Procedures for Prison Research with Health Outcomes

ANNEXE 1:RESEARCH, AUDIT OR EVALUATION?RESEARCH CLINICAL AUDIT SERVICEEVALUATIONThe attempt to derive generalisable newknowledge including studies that aim togenerate hypotheses as well as studiesthat aim to test them.Designed and conducted to produceinformation to inform delivery of bestcare.Designed and conductedsolely to define or judgecurrent care.Quantitative research – designed to testa hypothesis.Qualitative research –identifies/explores themes followingestablished methodology.Designed to answer the question:“Does this service reach apredetermined standard?”Designed to answer thequestion:“What standard does thisservice achieve?”Addresses clearly defined questions,aims and objectives.Quantitative research -may involveevaluating or comparing interventions,particularly new ones.Qualitative research – usually involvesstudying how interventions andrelationships are experienced.Usually involves collecting data that areadditional to those for routine care butmay include data collected routinely.May involve treatments, samples orinvestigations additional to routine care.Measures against a standard.Involves an intervention in use ONLY.(The choice of treatment is that of theclinician and patient according toguidance, professional standardsand/or patient preference.)Usually involves analysis of existingdata but may include administration ofsimple interview or questionnaire.Measures current servicewithout reference to astandard.Involves an interventionin use ONLY. (Thechoice of treatment is thatof the clinician andpatient according toguidance, professionalstandards and/or patientpreference.)Usually involves analysisof existing data but mayinclude administration ofsimple interview orquestionnaire.Quantitative research - study design mayinvolve allocating patients tointervention groups.Qualitative research uses a clearlydefined sampling frameworkunderpinned by conceptual or theoreticaljustifications.No allocation to intervention groups:the health care professional and patienthave chosen intervention beforeclinical audit.No allocation tointervention groups: thehealth care professionaland patient have chosenintervention beforeservice evaluation.May involve randomisation No randomisation No randomisationALTHOUGH ANY OF THESE THREE MAY RAISE ETHICAL ISSUES, UNDER CURRENT GUIDANCE:-RESEARCH REQUIRES R.E.C.REVIEWAUDIT DOES NOTREQUIRE R.E.C. REVIEWSERVICEEVALUATION DOESNOT REQUIRE R.E.C.REVIEWTaken from NRES definitions at www.nres.npsa.nhs.ukNB Whilst Audit and Service Evaluation are not required to be reviewed by REC,there are occasions when the content of the study means it is advisable for RECreview to take place. For example, an audit of rape trauma counselling hasethical implications and should be reviewed. If in doubt, contact the Chair orVice-Chair of a prison-specific REC (see Annexe 3), or alternatively email theNRES queries line (queries@nationalres.org.uk). If there is any risk of harm,then ethical review is probably advisable.