Integrated Research Application System (IRAS)

Site-specific assessment (SSA) for non-NHS sites

This document sets out general guidance on Site-Specific Assessment and completion of the Site-Specific Information (SSI) Form for non-NHS sites. Separate guidance is available within IRAS on the SSI Form for NHS sites.

Requirement for SSA at non-NHS sites

  • Site-specific assessment is an assessment of the suitability of the local research site and investigator to conduct the research.
  • SSA for non-NHS sites is required as part of the ethical review for the following types of research only:

(i)Clinical trials of investigational medicinal products (CTIMPs)

(ii)Clinical investigations of non-CE marked medical devices or CE marked devices which have been modified or are being used for a new intended purpose

(iii)Combined CTIMPs and clinical investigations of medical devices

(iv)Other clinical trials to study a novel intervention or randomised clinical trials comparing interventions in clinical practice

(v)Intrusive research involving adults unable to consent for themselves in England or Wales and requiring approval under the Mental Capacity Act 2005, and similar research in Northern Ireland

(vi)Research involving adults unable to consent for themselves and requiring approval under the Adults with Incapacity (Scotland) Act 2000.

  • For other types of research taking place at non-NHS sites, application for SSA is not required. All sites listed in the application to the REC, and any other sites added during the course of the study, will be deemed to be ethically approved as part of a favourable opinion from the REC. Management permission is still required from the organisation responsible for hosting the research before it commences at any site.
  • For detailed guidance on SSA procedures, see Section 4 of the NRES SOPs at

Identifying the research site

  • Research sites are organisations responsible for any participant-related research procedures specified in the protocol - including recruitment and informed consent.
  • The following are not considered to be research sites:

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

Clinicians, clinical units or organisations involved only in the identification of potential participants and/or facilitating recruitment by the research team, not responsible for informed consent or any other protocol procedures (“participant identification centres”)

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

  • 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.
  • In some cases, a study hosted by a NHS care organisation may involve routine protocol procedures being undertaken by non-NHS organisations under contractual arrangements with the NHS organisation. For example, MRI scans or laboratory analysis may be undertaken on premises owned by universities, research charities or private companies. These arrangements may be considered as a single NHS site where all of the following conditions are met:
  • All the participants are NHS patients recruited through the NHS organisation
  • The relevant NHS R&D office (which may be a joint research office acting on behalf of more than one organisation) assumes full responsibility under the Research Governance Framework for all procedures involving NHS patients at the site, including those undertaken by non-NHS organisations
  • Indemnity for all procedures is in place under the Clinical Negligence Scheme for Trusts (“NHS indemnity”).

Where any of these conditions are not met, the non-NHS organisation should be considered a separate site.

  • For further guidance on research sites, see Section 4 of the NRES Standard Operating Procedures

SSA exemption for non-NHS sites

Non-clinical research involving adults lacking capacity to consent

  • The main REC has the discretion to waive the requirement for SSA at non-NHS sites in the case of research involving adults lacking capacity to consent for themselves where the study involves no clinical interventions and either of the following apply:

(i)Studies with no local investigator. All recruitment procedures and all study procedures involving participants (e.g. questionnaires, observations) are undertaken directly by the Chief Investigator’s team. The role of local staff at the site is limited to facilitating the study, for example by helping to identify potential participants and relatives/consultees, who are then approached by the Chief Investigator’s team.

(ii)Low risk studies. In this case, SSA may be waived where the main REC is satisfied that the risk to participants lacking capacity is likely to be negligible and will not interfere with their freedom of action or privacy in a significant way or be unduly invasive or restrictive. These criteria could apply for example to studies limited to use of personal data, or the administration of a simple questionnaire involving minimal burden.

  • Before confirming SSA exemption, the main REC will require assurances that the CI’s team will have adequate arrangements in place for the conduct of the study locally, including procedures for identifying suitable sites, participants and relatives/consultees. Where local site staff will be responsible for undertaking recruitment or other study procedures, the main REC should be satisfied that they will have appropriate training.
  • The CI or sponsor may submit a request for SSA exemption either with the main application or in further correspondence at any time. However, the Committee may decide to give exemption without receiving such a request.

Subsidiary sites in clinical research

  • In clinical research the main sites undertaking recruitment and administering the interventions will always require SSA. However, it may be necessary to arrange for routine clinical procedures required by the protocol to be carried out by other organisations in support of the research. For example, routine imaging using standard clinical protocols may be undertaken by a private scanner centre under contractual arrangements with the NHS care organisation where the participants are recruited. Unless the NHS organisation accepts full governance responsibility for these procedures and assures NHS indemnity, the responsible non-NHS organisation should be considered a separate research site or “subsidiary site”.
  • However, the Chief Investigator or sponsor may request exemption of non-NHS subsidiary sites from the requirement for SSA by writing to the main REC giving the name and address of the subsidiary site, the name of the person who will act as local Principal Investigator (i.e. take responsibility for the conduct of study procedures) and brief details of the routine procedures to be conducted.

Identifying the SSA REC

  • For non-NHS sites, applications for SSA should be submitted to an appropriate Research Ethics Committee (“SSA REC”). This will normally be a local REC in the domain where the site is located. For commercially sponsored Phase 1 trials, specific SSA RECs are assigned to undertake SSAs at each commercial unit in the UK. For details of assigned SSA RECs for Phase 1 trials, see the latest list on the NRES website, published at
  • The SSA may be undertaken by the main REC for the study itself where the site is within its domain, or exceptionally for sites outside its domain where there is no other suitable REC.
  • For further case-by-case advice on the appropriate REC to undertake SSA, please contact the REC operational manager for the relevant area of the UK.

Applying for SSA

  • Application for SSA comprises the SSI Form together with the following:
  • Short CV for the Principal Investigator
  • Local versions on headed paper of all documentation to be used to recruit participants at the site, including documentation for relatives/consultees in the case of adults lacking capacity.
  • MHRA accreditation certificate (where applicable - Phase 1 trial units only)
  • Evidence of insurance or indemnity cover for the Principal Investigator (except for commercial Phase 1 trial sites)
  • Evidence of professional registration for the Principal Investigator.
  • The SSI Form should only be completed after the main study application form (Parts A-D) has been completed by the Chief Investigator, as this will pre-populate some sections of the SSI Form. The CI will then forward the application to the PI to complete the remaining questions in the SSI Form.
  • Where the SSA is to be undertaken by the main REC, the SSI Form should be included with the main application for ethical review. Otherwise it should be submitted separately to the appropriate SSA REC.

SSA process

  • Where the SSA is undertaken by the main REC, it will be undertaken as part of the main review of the study. Where a favourable opinion is given, ethical approval for the site will be confirmed in the main opinion letter.
  • Where SSA is the responsibility of another REC, it will be reviewed by a sub-committee of the SSA REC, normally in correspondence involving a minimum of two members. The SSA REC will then notify the main REC, within 25 days of receiving a valid application for SSA, whether or not it has any objection to the research going ahead at the site.
  • On receiving the advice from the SSA REC, the main REC will confirm in writing to the Chief Investigator whether or not the site is ethically approved. If notice of no objection is received before the final opinion is given on the main application, site approval will be included in the main opinion letter. If it is received subsequently, a further letter will be issued.

General guidance on the SSI form

  • The Site-Specific Information (SSI) Form is an integrated form for use with both NHS and non-NHS sites. The answer to the filter question will determine whether the site is NHS or non-NHS and generate the appropriate dataset.
  • Where the applicant indicates that the SSA is to be undertaken by a REC other than the main REC, a Summary of the Study will appear in the SSI Form, populated from fields within Part A of IRAS. This provides the SSA REC with background information about the study and avoids the need to provide a copy of the main application form or protocol. The SSA REC will not re-review the information submitted from Part A.
  • Where the answer to Question 4 indicates that the site is accredited by the MHRA under its Phase 1 accreditation scheme, a number of subsequent questions will be disabled, as they relate to issues routinely addressed by the GCP inspectors within the accreditation process and do not need to be re-reviewed by the SSA REC for each trial undertaken by the unit.
  • The name of the main REC and the REC reference number for the main application should appear automatically at the top of the form.
  • The fields for the name of the SSA REC and REC reference number may be left blank.

Question 1Name of trial site

  • The trial site may be:

a private company or corporation (for example, a pharmaceutical or biotechnology company or a Site Management Organisation)

a private hospital

a private clinical practice

  • You should also name any other locations at which trial procedures will be conducted (excluding the analysis of data produced by the trial and production of reports).
  • The SSA REC may wish to consider issues such as:

availability of necessary facilities and support services at these locations (taking into account information given at Questions 22 and 24)

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

whether research participants will have easy and safe access to the site.

Question 2Site Management Organisation

  • The Site Management Organisation may be the sponsor company itself or a Contract Research Organisation which conducts the research on behalf of the sponsor. In some cases it could be the company responsible for a private hospital.
  • If no Site Management Organisation is involved (for example, where the research is undertaken by a private clinical practice), state “None”.

Question 3Management and monitoring

  • The individual with responsibility for monitoring the research on behalf of the sponsor should be cited in all cases.

Question 4Accreditation

  • Information about accreditation of Phase 1 trial sites by the Medicines and Healthcare products Regulatory Agency (MHRA) is available at
  • Please consult the GCP Inspection Team at the MHRA for further guidance on the accreditation scheme and application process. Contact details are available at the link above.
  • Where current accreditation is held, please enclose a copy of the accreditation certificate with the application to the SSA REC.
  • Accreditation is not a legal requirement and is not a precondition for ethical approval for the site. However, where accreditation is held this will provide a robust assurance to the SSA REC of the general suitability of the site to conduct Phase 1 trials and related research studies. Where the site is not accredited, the SSA REC may require further documentation in support of the application, and may wish to arrange its own visit to the site.
  • A number of questions in the SSI Form are disabled for sites with a current accreditation from the MHRA, as they relate to issues routinely addressed by the GCP inspectors within the accreditation processand do not need to be re-reviewed by the REC for each trial undertaken by the unit.
  • Any significant changes at accredited sites, potentially affecting the accreditation status (e.g. changes in key personnel, facilities or emergency procedures), should be notified to the MHRA and SSA REC as soon as possible.

Question 5Principal Investigator

  • The PI should submit a summary CV with information relevant to the current 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.
  • 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 6 Members of the local research team

  • List other members of the research team who will have a significant research role (e.g. other clinical investigators, trial nurses, staff who will interview participants).

Question 7Conflicts of interest

  • Any potential conflicts of interest should be raised here. The SSA REC will consider whether the issues raised pose any ethical concerns for the project.

Question 8Local study dates

  • Give the proposed start date and the proposed end date for the research at this site. These may differ from the overall study dates. You may not know these dates exactly, but a rough estimate should be supplied.
  • For CTIMPs, please give planned end dates both for the final clinical intervention (e.g. last administration of IMP) and the conclusion of all trial procedures (i.e. last data capture).
  • For all other studies, the end date is the date on which all procedures specified in the protocol are concluded.

Questions 9-2and 9-2Local variations in study procedures

  • The tables have been populated with information from Part A, completed by the CI. Please insert details of the local members of the research team who will conduct procedures.
  • If any variation is proposed in the interventions or procedures to be undertaken at this site, select Yes. This will allow you to make any alterations to the information in the table. The review will check that any variation is permitted within the terms of the protocol and the full application submitted to the main REC. If not, the PI should advise the CI to notify the main REC and seek ethical review of a protocol amendment applicable to the site and, if appropriate, the local version of the participant information sheet. SSA RECs do not have authority to approve such amendments.
Question 11Number of participants
  • If there is more than one group, state how many participants will be recruited in each group.
  • “Participants” may include patients who are not approached but whose records or samples are to be studied.

Question 12Recruitment of participants

  • Explain how potential participants will be identified and approached. Who will review registers, lists or medical records to identify participants? Who will write to potential participants inviting them to take part? Will potential participants be referred from one organisation to another?

Question 13Obtaining informed consent

  • The review will check that the person(s) taking informed consent locally are appropriate for the task. They should be fully informed about the nature of the study. They should be aware of the process of taking consent, including any specific issues relating to consent with the potential participant population, and familiar with “best practice”. Any specific training received should be described.
  • This person should have sufficient time and expertise to answer questions that might be raised by the research participants.

Question 14-1Adults with incapacity - CTIMPs

  • Explain what local arrangements will be made to seek consent from a legal representative for the inclusion of adults unable to consent for themselves.

Question 14-2Adults with incapacity – research in England and Wales

  • Explain what local arrangements will be made to seek advice from a consultee before including adults unable to consent for themselves in the research.
  • This question applies only to conduct of the research at sites in England and Wales.

Question 14-3Adults with incapacity – research in Scotland

  • Explain what local arrangements will be made to seek consent from a guardian or welfare attorney, or the adult’s nearest relative, before including adults unable to consent for themselves in the research.
  • This question applies only to conduct of the research at sites in Scotland.

Question 14-4Adults with incapacity – research in Northern Ireland