1

Northern Ireland Hospice Research

Governance

Guidance Note 1

Pre-Application Guidance for Applicants

How to Prepare an Application to conduct Research Studies in

Northern Ireland Hospice

Author:

Dr. Dorry McLaughlin, Lecturer in Palliative Care/ Head of Education and

Research, Northern Ireland Hospice

July 2013

(Adapted from HSC Trust Research Governance Permission Note 1.

Replaces Research Management System NIHCP3/2008)

Date Introduced: August 2013

Date Reviewed: July 2014

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Table of Contents

Page

1 Introduction

Integrated Research Application System (IRAS) ……… 4

2 Pre-Application Stage

Setting up a Research Study …………………………….. . 7

Feasibility ……………………………………………………. . 7

Funding ……………………………………………………….. 7

Sponsorship ………………………………………………… . 8

Indemnity............................................................................ 9

Scientific Review (Peer Review) ………………………….. 10

Principal Investigator/Local Collaborator ………………. 10

Honorary Contracts …………………………………………. 11

Intellectual Property ……………………………………….. .. 11

Personal Public Involvement ………………………………. 11

Good Clinical Practice ………………………………………. 12

Clinical Research Support Centre ………………………… 12

Submitting the Application for R&D Permission ………. 12

Disputes/Resolutions ……………………………………….. 13

Appendices

Appendix 1

Contacts for Northern Ireland Hospice…………………………………. 14

Contacts for Trust Research Governance Offices …………………… 14

Appendix 2

Flowcharts

Overview of permission process ………………………………………………15

Sponsorship and Funding……………………………………………………… 16

Ethics Approval …………………………………………………………………. 17

Final Approval……………………………………………………………………. 18

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Appendix 3

Research Proposal Form ………………… 19

Appendix 4

Risk Assessment Form…………………………………………………………. 21

Appendix 5

Peer Review Report Form……………………………………………………. 23

Appendix 6

Notification of a Proposed Substantial Amendment Form………………… 25

Appendix 7

Glossary of Terms ……………………………………………………………. 27

Appendix 8

Check List for Applicant………………………………………………………. 31

The author wishes to thank Professor George Kernohan, University of

Ulster/ Co-Chair NI Hospice Research Committee for peer reviewing and

advising on aspects of research governance within this document.

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1 Introduction

1.1 Research Governance is an administrative system to control and authorise

research studies involving patients, carers, volunteers or staff working in Northern Ireland

Hospice. These guidelines have been adapted for Northern Ireland Hospice from those

used by the five HSC Trusts in Northern Ireland. The Northern Ireland Hospice Research

Governance Committee, is co-chaired by both academic and clinical personnel, and is

responsible for ensuring research governance within the organisation.

Applicants wishing to conduct a multi-centre study across a number of organisations must

identify a lead organisation who is willing to undertake the global (generic) governance

checks on behalf of the other participating organisation. Local governance checks will be

undertaken by each participating organisation. In order to identify a Lead organisation

(usually a Trust), contact one of the HSC Trust Research Offices (Appendix 1). For

studies being initiated and led from one of the other devolved nations co-ordinating centres

(England via CSP, Scotland via NRS Permissions Co-ordinating Centre and Wales via

NISCHR Permissions Co-ordinating Unit), the Western Health and Social Care Trust

Research Office has agreed to act as the initial point of contact for these applications.

It is important to determine whether the project that you are initiating is audit, service

evaluation or a research study. Research aims to obtain new knowledge and to find out

what treatments are the most effective. Audit is about quality and seeks to find out if best

practice is happening. More details can be seen at the following website:

www.hqip.org.uk/assets/Downloads/Audit-Research-Service-Evaluation.pdf All research involving patients

must obtain a favourable opinion from a HPSS or NHS Research Ethics Committee. Other

research studies not involving patients will still require appropriate ethical review which

may involve an ethics committee at a university such as University of Ulster or Queen’s

University, Belfast (see appendix 2). All research applications must be submitted to

Northern Ireland Hospice by using the web-based Integrated Research Application System

(IRAS).

IRAS

1.2 IRAS:

• Is a web-based system for applying for permissions and approvals for health and

social care / community care research in the UK.

• Enables you to enter the information about your project once instead of duplicating

information in separate application forms.

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• Uses filters to ensure the data collected and collated is appropriate to the type of

study, and consequently the permissions and approvals required.

• Helps you meet regulatory and governance requirements.

1.3 IRAS captures the information needed for the relevant approvals from the following

review bodies:

• Administration of Radioactive Substances Advisory Committee (ARSAC)

• Gene Therapy Advisory Committee (GTAC)

• Medicines and Healthcare products Regulatory Agency (MHRA)

• Ministry of Justice

• NHS / HSC Research and Development offices

• NRES / NHS / HSC Research Ethics Committees

1.4 IRAS is just one element of a broader effort to reduce bureaucracy for

researchers. IRAS can be accessed at: www.myresearchproject.org.uk, and an account

should be created by following the instructions on the website.

It is recommended that new researchers should undertake the e-learning IRAS

training programme available on www.myresearchproject.co.uk under Quick Links

section. By doing so, this should familiarise applicants with the software and

enable efficient navigation through the system.

1.5 It is hoped by adopting a streamlined approach to research governance that it will

encourage researchers and enhance the attractiveness of Northern Ireland as a site for

large scale research projects (commercial and non-commercial).

Furthermore, by forging links with the other research governance permission initiatives led

in England, Scotland and Wales, the aim is to streamline the processes for cross border

studies in an attempt to attract UK-wide studies opening in a more timely and efficient

manner.

1.6 To carry out research within Northern Ireland Hospice Research Governance

Permission is required before a study can commence. Research Governance Permission

is required if your research involves:

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• Patients/clients (tissue, organs, data)

• Staff or volunteers

• Resources (consumables, equipment)

• Premises (facilities)

1.7 The Research Governance system is designed to:

(a) provide a streamlined and consistent approach for obtaining

Research Governance Permission for studies and

(b) protect all those involved in research (participants, researchers, care

organisation and employing organisation) by ensuring that all regulatory and

governance approvals are in place and are adhered to.

Occasionally under strictly controlled conditions, the Hospice may use

patient information for research. Any information will generally be

anonymised, so that patients are not identified. However if patients are to be

identified or personally involved in the research study consent will be

obtained.

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2 Pre-Application Stage

Firstly it is important to clearly establish that you are actually conducting research within

Northern Ireland Hospice, rather than service evaluation/service development or clinical

audit. (See www.nres.npsa.nhs.uk or email: queries@npsa.nhs.uk). The following areas

have been identified for the applicant to consider, prior, to submitting an IRAS application

to Northern Ireland Hospice for research governance permission.

Setting up a Research Study

2.1 When setting up a research study it is important to make contact with the Northern

Ireland Hospice in the early stages of the study development. Key areas of feasibility,

funding, sponsorship, scientific review, indemnity, identification of local Principal

Investigator/Local Collaborator, and requirement for honorary contracts, must be secured,

prior to submitting IRAS applications for Northern Ireland Hospice Research Governance

Permission. This will ensure that relevant governance issues can be identified early in the

process, avoiding delays in the later stages. For non-Northern Ireland Hospice staff, it is

advisable that researchers involving Universities should similarly make early contact with

the Education and Research Department, for advice. Projects should be initiated and

prepared in draft through the Integrated Research Application System. Draft applications

can be transferred to members of the research team for review and, where applicable, to

the Northern Ireland Hospice and relevant HSC Trust Research Office to review in terms

of application for sponsorship and funding only.

Feasibility

2.2 The feasibility of all studies should be considered as part of the development of the

study protocol, with particular reference to the patient/client population to be sampled and

available resources. If the study requires input from support departments of HSC Trusts,

e.g. Pharmacy, Laboratory, Medicine, Radiology/ Radiation Protection, contact must be

made with the Heads of those Services/Departments to discuss feasibility and costs at an

early stage. Details of contacts for support departments is available from HSC Trust

Research Offices.

Funding

2.3 For externally sponsored and funded studies, applicants can proceed directly to

IRAS submission, and should make immediate contact with Northern Ireland Hospice.

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2.4 Applicants should provide written evidence of funding arrangements for the

research study. If funding has not yet been secured before submission for research

governance approval, the funding body may require changes to the research study, which

could result in the need to submit substantial amendments (appendix 5) or even withdraw

and re-submit the application.

2.5 Northern Ireland Hospice research governance permission for the conduct of

research requires assurance that the study is properly funded with sufficient personnel,

financial and material resources to ensure responsible conduct of the study until

completion. This shall include an assessment on research, treatment and service support

costs as well as impact upon the provision of care and services by Northern Ireland

Hospice. All financial aspects of projects may need to be reviewed by Northern Ireland

Hospice Finance staff before final research governance permission can be granted. It is

extremely important that all financial implications to the organisation are carefully

considered at the outset of a project.

2.6 Researchers are reminded that research that requires access to the resources,

patients, staff and/or premises of Northern Ireland Hospice will, in many cases, have cost

implications for the organisation concerned.

2.7 Researchers are requested to ensure that ALL grant applications in support of

research studies involving Northern Ireland Hospice take account of these costs and

include sufficient funds to cover them.

Sponsorship

2.8 It is a requirement for all research to have a sponsor. The main role(s) of the

sponsor are to assure the scientific quality of the research and that arrangements are in

place for the management and monitoring of the project.

2.9 The sponsor takes responsibility for the initiation, management, indemnity and, where

necessary, financing (or arranging the financing of that research study). This involves

ensuring the design of the study meets the required standards and that arrangements are

in place to ensure appropriate conduct and reporting.

2.10 Prior to requesting any study approvals through IRAS (REC, R&D, MHRA etc)

sponsorship arrangements must be in place. Where an external sponsor cannot be

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secured for a project, application may be made to a HSC Trust Research Office or

university to sponsor/co-sponsor your project. If the HSC Trust is sponsoring your project

it will ensure that it is of an appropriate scientific quality. If the study has been, or will be

reviewed for scientific quality by an external funder it may not need further review. If the

study will not be reviewed by an external funder, the HSC Trust Research Office may

facilitate the peer review of the project.

2.11 The Northern Ireland Hospice must verify that the sponsorship/co-sponsorship

arrangements are appropriate for a study whether the study will be sponsored/co-

sponsored by the HSC Trust or a university.

Once the sponsor is agreed, it is a formal requirement to have the sponsor either:

• Sign / electronically authorize the “Declaration by the sponsor's representative” part

of the IRAS application; or

• Enclose a letter confirming their agreement to the “Declaration by the sponsor’s

representative” part of the IRAS application.

2.12 When making a sponsorship/co-sponsorship application to the HSC Trust Research

Office/University the following should be submitted:

• Draft IRAS NHS R&D Form and IRAS SSI Form1

• Research Protocol (version control and date)

• External Referees or other scientific critique report (if available) or Funding

Confirmation letter from a recognised funder completing peer review

• Peer review nominations (if external scientific critique not available)

2.13 The university/ Trust Research Office will review your project, complete a peer

review if required, assess the appropriate sponsorship/co-sponsorship arrangements,

initiate sponsorship/co-sponsorship agreements and negotiate contracts.

Indemnity

2.14 Before a research project starts it is imperative that agreements are in place

clarifying the legal responsibility for death or injury to a patient or volunteer as a result

of their participation in the research study. It is the responsibility of the chief

1 At this stage, the IRAS form does not need to be fully completed but should contain as much information as available

at the time of sponsor request.

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investigator to ensure that the Hospice is informed of any planned research and

indemnity arrangements are in place prior to commencement of the study.

2.15 In circumstances where a Pharmaceutical Company are involved and are supplying

indemnity cover for the research project, documentary evidence of this must be

submitted to Northern Ireland Hospice prior to commencement of the study. In

circumstances where indemnity is not available from an external source then the

study and all relevant documentation must be presented to the Northern Ireland

Hospice Senior Management Team who will consult with Northern Ireland Hospice

Insurers to determine if the project is indemnified. If the project is not indemnified an

estimate for this process will be sought from the insurers.

Please note that Northern Ireland Hospice may not always be in a position to

meet insurance costs

Scientific Review (Peer Review)

2.16 When making an application, the organisation expects to receive a research study

protocol that has already obtained a favourable scientific review (also known as peer

review or scientific critique). For studies conducted by University staff and students, these

will normally already have been subject to peer review. The sponsor of the research is

responsible for the scrutiny of the hypothesis, design, methodology and analysis of a

proposed research study. This review should be carried out by independent

experts. Arrangements for peer review should be commensurate with the scale of the

research and the potential risks or burdens involved for participants. A risk assessment

should be carried out for each research project associated with Northern Ireland Hospice

(appendix 3).

Principal Investigator/Local Collaborator

2.17 Where a Chief Investigator is not based in Northern Ireland Hospice, a Principal

Investigator/Local Collaborator must be identified for Northern Ireland Hospice –

dependent on the contribution/collaboration required. If you are unable to identify a

suitable Principal Investigator/Local Collaborator within Northern Ireland Hospice, contact

the Education and Research Department who will be able to assist in identifying a suitable

member of staff to fulfill such a role and to be a point of contact until the study is

completed.

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Honorary Contracts

2.18 For research involving non Northern Ireland Hospice staff wishing to have access to

patients/clients, staff, premises, it is a requirement that an honorary contract

application/letter of access be completed (along with any necessary pre-employment

requirements for e.g. occupational health clearance, Access NI). Further details of

honorary contract applications can be obtained from Northern Ireland Hospice as local

requirements may differ. It is advisable to make early application for honorary research

contracts, as these involve other support departments – e.g. Human Resources and

Occupational Health Departments. It is hoped that a HSC Research Passport or Regional

HR process will be introduced to avoid the need for duplication of checks and issuing of

honorary contracts. It is envisaged that in many instances a letter of access may suffice,

rather than an honorary contract. This work is in progress and being led by the R&D

Managers in association with other stakeholders, to reach a resolution to streamlined

honorary research contracts.

Intellectual Property

2.19 Encouraging and exploiting innovation is one of the strategic priorities for the HSC

R&D Strategy “Research for Health & Wellbeing 2007-12”. The importance of identifying,

managing and exploiting innovation is also stressed in the Research Governance

Framework for Health and Social Care 2006. Accordingly all HSC bodies must identify,

manage and exploit Intellectual Property Rights (IPR), arising from HSC research. This

requirement is reinforced in the Controls Assurance Standard for Research Governance.

Criterion 13 of this standard, requires Trusts/organisations to supply evidence verifying

that they have satisfactorily complied with these requirements.

The HSC R&D Division of the Public Health Agency established HSC Innovations, as a

regional service for the support and management of innovation and IP within the HSC.

HSC Innovations has the necessary professional resources and funding to offer this

essential support service to HSC Bodies and Northern Ireland Hospice, and all HSC Trusts

have signed a Memorandum of Understanding to this effect with HSC Innovations. Further

advice on IP for HSC R&D can be obtained via the HSC Trust Research Offices.

Personal and Public Involvement (PPI)

2.20 Organisations have a statutory duty to involve users and the public in the

commissioning, planning and delivery of all Health and Social Care services. This process

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is known as PPI. Integrating PPI into the research process ensures that researchers

prioritise topics that are important for service users, and formulate questions, processes

and outcomes that are patient and public centric rather than solely researcher led.

Engaging with PPI representatives as partners rather than research subjects has been

shown to produce a range of benefits and impacts. It brings about benefits to researchers,

PPI representatives themselves and to the wider community. In relation to engaging PPI

representatives within specific research projects, it is recommended where no PPI contact

is available to the researcher, to make contact with the Education and Research

Department who may be able to assist in identifying suitable contacts.

Good Clinical Practice (GCP) Training

2.21 Anyone wishing to participate in clinical trials involving Health and Social Care must

have completed GCP training and provide Northern Ireland Hospice with certified

evidence. GCP training must be updated every 3 years, and is provided by the HSC

Trusts on a regular basis.

Clinical Research Support Centre (CRSC)

2.22 The aim of the CRSC is to promote and support high quality research and

development covering the spectrum of Health and Social Care activity from clinical

practice to health and social services provision. The CRSC team can offer support at

various stages of a research project from, planning a study, conducting a study and

developing research skills. Other such services include Data Management services,

clinical research monitors and training workshops. For further guidance, contact the Trust

Research Offices.

Submitting the Application for R&D Governance Permission

2.23 Once all of the stages of pre-application are complete, the application may be

formally submitted to the Education and Research Department where it will be forwarded

to the appropriate Directors for initial approval. The application will then be reviewed by the

Northern Ireland Hospice Research Governance Committee and applicants seeking to do

research studies involving Northern Ireland Hospice patients, carers, staff or volunteers

will be asked to attend one of the committee meetings to discuss the study. See Appendix

2 of this document for an overview of the research permission process and for details of

application for a single site study or a multi-centre study. Annual Reports and End of

Study Reports should be submitted to the Northern Ireland Hospice Research Governance

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Committee using the relevant forms available from the Office for Research Ethics

Committees Northern Ireland (ORECNI).

Disputes/Resolutions

2.24 Any concerns or dissatisfaction with the Northern Ireland Hospice Research

Governance Permission process must be addressed, in the first instance, to the Head of

Education and Research. If a satisfactory outcome is not reached, then the relevant Chair

of the Northern Ireland Hospice Research Governance Committee may be approached to

resolve any outstanding issues. Any remaining issues can be addressed through the

Director of Medical and Care Services , the Director of Nursing and Patient Care Services

or the Director of Children’s and Young People’s Services, as appropriate.

HSC Research Office Contact Details

2.25 Contact details for Northern Ireland Hospice and, where appropriate, each HSC

Trust Research Offices can be found at Appendix 1

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APPENDIX 1

Education and Research Department, Northern Ireland Hospice, Jennymount Business Park, North Derby Street, Belfast. BT15 3HN Research & Development Office Belfast Health & Social Care Trust Room 2010, 2nd Floor King Edward Building Royal Hospitals Site Grosvenor Road Belfast, BT12 6BA Tel: 028 9063 6366 Email:Alison.Murphy@belfasttrust.hscni.net Research & Development Office Southern Health and Social Care Trust Ramone Building Craigavon Area Hospital 68 Lurgan Road, Portadown BT63 5QQ Tel: 028 38614274 Email:Irene.Knox@southerntrust.hscni.net Research & Development Office South Eastern Health and Social Care Trust Room 19, Home 3 Ulster Hospital Dundonald Belfast BT16 1RH Tel: 028 90553101 Email: Paul.Carlin@setrust.hscni.net Research & Development Office Northern Health & Social Care Trust Bush House Antrim Area Hospital Antrim BT41 2QB Tel: 028 94424653/028 27661260 Email: Margaret.Smyth@northerntrust.hscni.net Research & Development office Western Health & Social Care Trust Clinical Translational Research & Innovation Centre (C-TRIC)

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Altnagelvin Area Hospital Glenshane Road Londonderry, BT47 6SB Tel: 028 71611362 Email: Sally.Doherty@westerntrust.hscni.net

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APPENDIX 2

Flowchart of the Northern Ireland Hospice permission process overview

INITIAL APPROVAL Submit IRAS Form/Research Proposal

(6 page)/Risk Assessment and Peer Review Report to

Director of Medicine and Care Services / Director of Nursing and Patient Care Services or Director of Children’s and Young People’s Services for

approval via the Education and Research Department

PROTOCOL APPROVAL

Northern Ireland Hospice Research Governance Committee

SPONSORSHIP AND FUNDING Is a sponsor secured? Is funding agreed? Is indemnity agreed

ETHICS APPROVAL Office of Research Ethics Committee (ORECNI) or/and University of Ulster/QUB Ethics Committee

FINAL APPROVAL Chair of Northern Ireland Hospice Research Group Are ethics approval, sponsorship & funding secured? Are all honorary contracts in place? Has indemnity been confirmed?

RESEARCH Follow agreed protocol. Manage, monitor and report. Forward annual research reports Forward end of study report

CLOSURE

Disseminate findings. Manage intellectual property rights. Formally close the project. Ensure Northern Ireland Hospice research database is completed

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Appendix 2.1

Sponsorship and Funding

Detailed Approved Protocol Compiled on IRAS

(Research Proposal)

Submit to Funder(s)

Is Funder also Sponsor?

Internally driven peer review

Submit for registration or approval, if necessary.

YES

NO

If favourable review

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APPENDIX 2.2

Ethics Approval

Approved Protocol (Research Proposal)

Complete IRAS REC Application and Submit

REC Approval

Appeal

Proceed to Final Approval

Annual Reports and End of Study Report to ORECNI

Revise IRAS REC Application and

Submit

ENDS

YES NO

YES

YES

NO

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APPENDIX 2.3

Final Approval

All Contracts in Place

Northern Ireland Hospice. Research Group Approval

Ends

NO

YES

YES

All Relevant Documentation

Indemnity Confirmed

1. If indemnity from an external source submit evidence Ulster University/Northern Ireland Hospice Research Group.

2. If source of indemnity is N.I.H. obtain documentary evidence.

Research Commences Annual Report and End

of Study Report to NI Hospice and ORECNI

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APPENDIX 3 Research Proposal Form

Part 1- Preliminary Approval

Short Project Title

Date submitted Submitted by

Having reviewed the Project Outline presented, we can confirm that the proposed project: 1. Aligns with our research strategy, 2. Has included all the major resource components, and 3. It appears feasible for the research to be conducted in this organisation.

On that basis, we grant preliminary approval for the project.

Signed by Director of Nursing & Patient Services Director of Medical and Care Services Director, Children’s & Young People’s Services

Date of signing

Name Please print clearly

Director of Nursing & Patient Services Director of Medical and Care Services Director of Children’s & Young People’s Services

1

Part 2 – Protocol Approval

Date submitted Submitted by

Having reviewed the Protocol presented, we confirm that: 1. All sections are completed, the level of detail is appropriate and it contains nothing

extraneous that should be removed. 2. In the following table, all Departments impacted by the project have been identified

correctly and their agreement to provide the requested resource/service has been sought and received. Please complete both rows and all columns with “yes” or “no”, as appropriate.

Department Medical Nursing

Social Work Physiotherapy

Occupational Therapy Chaplaincy

Human Resources Administration

Impacted?

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Agreed?

3. There is evidence that any legal and/or ethical requirements have been taken into

consideration, and 4. The presentation is of a high standard. 5. External peer review is required YES/NO

On that basis, we grant approval for the Protocol.

Signed by

Date of signing

Name Please print clearly

On behalf of the 1Northern Ireland Hospice Research Group

Part 3 - Financial Approval

Having reviewed the costings section of the Protocol presented, I confirm that: 1. All reasonably foreseeable resources required and other costs have been identified

and included, 2. Correct values have been applied for all standardised costs, and 3. Non standard costs have been correctly quantified.

On that basis, I agree with the financial costing for the project

Signed by

Date of signing

Name Please print clearly

Administrative Director/ Finance Manager

1 Department

Part 4 - Final Approval

Date submitted Submitted by

Having reviewed the following documentation: 1. Finalised working Protocol, 2. Funding confirmation, 3. Sponsorship agreement, 4. Favourable Ethics Committee opinion,

And, if applicable: 5. Statutory approval, 6. Commercial contract(s).

We grant approval for the project to start, subject only to receipt of a copy of the Certificate of Indemnity

Signed by

Date of signing

Name Please print clearly

On behalf of the 1 Northern Ireland Hospice Research Group

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APPENDIX 4

Risk Assessment Form

Name of Chief Investigator Organisation

Project Title

Hazard(s) – Please identify and describe

Who is exposed to the hazard? (e.g. Research subjects/ participants/ staff/students/)

Inherent Risk (i.e. the risk present before any precautions are put in place) – Please refer to the table overleaf to assess the risk and then record it below None

Low

Medium

High

Very High

Controlling the Inherent Risk For inherent risk in the medium to very high range, please describe the precautions to be put in place: Will these precautions eliminate, significantly reduce or otherwise reduce the inherent risk? Please comment:

Residual Risk- (eg: remaining risk once precautions are put in place)

Please refer to the table overleaf to assess the remaining risk and then record it below None Low Medium High Very High

Please note that if the residual risk is not in the none/low range, you might need to take further steps to address the risk or consider redesigning your research proposal

I confirm that an appropriate risk assessment has been conducted Signature………………………………… Date……………………… (Chief Investigator)

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Please use the table below to assess the inherent risk and then the residual risk. For example, where the potential harm is assessed to be minor (e.g. slight physical discomfort or pain, temporary emotional upset or similar) and the probability is assessed to be likely, then the risk is deemed to be in the medium range. It is expected that research being conducted within the organisation will fall within the None to Low range of risk. Studies that are likely to fall within the High to Very High range of risk are unlikely to be permitted to proceed.

POTENTIAL HARM

PROBABILITY NONE INSIGNIFICANT MINOR MODERATE MAJOR

UNLIKELY None Low Low Medium High

POSSIBLE None Low Medium High Very High

LIKELY None Low Medium High Very High

ALMOST CERTAIN None Low High Very High Very High

POTENTIAL HARM INSIGNIFICANT – reflective of trivial, routine or commonplace day-to-day levels of harm MINOR – unexpected event requiring minor remedial action e.g. first aid attention sufficient to treat minor injury, interview suspended due to temporary upset of participant MODERATE – e.g. results in time of work, broken bones, hospitalization, reversible disablement, serious emotional upset or psychological reaction, threat of violence to researcher, potential legal challenge to the researcher or the University MAJOR – e.g. loss of limb, loss of sight in one or more eyes, permanent disablement, death, irreversible psychological harm, violence against researcher

PROBABILITY UNLIKELY – probably will never happen POSSIBLE – might happen but would be an unusual occurrence LIKELY – expected to happen sometimes ALMOST CERTAIN – expected to happen frequently

NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance

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Appendix 5 Peer Review Report Form

Project Title

Chief Investigator

On the basis of the assessment below, this application:

• should proceed to the Office for Research Ethics Committees N. Ireland (ORECNI)

• should be amended by the applicant as indicated in the comments and then proceed to the Office for Research Ethics Committees N. Ireland (ORECNI)

• requires substantial changes and should be revised and returned for further review

• is not viable in its current form and should be withdrawn by the applicant

Peer Review conducted by Date

1.

2.

The application and both pages of this form should now be returned to the Chief Investigator

If the answer to any of the following questions is ‘No’, please use the box to add comments where appropriate Yes No 1. Does the proposed research make a contribution to the knowledge base or is it otherwise justified for educational or training purposes?

NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance

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Yes No 2. Does the application demonstrate appropriate understanding of the background and key issues on the part of the applicant(s)?

3. Does the applicant have a record of research in the area or is the study otherwise justified as a research/scientific training exercise?

4. Are the aims and objectives/research questions clearly stated?

5. Is the methodology adequate and appropriate?

6. Is the project planning adequate?

7. Is the envisaged outcome likely to be achieved?

8. Have the likely risks and ethical issues been identified and addressed?

NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance

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Appendix 6

Notification of a Proposed Substantial Amendment Form

Chief Investigator: Approved Study Title:

New/Amended Title (if appropriate):

Type of Amendment (please indicate any that apply):

• Amendment to application form [ ]

• Amendment to description/protocol [ ]

• Amendment to the information sheet/consent or other [ ] supporting information

Please submit the appropriate amended documentation in each case, ensuring that new text is highlighted to enable comparison with the previous version to be made.

Summary of Changes:

NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance

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Summary of Changes (continued):

Additional ethical considerations:

List of enclosed documents:

Declaration: I confirm that the information in this form is accurate and that implementation of the proposed amendment will benefit the study appropriately. Signed ………………………………………………………………………………… Date ……………………….. (Chief Investigator)

Northern Ireland Hospice/Ulster University Research Group Decision This amendment: is appropriate to the needs of the study, and should be implemented [ ] is appropriate to the needs of the study, and should be submitted to OREC [ ] is NOT appropriate and should be reconsidered or withdrawn [ ] Signed ………………………………………………………………………………… Date ………………………….. (Chair of Northern Ireland Hospice/ Ulster University Research Group)

NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance

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Appendix 7 Glossary

Amendment A change made to the terms of an application for NHS permission, the protocol or any other supporting documentation after the study has started. A study is normally considered to start with the commencement of any protocol procedures. ARSAC Administration of Radioactive Substances Advisory Committee. Chief Investigator (CI) The investigator with overall responsibility for the research. In a multi-site study, the CI has coordinating responsibility for research at all sites. Global governance checks The checks generic to the study. They are undertaken once on be half of all NHS organizations/care organisations taking part in the study. Governance checks A number of checks which aim to provide assurances that a study complies with applicable regulatory and statutory requirements. GTAC Gene Therapy Advisory Committee. GTAC has UK-wide responsibility for the ethical oversight of proposals to conduct clinical trials involving gene or stem cell therapies. The Committee also advises Ministers on the development and use of gene and stem cell therapies and works with other Government agencies with an interest in this area, such as the Medicines and Healthcare products Regulatory Agency (MHRA), the Health and Safety Executive (HSE) and the Human Tissue Authority HSC Health and Social Care IRAS Integrated Research Application System. Local Collaborator Studies that do not require a local principal investigator at each site, but require someone that is willing to act as the Northern Ireland Hospice contact for the coordination and facilitation of the research. Local governance checks The checks required to be undertaken by an individual organisation in respect of the study. They must be conducted by Northern Ireland Hospice. MHRA Medicines and Healthcare products Regulatory Agency. NHS National Health Service. NHS organisation All organisations within the National Health Service who provide health or social care (i.e. NHS Trust). NHS permission The permission from the NHS organisation providing care to

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conduct the research at a NHS site before any research procedures are commenced at a particular site, i.e. permission from the Local Health Boards. Also known as R&D approval or Research Governance Approval. NHS REC Form The application form which collects the study data required by a Research Ethics Committee to review a study. The online form is a smart form designed to save time when completing it. As certain questions are answered, information will auto populate in other relevant places and the answers to certain questions will deactivate or activate other sections of the form. NHS/HSC R&D Form The NHS/HSC R&D form is split into NHS/HSC R&D form (project information) and NHS/HSC R&D form (SSI). Applications for NHS permission require both forms, the NHS/HSC R&D form (project information) which contains the project-wide information and the relevant NHS/HSC R&D form (SSI) with local information. These forms are used by the R&D or Research Governance offices to review a study. The project-wide information allows the study to be assessed and the SSI local information allows an assessment of the suitability of the local investigator, site and facilities. NRES National Research Ethics Service. Primary care The provision of services by GPs and primary care teams in health centres and surgeries; and the services provided by independent contractor professions like opticians, dentists and pharmacists. Principal Investigator (PI) Where the research takes place in more then one site, this is the individual who is responsible for the research at a particular site; there will be one PI per site. R&D Research and Development. REC Research Ethics Committee. Research The attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. Scientific review The scrutiny of the hypothesis, design, methodology and statistics of a proposed research study. The Research Governance Framework for Health and Social Care 2006 states that the review should be by experts in the relevant fields able to offer independent advice on the quality of the research study. Arrangements for review should be commensurate with the scale of research. Sponsor The person who takes responsibility for initiation, management and financing (or arranging finance) for that trial/study. SSI Site Specific Information. Supporting documentation All documents associated with the main application for obtaining NHS permission.

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Validation A check carried out by the RMG office to verify that an application is complete and may be accepted for review.

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Appendix 8 Check List for Applicant

Northern Ireland Hospice Research Governance Submit to the Education and Research Department for initial organisational approval:

• Completed IRAS Form (including details of sponsor, indemnity and any funding)

• Completed 6 page Research Protocol (Research Proposal)

• Completed Risk Assessment

• Completed Peer Review Report Following ethical review (by ORECNI or University REC) submit evidence of this process and the outcome:

• Research Ethics Review Report Submit during the research process:

• An annual report

• An end of study report (Forms to complete these reports are available from ORECNI)

Initial approval forms and annual/end of study reports should be forward to Tracey McTernaghan who can be contacted at: tracey.mcternaghan@nihospice.org :