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","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266452,"name":"TextBox15","text":"List the languages expected to be represented by the subjects","required":false,"helpText":"","label":"","type":"textbox","dependencies":[{"targetId":2266451,"type":"displayed"},{"targetId":2266451,"type":"required"}]},{"dataId":2266453,"name":"TextArea64","text":"Describe the mechanisms for identifying and providing certified interpreters","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266451,"type":"displayed"},{"targetId":2266451,"type":"required"}]},{"dataId":2266454,"name":"TextArea30","text":"Describe the mechanisms for identifying and providing qualified/certified translators for written documents.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266451,"type":"displayed"},{"targetId":2266451,"type":"required"}]},{"dataId":2266455,"name":"Group66","text":"Is the research being reviewed by the Full Board?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266451,"type":"displayed"},{"targetId":2266451,"type":"required"}],"children":[{"dataId":2266456,"name":"Radio49","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266457,"name":"Radio50","text":"Yes.","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266458,"name":"TextArea65","text":"Describe the mechanism for verifying the accuracy of translated print materials for greater than minimal risk studies.","description":"For example: certified translator or back translation for projects designated greater than minimal risk.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266451,"type":"displayed"},{"targetId":2266451,"type":"required"},{"targetId":2266457,"type":"displayed"},{"targetId":2266457,"type":"required"}]}]}]},{"dataId":2266459,"name":"AttachButton1","text":"Attach documents verifying translators' qualification and/or certification. ","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266451,"type":"displayed"}]}]}]},{"dataId":2266460,"name":"Group137","text":"Eligibility Screening
","description":"","required":false,"helpText":"(g) Screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject?s legally authorized representative, if either of the following conditions are met:

(1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or

(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
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","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266464,"name":"TextArea10","text":"Describe how potential subjects will be screened before consent to ensure they meet inclusion and exclusion criteria. (This may be part of your recruitment plan as well.)","required":true,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266463,"type":"displayed"},{"targetId":2266463,"type":"required"}]},{"dataId":2266465,"name":"AttachButton42","text":"Attach any screening documents used before consent.  (A screening script may also described in the Recruitment Section.)","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266463,"type":"displayed"}]}]}]},{"dataId":2266466,"name":"Group139","text":"Will you screen participants after consent?","description":"","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266467,"name":"Radio185","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266468,"name":"Radio186","text":"Yes

","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266469,"name":"TextArea9","text":"Describe how potential subjects will be screened or tested after consent to ensure they meet inclusion and exclusion criteria.","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266468,"type":"displayed"},{"targetId":2266468,"type":"required"}]},{"dataId":2266470,"name":"AttachButton32","text":"Attach any screening tools used after consent.","description":"Projects involving exercise may wish to use HRP250 Screening Questionnaire for Research Involving Exercise
","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266468,"type":"displayed"}]}]}]},{"dataId":2266471,"name":"Group88","text":"Will subjects' medical, academic, or other personal records be accessed for screening purposes?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266472,"name":"Radio100","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266473,"name":"Radio101","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266474,"name":"TextArea4","text":"Specify
  1. What types of records.
  2. What information you will take from the records.
  3. How will you use the information.
  4. How HIPAA and/or FERPA regulations will be followed.
","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266473,"type":"displayed"},{"targetId":2266473,"type":"required"}]}]}]}]},{"dataId":2266475,"name":"Group84","text":"Numbers","description":"","required":false,"helpText":"","label":"","type":"question","children":[{"dataId":2266476,"name":"TextBox16","text":"Maximum number of subjects to complete the informed consent process","description":"","required":true,"helpText":"This number should be intentionally higher than the number needed. It allows for screen failures or withdrawals","label":"","type":"textbox"},{"dataId":2266477,"name":"TextBox17","text":"Number of subjects needed to complete the research","description":"","required":true,"helpText":"","label":"","type":"textbox"},{"dataId":2266478,"name":"TextArea66","text":"What are the factors used to support the proposed sample size (e.g. power) or how was the number to complete the research determined?","description":"","required":true,"helpText":"","label":"","type":"textarea"}]}]},{"dataId":2266479,"name":"Section12","text":"","label":"Recruitment","type":"question","dependencies":[{"targetId":2266222,"type":"displayed"},{"targetId":2266207,"type":"displayed"},{"targetId":2266208,"type":"displayed"},{"targetId":2266209,"type":"displayed"},{"targetId":2266211,"type":"displayed"},{"targetId":2266212,"type":"displayed"},{"targetId":2266213,"type":"displayed"}],"children":[{"dataId":2266480,"name":"Group34","text":"Recruitment plan","description":"","required":false,"helpText":"","label":"","type":"question","children":[{"dataId":2266481,"name":"TextArea105","text":"Describe the recruitment plan.
","description":"
Where are you recruiting from?How will you reach participants?
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","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266486,"name":"TextBox53","text":"Which sources?","required":false,"helpText":"","label":"","type":"textbox","dependencies":[{"targetId":2266485,"type":"displayed"},{"targetId":2266485,"type":"required"}]},{"dataId":2266487,"name":"Group33","text":"Letter of Support","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","dependencies":[{"targetId":2266485,"type":"displayed"}],"children":[{"dataId":2266488,"name":"CheckBox29","text":"Same as study location","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2266489,"name":"CheckBox31","text":"Letter of Support forthcoming; will be signed upon RMU approval
","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2266490,"name":"CheckBox32","text":"Attached","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266491,"name":"AttachButton12","text":"Attach a letter(s) of support for recruitment","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266485,"type":"displayed"},{"targetId":2266485,"type":"required"},{"targetId":2266490,"type":"displayed"},{"targetId":2266490,"type":"required"}]}]}]}]}]}]},{"dataId":2266492,"name":"Group98","text":"Materials","description":"","required":false,"helpText":"","label":"","type":"question","children":[{"dataId":2266493,"name":"Group99","text":"What materials will be used to recruit subjects?","required":true,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2266494,"name":"CheckBox66","text":"Email / Letter","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266495,"name":"TextArea59","text":"How will the above item be used to recruit subjects?
","description":"Provide specific details , including who will send it and to whom.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266494,"type":"displayed"},{"targetId":2266494,"type":"required"}]},{"dataId":2266496,"name":"AttachButton27","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266494,"type":"displayed"},{"targetId":2266494,"type":"required"}]}]},{"dataId":2266497,"name":"CheckBox65","text":"Flyer","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266498,"name":"TextArea60","text":"How will the above item be used to recruit subjects?
","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266497,"type":"displayed"},{"targetId":2266497,"type":"required"}]},{"dataId":2266499,"name":"AttachButton28","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266497,"type":"displayed"},{"targetId":2266497,"type":"required"}]}]},{"dataId":2266500,"name":"CheckBox68","text":"Social Media Post","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266501,"name":"TextArea61","text":"How will the above item be used to recruit subjects?
","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266500,"type":"displayed"},{"targetId":2266500,"type":"required"}]},{"dataId":2266502,"name":"AttachButton29","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266500,"type":"displayed"},{"targetId":2266500,"type":"required"}]}]},{"dataId":2266503,"name":"CheckBox67","text":"Telephone Script","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266504,"name":"TextArea62","text":"How will the above item be used to recruit subjects?
","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266503,"type":"displayed"},{"targetId":2266503,"type":"required"}]},{"dataId":2266505,"name":"AttachButton30","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266503,"type":"displayed"},{"targetId":2266503,"type":"required"}]}]},{"dataId":2266506,"name":"CheckBox69","text":"Other","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266507,"name":"TextBox1","text":"Describe","required":false,"helpText":"","label":"","type":"textbox","dependencies":[{"targetId":2266506,"type":"displayed"},{"targetId":2266506,"type":"required"}]},{"dataId":2266508,"name":"TextArea63","text":"How will the above item be used to recruit subjects?
","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266506,"type":"displayed"},{"targetId":2266506,"type":"required"}]},{"dataId":2266509,"name":"AttachButton31","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266506,"type":"displayed"},{"targetId":2266506,"type":"required"}]}]}]}]},{"dataId":2266510,"name":"Group55","text":"Incentives, Costs and Compensation","description":"","required":false,"helpText":"","label":"","type":"question","children":[{"dataId":2266511,"name":"Group56","text":"Will you give subjects gifts, payments, or services without charge?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266512,"name":"Radio55","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266513,"name":"Radio56","text":"Yes

","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266514,"name":"Group57","text":"Check all that apply","description":"","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","dependencies":[{"targetId":2266513,"type":"displayed"},{"targetId":2266513,"type":"required"}],"children":[{"dataId":2266515,"name":"CheckBox52","text":"Gifts","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266516,"name":"TextArea37","text":"Describe the items you will give and their value.","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266515,"type":"displayed"},{"targetId":2266515,"type":"required"}]}]},{"dataId":2266517,"name":"CheckBox53","text":"Payments","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266518,"name":"TextArea38","text":"
Describe
  1. The amount.
  2. How it was determined.
  3. How it will be given. E.g., check, cash or gift certificate
  4. Whether the subject is compensated by the number and type of procedures performed, the amount of time involved, or for each sample collected.
  5. Whether the amount is pro-rated if the subject does not complete the study.
","description":"Please use the numbering formatting to be sure you have answered each element of the item.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266517,"type":"displayed"},{"targetId":2266517,"type":"required"}]}]},{"dataId":2266519,"name":"CheckBox54","text":"Services without charge

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266520,"name":"TextArea39","text":"Describe the services and their value.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266519,"type":"displayed"},{"targetId":2266519,"type":"required"}]}]}]},{"dataId":2266521,"name":"Group59","text":"Will any of the subjects or their third-party payers be charged for any research procedures?","required":true,"helpText":"It may be that part of the intervention is standard care and can be billed. Any intervention that is experimental cannot. If you were comparing the outcomes of two different, but each standard care interventions, it may be that your local institution could bill for both.

","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266522,"name":"Radio57","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266523,"name":"Radio58","text":"Yes

","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266524,"name":"TextArea40","text":"Explain which study procedures will be billed and who will be responsible for paying. ","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266523,"type":"displayed"},{"targetId":2266523,"type":"required"}]}]}]},{"dataId":2266525,"name":"Group58","text":"Will you offer extra credit for student participants?","description":"If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized.","required":false,"helpText":"?Reasonable levels of extra credit or rewards may be offered for participating in research. If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. However, if participation in research is a course requirement, students must be informed of non-research alternatives involving comparable time and effort to fulfill those requirements in order for the possibility of undue influence to be minimized. Moreover, students must not be penalized for refusing to participate in research (45 CFR 46.116(a)(8)).?","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266526,"name":"Radio51","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266527,"name":"Radio52","text":"Yes

","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266528,"name":"TextArea36","text":"Describe the credit and what alternative(s) will be offered for students who choose not to participate.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266527,"type":"displayed"},{"targetId":2266527,"type":"required"}]}]}]}]}]},{"dataId":2266529,"name":"Section19","text":"","label":"Informed Consent","type":"question","dependencies":[{"targetId":2266222,"type":"displayed"},{"targetId":2266207,"type":"displayed"},{"targetId":2266208,"type":"displayed"},{"targetId":2266209,"type":"displayed"},{"targetId":2266211,"type":"displayed"},{"targetId":2266212,"type":"displayed"},{"targetId":2266213,"type":"displayed"}],"children":[{"dataId":2266530,"name":"Label16","text":"","required":false,"helpText":"","label":"","type":"label"},{"dataId":2266531,"name":"TextArea54","text":"Voluntary participation","description":"","required":true,"helpText":"","label":"","type":"textarea"},{"dataId":2266532,"name":"Group79","text":"Documents","description":"","required":true,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2266533,"name":"CheckBox59","text":"HRP 220 Adult Consent to Participate

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266534,"name":"AttachButton21","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266533,"type":"displayed"},{"targetId":2266533,"type":"required"}]}]},{"dataId":2266535,"name":"CheckBox60","text":"HRP 221 Parent/Guardian Permission for minor child

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266536,"name":"AttachButton22","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266535,"type":"displayed"},{"targetId":2266535,"type":"required"}]}]},{"dataId":2266537,"name":"CheckBox61","text":"HRP 222 Assent to participant (Used with minors, as applicable.)

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266538,"name":"AttachButton23","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266537,"type":"displayed"},{"targetId":2266537,"type":"required"}]}]},{"dataId":2266539,"name":"CheckBox62","text":"HRP 223 Short Form Consent and oral script (Used with individuals with low literacy. )

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266540,"name":"Label14","text":"Please review

as there are requirements for interpreters and a witness.
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","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266543,"name":"AttachButton25","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266542,"type":"displayed"},{"targetId":2266542,"type":"required"}]}]},{"dataId":2266544,"name":"CheckBox64","text":"HRP 226 Interview Guide (Includes boilerplate language for recorded consent.)

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266545,"name":"Label13","text":"","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2266544,"type":"displayed"}]},{"dataId":2266546,"name":"AttachButton26","text":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266544,"type":"displayed"},{"targetId":2266544,"type":"required"}]}]},{"dataId":2266547,"name":"CheckBox15","text":"None

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266548,"name":"Label9","text":"Complete the Waiver or Alteration of Consent below.","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2266547,"type":"displayed"}]}]}]},{"dataId":2266549,"name":"Group27","text":"Process","description":"","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2266533,"type":"displayed"},{"targetId":2266533,"type":"required"},{"targetId":2266535,"type":"displayed"},{"targetId":2266535,"type":"required"},{"targetId":2266537,"type":"displayed"},{"targetId":2266537,"type":"required"},{"targetId":2266542,"type":"displayed"},{"targetId":2266542,"type":"required"},{"targetId":2266544,"type":"displayed"},{"targetId":2266544,"type":"required"}],"children":[{"dataId":2266550,"name":"Group116","text":"How will you conduct the consent process?","required":true,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2266551,"name":"CheckBox127","text":"In person, face to face","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266552,"name":"TextArea55","text":"Receipt
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","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266557,"name":"Label33","text":"","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2266556,"type":"displayed"}]},{"dataId":2266558,"name":"TextArea89","text":"Receipt","description":"Describe when and how subjects will receive the informed consent document(s).","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266556,"type":"displayed"},{"targetId":2266556,"type":"required"}]},{"dataId":2266559,"name":"TextArea90","text":"Consideration","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266556,"type":"displayed"},{"targetId":2266556,"type":"required"}]},{"dataId":2266560,"name":"TextArea91","text":"Understanding","description":"","required":false,"helpText":"There are many ways to assess understanding. E.g. teach back, tell me in your own words, stopping at each section for questions. The Office of Human Research Protection (OHRP) has a video you may wish to watch.","label":"","type":"textarea","dependencies":[{"targetId":2266556,"type":"displayed"},{"targetId":2266556,"type":"required"}]},{"dataId":2266561,"name":"TextArea92","text":"Documentation","description":"Describe when, where, and how the consent process will be documented, including  if, when, and how participants will receive a signed copy.","required":false,"helpText":"If the consent process will be conducted remotely review the IRB Guidance on Remote Consent Procedures.
","label":"","type":"textarea","dependencies":[{"targetId":2266556,"type":"displayed"},{"targetId":2266556,"type":"required"}]}]}]},{"dataId":2266562,"name":"Group141","text":"Will you need to request a Waiver or Alteration of Consent to delete or change elements of the informed consent process?","description":"","required":true,"helpText":"46.116 General Requirements for Informed Consent","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266563,"name":"Radio98","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266564,"name":"Radio99","text":"Yes","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":2266565,"name":"Group77","text":"Request for Waiver or Alteration of Consent (HRP 208)","description":"","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2266542,"type":"displayed"},{"targetId":2266542,"type":"required"},{"targetId":2266544,"type":"displayed"},{"targetId":2266544,"type":"required"},{"targetId":2266674,"type":"displayed"},{"targetId":2266564,"type":"displayed"},{"targetId":2266564,"type":"required"},{"targetId":2266547,"type":"displayed"},{"targetId":2266547,"type":"required"}],"children":[{"dataId":2266566,"name":"Group105","text":"What type(s) of waiver (omit/leave out) or alteration (change) are you requesting?","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2266567,"name":"CheckBox116","text":"A. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials 45 CFR 46.116(e)

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266568,"name":"TextArea72","text":"Describe how the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

A. Public benefit or service programs;
B. Procedures for obtaining benefits or services under those programs;
C. Possible changes in or alternatives to those programs or procedures; or
D. Possible changes in methods or levels of payment for benefits or services under those programs","required":false,"helpText":"(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
(b) and (c) of this section provided the IRB satisfies the requirements of paragraph (e)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.

(3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

(i) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

(A) Public benefit or service programs;

(B) Procedures for obtaining benefits or services under those programs;

(C) Possible changes in or alternatives to those programs or procedures; or

(D) Possible changes in methods or levels of payment for benefits or services under those programs; and

(ii) The research could not practicably be carried out without the waiver or alteration.
","label":"","type":"textarea","dependencies":[{"targetId":2266567,"type":"displayed"},{"targetId":2266567,"type":"required"}]},{"dataId":2266569,"name":"TextArea73","text":"Describe why/how the proposed project could not be practicably carried out without the waiver.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266567,"type":"displayed"},{"targetId":2266567,"type":"required"}]}]},{"dataId":2266570,"name":"CheckBox117","text":"B. General waiver or alteration of consent 45 CFR 46.116(f)

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266571,"name":"Label32","text":"
  1. Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
  2. Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.
  3. Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: (i) The research involves no more than minimal risk to the subjects; (ii) The research could not practicably be carried out without the requested waiver or alteration; (iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; (iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and (v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2266570,"type":"displayed"}]},{"dataId":2266572,"name":"TextArea74","text":"Describe the proposed waiver (omission) or alteration (change) of some or all of the elements the informed consent.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266570,"type":"displayed"},{"targetId":2266570,"type":"required"}]},{"dataId":2266573,"name":"TextArea75","text":"Describe why/how the proposed project involves no more than minimal risk to the subjects.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266570,"type":"displayed"},{"targetId":2266570,"type":"required"}]},{"dataId":2266574,"name":"TextArea76","text":"Describe how the research could not practicably be carried out without the requested waiver or alteration.","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266570,"type":"displayed"},{"targetId":2266570,"type":"required"}]},{"dataId":2266575,"name":"TextArea77","text":"If the research involves using identifiable private information or identifiable biospecimens, describe how the research could not practicably be carried out without using such information or biospecimens in an identifiable format.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266570,"type":"displayed"},{"targetId":2266570,"type":"required"}]},{"dataId":2266576,"name":"TextArea78","text":"Describe if and how you will provide the subjects or legally authorized representatives with additional pertinent information after participation (if appropriate).","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266570,"type":"displayed"},{"targetId":2266570,"type":"required"}]}]},{"dataId":2266577,"name":"CheckBox118","text":"C. Waiver of Signed Consent under 45 CFR 46.117(c)

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266578,"name":"Label31","text":"(Signed consent is a separate requirement from those listed in 45 CFR 46.116 (a) and (b) and requires a separate request.)

An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:

  1. That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
  2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
  3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
","required":false,"helpText":"
h.
","label":"","type":"label","dependencies":[{"targetId":2266577,"type":"displayed"}]},{"dataId":2266579,"name":"Group109","text":"What reason do you have for requesting a waiver of signed consent?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266577,"type":"required"},{"targetId":2266577,"type":"displayed"}],"children":[{"dataId":2266580,"name":"Radio125","text":"The research presents no more than minimal risk to the subjects.","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266581,"name":"TextArea84","text":"Describe why/how the research presents no more than minimal risk of harm to subjects.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266580,"type":"displayed"},{"targetId":2266580,"type":"required"}]},{"dataId":2266582,"name":"TextArea85","text":"Describe why/how the research involves no procedures for which written consent is normally required outside of the research context.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266580,"type":"displayed"},{"targetId":2266580,"type":"required"}]}]},{"dataId":2266583,"name":"Radio126","text":"Waiver of consent because the only record linking the subject to the research would be the consent document.","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266584,"name":"TextArea83","text":"Describe why/how the only record linking the subject and the research would be the consent document.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266583,"type":"displayed"},{"targetId":2266583,"type":"required"}]},{"dataId":2266585,"name":"TextArea82","text":"Describe why/how the principal risk would be potential harm resulting from a breach of confidentiality.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266583,"type":"displayed"},{"targetId":2266583,"type":"required"}]},{"dataId":2266586,"name":"Group108","text":"Will each subject (or legally authorized representative) be asked whether they want documentation linking the subject with the research?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266583,"type":"displayed"},{"targetId":2266583,"type":"required"}],"children":[{"dataId":2266587,"name":"Radio123","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266588,"name":"Radio124","text":"No. Note that checking ?No? does not satisfy the Federal regulatory requirements.

","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266589,"name":"Group107","text":"Will the subject's (or legally authorized representative?s) wishes regarding question 10 (c) above govern?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266583,"type":"displayed"},{"targetId":2266583,"type":"required"}],"children":[{"dataId":2266590,"name":"Radio121","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266591,"name":"Radio122","text":"No.  Note that checking ?No? does not satisfy the Federal regulatory requirements.


","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266592,"name":"Group106","text":"Are the subjects (or legally authorized representatives) members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266583,"type":"displayed"},{"targetId":2266583,"type":"required"}],"children":[{"dataId":2266593,"name":"Radio119","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266594,"name":"Radio120","text":"No

","required":false,"helpText":"","label":"","type":"radio"}]}]}]}]},{"dataId":2266595,"name":"CheckBox119","text":"D. Waiver of Child Assent under 45 CFR 46.408(a)

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266596,"name":"Label29","text":"An IRB may waive child assent for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate, if the investigator can establish:

  1. Even where the IRB determines that the subjects are capable of assenting, that consent should be waived under 46.116 as described above, OR
  2. hat the capability (capacity) of some or all of the children involved in the study is so limited that they cannot reasonably be consulted regarding their assent to the study based on their: (1) age, (2) maturity, and/or (3) psychological state, OR
  3. That the intervention or procedure involved in the research: a) Holds out a prospect of direct benefit that is important to the health or well-being of the children, and b) Is available only in the context of the research.
","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2266595,"type":"displayed"}]},{"dataId":2266597,"name":"Group28","text":"Are you requesting a waiver of the requirements of child assent based on satisfaction of the requirements for a waiver under 45 CFR 46.116 as described in section B. above?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266595,"type":"displayed"},{"targetId":2266595,"type":"required"}],"children":[{"dataId":2266598,"name":"Radio113","text":"No.","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266599,"name":"Radio118","text":"Yes. Section B above completed.","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266600,"name":"Group80","text":"Is the capability (capacity) of some or all of the children involved in the study so limited that they cannot reasonably be consulted regarding their assent to the study because of: 
  1. age
  2. maturity, and/or
  3. psychological state?
","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266595,"type":"displayed"},{"targetId":2266595,"type":"required"}],"children":[{"dataId":2266601,"name":"Radio114","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266602,"name":"Radio116","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266603,"name":"TextArea80","text":"Elaborate and explain your answer, making sure to provide the IRB with any information that should be taken into consideration","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266602,"type":"displayed"},{"targetId":2266602,"type":"required"}]}]}]},{"dataId":2266604,"name":"Group104","text":"Does the intervention or procedure involved in the research a) holds out a prospect of direct benefit that is important to the health or well-being of the children and b) is available only in the context of the research?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266595,"type":"displayed"},{"targetId":2266595,"type":"required"}],"children":[{"dataId":2266605,"name":"Radio115","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266606,"name":"Radio117","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266607,"name":"TextArea79","text":"Elaborate and explain your answer, making sure to provide the IRB with any information that should be taken into consideration","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266606,"type":"displayed"},{"targetId":2266606,"type":"required"}]}]}]}]},{"dataId":2266608,"name":"CheckBox120","text":"E. Waiver of Parental Consent under 45 CFR 46.408(c)

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266609,"name":"Label30","text":"In addition to the provisions for waiver contained in 46.116 of Subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":2266608,"type":"displayed"}]},{"dataId":2266610,"name":"Group110","text":"Are you requesting waiver of the requirements of parental consent based on satisfaction of the requirements for waiver under 45 CFR 46.116 as described in section B. above?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266608,"type":"displayed"},{"targetId":2266608,"type":"required"}],"children":[{"dataId":2266611,"name":"Radio127","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266612,"name":"Radio128","text":"Yes. Complete B. General Waiver above","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266613,"name":"Group111","text":"Is the research protocol designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children)?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":2266608,"type":"displayed"},{"targetId":2266608,"type":"required"}],"children":[{"dataId":2266614,"name":"Radio129","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266615,"name":"Radio130","text":"Yes. Complete B. General Waiver above","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266616,"name":"TextArea86","text":"Explain how an appropriate mechanism for protecting the children who will participate as subjects in the research will be provided. Address the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266608,"type":"displayed"},{"targetId":2266608,"type":"required"}]},{"dataId":2266617,"name":"TextArea87","text":"Explain how/why the waiver is not inconsistent with federal, state, or local law.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266608,"type":"displayed"},{"targetId":2266608,"type":"required"}]}]}]}]}]},{"dataId":2266618,"name":"Section13","text":"","label":"Design & Methodology","type":"question","dependencies":[{"targetId":2266222,"type":"displayed"},{"targetId":2266204,"type":"displayed"},{"targetId":2266213,"type":"displayed"}],"children":[{"dataId":2266619,"name":"Group85","text":"Design","description":"  ","required":false,"helpText":"","label":"","type":"question","children":[{"dataId":2266620,"name":"TextBox8","text":"Describe the research design","description":"A simple statement of the design proposed to test the hypothesis(es).","required":true,"helpText":"","label":"","type":"textbox"}]},{"dataId":2266621,"name":"Group86","text":"Methodology","description":"   ","required":false,"helpText":"","label":"","type":"question","children":[{"dataId":2266622,"name":"Group93","text":"How will the data be collected?","required":true,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2266623,"name":"CheckBox13","text":"Prospectively - Data being collected for this study based on an intervention implemented by the study team.","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2266624,"name":"CheckBox14","text":"Retrospectively - Data has already been collected  OR you indicated Exempt, Category 4 in the Study Information Section.
","required":false,"helpText":"","label":"","type":"checkbox"}]}]},{"dataId":2266625,"name":"Group130","text":"Prospective study procedures","description":"    ","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2266623,"type":"displayed"},{"targetId":2266623,"type":"required"}],"children":[{"dataId":2266626,"name":"TextArea94","text":"Describe the procedures/activities that the participants  will be asked to complete/undergo after consent in the order they will take place.
","description":"","required":false,"helpText":"","label":"","type":"textarea"},{"dataId":2266627,"name":"TextArea15","text":"Study procedures summary","description":"","required":false,"helpText":"","label":"","type":"textarea"},{"dataId":2266628,"name":"AttachButton10","text":"Submit a flow sheet as a separate document if it will aid understanding.","required":false,"helpText":"","label":"","type":"attachment"},{"dataId":2266629,"name":"Group159","text":"Will devices or drugs be used?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266630,"name":"Radio191","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266631,"name":"Radio192","text":"Yes

","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266632,"name":"Group158","text":"Will participants be asked to consume anything?","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266633,"name":"Radio189","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266634,"name":"Radio190","text":"Yes","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":2266635,"name":"Group50","text":"Retrospective data analysis","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2266624,"type":"displayed"},{"targetId":2266624,"type":"required"}],"children":[{"dataId":2266636,"name":"TextArea93","text":"Describe what data will be analyzed and how it will be used to answer the research question.","required":false,"helpText":"","label":"","type":"textarea"}]},{"dataId":2266637,"name":"Group29","text":"Location","description":"  ","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2266623,"type":"displayed"},{"targetId":2266623,"type":"required"}],"children":[{"dataId":2266638,"name":"TextBox20","text":"Where will this study take place?
","description":"","required":true,"helpText":"","label":"","type":"textbox"},{"dataId":2266639,"name":"TextArea16","text":"Describe the physical setting(s) where the subjects will participate in this research.","description":"","required":true,"helpText":"","label":"","type":"textarea"},{"dataId":2266640,"name":"TextArea23","text":"Describe any special considerations associated with the subject tasks at the location(s)","description":"For example, if subjects are students, address
  1. whether class time is used or activities will take place outside of classroom time
  2. what nonparticipating students will or will not do
  3. supervision of non -participants
  4. procedures used to pull out children/subjects during class time, etc.
","required":false,"helpText":"","label":"","type":"textarea"},{"dataId":2266641,"name":"Group32","text":"Permission to use location(s) demonstrated by:","description":"Check all that apply.","required":true,"helpText":"","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":2266642,"name":"CheckBox4","text":"Letter(s) of Support

","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266643,"name":"AttachButton7","text":"Attach signed letter(s)","description":"","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266642,"type":"displayed"},{"targetId":2266642,"type":"required"}]}]},{"dataId":2266644,"name":"CheckBox5","text":"Letter of Support forthcoming; will be signed upon RMU approval OR Local IRB approval pending

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2266645,"name":"CheckBox6","text":"Local IRB has approved","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":2266646,"name":"AttachButton53","text":"Attach local IRB Approval letter.","description":"","required":false,"helpText":"","label":"","type":"attachment"}]},{"dataId":2266647,"name":"CheckBox7","text":"Permission not required - public location,  participant home, or project conducted remotely.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":2266648,"name":"CheckBox33","text":"Permission not required - PI owns study site.","required":false,"helpText":"","label":"","type":"checkbox"}]}]},{"dataId":2266649,"name":"Group119","text":"In Person Research and COVID Mitigation","description":"If the project will be conducted in person/face-to-face, the University Guidance requirements must be met.
","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2266623,"type":"displayed"},{"targetId":2266623,"type":"required"}],"children":[{"dataId":2266650,"name":"Group120","text":"Will any part of the study be conducted in person?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266651,"name":"Radio135","text":"No","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2266652,"name":"Radio136","text":"Yes

","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":2266653,"name":"AttachButton36","text":"Attach a pdf of the email received after completing the Resuming Face to Face Research Acknowledgment.","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266652,"type":"displayed"},{"targetId":2266652,"type":"required"}]},{"dataId":2266654,"name":"AttachButton37","text":"Attach a COVID Mitigation Protocol using the RMU Template or documentation of all local COVID mitigation protocols.","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":2266652,"type":"displayed"},{"targetId":2266652,"type":"required"}]}]},{"dataId":2266655,"name":"Group37","text":"Research tasks vs standard care","description":"This is intended to assess whether subjects are receiving standard care as part of the study or how the subjects might perceive their requested tasks.","required":false,"helpText":"","label":"","type":"question","dependencies":[{"targetId":2266623,"type":"displayed"},{"targetId":2266623,"type":"required"}],"children":[{"dataId":2266656,"name":"Group36","text":"Would subjects undergo these or similar procedures (for example, medical, psychological, or educational intervention) if they were not taking part in this research?","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":2266657,"name":"Radio30","text":"No","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":2266658,"name":"TextArea17","text":"Describe how the research procedures differ from standard care subjects would otherwise receive.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":2266657,"type":"displayed"},{"targetId":2266657,"type":"required"}]}]},{"dataId":2266659,"name":"Radio31","text":"Yes
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