Research Governance Policy Practice Guidance Note Research ...… · RGP-PGN-01 - Research and...

Northumberland, Tyne and Wear NHS Foundation Trust RGP-PGN-01 – Research and Development Project Approval Procedure – V01– Issue 2 – Sep 17 Part of NTW(O)47 – Research Governance Policy

Research Governance Policy Practice Guidance Note Research and Development Project Approval Procedure - V01

Date Issued Planned Review PGN No:

Issue 1 – Nov 14

Issue 2 – Sep 17

November 2017 RGP-PGN-01

Part of NTW(O)47 – Research Governance policy

Author/Designation Simon Douglas - Senior Manager for Research Innovation and Clinical Effectiveness

Responsible Officer / Designation

Rajesh Nadkarni- Medical Director

Contents

Section Description Page No

1 Introduction 1

2 Purpose of this document 1

3 Research Requiring Ethics 2

4 Overview of Process 3

5 Service Management Approval 4

6 Research Not Requiring Ethics 4

7 Service Evaluations/Service Development Projects 4

8 Overview of process 4

9 Student Projects 5

10 Requiring REC

10.1 – Non-REC

5

11 Approval

11.1 – Pre approval

11.2 – Contracts

11.3 – Conditions of approval

11.4 – 70 Day metrics

11.5 – End of Study requirements

5

12 Audit and Monitoring 7

13 Additional Requirements

13.1 – HR Involvement

13.2 - Caldicott

7

14 Amendment Process 7

15 Study Documentation 8

Northumberland, Tyne and Wear NHS Foundation Trust 2 RGP-PGN-01 - Research and Development Project Approval Procedure – V01– Issue 2 – Sep 17 Part of NTW(O)47 – Research Governance Policy

Appendices – listed within PGN

Document No:

Description Issue Issue Date

Review date

Appendix 1 Examples of research requiring NHS R&D review but not ethical review (Page 09)

1 Nov 14 Nov 17

Appendix 2 Examples of substantial and non-substantial amendments (Page 11)

1 Nov 14 Nov 17

Appendices listed separate to PGN

Appendix 3 Research Approval Application 1 Nov 14 Nov 17

Appendix 4 Service Evaluation Application 1 Nov 14 Nov 17

Northumberland, Tyne and Wear NHS Foundation Trust 1 RGP-PGN-01 – Research and Development Project Approval Procedure – V01– Issue 2 – Sep 17 Part of NTW(O)47 – Research Governance Policy

1 Introduction 1.1 The Research Governance Framework (RGF) (2005) requires all Trusts to give

approval for research and development activity and hence for all those conducting such activity to register their projects. NHS Trusts are required to ensure that all research projects comply with the RGF in respect of:

Ethics

Scientific quality

Data protection and information governance

Financial probity

Exploitation of intellectual property

Health and safety (including safety reporting)

1.2 Such projects will include research and service development/evaluation projects, with the aim of ensuring the highest possible standards in all such activity. Research projects will be required to seek additional approval from Research Ethics Committees.

1.3 All research projects must be registered with and approved by the Research,

Innovation and Clinical Effectiveness Department. This is important because:

It is good practice

We are required by NHS funding arrangements to register research

The department needs to maintain a record of research in order to demonstrate to the Department of Health, the National Institute for Health Research (NIHR) and the Care Quality Commission (CQC) the level of research activity within the Trust

The Trust Board require assurance of the level and quality of the research being conducted by their staff and/or on their premises

It helps the department make links with researchers and offer appropriate advice and support

The registration process enables researchers to gain mandatory peer review for their projects

2 Purpose of this document 2.1 All research and service evaluations wishing to run within Northumberland, Tyne

and Wear NHS Foundation Trust (the Trust/NTW) require R&D approval. The review and checks that need to be undertaken for each study can be complicated and varied. This PGN aims to provide guidance for the various steps and processes required for a study to gain R&D approval.


2.2 This PGN should be used as an overview and guide to the Trust’s R&D approval

process for:

Own account research

Hosted research

Service evaluations

Student projects

3 Research Requiring Ethics 3.1 All projects requiring research ethical review need to be submitted via the

Integrated Research Application System (IRAS). IRAS allows for the creation of the Research Ethics Committee (REC), R&D and Site Specific Information (SSI) forms required by the study for submission to REC and the relevant R&D departments. Where the Trust is to act as sponsor, the researcher must contact the Senior Manager for Research, Innovation and Clinical Effectiveness as early as possible to confirm suitability of the Trust sponsoring the study please allow a minimum of 2 week notice period when requesting NTW sponsorship (please see practice guidance note RGP-PGN-02 – NTW Sponsorship, which sits with NTW(O)47 – Research Governance Policy). The IRAS submission can then be electronically authorised.

3.2 Researchers must provide study information and documentation as early as

possible to the R&D team to allow for a timely, smooth progression through the approval process. In the first instance the R&D team request the following documentation:

Protocol

Participant information sheet

Consent form

3.3 The R&D team aim to undertake the governance review and issue a response within 2 weeks of a valid study submission.

Please note Research and Development permission will only be granted once

ethical favourable opinion is granted

http://www.myresearchproject.org.uk/


4 Overview of Process

4.1 In all cases (research or service evaluation) we ask that researchers talk to the R&D team as early as possible in the process.

For studies progressing through IRAS;

SSI Q23 – to allow researchers to complete Q23 on the SSI form, the R&D team must have been consulted about the project

For CSP route studies, if an SSI is submitted without Q23 completed or if no discussions have taken place, the study will be deemed invalid and will be rejected until discussions have been held

For non-CSP studies, studies submitted without pre-warning cannot be guaranteed a 2 week response turn around. In both circumstances, a delay at submission stage will impact on overall timeframes

4.6 Valid Submission Requirements

IRAS forms – R&D and SSI

Study documentation (protocol, patient information sheet, consent forms etc.)

Service management approval – Service Managers can return a signed form or email approval through to the R&D team

Favourable ethical opinion – projects can be submitted prior to final ethical approval however the project will only be approved upon receipt of the REC final opinion letter


5 Service Management Approval

5.1 Research wishing to run within the Trust needs to receive approval of the clinical management team appropriate to the service(s) the research will involve. The service management approval form needs to be completed and sent to the appropriate manager with a minimum of 6 weeks’ notice to allow review and consideration of the project. Service management approval is required prior to SSI submission, studies will not be granted approval if the clinical management team has not reviewed and agreed to the study running within their service area.

6 Research Not Requiring Ethics

6.1 Where a project is deemed to be research but which does not require ethical review, researchers are required to complete the NTW research registration form. This form needs to be signed by the appropriate Associate Director and submitted to the R&D facilitator along with the relevant study documentation for governance review. Projects will be reviewed and a response issued within 2 weeks of a valid submission. Appendix 1 provides examples of projects requiring R&D approval but not ethics review.

7 Service Evaluations/Service Development Projects

7.1 Service evaluations do not require REC review/opinion. Researchers are asked to complete the NTW service evaluation registration form; this needs to be signed by the researcher and the appropriate Associate Director / line manager. The completed form needs to be sent to the R&D facilitator along with the relevant study documentation to allow a proportionate governance review to take place. The R&D team aim to undertake the governance review and issue a response within 2 weeks of a valid submission.

8 Overview of Process


9 Student Projects

9.1 Please refer to the student guidance document

10 Requiring REC

Student projects requiring NHS ethical opinion are required to follow the

IRAS project route - See student guidance document

10.1 Non-REC

Student projects not requiring NHS ethical opinion are

required to be registered with the Trust using the student

project registration form , the form needs to be signed by the

student as well as the appropriate Associate Director on

behalf of the Trust. We aim to undertake the governance

review and issue a response within 2 weeks of a valid

submission

o Valid Submission Requirements

o IRAS route – see research project section

o Non-IRAS

Completed and signed NTW registration form

Associated study documentation

Letter of support from university

11 Approval

11.1 Pre-approval

11.1.1 Researchers are strongly encouraged to approach the R&D team as early as possible with regards their project/evaluation. Time spent at early discussion stages will aid in preventing unnecessary delays in the later approval stages

11.1.2 The R&D facilitator can support researchers to decide which pathway individual projects need to follow; IRAS training and one to one sessions are offered to support researchers submitting to ethics.

11.1.3 For large, multicentre or commercial studies requiring contracts or agreements, early involvement by the R&D team is vital to prevent delays.

11.1.4 Once the governance review has been performed and approval has been granted, the study/evaluation will be logged on the R&D tracker, the approval letter will be emailed to the CI/Principle Investigator (PI)/research team.


11.2 Contracts

11.2.1 All study contracts and agreements, from draft to final versions, must be directed to the Senior Manager for Research, Innovation and Clinical Effectiveness for review and Trust sign off.

11.3 Conditions of Approval

11.3.1 NTW R&D approval is granted with specific conditions attached:

11.3.2 R&D to be notified of:

Commencement and completion of the study/evaluation

Date of first participant recruited (where applicable)

Any significant changes to the study/evaluation

Suspension or abandonment of the study/evaluation

Copy of annual REC report and end of project REC report

All publications and/or conference presentation of the study/evaluation findings

11.3.3 If these conditions are not met, the R&D team reserve the right to temporarily suspend any study/evaluation until conditions are met. If conditions continue to fail to be met or R&D are not assured the study/evaluation is being conducted appropriately, approval will be withdrawn and the study/evaluation will not be eligible to continue to run within the Trust.

11.4 70 day metrics 11.4.1 For all research projects going through the IRAS process, researchers will be

required to provide the date of recruitment of the first participant (for NTW) 11.4.2 For studies falling into categories 1-4 (see below) on the IRAS form, researchers

are required to report their first patient recruited to allow monitoring of time to target. Studies have 30 days from R&D approval to recruit their first patient (for that particular site).

11.4.3 The categories cover:

Clinical trial of an investigational medicinal product

Clinical investigation or other study of a medical device

Combined trial of an investigational medicinal product and an investigational medical device

Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice


11.4.4 When NTW send out the approval letter, the email will include the individual dates appropriate to that study:

Valid Submission Date

NTW Sign Off Date 30 Day first patient in (from NTW sign off)

70 day first patient in (from valid

submission)

11.5 End of Study Requirements 11.5.1 Once a study/evaluation has been completed, researchers are asked to contact the

R&D facilitator to confirm completion. As per the approval conditions, researchers are expected to submit study/evaluation findings, copies of reports, presentations or publications to the R&D team. Upon confirmation of the study/evaluation completion, the R&D team will issue an end of study/evaluation letter to the research team.

12 Audit/Monitoring 12.1 NTW is required to audit a minimum of 10% of its sponsored and hosted studies –

R&D approval is granted on the acceptance and condition that studies are subject to routine audit (please see practice guidance note RGP-PGN-03 – Audit and Monitoring, which sits with NTW(O)47 – Research Governance Policy)

13 Additional Requirements 13.1 HR Involvement

For researchers external to NTW, where honorary research contracts/letters of access are required please refer to the practice guidance note RGP-PGN-04 – Honorary Research Contract Process which sits with NTW(O)47 – Research Governance Policy; this document outlines the process to be followed

13.2 Caldicott

For studies requiring caldicott approval, the form must be completed and submitted to the research facilitator in the first instance. R&D will undertake an initial review, valid forms will be sent to the caldicott guardian for sign off

14 Amendment Process 14.1 Amendments are changes (substantial or minor) made to a research study after a

favourable ethical opinion or NHS Trust approval has been granted. They can be made to the protocol, other essential documentation or other aspects of studies arrangements.


14.2 A substantial amendment is a change that is likely to have a significant impact on the safety or physical or mental integrity of the clinical trial subjects, or the scientific value of the clinical trial. It is up to the sponsor of a clinical trial to assess whether an amendment is to be regarded as substantial or not. It is also the responsibility of the sponsor to decide whether a substantial amendment requires authorisation or an ethical opinion or both

14.3 Non-substantial amendments do not require prior authorisation but the changes

must be recorded by the sponsor along with the rationale as to why the amendment is deemed non-substantial. (Appendix 2 for examples of substantial and non-substantial amendments)

14.4 Once a valid amendment has been submitted, the Trust will issue a response (approval or rejection) within 35 days. Researchers will receive a standard email of the R&D response to the study amendment.

14.5 Where applicable – email notification will clearly state that an amendment cannot be

implemented until any necessary regulatory approvals have been received. 15 Study Documentation 15.1 CI/PI/research teams are responsible and accountable for the maintenance and

safe storage of all study documentation for their site i.e.: TMF/ISF in line with Good Clinical Practice (GCP) guidelines. We ask that all researchers familiarise themselves with the Trust’s practice guidance note RGP-PGN-006 – Study Documentation and Archiving, which sit with NTW(O)47 – Research Governance Policy


Appendix 1 Research requiring NHS R&D review but not ethical review

The following types of research project do not require application for ethical review but still require NHS R&D permission:

Projects limited to the use of samples/data samples provided by a Research Tissue Bank (RTB) with generic ethical approval from a REC, in accordance with the conditions of approval.

Samples/data must be non-identifiable to the research at point of access otherwise further ethical review of the project is required.

Projects limited to the use of data provided by a Research Database with generic ethical approval from a REC, in accordance with the conditions of approval

Data must be non-identifiable to the research at point of access, otherwise further ethical review of the project is required

Research involving previously collected, non-identifiable information Research limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection) is generally excluded from REC review, provided that the patients or service users are not identifiable to the research team in carrying out the research. This exception also applies to research undertaken by staff within a care team using information previously collected in the course of care for their own patients or clients, provided that data is anonymised or pseudonymised in conducting the research.

Research involving previously collected, non-identifiable tissue samples

Research limited to use of previously collected, non-identifiable material consisting of, or including, cells in accordance with the terms of donor consent is generally excluded from REC review. However, REC review would be required if any of the following applied:

Consent for research had not been given, or the research is not within the terms of the consent

The samples will be held of premises in England, Wales or Northern Ireland without a licence from the Human Tissue Authority to store relevant material for scheduled purposes


The research also involves removal, storage or use of new samples from the living or the deceased

The research also involves use of identifiable information held with the samples

Research involving acellular material

Research limited to acellular material (e.g. plasma, serum, DNA) extracted from tissue previously collected in the course of normal care is generally excluded from REC review, provided that the patients or service users are not identifiable to the research team in carrying out the research This exception applies to research undertaken by staff within a care team using samples previously collected for clinical purposes from their own patients or clients, provided that the samples/data are anonymised or pseudonymised in conducting the research. However, REC review would be required if the research involved

o Collection of tissue samples from patients in order to extract acellular material for the research

o Collection of information from patients

o Use of previously collected information from which patients could be identified by the researchers

o Analysis of DNA in material from the living, where consent for research is not in place from the person whose body manufactured the DNA

Research involving the premises or facilities of care organisations REC review is not required for research involving use of, or access to, a care organisations premises or facilities, provided that review is not required under any other applicable legal or policy requirement. For example, a Phase 1 clinical trial undertaken by a Contract Research Organisation on premises rented from a NHS Trust would legally require REC review under the Clinical Trials Regulations. However, research undertaken by a university department on NHS premises, involving healthy volunteers not recruited as NHS patients and not subject to any legal requirements, would not require review by a Rec within the UK Health Departments Research Ethics Service and could be reviewed by the university’s research ethics committee.

Research involving staff as participants REC review is not normally required for research involving NHS or social care staff recruited as research participants by virtue of their professional role.


Appendix 2

Examples of substantial and non-substantial amendments

Examples of Substantial Amendments:

Changes to the design or methodology of the study, or to background information affecting its scientific value

Changes to the procedures undertaken by participants; any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study

Significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets for relatives or carers

A change of sponsor(s) or sponsor’s legal representative

Appointment of a new chief investigator or key collaborator

A change to the insurance or indemnity arrangements for the study

Inclusion of a new trial site (not listed in the original application) in a CTIMP

Appointment of a new principle investigator at a trial site in a CTIMP

Temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt

A change to the definition of the end of the study

Any other significant change to the protocol in terms of the REC applications Examples of Non-Substantial Amendments

Minor changes to the protocol or other study documentation eg; correcting errors, updating contact points, minor clarifications

Updates of the investigator brochure (unless there is a change to the risk/benefit assessment for the trial)

Changes to the chief investigators research team (other than appointment of key collaborators)

Changes to the research team at particular trial sites (other than appointment of a new principle investigator in a CTIMP)


Changes in funding arrangements

Changes in the documentation used by the research team for recording study data

Changes in the logistical arrangements for storing or transporting samples

Inclusion of new sites and investigators in studies other than CTIMPs

Extension of the study beyond the period specified in the application form

Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator or other study staff are minor amendments but should be notified to the main REC for information.

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