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

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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

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INSTITUTIONAL REVIEW BOARD

• The Institu

stituti tiona

• nal Review

w Board consis sists ts of a commi mitt ttee ee estab ablished ished to advocat

• cate

e for the prot

• tecti

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.

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• The

e purp urpose se of an IRB is to revie iew resear search ch invol

• lving

ving hum uman an su subject jects s to ensure ure thei eir r rights ts and welf lfare re are adeq equa uately ly prot

• tect

ected. d.

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THE ROLE OF THE IRB MEMBERS IRB FUNCTION

• 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

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

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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)”

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IRB REVIEW OF RESEARCH

• Al

All resear search ch projec jects ts are catego gori rize zed d into

• one

e of three ree categori egories es for the IRB revi view proce cess. s.

• Ex

Exem empt- Ex Explanati nation

• n 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

• r in study

y det eterm rminati nation

• n
• Minimal

mal risk k is the probabi bability lity and magnitu nitude de of phys ysica cal l or psy sychol chological

• gical 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.

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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

• nal testi

ting, ng, sur urveys ys or obser servati tion

• n of

pub ublic c beha ehavior vior

• Used

ed caut utiously iously with th vul ulner nerable able popul ulati tions

• ns (senior

eniors, s, prisoner

• ners,

s, childr ldren, en, pregnan gnant t women,

• men, fetuse

etuses)

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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

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LEVELS OF REVIEW- FULL BOARD

(REVIEWED BY CHAIR AND IRB MEMBERS)

• Prot
• tocols
• cols which

ich mee eet t the e defini initi tion

• n 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

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THE IRB HAS THE AUTHORITY TO:

• Ap

Approve

• Requi

uire re modif dificat cations ions

• Table

le

• Disapprove

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KEY TERMS

An Anon

• nym

ymou

• us – No
• one,

e, not

• t even

en the e resear earche cher, , is s aware re of who ho compl pleted ed the e inform

• rmati

tion

• n

Conf nfide identi ntiality ality- The e resear search ch kno nows ws who

• comple

leted d the e informat

• rmation,

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
• lves

es consi nside dera rati tion

• n of wheth

ther er the e partici ticipa pants nts will be comf mfor

• rtable

table with h the Hu Human n Resear search ch si situa uati tion

• n

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REQUIRED TRAINING

• CITI

TI online ine hum uman an sub ubject jects s prot

• tect

ction ion trainin ning.

• g. Study

udy will not

• t 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

• medica

cal l Resear search ch Invest estiga gator

• rs

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

• gram.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

QUESTIONS ?

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