The document summarizes policies and procedures for IRB meeting administration at the University of Oklahoma. Key points include:
- The IRB meets monthly or at a frequency determined by the chair to review research proposals requiring full board review.
- A quorum must be present to convene meetings and take votes. Quorum is defined as over half of board members and must include at least one scientific, non-scientific, and non-affiliated member.
- Primary reviewers cannot review their own studies. Meeting materials are sent to members in advance.
- Motions for approval, conditional approval, deferral, disapproval, or abstention are taken by majority vote. Approved research requires majority approval vote
The document summarizes policies and procedures for IRB meeting administration at the University of Oklahoma. Key points include:
- The IRB meets monthly or at a frequency determined by the chair to review research proposals requiring full board review.
- A quorum must be present to convene meetings and take votes. Quorum is defined as over half of board members and must include at least one scientific, non-scientific, and non-affiliated member.
- Primary reviewers cannot review their own studies. Meeting materials are sent to members in advance.
- Motions for approval, conditional approval, deferral, disapproval, or abstention are taken by majority vote. Approved research requires majority approval vote
The document summarizes policies and procedures for IRB meeting administration at the University of Oklahoma. Key points include:
- The IRB meets monthly or at a frequency determined by the chair to review research proposals requiring full board review.
- A quorum must be present to convene meetings and take votes. Quorum is defined as over half of board members and must include at least one scientific, non-scientific, and non-affiliated member.
- Primary reviewers cannot review their own studies. Meeting materials are sent to members in advance.
- Motions for approval, conditional approval, deferral, disapproval, or abstention are taken by majority vote. Approved research requires majority approval vote
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" 6ersion 7o" - Pae ' of 8 Effective %ate9 ):':42 3upersedes %ocument9 '':'-:41 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 6ersion 7o" - Pae ) of 8 Effective %ate9 ):':42 3upersedes %ocument9 '':'-:41 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 6ersion 7o" - Pae * of 8 Effective %ate9 ):':42 3upersedes %ocument9 '':'-:41 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 6ersion 7o" - Pae - of 8 Effective %ate9 ):':42 3upersedes %ocument9 '':'-:41 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 6ersion 7o" - Pae . of 8 Effective %ate9 ):':42 3upersedes %ocument9 '':'-:41 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 6ersion 7o" - Pae 1 of 8 Effective %ate9 ):':42 3upersedes %ocument9 '':'-:41 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 $hecklist 6ersion 7o" - Pae 2 of 8 Effective %ate9 ):':42 3upersedes %ocument9 '':'-:41 3OP *4*B 0.+ Mi)(es +or specific information reardin meetin minutes, refer to 3OP *4*$" 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
Dkit Research Ethics Committees Standard Operating Procedures (Sops) These Are Adapted From The Model Sops Developed by The Association of Research Ethics Committees (2013)