The Research Project: ethical approval process John Witton Addictions Department

Outline of the talk Refresher on why research projects need ethical approval Audit vs Research Ethics committees The application process and the joys and horrors of the IRAS form Some things to play close attention to Useful sources of information and guidance

Ethical approval Ethical approval from King’s is mandatory when KCL staff/student research: includes human participants OR raises other ethical AND is undertaken by KCL staff or students

What kinds of research? Research involving human participants includes: Interviews Questionnaires Focus groups Observation Taking and using samples Giving drugs Physical activity

Why do you need ethical approval? Ensures generally accepted ethical standards are followed –consent, confidentiality, conduct Ensures you have thought through the research/audit proposed - why, how, when, where and who – so you do not waste people’s time, conduct research that is new and valuable and the research is likely to succeed Protects you and your study participants Mandatory requirement of the host university/clinical setting. Not following an approved ‘procedure’ can be reported as misconduct So you are covered by insurance if anything were to go wrong (and no-fault compensation) Funders will want to know Publishers will want to know

Research versus audit: research Research usually involves asking clearly defined questions and setting hypotheses Uses methods than are replicable Can use RCTs, cohort studies, placebos, database etc

Research versus audit: audit Audits aim to improve quality of patient care and clinical outcomes Audits review practice against evidence-based standards Are clinicians following best practice? What is happening to patients as a result of current practice? Results are specific to a particular tem or service Normally an audit (and service evaluation) does not need ethical approval But audits should still be conducted within an ethical framework – information sheets for patients etc.

Ethics committees King’s College London Committees Social Care Research Ethics Committee (all social care research funded by the Department of Health) NHS Research Ethics Committees patients and users of the NHS, or their carers NHS staff NHS premises Mental Capacity Act 2005 Human Tissue Act 2004

Ethic committee composition eg Harrow Research Ethics Committee Translator Pharmacist Consultant anaesthetist Research nurse Barrister Doctor of Medicine GP Consultant psychologist Retired IT consultant Business consultant

Where to get guidance http://www.kcl.ac.uk/iop/research/office/index.aspx

Preparing your ethics application Go to the Research Ethics web pages Read the guidelines Speak to your supervisor Download the current version of the application form and guidelines. Submit the correct number of copies, with the necessary signatures before the relevant deadline. Apply in plenty of time prior to your preferred start date. The length of approval asked for should cover the study up to publication.

Getting the application form right All applications go through a pre-review check by the Senior Research Ethics Officers. Applications will be assigned a unique reference number and will be sent to the Subcommittee for full review. Incomplete applications will be returned to the researcher and not sent to the Subcommittee for review.

What needs to be submitted? Application Form Information sheet for participants Consent form Supplementary documents may be needed: Questionnaire Topic guide Permission letters

The IRAS form Integrated Research Application System (IRAS) Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK Enables you to enter the information about your project once instead of duplicating information in separate application forms Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required Helps you to meet regulatory and governance requirements Further information: http://www.hra.nhs.uk/research-community/applying-for-approvals/

Outcomes The results of an application will fall under one the following categories: Full approval -the research may commence. Approval in Principle-amendments are requested before full approval can be granted. Deferred-the Committee will need to seek expert advice before a decision is made. Not Approved-the application is seriously flawed and must be resubmitted to the full Committee. Rejected-the study is deemed unethical and cannot be resubmitted.

What could you get wrong? It was sent it to the wrong Committee. It has track changes. No information sheet is an immediate return. You did not submit the required number of copies or collate your application; it is your responsibility to ensure the applications are collated and ready to be sent to the individual committee members.

Application not approved because… Required sections have not been completed The recruitment process is unclear/insufficiently detailed. Power calculation if needed not carried out Consent procedure has not been sufficiently detailed and you have not taken into account: The age, reading ability or language spoken/written by participants. Any permission needed from outside organisations.

Application not approved because… Supporting documents have not been submitted which prevents immediate approval. E.g. Interview schedule/questionnaires. Consent forms. Advertising –posters/emails.

Application not approved because… Standard procedures have not been included. Such as: Arrangements for confidentiality Exclusion criteria Risks and benefits. Regardless of the type of project, the research proposal and procedures must always be of good quality.

Application not approved because… The application does not identify or address how you will minimise/avoid: Potential risks to the participants (physical or mental) and the researcher. Any conflict of interest; the researcher has another position within the chosen organisation or is in a position of authority.

But experience shows Careful preparation means your project will get ethical approval Prepare well in advance Involve your supervisor

Further information Research ethics FAQs: http://www.kcl.ac.uk/research/ethics/training/faqs/ “Does my research require ethical approval flowchart”: http://www.kcl.ac.uk/research/ethics/ How to write an information sheet: http://www.kcl.ac.uk/research/ethics/training/infosheet.html Research in the workplace: http://www.kcl.ac.uk/research/ethics/training/workplace.html