Ethics in Practice: BSREC and NHS Research Ethics Committees

Tuesday 15th April 2014

Graham Hewitt – WMS,Research Ethics and Governance Manager

What has this got to do with me?

• University of Warwick Research Code of Practice states• “Any University of Warwick student or member of

staff, who wishes to undertake research involving human participants, their data and/or tissue (this may also include research involving the data of deceased participants) under the auspices of the University, must obtain appropriate ethical approval.”

What has this got to do with me (cont’d)?

• Research Ethical Review increasingly required by:

• Funders

• Journals

Ethics CommitteesSummary• Ethics Committees are responsible for acting primarily in

the interest of potential research participants• They also take into account the interests, needs & safety

of researchers trying to undertake good quality research

But - the goals of research & researchers will always be secondary to the dignity, rights, safety & well-being of research participants

• Important that applications to Ethics Committees demonstrate that consideration has been given to these principles & adequate steps taken to address them.

Research jargon

HRA Health Research Authority

NRES National Research Ethics Service – comprehensive resource for NHS studies

IRAS Integrated Research Application System – online application system for research in NHS heath and social care settings

BSREC Biomedical and Scientific Research Ethics Committee – the Research Ethics Committee of the Faculties of Science and Medicine, which reports to the University’s Research Governance and Ethics Committee (URGAEC)

CI (Chief Investigator) – overall responsibility for the study:• For student research up to doctoral level: academic supervisor is the CI• For PhD studies: the student is the CI and the academic supervisor is the PI

PI (Principal Investigator) – responsible for specific site(s) in multi-site studies; the CI/PI may be the same person.

What ethical review does my study require?Type of study Ethical approval required

• Literature/systematic review of published data

• Service Evaluation in the NHS• Clinical Audit in the NHS

• Supervisor/Course Director• Head of NHS Department

• Secondary analysis of unpublished data, e.g. anonymised routine clinical data & student data

• Research involving human participants, but not NHS Patients

• UoW BSREC Process

• Research involving NHS patients/identifiable data/identifiable samples etc.

(But not Audit or Service Evaluation)

• NHS Ethical Approval (National Research Ethics Service (NRES))

Audit, Service Evaluation or Research?Comparison:

In research studies:

In audits: In service evaluations:

Intent: Primary aim is to derive new knowledge; discovering the right thing to do

To produce information to inform delivery of best care against a current standard

To define or judge current care without reference to a current standard

Treatment: May test a new practice, therapy/drug which may lead to change in clinical practice

Only use treatment (intervention) arising from evidence-based clinical judgement & necessity

Only use treatment (intervention) arising from evidence-based clinical judgement & necessity

Allocation: Only research allocates treatment by a protocol

No allocation: health professional & patient have chosen intervention before audit

No allocation: health professional & patient have chosen intervention before service evaluation

Randomisation: Only used in research

N/A N/A.

Types of ethical approval

NHS REC process

How to apply for ethical approval via NRES

Research Sponsorship (1)

• The Research Governance Framework for Health & Social Care (RGF, 2005) outlines the responsibilities of research sponsors.

• All studies in the NHS must have a research sponsor

• All Clinical Trials of Investigational Medicinal Products (CTIMPS) must have a research sponsor by law

Research Sponsorship (2)

The research sponsor is the individual or institution that takes responsibility for the initiation, management, and financing (or arranging the financing) of the study. The sponsor must satisfy itself that the study meets the relevant standards and ensure that arrangements are put and kept in place for management, monitoring, and reporting.

Research Sponsorship at WarwickIf you would like the University to act as sponsor for

your study please read the University of Warwick Sponsorship Principles for guidance and contact RSS. If you are based in WMS, this will be dealt with when you apply to BSREC, or, if you are submitting a study to an NHS REC, please allow ten working days and e-mail your study documentation to the WMS Research Ethics and Governance Office via:

WMSSponsorship@warwick.ac.uk http://www2.warwick.ac.uk/services/rss/researchgovernance_ethics/

research_code_of_practice/humanparticipants_material_data/sponsorship/

BSREC process

BSREC Triaging Categories

• Out of remit / No review

• Delegated to academic supervisor• Light Touch Review (Single

reviewer)• Full Review (Two reviewers)

Any of above 3 can reach Committee

Out of Remit / No Review

– Secondary analysis of published or other freely available data

– Clinical Audits

– Service Evaluation and Development Projects within the NHS

– Minor amendments to previously approved projects

– Undergraduate projects with primarily an educational purpose, including projects for the purpose of research methods training, provided they do not:

• Seek to recruit participants beyond the students’ social circle, family, peers, or colleagues

• Receive external funding• Include any form of deception or coercion• Involve the administration of any substance• Involve participants being subjected to any invasive procedure

Out of Remit / No Review

In addition, the Committee would not normally undertake ethical review for:

• Interview/consultation with key informants/service users during the development of research proposals/protocols;

• Stakeholder consultations during the developmental stage of research proposals/protocols.

Delegated to academic supervisorThe ethical review and approval:• Undergraduate and taught postgraduate student (but

not masters by research, doctoral student, or staff) research and service evaluation projects

• That are limited to interviews, focus groups, and questionnaire completion, or the evaluation of software and e-learning materials,

• With non-vulnerable or dependent participants (e.g. Not receivers of health or social care, primary or secondary education, or criminal justice services),

• Where the research does not investigate sensitive or intrusive matters (e.g. Health status, criminal activity, or sexual history).

Light Touch Review (Single reviewer)

– Research using the secondary analysis of existing anonymised collected human data

• Research using routinely collected human data within a clinical care team or service provision team, or outside a clinical care team or service provision team where the data has been anonymised prior to its passing to the researcher/s.

• Research using routinely collected student assessment data within a course or Department/School where the data has been anonymised prior to its passing to the researcher/s.

– Questionnaire and similar low risk studies undertaken by staff or PhD students

– Substantial amendments to projects previously approved by BSREC

Full Review (Two reviewers)

– Research with human participants, their identifiable data, or tissue

– That is not excluded on the grounds

of criteria detailed earlier

BSREC Application Process

Simple Application Form

Protocol– Lay Summary– Ethical Considerations

• Informed Consent• Participant Confidentiality and Data Security

Supporting documentation

BSREC Amendment Process

Simple Application Form

Copies of any changed documentation

BSREC Amendment Guidance

Substantial Amendment– is defined as an amendment to the terms of the

application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree:

• The safety or physical or mental integrity of the subjects of the study;

• The scientific value of the study; • The conduct or management of the study; or • The quality or safety of any investigational medicinal product

used in a trial.

Anything else is a Non-Substantial Amendment

Substantial Amendments - Examples

• 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 principal 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 or the terms of the BSREC application.

Non-Substantial Amendment- Examples • Minor changes to the protocol or other study documentation, e.g. Correcting

errors, updating contact points, minor clarifications;

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

• Changes to the chief investigator’s research team (other than appointment of key collaborators);

• Changes to the research team at particular trial sites (other than appointment of a new principal 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.

Ethical Review

Ethical Considerations

– Informed Consent

– Participant Confidentiality and Data Security

– Right of Withdrawal

– Process for dealing with sensitive disclosures

– Benefits and risks

– Other Issues

Common mistakes that delay approval• Submission to the wrong Research Ethics Committee• Study design unclear/unlikely to achieve stated

objectives• Failure to register study with appropriate NHS Trust(s)• Means of accessing participants unclear• Steps to ensure confidentiality, anonymity, secure

storage of data not specified• See University’s Data Protection Policy• Encryption advice.

Common mistakes that delay approval (Cont’)• Information in Protocol or Application Form inconsistent

with information in other documents• Missing information and/or documents i.e. Informed

consent documentation• Poor grammar & spelling particularly in Participant

Information Sheet/Consent Forms that materially affect the meaning of the text

• Title, submission date & version control missing• Original signed copy (by applicant, & if a student, by their

Academic Supervisor) of the Application Form or BSREC Application Form not posted to BSREC Administrator.

Other Approvals

• Supervisors are responsible for directing students to seek all necessary approvals

• These may include:

• NHS R&D Approval• Honorary Contracts/Letters of Access

• Human Tissue Use Regulations• Mental Capacity Act Regulations• Social Services

NHS R&D Approval (IRAS)• As laid out by RGF, NHS Trusts must

give NHS R&D Approval for a study within the NHS to proceed

• Honorary Research Contracts or similar may be necessary

• Can be lengthy and frustrating – 6 months or longer not uncommon!

• Varies from NHS Trust to NHS Trust

Human Tissue Act/AuthorityConsent and licensing at centre of regulation

The HTA’s regulatory aim• To create an effective regulatory framework for the

removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence, through process of licensing and inspection

How HTA licenses and inspects?• Compliance reporting• HTA evaluate evidence in compliance report• Inspect according to risk

Human Tissue Studies

•Register Study with Human Tissue Office

•Authority to Import Human Samples Form

•Attend Training in Human Tissue Use

•Complete MRC e-learning module

•Undertake Biological Risk Assessment (BRA)

•Obtain Materials Transfer Agreement (MTA)

Human Tissue Studies (cont’)

John Davey (Designated Individual)Tel: 02476 524204J.Davey@Warwick.ac.uk

Emily Dight (HTA Administrator)Tel: 02476 968583Tel: 02476 151755E.C.Dight@Warwick.ac.uk

http://www2.warwick.ac.uk/services/rss/researchgovernance_ethics/research_code_of_practice/humanparticipants_material_data/research_human_samples-copy/

Mental Capacity Act 1Came into force on 1st October 2007

Covers non-CTIMP research• MHRA has remit for persons lacking mental

capacity and Clinical Trials of Investigational Medicinal Products (CTIMPs)

New research starting after 1 October 2007 must have section 30-33 approval from an NHS REC if involving one or more adults unable to consent for themselves

Mental Capacity Act 2

The appropriate body can only approve a research project if the research is linked to: – an impairing condition that affects the person

who lacks capacity, or – the treatment of that condition

And

there are reasonable grounds for believing that the research would be less effective if only people with capacity are involved, and

– the research project has made arrangements to consult carers and to follow the other requirements of the Act.

Mental Capacity Act 3

Further Information:

– Mental Capacity Act 2005 Code of Practice

– Ministry of Justice

Research Ethics in Social Care

Approach local Social Services Department/s in first instance!

Social Care Research Ethics Committee (SCREC) – Accessed via IRAS– Meets monthly– Still in relative infancy (started June 2009)– Approach direct by telephone– www.screc.org.uk

Social Care Research Ethics Committee (SCREC)

Limited Remit:

• Research funded by the Department of Health• Research that may involve people lacking mental

capacity• Research that involves sites in England + in one or

more other country that makes up the United Kingdom

• Research on integrated services (health & social care) or multi-site research involving both health & social care contexts, provided no clinical intervention is involved

Avoiding delays

• Don’t be tempted to split studies that involve elements of NHS & non-NHS data – describe study in full & submit it to the appropriate NHS REC

• Plan ahead: completing documentation properly takes time but may avoid amendments/delays

• Allow 3-6 months for Trust Approval• Read NRES/BSREC guidance: submit applications & all

relevant documentation in required format(s).

If in doubt...

• Visit the BSREC website in the first instance: http://www2.warwick.ac.uk/services/rss/researchgovernance/research_code_of_practice/researchethicscommittees/biomed/

• E-mail BSREC Administrator with any queries not answered by the BSREC website: bsrec@warwick.ac.uk