DR TAMSIN NEWLOVE-DELGADO MRCPSYCH MFPH

NIHR DOCTORAL RESEARCH FELLOWUNIVERSITY OF EXETER MEDICAL SCHOOL

Research questions, governance, ethics and

funding

PLAN OF THE DAY

o 10-11.30 ish o Framing a research question - remindero Research governanceo Research ethicso Research funding

o 11.30-11.45 - Break

o 11.45-12.30 – Journal club

o 13:00-15:00 – Study designs: case control, cohort and qualitative

MRCPsych exam – Paper 3 Critical Review

Approx one third of the examResearch methodsStatisticsEvidence based practiceCritical appraisal

Exam syllabus links to today

1. Translation of clinical uncertainty into an answerable question

3.1.10Knows the benefits and weaknesses of different

quantitative study designs to address different clinical

questions: Cohort studies Case control

3.4 Qualitative methods: methodologies, sampling, data collection, quality, analysis etc

WHAT MAKES A GOOD RESEARCH QUESTION?

1. Framing the question

FINER criteria

PICOT

2. Research Governance

Tuskegee syphilis experiment 1932-1972

Other examples

What is research governance?

Principles, processes and standardsImprove research and safeguard public by:

Enhancing ethical awareness and scientific quality Promoting good practice Reducing adverse incidents and ensuring lessons are

learned Forestalling poor performance and misconduct

DH research Governance Framework

EthicsScienceHealth and SafetyInformationFinanceQuality

Influential legislation

Who is responsible?

Research governance is the responsibility of everyone involved in research

Think about it: When asked to take part in a project When writing own proposal – consider time and

resources needed If a project is using NHS patients, staff, resources or

premises, NHS Research and Development (R and D) approval required – even for non-clinical research

3. Research ethics

Importance

To protect patientsTo protect researchersUsually a mandatory requirement of the

institution, and the funderA pre-requisite of publication

Key ethical principles

Declaration of Helsinki:

Key ethical principles

Could also be expressed as: Knowledge Necessity: Benefit Consent

The three Cs of research ethics

Informed consent

UK case law on consent: Consent should be given by someone with the mental

ability to do so Sufficient information should be given to the

participant Consent must be freely given

Informed consent

Competency

Voluntariness

Consider the factors which might affect voluntariness

Ideally should be an independent researcherEmphasise that can withdraw at any timeCooling off period

Information - disclosure

Example of a BAD participant information sheet (adapted from my GOOD PhD one!)

Take 5 minutes to read through and spot what’s missing or wrong

Information: Disclosure

Aims and methodsFunding source and conflicts of interestBenefits – ‘reasonably expected’

Are there likely to be any benefits to the participants? If not, this should be made clear Randomisation

Risks and inconveniences – ‘foreseeable’Duration of involvementWhat happens to data/samplesWithdrawing from the trial

Some examples

Ethical pitfall examples..........What might be the problem with these

research scenarios?If you were on the Ethics Committee, would

you: Accept outright Reject outright Request amendment – what/and what more might you

want to know?

SCENARIO 1

An epidemiological cross sectional study is inviting men and women aged 65-84 for a cognitive assessment and MRI to measure their burden of cognitive impairments. All participants will be scanned, and all will receive feedback on any abnormalities found in their scan.

Issue here around feeding back...Is it unethical to inform patients about

abnormalities that are likely to be of no clinical significance and/or for which no further investigations or treatment exist?

SCENARIO 2

A pilot non-controlled trial of art and music reminiscence programme for people with advanced dementia. The researchers plan to assess the capacity of each participant individually and then consult the relatives of those who don’t have capacity to consent.

Does this research have the potential to directly benefit the patients?

Can it be done in other groups instead?Are the risks disproportionate?

SCENARIO 3

A basic science cohort study involving collecting blood samples once every three months for 5 years to monitor the concentrations of a biomarker in patients in a medium secure psychiatric unit. The current plan is for the consultant forensic psychiatrist to recruit patients to the trial.

Consent to samples and storage of samples (Human Tissue Act)

VoluntarinessWill it be made clear that there’s no direct

benefit to the patients?

Psychiatric research ethics

‘Although certain individuals with psychiatric disorders may at times lack the capacity to consent, the vast majority of people with a mental illness have the right to decide for themselves whether or not they wish to take part in a study’

The Royal College of Psychiatrists statement on research ethics

Psychiatric research ethics

There are specific groups of individuals in psychiatric or other research who require additional safeguards : Children People with learning disabilities People detained under the Mental Health Act People with reduced or lost capacity due to dementia And others……………….

The mental capacity act and research

Aim is to balance the importance of properly conducted research with the need to protect the interests and respect the current or previously expressed wishes of those involved.

Covers ‘intrusive research’ – covers data collection as well as collection of samples

Including participants who lack capacity: 2 questions

Is the research related to the impairing condition that causes the lack of capacity – or to treatment of the condition?

Could the research be carried out as effectively with people who do have the capacity to consent?

Including participants who lack capacity: 2 questions

Study must meet one of these requirements:

OR

It is likely to be of benefit to the person – either directly or indirectly;

and that the benefit is in proportion to any risks/burden

The research will serve to increase knowledge of cause, treatment or

care of people with the same/similar condition – AND that the risks will be

negligible with no significant interference with privacy or freedom

Consultees for those lacking capacity

The researcher should take ‘reasonable steps’ to identify a ‘personal consultee’

This is a close contact who is not acting in a paid capacity

If no personal consultee is available, the researcher should nominate a ‘nominated consultee’

Can be a professional but must have no connection with the research study

Exclusions from mca in research

Generally speaking………..Under 16sClinical Trials covered under Clinical Trials

RegulationsResearch involving only anonymised dataSome human tissue researchSpecial permissions……..

Practicalities of ethical approval

Is it research or not?Can check with NHS R and D

Practicalities of ethical approval

If not managed as research, don’t need NHS R and D or REC approval, but may need other local/institutional approval processes

If project is research and involves participants or data from the NHS, it will require NHS Ethics approval

Guidance is available from the National Research Ethics Service: http://www.nres.nhs.uk

Applications are through the Integrated Research Applications Systems (IRAS): https://www.myresearchproject.org.uk/

Mhra: medicine and healthcare regulatory agency

Deals with clinical trialsCovers:

New drugs Old drugs being tested for a new use Old drugs reformulated/packaged differently Possibly more!

These will require authorisation from MHRA

4. Research funding

What proportion of the medical research budget is spent on mental health research?

Guesses?

Spending on health specific categories by year compared with health burden.3 DALY=disability adjusted life year.

Kingdon D , and Wykes T BMJ 2013;346:bmj.f402

©2013 by British Medical Journal Publishing Group

Funders of mental health research

Mechanisms of funding

National commissioned callsGrants and researcher-led proposals

NIHR Programme Grants for Applied Research 

Fellowships for research and research training from big funders

Mental health research networks locally

NIHR Mental Health Clinical Research Network – West Hub

NIHR Peninsula Comprehensive Local Research Network (CLRN)

NIHR Research Design ServiceUniversity of Exeter – Mental Health

Research Group, Child Health Research Group

Thank you

Questions?