Developing a Research Protocol/Proposal

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Cornelia Hopkins
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1 Developing a Research Protocol/Proposal Helen Neilens Research Advisor Plymouth Hospitals NHS Trust hneilens@nhs.net

2 My Role To help researchers follow the research procedures and processes necessary to conduct NHS research inc. ethics and sponsorship To help researchers explore funding opportunities To advise on research design To help researchers develop their research protocol Signposting to the right person to speak to To support collaborative research across institutions

3 Rewards of conducting research Furthering knowledge Improving patient care Providing income Generating publications Boosting your own career

5 Research Governance Framework defines the broad principles of good research governance and is key to ensuring that health and social care research is conducted to high scientific and ethical standards. National laws that govern clinical trials - The Medicines for Human Use (Clinical Trials Regulations) - Data Protection - Declaration of Helsinki - Human Tissue Act (2004) - Mental Capacity Act (2005) - ICH GCP ICH Harmonised Tripartite Guideline for Good Clinical Practice - standard for the conduct of clinical trials, covering aspects of preparation, monitoring, reporting and archiving

6 The Protocol A research protocol is a detailed set of instructions written by scientific researchers that outline the procedures for conducting the experiment and collecting data. Do not confuse a research protocol with a research proposal. A proposal is meant to persuade your instructor, peers, or a grant-making committee, while a research protocol is meant to detail a study's methodology in straightforward fashion to satisfy an entity's human subjects requirements.

7 The research team Team needs to represent the range of skills needed to answer the research question, eg: Clinical specialists Research expert Statistician Nurse Service user

8 They look like this

9 Not like this

10 What to include in a protocol Title Summary Research Question Background and rational Lead up to how the research fills the gap Aims and Objectives Plan of Investigation

11 Formulating an answerable research question

12 Example research question Population Intervention Comparison Outcomes In the treatment of adults with moderate depression is the addition of cognitive therapy to usual care (Prozac) associated with a change in depression? Adults with diagnosis of moderate depression Cognitive therapy plus drug (Prozac) Care-as-usual (Prozac alone) e.g. HADS;SF-36;EQ-5D Semi-structured feedback interviews Cost of intervention

13 How many of these patients do you see, say, per month?

14 Thousands!

15 Can you just check how many it is over the coming month?

16 Hundreds!

17 How many of those were eligible?

18 Quite a few!

19 And how many would be willing to participate?

20 It was a quiet month!

21 And how many will you follow up?

22 OK I ll ask another site

23 Numbers of potential participants How many patients of this group enter the trust/are seen in your practice? How many of these fulfil the inclusion criteria? What is your predicted recruitment rate (be pessimistic)? What is your predicted attrition? What are these estimates based on?

24 Population What is the target population? How will sample be selected? Qualitative research samples based on feasibility and saturation For quantitative research seek advice from statistician You may need a sample size calculation? Inclusion/Exclusion criteria

25 Recruitment and consent Details of how participants are going to be recruited Who is consenting and how Patient Information sheets Consent forms Ethical considerations

26 Feasible Intervention

27 Comparison Placebo - receives inert substance/intervention - controls for the psychological effect of being treated - possible ethical issues Care as usual

28 Outcomes Outcome measures what could this exposure/intervention really affect? Objective clinical measures, eg. bp, mortality, length of inpatient stay Subjective patient-orientated measures, eg. QOL, pain scores, satisfaction

29 Arrive in ED Seen by Doctor Patient pathway Ineligible No SVT diagnosed? Yes Verbal and written explanation of trial flowchart Non-participant No Agree to take part in trial? Yes Written consent Randomise Standard Vasalva Modified Vasalva Yes Sinus rhythm achieved? Sinus rhythm achieved? Yes No No Standard Vasalva Modified Vasalva Sinus rhythm achieved? No Adenosine administered No Sinus rhythm achieved? Yes Yes Study end Study end Study end Study end Study end

30 Data Management and statistics What type of data Quantitative or qualitative How is it to be collected and by whom Data collection sheets in the appendix When is it to be collected It must state when all outcome measures are to be taken How is it to be analysed Statistical methods How is it to be stored Where and for how long, what format Participant safety data monitoring committee assessing and reporting adverse events

31 Project Management - Personnel - Time-schedule Gantt chart - day to day study management Ethical considerations Possible implications of study - Clarify the benefits of the research References Appendices - consent forms - patient information sheets - data collection sheets - doctors letters etc. Protocol continued

32 Project timetable (Gantt charts) Months Ethics approval Participant Recruitment 6 mth follow-up Etc Leave realistic time for ethics / governance approval Provide sufficient detail

33 Costing your project Find someone who knows what they are doing and who: understands the forms Enlist help of finance department - Seek help with salaries of research staff - Include all expenses Admin support Office stationery Telephone costs Travel expenses Conference visits etc. Don t underestimate the time this will take start early

35 Sources of Funding Drug companies NHS National schemes: Health Technology Assessment, SDO, i4i Research for Patient Benefit scheme (RfPB) MRC, ESRC and other research councils Royal Colleges and professional associations Medical and health-related charities

36 HS&DR HTA RfPB PHR EME i4i PGAR RCF RCF Charity

38 Study Sponsorship The Research Governance Framework (2005) requires all studies to have an identified Sponsor Who is the sponsor? The Sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study

39 PHNT sponsorship procedure protocol development risk assessment LOW e.g. questionnaires - MEDIUM e.g. involve radiation - HIGH e.g. drugs trials R&D reviews R&D Sponsorship approval

41 Ethics Ethics approval sought after approval given for the project by the sponsor IRAS Integrated Research Application System ( Valuable scientific question Valid scientific methodology Fair participant selection Favourable risk-benefit evaluation risks minimized Independent review Informed consent Respect for enrolled participants Confidentiality Data monitored for safety Vulnerable participants

42 Forward Planning Find out Ethics Committee deadlines ( Contact R&D for Research Governance support Allow time for protocol development, approvals and signatures 4 days before deadline phone REC for a number Submit all paperwork IRAS form Written protocol Information sheets, consent forms & any letters Interview schedule or questionnaires (if applicable) Data collection sheets

43 Questions?

Standard Operating Procedures (SOP) Research and Development Office

Standard Operating Procedures (SOP) Research and Development Office Title of SOP: GCP Inspection Procedures (MHRA) SOP Number: 15 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review