Research & Development Guidance for Students

Research & Development Guidance for Students

2 Contents Introduction 3 Understanding the Research Approval Process 3 Is My Project Audit, Research or Something Else 4 What Next? 4 R&D Step by step Guide 6 Documents Required For R&D Review 10 Appendices Appendix 1 Research and Clinical Audit Definitions (word doc) 12 Appendix 2 - Checklist 15 Appendix 3 - NTW R&D Contact Information 16 Table 1 Research and Clinical Audit Definitions 4

3 Introduction This guidance document has been put together by NTW s R&D Department to map out a standardised approach for students undertaking research as part of their academic qualification. It is intended to apply to all students with an interface with NTW, whether that be as a result of their employment situation within the Trust or their use of Trust staff or patients as participants in their research. This could apply to many types of student projects, the majority of which should are included in this document, but if you are in any doubt about whether it applies then please contact the R&D department. Understanding the Research Approvals Process Research which takes place in the NHS is governed by legislation and underpinned by guidance, from the EU Clinical Trials Directive to the Research Governance Framework which states: Everyone involved in research with human participants, their organs, tissue or data is responsible for knowing and following the law and the principles of good practice relating to ethics, science, information, health and safety, and finance set out in this framework. All those involved in research also have a duty to ensure that they and those they manage are appropriately qualified, both by education and experience, for the role they play in relation to any research. They must be aware of, and have ready access to, sources of information and support in undertaking that role. [Research Governance Framework, 2005, p.19] This places a number of duties on the NHS to ensure standards of quality, safety and ethics of research which utilises its patients. We therefore have a responsibility to evaluate each research project which involves Trust staff and/or patients to provide assurances that it meets these standards. Northumberland Tyne & Wear R&D Department therefore provides these assurances to the Trust Board through a process of approvals for each research project. Ethical Review Process This is a separate approval process from ethics approval, which must also be sought by students and anyone else undertaking a research project which involves NHS patients. Ethics review requirements are detailed on the National Research Ethics Service website.

4 Is my Project Audit or Research or something else? There is often confusion over whether a project is audit, research or service evaluation. The table below identifies the key features of each (also see Appendix 1 for more detailed explanation). It is important to understand this first since the route for gaining Trust approval is different for each. Table 1 Research and Clinical Audit Department Definitions Research Service Evaluation Clinical Audit Designed and conducted solely to define or judge current care. The attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them. Quantitative research designed to test a hypothesis. Qualitative research identifies/explores themes following established methodology. Addresses clearly defined questions, aims and objectives. Quantitative research may involve evaluating or comparing interventions, particularly new ones. Qualitative research usually involves studying how interventions and relationships are experienced. Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care. Quantitative research study design may involve allocating patients to intervention groups. Qualitative research uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications. Designed to answer: What standard does this service achieve? Measures current service without reference to a standard. Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference. Usually involves analysis of existing data but may include administration of interview or questionnaire. No allocation to intervention: the health professional and patient have chosen intervention before service evaluation. Designed and conducted to produce information to inform delivery of best care. Designed to answer: Does this service research a predetermined standard? Measures against a standard. Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference. Usually involves analysis of existing data but may include administration of simple interview or questionnaire. No allocation to intervention: the health professional and patient have chosen intervention before audit. May involve randomisation. No randomisation. No randomisation. Normally requires REC review check Does not require REC Does not require REC with the R&D Department. review. review. What Next? Now that you have decided what kind of project you are undertaking the route for approvals is much easier to determine, the major types of projects are listed below 1) Projects Not Requiring Ethical Review (including service evaluation/service development)

5 For small scale student projects which do not require ethical review (particularly when they are service evaluation or development) there is a student project registration form which will need to be completed and submitted to the R&D team along with the associated project documentation (see checklist for full list). There is a minimum turnaround time of two weeks so please make sure the application is received by R&D a minimum of two weeks prior to when you need to start, preferably longer. 2) Projects requiring ethical review For research projects which require ethical review (see here for guidance on whether you need ethical review or not) students will use IRAS (Integrated Research Application System). IRAS actually comes with an excellent user guide but if you are really struggling then please contact the R&D office who should be able to help. Some important points to note: We ask that you inform the R&D department as early as possible for these projects to ensure we can facilitate a smooth and timely progression through the system. NTW will generally be the sponsor for your project and therefore the REC and R&D forms within IRAS need to be signed off by Simon Douglas, Senior Manager for Research, Innovation and Clinical Effectiveness. We can offer IRAS guidance and support where required but please check the user guide first. Please note an approval letter will not be issued until confirmation of REC favourable opinion has been provided. See below for a more detailed step by step guide on the process

Projects requiring ethical review As mentioned above a project which involves NHS patients will normally be subject to review by an ethics committee. This is accessed through the IRAS portal. The essence of IRAS is that it reduces work by streamlining the applications system so generally information is only entered once despite being on several forms. If you are hoping to recruit NHS patients as participants you will usually require: ethics application, R&D form SSI (Site Specific information) form for each Trust. The SSI form is generated through the Trust being named on the R&D form. Once the main ethics application is nearly ready to submit it is worthwhile letting the R&D Department know that the project is going to involve the Trust and to expect an SSI form. We recommend arranging for the Department to see a draft SSI form prior to submission to ensure there will be no major problems. Once you have submitted the SSI form to the Trust, and as long as your project has been approved by the ethics committee we should be able to provide approval within 2 weeks (or quicker if the project documentation has been submitted for pre-checking). This will be in the form of an approval letter which then allows you to conduct your research within the Trust. Step by step guide to process for studies requiring ethical review Student provides advanced warning of study and provides draft submission and study documentation to R&D team To aid in keeping timescales from unnecessarily spiralling, the R&D team ask that students undertaking REC reviewed projects, contact the R&D team as early as possible to make the team aware the project is in the pipeline and to hold initial discussions around the project

feasibility. We ask where possible that draft documents are submitted to the team for early review. If NTW is to be the study sponsor (if you need advice regarding who your study sponsor is please contact the R&D department) you will need to gain sponsorship agreement from the Trust R&D Senior Manager. This can be done electronically via IRAS (please note the email address for Simon Douglas, Senior Manager for Research, Innovation and Clinical Effectiveness is simon.douglas@ncl.ac.uk this is for IRAS authorisations only.) R&D department review IRAS forms Early review of draft IRAS forms allows the R&D team to understand the nature of the project and to allow them to offer as much guidance as required to the student to ensure a smooth IRAS/REC process. R&D team provide initial agreement in principle and validate the submission The R&D team will provide an agreement in principle for the study to go ahead subject to REC approval. If NTW are the sponsor validation is complete once Simon Douglas, Senior Manager for Research, Innovation and Clinical Effectiveness, electronically authorises the IRAS documents. Researcher submits final documentation set to ethics The student completes the IRAS submission of documents required for REC review. It is not necessary to submit NHS R&D/SSI forms at this stage as if there are changes to the project they will need to be resubmitted. REC favourable opinion granted REC issue an electronic favourable opinion letter to the student with a copy sent to Simon Douglas, If sponsor. Submit documents to R&D Students are asked that once they received their favourable opinion they contact the R&D team to confirm this status along with submitting all of the necessary documents for NHS R&D approval see checklist appendix 3. Research project is reviewed,registered and approved for NTW (approval letter is sent to student and University contact) Once all of the appropriate governance is complete, the R&D team will issue the NTW approval letter. Upon receipt of this letter (emailed to student and copied to University contact) the project is then eligible to proceed. 7

8 Projects Not Requiring Ethical Review A project which does not require ethical review must still receive permission from the R&D department before it can proceed if it involves NTW staff. Step by step guide to process for studies not requiring REC review Student submits completed (signed) student project registration form to R&D team with associated documents Students are asked to complete the student project registration form and have it signed by their university supervisor and Trust Service Manager (appropriate to the service with which the project will be undertaken); these signatures provide confirmation that the university and Trust are happy for the project to be undertaken. The form and associated project documents need to be emailed (where possible) to the R&D team for review. R&D department review study documentation The R&D team will undertake an initial review of the form and documentation to ensure everything is in place. R&D team suggests amendments to documentation (if required) Where appropriate (and if necessary) the R&D team will make suggestions for amendments or revision of documentation for the benefit of the researcher and the project. R&D team validate the submission Once the R&D team are happy that a full document set (completed form and all associated study documents alongside a completed NTW R&D checklist) has been submitted the team will validate the submission by issuing it with an NTW research registration number (unique research identifier). The team endeavour to achieve a two week turn around from validation to issue of approval letter. R&D team undertake risk analysis and research governance tasks Each project undergoes a risk analysis and governance review proportionate to the individual project, this allows the team to ensure all approvals are in place and that the project is appropriate to be undertaken within NTW and to involve NTW staff/service users.

9 Research project is registered and approved for NTW (approval letter is send to student and copied to University contact) Once all of the appropriate governance is complete the R&D team will issue the NTW approval letter. Upon receipt of this letter (emailed to student and copied to University contact) the project is then eligible to proceed.

10 Documents Required for R&D Review Completed Project Registration Form * Unless you have completed an IRAS application, there is a specific Student Project Registration Form which must be completed prior to you submitting your project for review. This form will ask for your service line manager (the manager of the service you are working with for your project) to sign indicating that they are aware of the project and happy for it to be conducted within their service involving either their service users and or staff. In addition we ask that you enclose a copy of the following documents with your registration form: Completed Document checklist See appendix 2 Protocol/Proposal Written explanation of what your project is about, your research question and objectives. The participants you will invite to take part, your methodology and how you intend to analyse the data gathered. Patient/Participant Information Sheets Your project may or may not involve service users and or staff, we require an information sheet, suitable for your participants to fully understand what they are being asked to be involved in and which provides contact information if they wish to find out more information or speak to someone if they have question. Participants must be give adequate time to read the information sheets prior to consenting to take part in your project. Consent Forms Consent forms need to clearly state what the participants are agreeing to by taking part in your project, participants need to either initial or tick next to each statement as well as signing the consent form GP/Consultant Information Sheets/Letters * If you plan to inform a patient/service users GP or consultant you will need to formulate a letter template to ensure the correct information regarding your project is passed on Copy of Questionnaire/Interview Themes * For projects involving a questionnaire we require a copy of the questionnaire, for projects involving interviews or focus groups we need to see an outline of the themes you intend to cover

11 Copy of Any Advertisements* If you need to advertise your project (either within the university or around the Trust) we need to have a copy of the advert itself if you are using an advert to attract service users to your project, the advert needs to be REC reviewed. Evidence of Academic and NHS Supervisor Support A letter of support from your academic supervisor will act as a peer review to ensure the Trust that your project has been authorised by the university (if your project undergoes university ethics review a copy of the ethical review outcome will be required). Evidence of your NHS supervisors support will come from a signed student registration form or via a letter of support to the R&D department. REC Favourable Opinion Letter* For projects requiring ethical review through IRAS, prior to issuing an approval letter NTW need to have been in receipt of a REC favourable opinion letter as soon as you receive your REC letter please contact the R&D team to ensure they are aware of the REC outcome. (*Where applicable)

12 Appendix 1 Research and Clinical Audit Definitions Research Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods Research generates evidence to refute or support or develop a hypothesis. Research aims to find out what happens if we add or change (manipulate) clinical or service practice in some way, or aims to find out in a systematic way the views/ opinions/ experiences/ understandings of stakeholders. It may also require only observation, without any intervention, and may be prospective or retrospective. It may be qualitative or quantitative in approach. Research is designed so that the results of the research or the theories derived from the research should be generalisable or transferable beyond the sample upon which the research was based. Research is likely to involve one or more of the following: Usually involves well-defined, often strict selection criteria for the sample selected Should be protocol-driven, although the design of qualitative research may require sufficient flexibility to respond to discoveries during the research process Quantitative research is designed so that it can be replicated. It may not be possible to replicate qualitative research, but it should be possible to form a judgement of the validity of the qualitative research process. In quantitative research, the sample size is usually defined by statistical methods. In qualitative research, statistical sample calculations and statistical sampling methods may not be applicable. There should however be a clear rationale for the sampling procedure used. Quantitative research usually involves statistical analysis to extrapolate from the sample to a wider population. This includes studies where only simple descriptive statistics such as percentages are appropriate. May test a new or additional practice, therapy or drug May involve contact with participants May involve experiments on human subjects, whether patients, patients as volunteers, or healthy volunteers May be invasive May involve collecting data from medical records May solely involve collecting data from medical records May involve examining tissue or body samples May involve extra disturbance or work beyond that required for normal clinical management May use interviews or questionnaires Participants may be randomised Qualitative research uses a variety of methods, e.g. observation, interview, or other information, to describe, understand or interpret a situation or issue It is intended to publish and disseminate the results beyond the organisation, generally at conferences or in academic journals. The results may change practice if new interventions, tests, etc. are shown to be effective. Research Governance Framework for Health and Social Care, Second edition, 2005

13 Service Evaluations Evaluation was seen as a set of procedures to judge a pilot s merit by providing a systematic assessment of its aims, objectives, activities, outputs, outcomes, and costs Service evaluation provides practical information to help decide whether a development or service should be continued or not. Evaluation also involves making judgments about the value of what is being evaluated. Evaluations: May provide cost and/or benefit information on a service Uses quantitative and qualitative data to explore activities and issues May identify strengths and weaknesses of services May include elements of research e.g. collecting additional data or changes to choices of treatment It can be difficult to distinguish some types of evaluation from research. Although both research and evaluation may involve addressing clearly defined questions with systematic and rigorous methods, research aims to derive generalisable new knowledge. Service evaluation may result in generalisable knowledge but the potential for generalisability is not part of the design of the project. Often a service evaluation is performed to meet specific local needs. The generalisability of service evaluation may arise through a report or publication where context and methodology are described and readers are able to judge whether the situation is sufficiently representative to their own situation. If it is intended that the results of the service evaluation are to be used to influence practices or processes outside the immediate setting and the work was not managed within the Research Governance Framework, there would be a risk of the public being exposed to changes without a sound evidence base. Where it is intended to publish the results of an evaluation in a form that aims to generalise the results to others situations, the evaluation should therefore be managed within the Research Governance Framework. Clinical Audit Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery. Clinical Audit is directly related to assuring services against a standard that has already been set by examining: 1. Whether or not what ought to be happening is happening 2. Whether current practice meets required standards 3. Whether current practice follows published guidelines 4. Whether clinical practice is applying the knowledge that has been gained through research 5. Whether current evidence is being applied in a given situation

14 Clinical Audit: May or may not involve patient contact but generally does not involve changes to normal clinical management Usually involves no more than administration of a questionnaire but can potentially require substantial patient/carer input and carry risks of distress and psychological harm Participants are never randomised to different treatments or services. Participants may receive or have received different treatments or services before the clinical audit Results are not transferable to other settings May use research methodologies e.g. interviews, random sampling, descriptive (not inferential) statistical analysis Standards of good practice are the basis of measurement not hypotheses and/or theoretical constructs Clinical audit outcome is the quality assurance of practice Principles for Best Practice in Clinical Audit, National Institute for Clinical Excellence, 2002 Standards for Better Health, DH, 2004

15 Appendix 2 - Project Checklist **Please complete and include with your application** Completed Project Registration Form OR SSI form Protocol/Proposal Patient/Participant information sheet* Consent Forms* GP/Consultant Information Sheet/Letter* Copy of Questionnaire/Interview Theme* Copy of Study Advertisement* Evidence of Academic and NHS Supervisor Support REC Favourable Opinion Letter* (*where applicable) ( essential documents) Please endeavour to send electronic copies of your documents where possible

16 Appendix 3 - R&D Contact Information R&D Office Contacts Laura Frisby, Research Facilitator, E. laura.frisby@ntw.nhs.uk T. 0191 2232334 Simon Douglas, Senior Manager for Research Innovation and Clinical Effectiveness, E. simon.douglas@ntw.nhs.uk T. 0191 2232338 Karol Adams, Administrator, E. Karol.adams@ntw.nhs.uk T. 0191 223233