O F F I C E O F R E S E A R C H & C O M M E R C I A L I Z A T - PowerPoint PPT Presentation

U N I V E R S I T Y O F C E N T R A L F L O R I D A O F F I C E O F R E S E A R C H & C O M M E R C I A L I Z A T I O N 4 0 7 - 8 2 3 - 2 9 0 1 O R F A X 4 0 7 - 8 2 3 - 3 2 9 9 W W W . R E S E A R C H . U C F . E D U / C O M P L I A N C E / I R B . H T M L 1

S O P H I A F . D Z I E G I E L E W S K I , , P H . D . , L C S W I R B C H A I R M I C H A E L G . D E I C H E N , , M D , M P H I R B V I C E C H A I R I R B O F F I C E S T A F F : J E N N I F E R N E A L - J I M E N E Z , M D , M S , M S B , C C R P I R B A S S O C I A T E D I R E C T O R P A T R I A D A V I S , M S P , C I P K A M I L L E C H A P A R R O , B S G I L L I A N M O R I E N , B A R E N E A C A R V E R , M A 2

INSTITUTIONAL REVIEW BOARD • The Institu stituti tiona onal Review w Board consis sists ts of a commi mitt ttee ee estab ablished ished to advocat ocate e for the prot otecti ection n of the rights s and welfare e of human an participant icipants s involved d in research. ch. • Review w is requi quired ed for all resear arch ch involvin ing g human an participant icipants s conduct ducted ed by the Un Univer ersity sity of Cent ntral al Florida a (UCF). CF). • Approval al must st be obta taine ned d prior to initia iati ting ng research. ch. 3

IRB FUNCTION • The e purp urpose se of an IRB is to revie iew resear search ch invol olving ving hum uman an subject su jects s to ensure ure thei eir r rights ts and welf lfare re are adeq equa uately ly prot otect ected. d. THE ROLE OF THE IRB MEMBERS • Safeguar guardin ding g the e rights ghts and d welf lfare re • Revie iew w protocols cols • Assist st and d guid ide e resear searche chers 4

IRB RESPONSIBILITIES The IRB eva valua uates s proposa posals s for new resear earch ch and conduc ducts ts review w of on-going ng resear arch h When reviewing wing resear arch, h, the IRB consi sider ders: s: • The process for recruitment • Selection and informed consent of prospective research participants • Assessment of the risks and potential benefits • What additional safeguards are needed if vulnerable populations • Provision for protecting participants’ privacy and maintaining confidentiality. For on-going ng research ch • Evaluate proposed amendments • Requests for research continuation 5

HOW DO I KNOW IF A PROJECT NEEDS IRB REVIEW? Definition of “ rese esear arch ch ” + + Definition of “ human man sub ubject ject(s (s) ” 6

IRB REVIEW OF RESEARCH • Al All resear search ch projec jects ts are catego gori rize zed d into o one e of three ree categori egories es for the IRB revi view proce cess. s. • Ex Exem empt- Ex Explanati nation on of Resear search ch • Ex Expedi edited- Adul ult Conse nsent nt or Par Parent nt for Child ld Conse nsent nt • Ful ull Board d Revie iew *Level el of f risk k is an important tant factor or in study y det eterm rminati nation on • Minimal mal risk k is the probabi bability lity and magnitu nitude de of phys ysica cal l or psy sychol chological ogical harm m that t is s norma rmally ly enco coun untered red in the e daily y lives, s, or in the e rout utine ine medi edica cal, l, denta ental, l, or psychologica chological examin aminat ation ion of health althy y perso sons. ns. 7

LEVELS OF REVIEW- EXEMP MPT (REVIEWED BY CHAIR OR OTHER IRB MEMBER) Resear search ch on comm mmonly nly accep epted ed educat ational ional practice tices s or • un uniden dentif tifiabl able e data Requi uire res Ex Explanat nation ion of Resear earch ch conse nsent nt • Docume ment nt revi view, , educ ucati tional onal testi ting, ng, sur urveys ys or obser servati tion on of pub ublic c beha ehavior vior • Used ed caut utiously iously with th vul ulner nerable able popul ulati tions ons (senior eniors, s, prisoner oners, s, childr ldren, en, pregnan gnant t women, omen, fetuse etuses) 8

LEVELS OF REVIEW- EXPEDIT EDITED ED (REVIEWED BY CHAIR OR IRB DESIGNATED MEMBER) Minimal risk and fit into an “ Expe pedit dited ” category • Docume ment nt revi view • Sur urveys ys or Inter ervie views Collect lection ion of specime imens ns • • Rout utine ine nonin ninvasiv sive e procedures cedures 9

LEVELS OF REVIEW- FULL BOARD (REVIEWED BY CHAIR AND IRB MEMBERS) • Prot otocols ocols which ich mee eet t the e defini initi tion on of more re than n minima nimal l risk • Clinica ical l trials • PI is s invited ed to IRB RB meeti ting ng to clarify fy concerns ncerns 10

THE IRB HAS THE AUTHORITY TO: • Ap Approve • Requi uire re modif dificat cations ions • Table le Disapprove • 11

KEY TERMS An Anon onym ymou ous – No o one, e, not ot even en the e resear earche cher, , is s aware re of who ho compl pleted ed the e inform ormati tion on Conf nfide identi ntiality ality- The e resear search ch kno nows ws who o comple leted d the e informat ormation, ion, but ut no one ne else e will kno now Privacy cy- Refers to a person’s desire to control access of others to them emselv selves. s. It involv olves es consi nside dera rati tion on of wheth ther er the e partici ticipa pants nts will be comf mfor ortable table with h the Hu Human n Resear search ch si situa uati tion on 12

REQUIRED TRAINING • CITI TI online ine hum uman an sub ubject jects s prot otect ction ion trainin ning. g. Study udy will not ot be approved d un until l all KSP are trained ned. . Resea search ch Personnel sonnel mus ust t compl plete e eith ther er : • Group up I. Biomed omedica cal l Resear search ch Invest estiga gator ors s and d Key y Personn sonnel • Group 2. Social Behavioral Research Investigators and Key Personnel (Basic) • https ps://w ://www ww.ci .citi tiprogra ogram.o m.org rg/ • See e the e UCF F IRB websit ebsite e for access ss • http://www p://www.rese .research.uc ch.ucf. f.ed edu/ u/Co Complianc liance/irb.h e/irb.html tml 13

QUESTIONS ? 14