Guidelines for submission to the NSW Population and Health Services Research Ethics Committee. Version June 2015

Transcription

1 Guidelines fr submissin t the NSW Ppulatin and Health Services Research Versin June 2015

2 Cntents Sectin 1: Intrductin... 3 Sectin 2: Research Gvernance... 4 Sectin 3: Submissins t the NSW PHSREC... 5 Sectin 4: Lw and Negligible Risk Research... 7 Sectin 5: Data repsitries/prgram linkages... 8 Sectin 6: Extensin r addendum t a prject which already has apprval frm anther HREC Cntact fr all enquiries TRIM REF: E13/ June 2015 Page 2 f 11

3 Sectin 1: Intrductin The NSW (PHSREC) is a jint initiative f the Cancer Institute NSW and NSW Ministry f Health. The NSW PHSREC is accredited in NSW as a lead Human Research (HREC) fr general research. The Cmmittee has been certified under the Natinal Apprach t Single Ethical Review in the categry f Ppulatin health and/r public health. The NSW PHSREC undertakes scientific and ethical review f ppulatin health research utilising and/r linking rutinely cllected health (and ther) data, including: data cllectins wned r managed by NSW Ministry f Health (e.g. NSW Admitted Patient Data Cllectin; Perinatal Data Cllectin; NSW Emergency Department Data Cllectin; and New Suth Wales Ppulatin Health Surveys); data cllectins wned r managed by the Cancer Institute NSW, (e.g. NSW Central Cancer Registry, NSW Pap Test Registry, BreastScreen Registry). The NSW PHSREC will als review mixed methds research where a cmpnent f the research meets the abve descriptin (in the case f clinical trials, the Cmmittee will review a data linkage cmpnent, but is nt accredited t review the trial itself). If such research is multi-centre within the public health sectr, the NSW PHSREC can prvide single ethical review n behalf f the NSW Public Health Organisatins (PHOs) in which the research is t be cnducted. Please nte that all research invlving access t data cllectins wned r managed by NSW Health r the Cancer Institute NSW must be reviewed by the NSW PHSREC. There is n ther with a mandate t apprve research prpsals requiring access t these cllectins. Where the research prject may affect the health and wellbeing f Abriginal peple and cmmunities in NSW, apprval frm the Abriginal Health and Medical Research Cuncil (AHMRC) is required. Researchers are referred t fr mre infrmatin. TRIM REF: E13/ June 2015 Page 3 f 11

4 Sectin 2: Research Gvernance Site gvernance Fr sme research prjects, separate gvernance review at a particular site, r sites, will be required. This prcess is in additin t, and separate frm, the ethical review f the prject. Fr example, research studies which are t be carried ut in a Public Health Organisatin (PHO) will require separate site authrisatin frm the Chief Executive r delegate f that rganisatin. In such cases, a Site Specific Assessment (SSA) applicatin shuld be made t the Research Gvernance Officer f each PHO at which it is prpsed the research will be cnducted. Data gvernance fr Cancer Institute NSW and NSW Ministry f Health cllectins Prpsals invlving access t data cllectins wned r managed by NSW Health r the Cancer Institute NSW must be reviewed by the relevant Data Custdian befre applying t the PHSREC. Data Custdians fr these cllectins are required t sign ff n access t data fr each registry r dataset which is part f the current applicatin. The Data Custdian Sign Off frm must be submitted t the PHSREC. Fr mre infrmatin abut NSW Health datasets see and fr NSW data custdians, see Fr mre infrmatin abut the Cancer Institute NSW registries, see The Centre fr Health Recrd Linkage (CHeReL) Fr studies requiring linkage f NSW Health datasets, it is recmmended that the linkage is perfrmed by the Centre fr Health Recrd Linkage (CHeReL). If the research invlves linkage t the NSW Central Cancer Registry, there is a requirement that the linkage must be perfrmed by the CHeReL. Fr prjects invlving linkage by the CHeReL, please fllw their applicatin prcess. The CHeReL will btain data custdian sign-ff n yur behalf. Yu will need t submit yur Natinal Ethics Applicatin Frm (NEAF) and study prtcl t the CHeReL fr technical feasibility sign ff, prir t submitting t the PHSREC. Fr mre infrmatin abut the CHeReL, visit the website at The Secure Unified Research Envirnment (SURE) facility Depending n the nature f the data linkage fr which yu are applying, it may be a requirement f ne r mre data custdians that yur linked dataset is hused in the Secure Unified Research Envirnment (SURE) facility. The SURE is a remte-access cmputing envirnment that allws researchers t access and analyse linked healthrelated data files fr apprved studies in Australia. Fr mre infrmatin abut the SURE facility, visit the website at TRIM REF: E13/ June 2015 Page 4 f 11

5 Sectin 3: Submissins t the NSW PHSREC As f 01 July 2015 fr ALL APPLICATIONS, the NSW PHSREC n lnger requires paper cpies f submissins and subsequent crrespndence. Electrnic cpies f the fllwing dcumentatin shuld be submitted t Ethics@cancerinstitute.rg.au: The cmpleted submissin checklist Ethics applicatin frm: Fr mst applicatins t the NSW PHSREC, a Natinal Ethics Applicatin Frm (NEAF) will be required. Fr sme prpsals a Lw & Negligible Risk Research (LNR) frm may be apprpriate (see sectin 4). Applicatin frms are available via the Online Frms website Nte n Crdinating / Principal Investigatr: The Crdinating / Principal Investigatr is the individual wh takes verall respnsibility fr the research prject and submits the prject fr ethical and scientific review. They are respnsible fr nging cmmunicatin with the, and if the prject is undertaken at multiple sites, passing this infrmatin n t ther Principal (site) Investigatrs as listed n the NEAF. Nte n cmmissined research: In general, the Crdinating / Principal Investigatr shuld be smene frm the agency which has cmmissined the wrk, rather than the rganisatin which has been cntracted t undertake the wrk. Please cntact the Executive Officer fr mre infrmatin abut this requirement. Nte n Student prjects: It is nt the usual practice f the PHSREC t apprve a student as the Crdinating / Principal Investigatr f a study. Applicants shuld therefre appint a Crdinating / Principal Investigatr fr the applicatin wh is nt a student. Nte n signatures: Signatures fr ALL Investigatrs must be prvided in Sectin 10 f the NEAF. Unsigned dcumentatin will nt be accepted. Please see belw fr mre infrmatin regarding Electrnic submissin. A detailed Research Prtcl including bjectives, design, methdlgy, statistical analysis plan, ethical cnsideratins and hw the study will be cnducted and evaluated. Please refer t the Research Prtcl Template available n ur website Please d nt recycle dcuments used in funding applicatins. The review f yur ethics applicatin will be mre efficient if the prtcl is written specifically t address PHSREC requirements. Variable list(s) fr each data cllectin including Data Custdian signff where applicable. The Cmmittee recgnises that sme Data Custdians will nt prvide TRIM REF: E13/ June 2015 Page 5 f 11

6 sign-ff until after ethics apprval has been granted. In this case the applicant shuld seek the advice f the Executive Officer. Fr prjects invlving data linkage by the CHeReL: A signed letter f supprt frm the CHeReL as evidence that the prject is technically feasible. The CHeReL Applicatin fr Data The NSW Privacy Frm All dcumentatin relevant t the prject, such as Participant Infrmatin and Cnsent frm(s), survey tls, and questinnaires where applicable Crrespndence frm ther HREC in Australia where applicable (Please nte: if yur prject is an extensin r addendum t a current prject which has already been apprved by anther lead HREC in NSW, please see specific requirements in Sectin 6 belw). A brief Curriculum vita fr the Crdinating / Principal Investigatr. Electrnic cpies f all dcuments shuld be submitted t: Ethics@cancerinstitute.rg.au Electrnic Submissin: The NSW PHSREC is a paperless. Please d nt submit paper cpies f yur applicatin. The requirements fr electrnic submissin are utlined belw: Signatures fr ALL Investigatrs must be prvided in Sectin 10 f the NEAF Unsigned dcumentatin will nt be accepted Electrnic signatures can be inserted int a dcument and saved as a PDF, r individual signed pages can be scanned and saved as a PDF Electrnic and/r scanned signatures must clearly identify an Investigatr and indicate their cnsent fr the submissin All submissins and crrespndence must be sent frm a valid address linked t the cntact persn s rganisatin The Crdinating / Principal Investigatr must be cc d n all submissins t the PHSREC (including amendments and reprting). Fr additinal infrmatin regarding requirements fr electrnic signatures, please refer t Part 2, Divisin 2, Sectin 9 f the Electrnic Transactins Act 2000 N 8: TRIM REF: E13/ June 2015 Page 6 f 11

7 Sectin 4: Lw and Negligible Risk Research The Natinal Statement n Ethical Cnduct in Human Research 2007 describes research as lw risk where the nly freseeable risk is ne f discmfrt t participants. The Statement describes research as negligible risk where there is n freseeable risk f harm r discmfrt and any freseeable risk is nt mre than an incnvenience t the participants. A NSW Health Guidance dcument gives further infrmatin abut the type f research which qualifies as lw and negligible risk (LNR), and identifies categries f research which are exempt frm lw and negligible risk review. Researchers are advised t review these guidelines prir t cmmencing their applicatin: The NSW PHSREC will undertake expedited review f certain prjects that are cnsidered t be f lw r negligible risk t participants. The types f research that the NSW PHSREC will cnsider t be LNR are thse where: The level f intrusiveness and disruptin t participants is minimal (taking int accunt wh the participants are and whether they cnstitute a vulnerable ppulatin); The prject des nt (r des nt have the ptential t) invlve sensitive infrmatin abut participants; The threat t a participant s privacy and cnfidentiality is remte; and The prject invlves the use f data which has been stripped f identifiable infrmatin (such as name, address, dates f birth r death) and the ptential t re-identify the infrmatin is remte. The fllwing examples wuld nt qualify fr LNR review, since there is a ptential fr re-identificatin f infrmatin: prjects investigating rare events r utcmes prjects requiring the release f full date variables Researchers are asked t cntact the Executive Officer n (02) , t discuss whether their prpsed research qualifies as LNR research, prir t applicatin. The LNR ethics applicatin frm can be fund n the nline frms website at TRIM REF: E13/ June 2015 Page 7 f 11

8 Sectin 5: Data repsitries/prgram linkages This sectin describes the requirements fr submissins invlving large-scale data linkages designed t address multiple research questins. The Cmmittee recgnises that that plans fr specific prjects, unidentified at the time f the riginal submissin, may arise frm these linkages in the future. The Cmmittee refers t applicatins f this kind as data repsitries r prgram linkages and has specific prcesses related t these. In the first instance the Cmmittee apprves the linkage t undertake the prgram f wrk and then requires submissins fr each new prject cnducted under the auspices f the riginal apprval. The verarching linkage and brad tpic f investigatin must be submitted t the PHSREC as a full NEAF. The Cmmittee als requires a detailed Research Prtcl including bjectives, design, methdlgy, statistical analysis plan, ethical cnsideratins and hw the study will be cnducted and evaluated. Fr prgram linkages, Investigatrs must als prvide additinal infrmatin in the prtcl regarding data gvernance including infrmatin regarding transfer, access and/r use, strage (include site(s) at which data will be stred), retentin and dispsal f the data. Fr data repsitries, the PHSREC als requires researchers t utline the plicies and prcedures related t the management and gvernance f the repsitry. These plicies shuld address the fllwing pints: 1 Details f the nging management and gvernance f the data including the rles and respnsibilities fr the management f the infrmatin. The management structure must be independent f mvement f persnnel. Details f funding demnstrating that funding is available fr the management and prtectin f the data fr the apprval perid (5 years) Details f hw the privacy f the individuals is prtected and hw the impact n privacy is minimised (separatin principle) The data access plicy including a. The kinds f research fr which it can be used b. The access criteria applied t applicants t use data c. The cnditins f access d. Wh apprves access e. Whether the data can be used by researchers frm ther institutins The prcedure fr managing participants cnsent and ensuring that future research is within the parameters f the cnsent btained (if relevant) The plicies fr cllecting additinal infrmatin, cntacting participants and disclsing infrmatin t participants. 1 With thanks t the Department f Health Western Australia Human Research which develped these guidelines fr nging data repsitries TRIM REF: E13/ June 2015 Page 8 f 11

9 Details f the security plicy including: a. Physical and envirnmental security b. Human resurces security c. Cmmunicatins and peratinal security d. Access cntrls e. Cryptgraphy f. Incident and breach management g. Audit prgram Prpsals fr new prjects must be submitted t the Cmmittee as amendments accmpanied by a Request fr an Amendment t an Apprved Research Prject frm and prject-specific prtcl(s). Prject-specific prtcls shuld utline key research questins, and/r a clearly defined hypthesis (where apprpriate), and include detailed methds and statistical analysis plans. Where applicable, these must als include infrmatin regarding transfer, access and/r use, strage (include site(s) at which data will be stred), retentin and dispsal f the data. Generally these amendments will be apprved by the Executive Cmmittee but the Executive retain the right t refer them t the Full Cmmittee fr review if deemed necessary. TRIM REF: E13/ June 2015 Page 9 f 11

10 Sectin 6: Extensin r addendum t a prject which already has apprval frm anther HREC Smetimes submissins are made t the NSW PHSREC fr an extensin r addendum t a current prject which has already been apprved by anther. Fr example, a clinical prject apprved by an frm a PHO, may subsequently require apprval frm the NSW PHSREC fr access t data cllectins wned r managed by NSW Health r the Cancer Institute NSW. Fr these submissins applicants must clearly utline, in bth the NEAF and the prtcl, the parts f the prject which already have apprval frm the riginal Ethics Cmmittee, and thse that require subsequent apprval frm the PHSREC Bth the NEAF and prtcl shuld explicitly address the scientific and ethical issues related t the recrd linkage. The prtcl may be an amendment t an existing prtcl (infrmatin relating t data and linkage must be highlighted) r a new standalne data prtcl specific t this cmpnent f the research. The fllwing infrmatin is als required: ALL dcumentatin reviewed by the riginal HREC including riginal apprved participant infrmatin and cnsent dcuments (where applicable) and HREC letter f apprval The scpe f riginal ethics apprval; including details f riginal access t any nn- NSW Health r the Cancer Institute NSW datasets and the variables assciated with these. Where the new applicatin invlves the cllectin, use r disclsure f persnal health infrmatin which is identified, r frm which the identity f the persn can be reasnably btained the fllwing is als required: Specific details f participant cnsent fr the cllectin, use r disclsure f persnal health infrmatin OR A detailed plan t re-cnsent participants fr the cllectin, use r disclsure f persnal health infrmatin Apprval fr a waiver f the usual requirement fr cnsent frm the riginal OR A fully justified request fr a waiver f the usual requirement fr cnsent + NSW Privacy frm Variable list(s) fr each data cllectin t be accessed as part f the new applicatin including Data Custdian signff. TRIM REF: E13/ June 2015 Page 10 f 11

11 Cntact fr all enquiries Please phne the Administrative Officer n (02) r Ethics@cancerinstitute.rg.au TRIM REF: E13/ June 2015 Page 11 f 11