UNIVERSITY OF PITTSBURGH TRAINING FOR RESEARCHERS

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1 UNIVERSITY OF PITTSBURGH TRAINING FOR RESEARCHERS Overview The fllwing dcument utlines research training requirements fr individuals wh cnduct research at the University f Pittsburgh, including faculty, staff, and students. The University recgnizes that academic research is substantively, prcedurally, and administratively cmplex. The purpse f this training is nt nly t satisfy gvernment and University f Pittsburgh plicy requirements, but t enhance research activities at all stages. Our gal is t make training understandable and meaningful, while prviding it as efficiently as pssible. Cnstructive criticism abut the training prgram is always welcme, and shuld be directed t rcc@pitt.edu. Wh must cmplete the training? Anyne cnducting research* at the University f Pittsburgh is required t cmplete training prir t beginning the prject, regardless f funding surce. Training requirements vary based n the nature f the research. While there are bvius differences in training requirements fr thse perfrming animal subject research and human subject research, there are requirements that may be applicable t all research. Thse requirements that crss dmains are listed separately and shuld be reviewed clsely. * Fr thse in the Kenneth P. Dietrich Schl f Arts and Sciences, schlarly activities that meet the threshld t be cnsidered research (primarily natural and scial sciences) are when emphasis is n testing, verificatin, and use f empirical data. Web-based Training The University f Pittsburgh ffers several training resurces. The tw primary nline training prtals are: Cllabrative Institutinal Training Initiative (CITI) The CITI training prgram is a leading glbal prvider f nline research ethics educatin. Many f the CITI curses qualify fr cntinuing educatin credits (CMEs/CEUs) which can be purchased directly frm CITI. T access the CITI training, individuals must lg int the Pitt CITI access prtal using a Pitt HSCnnect username/passwrd as it prvides a database fr University Departments and ther systems t verify CITI training. Detailed instructins are displayed n the Pitt CITI Prtal lgin page at Questins shuld be directed t citi@pitt.edu. Internet-based Studies in Educatin and Research (ISER) The ISER web-based training site is cmprised f a series f institutinally develped training mdules t address particular training requirements. T access the ISER training mdules, individuals must lg int the ISER website available at using their Pitt HSCnnect username/passwrd. Individuals can g t t create a new 1

2 HSCnnect accunt r t update their prfile. It is imprtant nt t create duplicate accunts. The HSCnnect supprt team can be reached by calling All nline training is lgged and a recrd f training can be accessed n the HSCnnect database by the trainee r Schl/Department Administratrs as needed. The n-line applicatins fr animal studies (ARO) includes a display f training recrds fr bth CITI and ISER recrds. The nline applicatin fr human subjects research (OSIRIS) includes a display f CITI training recrds. Cmmunity Partner Research Ethics Training (CPRET) The Cmmunity Partner Research Ethics Training (CPRET) and Certificatin is intended fr cmmunity partners that are nn-university emplyees wh actively participate in research with human subjects (but will nt be listed as a member f the research team in the IRB applicatin). This curse prvides them with the pprtunity t learn abut cnducting research that is ethical and safe. partners@hs.pitt.edu fr mre infrmatin. Required Training All Investigatrs Respnsible Cnduct f Research (RCR) All individuals invlved in research are required t cmplete the CITI Respnsible Cnduct f Research curse befre participating in research activities. This requirement als applies t faculty mentrs listed in the IRB applicatin wh are respnsible fr the cnduct f research fr their students. Re-certificatin is required every 4 years. Respnsible Cnduct f Research (CITI) Trainees wh receive Natinal Science Fundatin (NSF), Natinal Institute f Health (NIH) r ther supprt frm a training grant may be required t cmplete additinal, in persn, discussin-based RCR training. The University f Pittsburgh Clinical & Translatinal Science Institute (CTSI) hlds RCR Center wrkshps which may meet these requirements. If yu have any questins abut this additinal requirement, cntact Karen Schmidt at kschmidt@pitt.edu. Cnflict f Interest (COI) The University f Pittsburgh COI Plicy ( ) requires that all investigatrs wh are externally funded (regardless f funding surce) must cmplete the CITI COI curse. Fr successful new applicatins fr research funding that are submitted after February 1, 2017, regardless f spnsr, release f funding will be cntingent upn all investigatrs n the prject having cmpleted COI training within 4 years f when the award is executed and befre initiating research. This supersedes the 2

3 previus requirement that training be cmpleted prir t submissin f a research funding applicatin. Re-certificatin is required every 4 years. Cnflict f Interest (CITI) NOTE: Investigatrs wh are nt supprted by agencies f the Public Health Service (PHS) and wh have previusly cmpleted the ISER COI mdule must cmplete the CITI Curse by July 1, 2018, r prir t cmmencing wrk n a PHS-funded research prject (whichever cmes first). [Please see the letter frm Prfessr Gerge A. Huber, Chancellr fr Research Cnduct and Cmpliance, issued January 25, 2018.] Investigatr includes any individual, regardless f title r psitin, wh is (r may be perceived t be) independently respnsible fr r significantly influences, the design, cnduct r reprting f the research. The Principal Investigatr (PI) is respnsible fr identifying the individuals wh meet this definitin (see guidance belw). When funding is awarded, the PI must prvide the Office f Research with a list f thse wh meet this definitin and the date f cmpletin f the CITI COI curse. It is the respnsibility f the PI t maintain a cpy f the curse cmpletin certificates n file fr all investigatrs and t update the list as persnnel changes ccur. Individuals wh cnduct research withut any external funding d nt need t cmplete the COI training mdule unless they have disclsed utside financial interests n their University faculty Researcher COI disclsure frm r have been directed by their department chair r dean t cmplete COI training. Guidance t address wh is an investigatr: This is a guidance tl and may nt capture all scenaris /descriptin f an investigatr. It is better t cmplete the training if there is any uncertainty. 1. The Principal Investigatr, any C-Investigatr and any thers wh are independently respnsible fr r wh have r may acquire the authrity frm the PI t significantly influence the directin f the research, data acquisitin, methd and analysis f the research are cnsidered Investigatrs. 2. Any C-Investigatr and any thers wh may be a c-authr n manuscripts r presentatin f the research findings are cnsidered Investigatrs (this als includes students wh meet this definitin). 3. Senir/Key Persnnel wh are identified n a grant r funding applicatin r reprt as cntributrs t the research are cnsidered Investigatrs whether r nt they receive salary supprt. 4. Cllabratrs and cnsultants at the University f Pittsburgh wh are independently respnsible fr r significantly influence any prtin f the research, data acquisitin, r methd and analysis f the research are cnsidered Investigatrs. 3

4 5. Sub-recipients, cllabratrs and cnsultants utside f the University f Pittsburgh wh are perfrming PHS funded research n behalf f Pitt wh are independently respnsible fr r significantly influence any prtin f the research, data acquisitin, r methd and analysis f the research are cnsidered Investigatrs and must cmplete COI training. The University f Pittsburgh will accept COI training frm utside Institutins that have PHS-cmpliant plicies. If the utside institutin des nt have a PHS-cmpliant COI plicy, the Investigatr must cmplete Pitt s CITI COI training mdule. 6. Pstdctral students and Clinical fellws may be cnsidered Investigatrs depending n their ability t independently and significantly influence the research. This shuld be determined by the PI n a case by case basis. 7. If an investigatr leaves the University befre the research is published and he/she is included as an authr, the COI training must have been cmplete at the time the wrk was dne that cntributes t the paper. Retraining after departure frm the Institutin is nt required. The fllwing are nt usually cnsidered Investigatrs: 1. Cnsultants wh prvide a fee fr service nly and d nt cnduct the research are nt cnsidered Investigatrs. 2. Administratrs r individuals wh perfrm rutine r supprtive tasks related t the research are nt cnsidered an Investigatr. Mre infrmatin is available n the Pitt COI ffice website at Animal Research Use and Care f Labratry Animals Anyne perfrming animal research, including faculty, staff, and students are required t have cmpleted apprpriate training prir t beginning the prject, regardless f funding surce. Nte that after cmpletin f training, the individual must be added t an active prtcl apprved by the Institutinal Animal Care and use Cmmittee (IACUC) prir t cmmencing animal research. All individuals engaged in animal research must cmplete the ISER Use and Care f Labratry Animals mdule befre being added t an IACUC prtcl and interacting with any animals. Re-certificatin is required every 4 years. Use f Labratry Animals in Research and Educatin (ISER) Animal Research: Species Specific All individuals engaged in animal research are required t cmplete relevant animal mdules available n the ISER r CITI website. See the IACUC training page ( fr mre infrmatin abut the mdules related t research n each species. Re-certificatin is required every 4 years. Animal-Based Research Mdules (ISER) 4

5 Animal Species Specific mdules Animal-Specific Curses (limited mdules) (CITI) Wrking with Amphibians in research setting Wrking with Guinea Pigs in research setting Wrking with Hamsters in research setting All individuals engaged in animal research are required t cmplete relevant animal mdules available n the ISER r CITI website. See the IACUC training page fr mre infrmatin abut the mdules related t research n each species. Re-certificatin is required every 4 years. Human Subject Research Human Subject Prtectins Any member f the research team interacting r intervening with human subjects r their data, including faculty, staff, and students are required t have cmpleted apprpriate training prir t beginning the prject. Members f the study team whse respnsibilities are limited t the entry f deidentified data are required at a minimum t cmplete Respnsible Cnduct f Research. All individuals, as defined abve, wh are engaged in human subject research are required t have cmpleted ne f the human subjects research curses listed belw based n their primary area f research. Re-certificatin is required every 4 years. Human Subjects Research (CITI) Bimedical curse Scial-Behaviral-Educatinal curse Research Specific Training Bisafety and Bisecurity Institutinal Bisafety Cmmittee (IBC) Bisafety NIH Guidelines (NIH Guidelines fr Research Invlving Recmbinant r Synthetic Nucleic Acid Mlecules) training is required fr all persnnel using materials r agents that cntain recmbinant and/r synthetic nucleic acid mlecules (DNA, RNA, r ther genetic material) at the University f Pittsburgh and affiliated institutins. Training fr investigatrs and research staff includes safety cnsideratins in the principles f cnstructin r handling f IBC-versight materials, and regulatry requirements. 5

6 Nte that if yu perfrm research activities such as: t amplify r clne plasmids in bacterial cultures, wrk with viral vectrs, perfrm experiments with sirna in viv r in vitr, cnduct clinical trials using agents that cntain recmbinant DNA r segments f genetic material, r maintain a breeding r crssing-breeding clny f rdents, then these activities must be registered with the Institutinal Bisafety Cmmittee Office, as they fall under experiments in the NIH Guidelines fr Research Invlving Recmbinant r Synthetic Nucleic Acid Mlecules. Additinal training and cnsultatin is ffered by the staff f the Institutinal Bisafety Office (IBC Office). Visit the Institutinal Bisafety Cmmittee (IBC) website ( mre infrmatin. Individuals are required t cmplete the NIH Guidelines curse n the ISER website. N recertificatin required. Bisafety-NIH Guidelines (ISER) Clinical Research Crdinatr This ptinal curse is highly recmmended fr new study crdinatrs as it prvides an verview f the rle and respnsibilities f a study crdinatr. It may als be used a refresher curse fr experienced crdinatrs. N re-certificatin required. Clinical Research Crdinatr (CITI) Clinical Trial Billing Cmpliance This ptinal curse is relevant t individuals whse respnsibility includes billing fr research prcedures. N re-certificatin required. Clinical Trial Billing Cmpliance (CITI) Envirnmental Health & Safety (EHS) The University f Pittsburgh Department f Envirnmental Health & Safety (EHS) prvides supprt and training t researchers and persnnel, including thse invlved in wrk with animal and/r human subjects. There are multiple regulatins, guidelines, and best practices that cntain training requirements fr emplyers. The department is practive in implementing training prgrams t meet these requirements, as well as t supplement and enhance envirnmental, health, and safety activities at the University f Pittsburgh. EHS prvides a variety f training ptins including bth live and nline training ptins t accmmdate the needs f the University cmmunity. Safety training requirements vary accrding t the research cnducted r wrk directed by the investigatr. Bldbrne pathgens training is required annually fr all persnnel with ptential expsure t human bld, human bdy fluids r ptentially infectius material in a research r teaching envirnment, in accrdance with OSHA regulatins. 6

7 Chemical hygiene training is required every 3 years fr all persnnel wh handle labratry chemicals. Training in the Shipment f Dangerus Gds is required every 2 years fr all persnnel that package certain materials fr shipment r label such material fr shipment. These fundamental safety training tpics are available nline thrugh the ISER web-based training site, and thrugh the EHS website. Additinal live sessins f training curses are ffered several times a mnth. Envirnmental Health and Safety (ISER) Bld-brne Pathgen Training (ISER) Chemical Hygiene Training (ISER) Live Training and Additinal EHS-Spnsred Online Training Schedule Shipment f Dangerus Gds EHS website at Exprt Cntrls This ptinal curse is highly recmmended fr individuals wh wrk with r may be respnsible fr federally cntrlled devices, materials, r technlgies. The U.S. Exprt Cntrls regulatins aim at prtecting the natinal security, ecnmic interests and freign plicies f the United States. Exprt laws regulate the transfer, release, r disclsure f cntrlled items, technlgy, and sftware t freign cuntries r t freign persns and entities within the U.S. N re-certificatin required. Exprt Cntrls (CITI) Gd Clinical Practice (GCP) The University f Pittsburgh recgnizes that GCP training is imprtant fr all researchers cnducting clinical trials t ensure the prtectin f human subjects and the integrity and quality f ur research. Therefre, all Investigatrs and research team members wh are engaged in the cnduct, versight r management f clinical trials (as defined by the NIH) are required t cmplete the CITI GCP training curse befre they participate in any research activities. The University has extended this requirement t all research studies that meet the definitin f a clinical trial regardless f the funding surce. It is the respnsibility f the Principal Investigatr t ensure that all members f the research team wh meet this requirement (see guidance belw) cmplete GCP training and maintain certificatin during the curse f the study. As f January 1, 2017, the Institutinal Review Bard (IRB) will nt apprve a new clinical trial submissin unless GCP training is cmplete. There are (2) GCP training curses available. If yu currently participate in an FDA regulated clinical trial r plan t d s in the future, cmplete the FDA regulated GCP curse. All thers shuld cmplete the Behaviral r nn-fda regulated GCP curse. Re-certificatin is required every 3 years. 7

8 Gd Clinical Practice (CITI) GCP fr Clinical Trials Invlving FDA regulated research GCP fr Clinical Trials Invlving Behaviral r nn-fda regulated research Guidance n wh must cmplete GCP training: Thse required t take GCP training include thse wh: 1. Manage participant recruitment and enrllment, including btaining cnsent 2. Perfrm research prcedures r evaluatins 3. Cntribute significantly t the cllectin and recrding f research data r 4. Cntribute significantly t data management 5. Have mre than minimal cntact with the research subjects r their identifiable study recrds r specimens Thse nt required t take GCP training include: Hspital staff (including nurses, residents, fellws, r ffice staff) wh prvide ancillary r intermittent care but d nt make a direct and significant cntributin t the study r administratrs r individuals wh perfrm rutine r supprtive tasks related t the research. * The NIH defines a clinical trial as: A research study in which ne r mre human subjects are prspectively assigned t ne r mre interventins (which may include placeb r ther cntrl) t evaluate the effects f thse interventins n health-related bimedical r behaviral utcmes. Humanitarian Use Device (HUD) UPMC requires this curse be cmpleted fr all research r clinical use f HUDs at any f their facilities. N re-certificatin required. Humanitarian Use Device (CITI) Human Stem Cell Research Human Stem Cell Oversight Cmmittee (hscro) The University f Pittsburgh s hscro Cmmittee is t ensure that all federal and Cmmnwealth f Pennsylvania regulatins gverning the cnduct f human embrynic stem cell research are met and that ther human stem cell research is cnducted in accrdance with the general principles expressed in the Natinal Academies Guidelines fr Human Embrynic Stem Cell Research, with the plicies and prcedures adpted by the hscro Cmmittee, and with ther relevant University f Pittsburgh research plicies. 8

9 Investigatrs are required t cmplete the CITI Human Stem Cell curse in cnjunctin with a submissin f a research prtcl t the hscro. Visit the Human Stem Cell Research Oversight Cmmittee (hscro) website ( fr mre infrmatin. N recertificatin required. Human Stem Cell Researchers (CITI) Internatinal Research This curse is required fr all members f the research team engaged in human subject research utside the United States. Re-certificatin is required every 4 years. Internatinal Research (CITI) Privacy & Infrmatin Security fr Researchers Anybdy wh encunters prtected health infrmatin (PHI) fr research purpses is required t cmplete the CITI Health Privacy and Infrmatin Security training. Re-certificatin is required every 4 years. Health Privacy (CITI) Infrmatin Security (CITI) This training is in additin t any clinical HIPAA training cmpleted thrugh UPMC r the Pitt Clinical HIPAA training n ISER. Radiatin Safety Radiatin safety training is required fr all persnnel using radiactive materials r wrking with radiatin prducing equipment at the University f Pittsburgh and affiliated institutins. Training fr radiatin wrkers includes instructin in the basic principles f radiatin prtectin and the applicable plicies, prcedures, and regulatry requirements. Persnnel are required t attend training sessins ffered by the Radiatin Safety Office. Radiatin safety trainings are available in three applicatin categries: 1) general istpes; 2) gamma and x-ray irradiatrs; and 3) analytical and research x-rays. The initial training sessins, available mnthly r as needed, are cnducted by staff f the Radiatin Safety Office. Registratins f the training sessins are made thrugh the Radiatin Safety Office 9

10 website. Refresher trainings, in-persn r nline, are required every 3 years. Visit the Radiatin Safety Office ( fr mre infrmatin. Research with Children The Children s Hspital f Pittsburgh f UPMC requires this mdule be cmpleted by all members f the research team participating in research activities cnducted at their facility. Re-certificatin is required every 4 years. Research with Children (CITI) 10