{"templateJson":{"children":[{"dataId":2275385,"name":"Section1","text":"Reviewer Checklist","label":"","type":"question","children":[{"dataId":2275386,"name":"Label1","text":"- Reviewers are encouraged to provide comments throughout the Sections of the submission that can be shared directly with the PI.
- This review checklist is focused on the regulatory criteria for approval.
- The Board Member Manual and all SOPs can be found in a Google Drive
","required":false,"helpText":"HRP314 Reviewer Checklist","label":"","type":"label"},{"dataId":2275387,"name":"Group13","text":"Submission Type","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275388,"name":"Radio6","text":"Initial - first review","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275389,"name":"Radio9","text":"Initial - revisions","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275390,"name":"Radio8","text":"Modification","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275391,"name":"Radio7","text":"Renewal","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275392,"name":"Group47","text":"Review Level","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275388,"type":"displayed"},{"targetId":2275388,"type":"required"}],"children":[{"dataId":2275393,"name":"Group1","text":"The project meets the criteria for which review level?","description":"","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275394,"name":"Radio1","text":"Exempt","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275395,"name":"Radio29","text":"Limited Review (at this time, RMU does not review projects for Broad Consent)","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275396,"name":"Radio2","text":"Expedited","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275397,"name":"Radio3","text":"Full Board
","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":2275398,"name":"Group48","text":"Exempt Criteria","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275394,"type":"displayed"},{"targetId":2275394,"type":"required"}],"children":[{"dataId":2275399,"name":"Group34","text":"Criteria for Exempt Determination","description":"The criteria for an exempt determination can be found at at 45 CFR 46.104.","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2275400,"name":"CheckBox15","text":"The project falls under one of the Exempt determination categories.","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275401,"name":"CheckBox21","text":"The project does NOT involve
- educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior
- benign behaviorial interventions of
of children.
","required":false,"helpText":"","label":"","type":"checkbox"}]}]},{"dataId":2275402,"name":"Group49","text":"Limited Review
","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275395,"type":"displayed"},{"targetId":2275395,"type":"required"}],"children":[{"dataId":2275403,"name":"Group17","text":"For purposes of conducting the limited IRB review required by ?46.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
","description":"- All must be checked for approval
","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2275404,"name":"CheckBox23","text":"N/A","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275405,"name":"CheckBox8","text":"Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of ?46.116(a)(1)-(4), (a)(6), and (d)","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275406,"name":"CheckBox9","text":"Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with ?46.117; and","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275407,"name":"CheckBox12","text":"If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.","required":false,"helpText":"","label":"","type":"checkbox"}]}]},{"dataId":2275408,"name":"Group50","text":"Expedited and Full Board Criteria for Approval of Research","description":"- The items below are the criteria found at 45 CFR 46.111.
- All must be checked yes for approval.
","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275396,"type":"displayed"},{"targetId":2275396,"type":"required"},{"targetId":2275397,"type":"displayed"},{"targetId":2275397,"type":"required"}],"children":[{"dataId":2275409,"name":"Group12","text":"Are risks to subjects are minimized by using procedures, that are consistent with sound research design and that do not unnecessarily expose subjects to risk?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275410,"name":"Radio17","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275411,"name":"Radio20","text":"No
","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275412,"name":"TextArea7","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275411,"type":"displayed"},{"targetId":2275411,"type":"required"}]}]},{"dataId":2275413,"name":"Radio53","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275414,"name":"Group27","text":"Are risks to subjects minimized by using procedures already being performed on the subjects for diagnostic or treatment purposes?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275415,"name":"Radio24","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275416,"name":"Radio31","text":"No
","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275417,"name":"TextArea8","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275416,"type":"displayed"},{"targetId":2275416,"type":"required"}]}]},{"dataId":2275418,"name":"Radio54","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275419,"name":"Group28","text":"Are risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275420,"name":"Radio32","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275421,"name":"Radio33","text":"No
","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275422,"name":"TextArea9","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275421,"type":"displayed"},{"targetId":2275421,"type":"required"}]}]},{"dataId":2275423,"name":"Radio55","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275424,"name":"Group35","text":"Is the selection of subjects is equitable?","description":"Consider the purpose and setting of the research, involvement of vulnerable subjects, selection criteria, and recruitment, enrollment, and payment procedures.","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275425,"name":"Radio37","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275426,"name":"Radio50","text":"No
","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275427,"name":"TextArea11","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275426,"type":"displayed"},{"targetId":2275426,"type":"required"}]}]},{"dataId":2275428,"name":"Radio56","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275429,"name":"Group36","text":"Does the research plan make adequate provision for monitoring the data collected to ensure the safety of subjects 46.111(6)?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275430,"name":"Radio51","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275431,"name":"Radio52","text":"No
","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275432,"name":"TextArea12","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275431,"type":"displayed"},{"targetId":2275431,"type":"required"}]}]},{"dataId":2275433,"name":"Radio57","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275434,"name":"Group37","text":"Are there adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data in accordance with 46.111(7)?
","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275435,"name":"Radio58","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275436,"name":"Radio59","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275437,"name":"TextArea13","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275436,"type":"displayed"},{"targetId":2275436,"type":"required"}]}]},{"dataId":2275438,"name":"Radio60","text":"N/A","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":2275439,"name":"Group39","text":"Subjects
","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275388,"type":"displayed"},{"targetId":2275388,"type":"required"}],"children":[{"dataId":2275440,"name":"Group26","text":"Who will be enrolled in this study?","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2275441,"name":"CheckBox24","text":"Adults","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275442,"name":"CheckBox25","text":"Children
","required":false,"helpText":"","label":"","type":"checkbox"}]},{"dataId":2275443,"name":"Group4","text":"Adults as subjects","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275441,"type":"displayed"},{"targetId":2275441,"type":"required"}],"children":[{"dataId":2275444,"name":"Group6","text":"Are any of the subjects being recruited from vulnerable populations?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275445,"name":"Radio18","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275446,"name":"Group16","text":"Population","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","dependencies":[{"targetId":2275445,"type":"displayed"},{"targetId":2275445,"type":"required"}],"children":[{"dataId":2275447,"name":"CheckBox4","text":"Elderly","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275448,"name":"CheckBox5","text":"Cognitively impaired","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275449,"name":"CheckBox6","text":"educationally or economically disadvantaged","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275450,"name":"CheckBox7","text":"","required":false,"helpText":"","label":"","type":"checkbox"}]},{"dataId":2275451,"name":"Group21","text":"Are there adequate protections in place for these group(s)?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275452,"name":"Radio49","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275453,"name":"Radio85","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275454,"name":"TextArea27","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275453,"type":"displayed"},{"targetId":2275453,"type":"required"}]}]}]}]},{"dataId":2275455,"name":"Radio48","text":"No
","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":2275456,"name":"Group11","text":"Children as subjects","description":"Refer to Subpart D ? Additional Protections for Children Involved as Subjects in Research","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275442,"type":"displayed"},{"targetId":2275442,"type":"required"}],"children":[{"dataId":2275457,"name":"Group14","text":"Determination of Risks to Children","description":"What is the risk to the child participant?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275458,"name":"Radio25","text":"46.404 Research not involving greater than minimal risk.
","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275459,"name":"Radio26","text":"46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275460,"name":"Radio27","text":"46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. ","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275461,"name":"Radio28","text":"46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275462,"name":"Label3","text":"You have selected a risk greater than minimal risk.
If this is an expedited review, consider whether the PI can make changes to lower the risk or the study should be referred to the Full Board.
","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2275459,"type":"displayed"},{"targetId":2275460,"type":"displayed"},{"targetId":2275461,"type":"displayed"}]},{"dataId":2275463,"name":"TextArea3","text":"Justification","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275458,"type":"displayed"},{"targetId":2275458,"type":"required"},{"targetId":2275459,"type":"displayed"},{"targetId":2275459,"type":"required"},{"targetId":2275460,"type":"displayed"},{"targetId":2275460,"type":"required"}]},{"dataId":2275464,"name":"Group32","text":"Parent Permission","description":"- The signature of only one parent is allowable in categories 46.404 and 46.405.
- IRB approval may be contingent on the signatures of both parents.
","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275465,"name":"Radio34","text":"Signature of one parent is sufficient.","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275466,"name":"Radio35","text":"Signature of both parents is required.
","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275467,"name":"TextArea1","text":"Justification","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275466,"type":"displayed"},{"targetId":2275466,"type":"required"}]}]}]},{"dataId":2275468,"name":"Group5","text":"Child Assent","description":"- Under 46.408: When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
- Please indicate below if written assent is required.
","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275469,"name":"Radio12","text":"Written assent is NOT required.","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275470,"name":"Radio13","text":"Written assent IS required and adequately described in the submission.
","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275471,"name":"Radio19","text":"Written assent IS required and NOT adequately described in the submission. (Comments left in the Informed Consent Section.)","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275472,"name":"TextArea15","text":"Justification/comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275469,"type":"displayed"},{"targetId":2275469,"type":"required"},{"targetId":2275470,"type":"displayed"},{"targetId":2275470,"type":"required"},{"targetId":2275471,"type":"displayed"},{"targetId":2275471,"type":"required"}]}]}]},{"dataId":2275473,"name":"Group15","text":"Informed Consent
","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275388,"type":"displayed"},{"targetId":2275388,"type":"required"}],"children":[{"dataId":2275474,"name":"Group3","text":"Waiver or Alteration of Consent","description":"Criteria for a general waiver or alteration of consent can be found at 45 CFR 46.116 (f)","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2275475,"name":"CheckBox1","text":"Not requested or consent will be documented face to face for some portion of the project.","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2275476,"name":"CheckBox2","text":"Criteria met, alteration or waiver requested for","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2275477,"name":"TextBox1","text":"describe","required":false,"helpText":"","label":"","type":"textbox","dependencies":[{"targetId":2275476,"type":"displayed"},{"targetId":2275476,"type":"required"}]}]},{"dataId":2275478,"name":"CheckBox3","text":"Criteria not met
","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2275479,"name":"TextArea25","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275478,"type":"displayed"},{"targetId":2275478,"type":"required"}]}]}]},{"dataId":2275480,"name":"Group51","text":"Consent document criteria","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275475,"type":"displayed"},{"targetId":2275475,"type":"required"}],"children":[{"dataId":2275481,"name":"Group24","text":"Is the written consent document accurate, complete, and consistent with the protocol?","description":"","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275482,"name":"Radio61","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275483,"name":"Radio62","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275484,"name":"TextArea14","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275483,"type":"displayed"},{"targetId":2275483,"type":"required"}]}]},{"dataId":2275485,"name":"Radio63","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275486,"name":"Group40","text":"Is the information to be given to the subject or their Legally Authorized Representative (LAR) in language understandable to the subject or LAR?","description":"- The target reading level for the general public is an 8th grade reading level.
- It may be higher for professional peers.
","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275487,"name":"Radio64","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275488,"name":"Radio65","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275489,"name":"TextArea17","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275488,"type":"displayed"},{"targetId":2275488,"type":"required"}]}]},{"dataId":2275490,"name":"Radio66","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275491,"name":"Group41","text":"Will the investigator give either the subject or LAR adequate opportunity to read the consent document before it is signed?","description":"- Best practice is a minimum of 24 hours between receipt of the consent document and assessment of understanding/signatures.
","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275492,"name":"Radio67","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275493,"name":"Radio68","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275494,"name":"TextArea18","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275493,"type":"displayed"},{"targetId":2275493,"type":"required"}]}]},{"dataId":2275495,"name":"Radio69","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275496,"name":"Group42","text":"Will the investigator obtain the legally effective informed consent of the subject or LAR?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275497,"name":"Radio70","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275498,"name":"Radio71","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275499,"name":"TextArea19","text":"Comments","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275498,"type":"displayed"},{"targetId":2275498,"type":"required"}]}]},{"dataId":2275500,"name":"Radio72","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275501,"name":"Group46","text":"Will consent be obtained only under circumstances that provide the prospective subject or LAR sufficient opportunity to consider whether or not to participate?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275502,"name":"Radio76","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275503,"name":"Radio77","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275504,"name":"TextArea20","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275503,"type":"displayed"},{"targetId":2275503,"type":"required"}]}]},{"dataId":2275505,"name":"Radio78","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275506,"name":"Group45","text":"Will consent be obtained only under circumstances that minimize the possibility of coercion or undue influence?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275507,"name":"Radio75","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275508,"name":"Radio79","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275509,"name":"TextArea21","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275508,"type":"displayed"},{"targetId":2275508,"type":"required"}]}]},{"dataId":2275510,"name":"Radio80","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275511,"name":"Group44","text":"Is there any exculpatory language through which the subject or LAR is made to waive or appear to waive the subject?s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability from negligence?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275512,"name":"Radio74","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275513,"name":"Radio81","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275514,"name":"TextArea22","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275513,"type":"displayed"},{"targetId":2275513,"type":"required"}]}]},{"dataId":2275515,"name":"Radio82","text":"N/A
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275516,"name":"Group43","text":"When a subject or LAR is unable to read: Will an impartial witness be present during the entire consent discussion and the consent document notes that the witness attests that the information in the consent document and any other information provided was accurately explained to, and apparently understood by, the subject or the subject's LAR, and that consent was freely given?
","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275517,"name":"Radio73","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275518,"name":"Radio83","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275519,"name":"TextArea23","text":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275518,"type":"displayed"},{"targetId":2275518,"type":"required"}]}]},{"dataId":2275520,"name":"Radio84","text":"N/A","required":false,"helpText":"","label":"","type":"radio"}]}]}]},{"dataId":2275521,"name":"Group18","text":"Initial Submission - Revisions","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275389,"type":"displayed"},{"targetId":2275389,"type":"required"}],"children":[{"dataId":2275522,"name":"Group2","text":"Requested changes have been marked \"resolved\" by staff.","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275523,"name":"Radio4","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275524,"name":"Radio5","text":"No
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275525,"name":"Group9","text":"Compare function used to review changes in responses.","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275526,"name":"Radio10","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275527,"name":"Radio11","text":"No
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275528,"name":"Group22","text":"Compare function used to review changes in documents.","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275529,"name":"Radio15","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275530,"name":"Radio16","text":"No
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275531,"name":"Group23","text":"Issues identified in prior review sufficiently addressed?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275532,"name":"Radio21","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275533,"name":"Radio22","text":"No
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275534,"name":"TextArea16","text":"Comments","description":"Please provide any general comments for either the IRB Staff or the study team.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275524,"type":"displayed"},{"targetId":2275524,"type":"required"},{"targetId":2275527,"type":"displayed"},{"targetId":2275527,"type":"required"},{"targetId":2275530,"type":"displayed"},{"targetId":2275530,"type":"required"},{"targetId":2275533,"type":"displayed"},{"targetId":2275533,"type":"required"}]}]},{"dataId":2275535,"name":"Group20","text":"Modification","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275390,"type":"displayed"},{"targetId":2275390,"type":"required"}],"children":[{"dataId":2275536,"name":"Group25","text":"Are the changes described in the summary fully reflected in the appropriate Sections?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275537,"name":"Radio23","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275538,"name":"Radio30","text":"No, comments made in the appropriate Sections.
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275539,"name":"Group7","text":"Do the changes affect the intervention/risk determination?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275540,"name":"Radio36","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2275541,"name":"TextArea5","text":"Describe","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2275540,"type":"displayed"},{"targetId":2275540,"type":"required"}]}]},{"dataId":2275542,"name":"Radio44","text":"No
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275543,"name":"Group10","text":"Do the changes affect the consent documents/process?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275544,"name":"Radio43","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275545,"name":"Radio45","text":"No
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275546,"name":"Group33","text":"Are the changes fully reflected in the documents?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2275544,"type":"displayed"},{"targetId":2275544,"type":"required"}],"children":[{"dataId":2275547,"name":"Radio46","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275548,"name":"Radio47","text":"No, comments made in the Informed Consent Section or on the document
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275549,"name":"TextArea10","text":"Comments","description":"Please provide any general comments for either the IRB Staff or the study team.","required":false,"helpText":"","label":"","type":"textarea"}]},{"dataId":2275550,"name":"Group19","text":"Renewal","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2275391,"type":"displayed"},{"targetId":2275391,"type":"required"}],"children":[{"dataId":2275551,"name":"Group29","text":"Project status","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275552,"name":"Radio38","text":"Open to enrollment","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275553,"name":"Radio40","text":"Closed to enrollment","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275554,"name":"Radio39","text":"Limited to follow up data collection
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275555,"name":"Group30","text":"Redacted Consent","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275556,"name":"Radio41","text":"Not required","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2275557,"name":"Radio42","text":"Correct and current
","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2275558,"name":"TextArea2","text":"Comments","description":"Please provide any general comments for either the IRB Staff or the study team.","required":false,"helpText":"","label":"","type":"textarea"}]},{"dataId":2275559,"name":"Group8","text":"Reviewer Certification","description":"See the Board Member Manual on how to complete the review.","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2275560,"name":"Radio14","text":"I certify that I have reviewed this submission and have completed the above Reviewer Checklist.","required":false,"helpText":"","label":"","type":"radio"}]}]}],"attachments":[]},"samples":[]}