only one SSI Form needs to be completed and details of protocol procedures conducted at other locations should be described here.

Question 4Participant Identification Centres

  • This question only applies if A73-1 and A73-2 are both answered Yes.
  • Provide details of Participant Identification Centres that will be involved in identifying potential participants for this research site.

Question 5Members of local research team

  • List other members of the research team for this research at this site who will have a significant research role (e.g. other clinical investigators, trial nurses, staff who will interview participants). Include a complete list of investigators who will be accountable to the named Principal Investigator for the site. Any staff, e.g. clinical trial administrators, who will have access to participant identifiable information should be included in this section. Indicate the individual’s role in the research team.
  • Do not give names of individuals whose involvement in the research is limited to carrying out their normal clinical or administrative duties.
  • All local investigators and research collaborators should comply with the requirements of the relevant Research Governance Framework. This can be found at:
  • Where possible, give details of time involvement in Whole Time Equivalents. A PI who will work half-time on this project would be 0.5 WTE, or four hours per week would be about 0.1 WTE based on a 37 hour week. If the involvement in the project is on one occasion rather than a regular input then give the total number of hours.
  • NHS organisations are required to ensure that anyone who has no contractual relationship with any NHS organisation, who will interact with individuals in a way that has direct bearing on the care of NHS patients, holds an NHS honorary research contract. The contract should cover the appropriate time period or have arrangements for extension if required. Where such a contract does not exist, this should be arranged with NHS R&D after submitting the form. A Research Passport system is being implemented during 2008/9 to support issuing of honorary research contracts. For more information see
  • In primary care, anyone who does not hold an honorary or employment contract with the NHS care organisation, who will interact with individuals in a way that has direct bearing on the care of NHS patients, must either:

be contracted to provide NHS services to the NHS care organisation, e.g. many GPs, or