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University of Oklahoma

Office of Human Research Participant Protection


SOP: 303B
IRB MEETING ADMINISTRATION
1. POLICY
Except when an expedited review procedure is used, the IRB will review proposed
research at convened meetins at which a !uorum is present" Each IRB will meet
monthly, or at some other fre!uency determined #y the IRB $hair and the HRPP
%irector for each campus"
Specific Policies
1.1 Qo!"
&he IRB meetin cannot #ein until !uorum exists" If !uorum is lost durin a
meetin, the IRB cannot take votes until the !uorum is restored" If !uorum can
not #e restored, the meetin is stopped" "
'"'"' ( !uorum is defined as more than one half of the num#er of mem#ers"
'"'") ( !uorum consists of mem#ers or their alternates and includes at
least one mem#er whose expertise is in a scientific area, one mem#er
whose expertise is in a nonscientific area, and one mem#er who is not
otherwise affiliated with the University"
'"'"* +or research involvin an +%(,reulated article, a licensed physician
must #e included in the !uorum"
'"'"- (n alternate mem#er may attend in the place of an a#sent mem#er in
order to meet the !uorum re!uirements outlined a#ove"
'"'"." ( special consultant/s0 may not #e used to esta#lish a !uorum"
'"'"1 Even if a mem#er a#stains from votin, the mem#er may #e used to
esta#lish a !uorum"
'"'"2 3ee 3OP '4-B, $onflict of Interest,IRB 5em#ers for information
concernin conflicts of interest for IRB mem#ers"
1.# P!i"$!% Re&ie'e!s
Primary reviewers shall not review their own studies"
1.3 Mee(i)* M$(e!i$ls Se)( P!io! (o IRB Mee(i)*s
&he process for compilin meetin materials for review #y IRB mem#ers is
descri#ed in 3ection 2"* #elow"
1.+ IRB ,iles
IRB files pertinent to the aenda items are availa#le to Board mem#ers
durin the meetin" &he IRB files are also availa#le in the IRB office prior to
the meetin for review #y an IRB mem#er" IRB mem#ers can ask the IRB
(dministrator to o#tain information provided to any individual reviewer" IRB
mem#ers can ask IRB 3taff to o#tain the protocol file and relevant IRB
minutes #efore or durin the convened IRB meetin"
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3OP *4*B
1.- Mi)(es
5inutes are recorded at each meetin, as descri#ed in 3OP *4*$, 5eetin
5inutes"
1.. Tele/co)fe!e)ci)*
(" $onvened meetin usin speakerphone9
3hould a mem#er not #e a#le to #e physically present durin a
convened meetin, #ut is availa#le #y telephone, the meetin can #e
convened usin a speakerphone" &he mem#er who is not physically
present is connected to the rest of the mem#ers via speakerphone" In
this manner, all mem#ers are a#le to discuss the protocol even thouh
one mem#er is not physically present" 5em#ers participatin #y
speakerphone may vote, provided they have an opportunity to review all
the material the other mem#ers have reviewed"
B" 5eetins $onducted 6ia &ele,$onference $alls9
On occasion, meetins may #e convened via a telephone conference
call" ( !uorum /as defined a#ove0 must participate for the conference
call meetin to #e convened" &o allow for appropriate discussion to take
place, all mem#ers must #e connected simultaneously for a conference
call to take place ,, ;telephone pollin; /where mem#ers are contacted
individually0 will not #e accepted as a conference call"
1.0 1i2eo/co)fe!e)ci)*
<ith the exception of the IRB $hair, IRB mem#ers from remote areas may
choose to attend the monthly IRB meetin via video,conference" &hese
mem#ers have the same responsi#ilities and votin privilees as the rest of
the IRB"
1.3 4)sc5e2le2 Mee(i)*s
It may #e necessary to hold unscheduled meetins in order to review studies"
&ypically, these meetins are held to review studies to provide treatment for
participants more !uickly than scheduled meetins= for example, HU%
protocols, &reatment I7% protocols, or studies that have a limited time for
enrollment"
1.6 1o(i)*
5em#ers of the IRB vote upon the recommendations made #y the primary
reviewers accordin to the criteria for approval /3OP -4*, Initial Review,
$riteria for IRB (pproval and 3OP -4-, $ontinuin Review0" 5em#ers also
determine level of risk, the fre!uency of review for each protocol, monitorin
re!uirements of the investiative site, and whether third party assessment
and follow,up will #e needed"
In order for a research pro>ect to #e approved it must receive approval from
the ma>ority of the IRB !uorum" If an approval ma>ority does not exist, the
study is 7O& approved"
3hould an IRB mem#er recuse him:herself, that mem#er is not counted
toward the !uorum" If !uorum is lost due to the recusal, any further
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3OP *4*B
discussion:deli#eration reardin the pro>ect must cease until !uorum can #e
re,esta#lished" &his may result in a deferral"
+ollowin discussion of the research pro>ect, the IRB $hair shall call for a
vote on one of the followin motions9 approve, continently,approve, defer,
disapprove, or a#stain" (n IRB mem#er can a#stain from votin if they are
undecided as to how to vote" &hat individual is still counted toward the
!uorum count= however, their a#stention is not counted as an approval" +or
example9 If a protocol is #ein voted on #y seven Board mem#ers and one
a#stains, a ma>ority of the remainin six must vote ?for@ the protocol in order
to receive approval= i"e" at least four must vote in favor of approval" In
addition, if the community mem#er a#stains from votin, that person is still
counted toward the !uorum and also fulfills the reulatory re!uirements as
havin a community mem#er present, #ut the a#stention does not count in
favor of approval= a ma>ority of the remainin mem#ers must still vote in favor
#efore approval can #e ranted"
%escription of the Options for 5otions9
App!o&e2 A &he research pro>ect has #een approved #y the convened IRB
as su#mitted and the investiator is not re!uested to revise any aspect of the
pro>ect" &he approval date is the date of the IRB meetin"
Co)(i)*e)(l% App!o&e2 A &he convened IRB imposes specific revisions that
re!uire simple concurrence re!uests from the Investiator or re!uires
modifications that are minor as defined in 3OP -4., (mendments" Research
cannot #e continently approved if the IRB re!uests clarifications, additional
information, or chanes that are more than minor" Examples of revisions that
cannot #e continently approved are9
o Indicate the num#er of participants to #e enrolled
o $hane the dru dosae to #e consistent
o Indicate why children cannot #e participants
o Provide additional details a#out the data monitorin plan"
(ll minor revisions must #e su#mitted and reviewed #y the IRB $hair or
desinated reviewer for final approval of the pro>ect #efore the study #eins"
&he approval date will #e the date that the IRB $hair reviews and approves
the re!uested revisions" If there are revisions that re!uire >udment/s0 not
allowa#le under expedited review procedures, these revisions must #e
presented to the IRB at the next convened meetin"
Defe!!e2 A &he convened Board re!uires sinificant additional information
and:or a risk:#enefit assessment could not #e made with the information
provided to make a determination reardin the research pro>ect" &he
Investiator may su#mit the re!uested information to #e reviewed at the next
scheduled IRB meetin"
Dis$pp!o&e2 A &he manitude and:or num#er of concerns, !uestions, or
pro#lems relatin to the research pro>ect are such that a Bcontinently
approvedC determination cannot #e made" &he Investiator has an opportunity
to respond in writin or in person reardin the determination" &he
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3OP *4*B
Investiator can resu#mit the research pro>ect= it underoes review aain #y
the convened IRB" %isapproved protocols cannot #e approved #y University
administration"
#. SCOPE
&hese policies and procedures apply to all research su#mitted to the IRB"
3. RESPONSIBILITY
&he HRPP %irector /or desinee0 will attend all IRB meetins to provide consistency
in applyin the federal reulations, state law, and Institutional and HRPP policies"
&he HRPP and IRB 3taff are responsi#le for the IRB meetin procedural conduct
and documentation"
&he HRPP and IRB 3taff are responsi#le to monitor the mem#ers present at the
convened meetin and determine that meetins are appropriately convened and
held"
Primary and secondary reviewers are responsi#le to conduct an in,depth review of
all materials"
(ll other IRB mem#ers are responsi#le to review all provided materials in enouh
depth to #e prepared to discuss the information at the convened meetin"
&he IRB $hair and:or IRB 6ice $hair is responsi#le for the IRB meetin review
conduct and leadin discussion for all #usiness which is addressed" &he IRB $hair
and:or IRB 6ice $hair directs that proceedins are recorded and that any mem#er
who has a conflict of interest does not vote or participate in the IRBCs consideration
of the study for determination, except as re!uested #y the IRB"
+. APPLICABLE REG4LATIONS AND G4IDELINES
-. $+R -1"'4*, -1"'48
)' $+R .1"'48
+%( Information 3heet, Duidance for IRBCs and $linical Investiators, 'EE8 Update
OHRP Duidance on <ritten IRB Procedures Fuly '', )44)
-. RE,ERENCES TO OT7ER APPLICABLE SOPS
3OP )4*, %uties of IRB 5em#ers, 3OP *4*$, IRB 5eetin 5inutes, 3OP -4*, Initial
Review,$riteria for IRB (pproval, and 3OP -4-, $ontinuin Review"
.. ATTAC7MENTS
)4*,( 7ew 3tudy Reviewer $hecklist A +ull Board
)4*,% Reviewer $hecklist for Research Involvin Prenant <omen G
+etuses
)4*,E Reviewer $hecklist for Research Involvin 7eonates
)4*,+ Reviewer $hecklist for Research Involvin Prisoners
)4*,D Reviewer $hecklist for research Involvin $hildren
)4*,H $ontinuin Review Reviewer $hecklist
)4*,I 5odification Reviewer $hecklist
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3OP *4*B
)4*,F <aiver of $onsent %ocumentation $hecklist
)4*,H 6( Research Reviewer $hecklist
*4*B,( Board 5eetin $hecklist
*4*B,B 3in,In 3heets,OH$
*4*B,B,' 3in,In 3heets,7orman
*4*B,$ Email from Deore Pospisil, O3OPH3, %HH3"
0. PROCESS O1ER1IE8
0.1 Qo!"
2"'"' ( !uorum is defined as more than one half of the num#er of mem#ers"
2"'") ( !uorum consists of mem#ers or their alternates and includes at least
one mem#er whose primary concerns are in scientific areas and one
mem#er whose primary concerns are in nonscientific areas"
2"'"* +or research involvin an +%(,reulated article, a licensed physician
must #e included in the !uorum"
2"'"- (n alternate mem#er may attend in the place of an a#sent mem#er in
order to meet the !uorum re!uirements outlined a#ove"
2"'". ( special consultant/s0 may not #e used to esta#lish a !uorum"
2"'"1 Even if a mem#er a#stains from votin, the mem#er may #e used to
esta#lish a !uorum"
2"'"2 If a mem#er recuses him:herself from deli#erations and votin due to a
conflict of interest, the mem#er must not #e used to esta#lish !uorum
for the duration of review of the item from which the mem#er is recused"
0.# P!i"$!% Re&ie'e!s
Prior to the meetin, the $hair or 6ice,$hair desinates primary reviewers for
each research proposal" &he primary and secondary reviewersC duties are
descri#ed in 3OP )4*, %uties of IRB 5em#ers"
0.3 Mee(i)* M$(e!i$ls Se)( P!io! (o IRB Mee(i)*s
2"*"' IRB staff sends all IRB mem#ers study documentation re!uired for
review the week prior to the reularly scheduled IRB meetin" &hese
documents include9
(enda
5inutes from the previous IRB meetin
Reviewer materials
&he IRB (dministrator or IRB (ssistant prepares the meetin aenda
and distri#utes it to IRB mem#ers prior to each meetin" ( copy of the
aenda is maintained on file with the meetin minutes" &he meetin
aenda reminds mem#ers at the outset of each meetin to declare any
potential $OI they may have with research that is #ein reviewed" &he
IRB minutes also specifically reflect such recusals as they occur durin
meetins" In addition to the items listed a#ove, Board mem#ers receive
in their packaes the followin documents9
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3OP *4*B
2"*") +or initial review #y a convened IRB, all IRB mem#ers receive9
(pplication for 7ew Research Pro>ect /Health 3ciences $ampus0 or
Institutional Review Board (pplication /7orman $ampus0
Proposed consent documents and scripts
+ull investiator or sponsor protocol
Recruitment materials
+or initial review #y a convened IRB, primary reviewers receive9
(ny relevant rant applications
&he investiatorCs #rochure /when one exists0
&he %HH3,approved sample informed consent document /when one
exists0
&he complete %HH3,approved protocol /when one exists0
(ppropriate reviewer checklist/s0
2"*"* +or $ontinuin Review #y a convened IRB, all IRB mem#ers receive9
(pplication for $ontinuin Review /Health 3ciences $ampus0 or
$ontinuin Review of (pproved Research /7orman $ampus0
+ull investiator or sponsor protocol updated with any chanes
$urrent and proposed consent documents and scripts
+or $ontinuin Review #y a convened IRB, primary mem#ers receive9
&he complete protocol includin any protocol modifications previously
approved #y the IRB
(ppropriate reviewer checklist/s0
2"*"- +or review of modifications to previously approved research, all IRB
mem#ers receive9
Protocol 5odification +orm /Health 3ciences $ampus0 or Re!uest for
5odification of (pproved Research /7orman campus0
$opies of all modified documents
2"*". +or review of modifications #y a convened IRB, primary mem#ers
receive9
(ppropriate reviewer checklist/s0
2"*"1 +or initial review, continuin review, or review of modifications #y the
expedited procedure, at least one reviewer will receive and review all
information that the convened IRB would have received"
Primary reviewers conduct an in,depth review of all materials" (ll other
IRB mem#ers are expected to review all provided materials in enouh
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3OP *4*B
depth to #e prepared to discuss the information at the convened
meetin"
B" Primary and 3econdary reviewers receive9
Proposed informed consent documents/s0 and:or script as appropriate
$opies of surveys, !uestionnaires, or videotapes
$opies of letters of assurance or cooperation with research sites
Investiator Brochure /if one exits0
(dvertisin intended to #e seen or heard #y potential su#>ects,
includin email solicitations and physician letters
+ull InvestiatorCs or 3ponsorCs protocol
( completed IRB (pplication
Drant (pplication9 &he primary reviewers review the rant application,
if any, to ensure that the research descri#ed in the IRB proposal is
consistent with the rant application" &he rant application is not
reviewed #y every IRB mem#er" ( copy of the rant application or
proposal is retained #y the IRB Office and made availa#le to any IRB
mem#er who may wish to review it" &he IRB may re!uire the
Investiator/s0 to9 /i0 summariIe, and cross,reference to the application,
specific information contained in the rant application= /ii0 identify any
IRB,approved protocols that descri#e the proposed research= and /iii0
either certify that the application or proposal is consistent with any
correspondin IRB protocol/s0 or su#mit protocol amendments to
reconcile any discrepancies"
IRB Review of 7IH,(pproved Informed $onsent %ocuments for 7IH,
3upported 5ulti,center $linical &rials9 If availa#le, for 7IH,supported
multi,center clinical trials, the IRB receives and reviews a copy of the
7IH,approved sample informed consent document and the full 7IH,
approved InvestiatorCs protocol as a condition for review and approval
of the local informed consent document" (ny deletion or su#stantive
modification of information concernin risks or alternative procedures
contained in the sample informed consent document must #e >ustified in
writin #y the Investiator, approved #y the IRB, and reflected in the
IRB minutes"
One or more of the appropriate reviewer checklist/s0 as follows9
a" 7ew 3tudy Reviewer $hecklist A +ull Board
#" Reviewer $hecklist for Research Involvin Prenant
<omen G +etuses
c" Reviewer $hecklist for Research Involvin 7eonates
d" Reviewer $hecklist for Research Involvin Prisoners
e" Reviewer $hecklist for Research Involvin $hildren
f" <aiver of $onsent %ocumentation $hecklist
" 6( Research Reviewer $hecklist
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3OP *4*B
0.+ Mi)(es
+or specific information reardin meetin minutes, refer to 3OP *4*$"
0.- 1o(i)*
+ollowin discussion of each aenda item, the IRB $hair or a mem#er makes a
motion, another mem#er seconds the motion, the IRB staff counts and records
all votes for, aainst, or a#stainin from the motion "
2"."' ( vote is considered official only when it takes place with a ma>ority of
the IRB mem#ers present"
2".") ( mem#er who is determined to have a conflict of interest on a study is
excused from IRB deli#erations and must not vote on the study"
2"."* ( mem#er who is excused from IRB deli#erations cannot #e counted
towards the !uorum"
2"."- 7o proxy votes are permitted"
APPRO1ED BY: 999999999999999999999999999 DATE: #:1:#000

NE;T ESTABLIS7ED RE1IE8 DATE: MAY #006
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3OP *4*B