{"templateJson":{"children":[{"dataId":1801362,"name":"Section3","text":"Identify type of Review","label":"","type":"question","children":[{"dataId":1801363,"name":"Group3","text":"","description":"After checking appropriate option, navigate to the next page to begin. Complete all applicable questions.  Incomplete submissions will be returned.  Refer to help text throughout the submission for additional information and guidance. When complete, click submit, and then click Certify.  (when there is a Faculty Sponsor, the Faculty Sponsor will also need to  certify)","required":false,"helpText":"If you are planning to conduct research with human subjects, complete the Initial IRB Review Request Form to request IRB review.

If you are unsure whether your project requires IRB review, submit a Not Human Subjects Research determination request. 

If you are collaborating with researchers at another institution whose IRB has reviewed the project and will act as the IRB of record, submit a Request to Rely on External IRB.
","compoundType":"checkbox","label":"","type":"question","children":[{"dataId":1801364,"name":"CheckBox3","text":"Initial IRB Review Request Form","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801365,"name":"CheckBox4","text":"Request for Determination of Human Subjects Research
(if you are unsure if your project requires IRB review)","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801366,"name":"CheckBox5","text":"Request to Rely on External IRB
","required":false,"helpText":"","label":"","type":"checkbox"}]}]},{"dataId":1801367,"name":"Section11","text":"PI Assurance","label":"1.1","type":"question","dependencies":[{"targetId":1801365,"type":"displayed"},{"targetId":1801364,"type":"displayed"},{"targetId":1801366,"type":"displayed"}],"children":[{"dataId":1801368,"name":"Group18","text":"All projects that meet the definition of research with human subjects (45 CFR 46.102) must be reviewed and approved or receive an exempt determination by the IRB  prior to beginning the research. Submissions are initially screened by IRB staff to determine completeness and appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process. Policies and Procedures and other important information can be found in the Investigator Manual
","description":"*Submissions requiring full committee review must be received at least 30 days prior to the scheduled committee meeting to allow time for pre-review. The IRB meets as needed during the regular academic year. IRB meeting schedule is posted here.
*Submissions requiring Exempt or Expedited review will be reviewed in the order received.
For more information about the IRB submission Process, IRB Tracking, and Kennesaw IRB Tasks, please refer to the Kennesaw IRB Website.","required":false,"helpText":"","label":"","type":"question"},{"dataId":1801369,"name":"Label6","text":"Principal Investigator's Assurance Statement

I certify that the information provided in this application is complete and accurate.

I understand that as principal investigator, I have ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights, safety and welfare of the human subjects, and strict adherence to the study protocol and any conditions or modifications stipulated by the KSU IRB.

I will submit modifications of the protocol and/or the informed consent form and/or any other documents to the IRB for approval prior to applying those changes in the study as required.

I agree to abide by the policies and procedures of the KSU IRB regarding the protection of human subjects including, but not limited to:
","required":false,"helpText":"","label":"","type":"label"},{"dataId":1801370,"name":"Group26","text":"","required":true,"helpText":"","compoundType":"radio","label":"","type":"question","children":[{"dataId":1801371,"name":"Radio36","text":"Acknowledged","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":1801372,"name":"Section12","text":"KSU Study Personnel","label":"1.2","type":"question","dependencies":[{"targetId":1801365,"type":"displayed"},{"targetId":1801364,"type":"displayed"},{"targetId":1801366,"type":"displayed"}],"children":[{"dataId":1801373,"name":"Label17","text":"ALL investigators who will be engaged in research activities must be included in the submission. This includes KSU faculty/staff/students, investigators from other institutions, unaffiliated investigators. (see help text for information on engagement in research)  

All responsible study personnel (principal investigators, co-investigators, faculty advisors, and unaffiliated investigators) are required to complete the CITI educational program.
Please visit the Compliance Website for more information and access to CITI training https://research.kennesaw.edu/irb/
*Study Personnel must complete either Social, Behavioral, and Educational Research with Human Subjects OR Biomedical Research with Human Subjects (depending on the type of research to be conducted in this protocol)
**Please note: Students Conducting No More Than Minimal Risk Research does NOT satisfy the IRB training requirement. ","required":false,"helpText":"A person is engaged in research when they, for the purposes of the research project,: (1) obtain data about the subjects of the research through intervention or interaction with them; (2) obtain identifiable private information about the subjects of the research;  (3) the informed consent of human subjects for the research; or (4) have access to and/or analyze identifiable data. ","label":"","type":"label"},{"dataId":1801379,"name":"PersonFinder3","text":"Principal Investigator
Identify the Principal Investigator","required":true,"helpText":"","label":"1.2.3","type":"personfinder","assignmentType":"PRINCIPAL_INVESTIGATOR","hasMultiple":false},{"dataId":1801374,"name":"Group25","text":"Is the PI faculty, staff, or student? ","required":false,"helpText":"","compoundType":"radio","label":"1.2.1","type":"question","children":[{"dataId":1801375,"name":"Radio34","text":"Faculty/Staff","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1801376,"name":"Radio35","text":"Student","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1801377,"name":"Label18","text":"Kennesaw State University students may serve as PI for their own research project and are responsible for submitting the IRB application. However, when a student is listed as the PI, a Faculty Sponsor must be listed on the submission.","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1801376,"type":"displayed"}]}]}]},{"dataId":2059397,"name":"Group9","text":"Is this project for thesis or dissertation? ","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":1801376,"type":"displayed"}],"children":[{"dataId":2059398,"name":"Radio10","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":2059399,"name":"Radio11","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1801378,"name":"PersonFinder2","text":"Faculty Sponsor
Identify the faculty sponsor ","description":"The Faculty Sponsor is ultimately responsible for the student(s) they sponsor in the conduct of human subjects research and therefore must meet all PI Eligibility requirements.  Upon completion of this initial submission form, prior to submission to the IRB, the Faculty Sponsor, along with the PI and Co-PI(s) will be asked to certify the submission.  The Faculty Sponsor, upon certification of the submission, certifies that he/she/they understands their responsibilities as Faculty Sponsor, that they have reviewed the submission, and that it is ready for IRB review.
","required":true,"helpText":"","label":"1.2.2","type":"personfinder","assignmentType":"CO_PRINCIPAL_INVESTIGATOR","hasMultiple":true,"dependencies":[{"targetId":1801376,"type":"displayed"}]},{"dataId":1801380,"name":"PersonFinder7","text":"Primary Contact
Identify the Primary Contact ","description":"The Primary Contact can be the lead PI on the study (most common) or another individual such as a project manager who is responsible for coordinating a study but is not necessarily an investigator. If the Primary Contact is not also an investigator on the project, CITI training is not required.  If the Primary Contact is also an investigator, please list in 1.2.5 or 12.6 as Co-PI or other Study Personnel. ","required":true,"helpText":"","label":"1.2.4","type":"personfinder","assignmentType":"PRIMARY_CONTACT"},{"dataId":2094210,"name":"PersonFinder1","text":"Co-Principal Investigator
Identify any investigators who will act as Co-Principal Investigator","required":false,"helpText":"","label":"1.2.6","type":"personfinder","assignmentType":"CO_PRINCIPAL_INVESTIGATOR","hasMultiple":true},{"dataId":1801381,"name":"PersonFinder8","text":"All other KSU Study Personnel
List all study personnel who are affiliated with KSU and have not already been identified above.  

*If you are unable to find an investigator using this option and the investigator is a  KSU student, the student will need to request a user account in Cayuse.  Please have the student investigator follow the link below to access the form to request a student user account. Do not submit until all study personnel are added to the submission.  Please note: users are uploaded to the system every Tuesday. 

CAYUSE USER ACCOUNT REQUEST FROM

","description":"","required":false,"helpText":"","label":"1.2.5","type":"personfinder","assignmentType":"INVESTIGATOR","hasMultiple":true}]},{"dataId":1932286,"name":"Section16","text":"Non-KSU Study Personnel","label":"1.12","type":"question","dependencies":[{"targetId":1801364,"type":"displayed"},{"targetId":1801365,"type":"displayed"},{"targetId":1801366,"type":"displayed"}],"children":[{"dataId":1932287,"name":"Group16","text":"Are there any investigators who are not affiliated with KSU?","required":false,"helpText":"","compoundType":"radio","label":"1.12.1","type":"question","children":[{"dataId":1932288,"name":"Radio15","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1932289,"name":"Radio16","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1932290,"name":"TextArea21","text":"List all Non-KSU investigators, their affiliated institution (if any), and a summary of the research activities in which they will be engaged","description":"","required":false,"helpText":"","label":"1.12.2","type":"textarea","dependencies":[{"targetId":1932288,"type":"displayed"}]},{"dataId":1932291,"name":"AttachButton6","text":"Attach CITI training records for Non-KSU study personnel.
NOTE: If you are completing a Request to Rely on an External IRB (KSU IRB will not be the IRB of record), it is not necessary to attach the CITI training records for the Non-KSU investigators.","description":"","required":false,"helpText":"","label":"1.12.3","type":"attachment","dependencies":[{"targetId":1932288,"type":"displayed"}]},{"dataId":1932513,"name":"Group4","text":"For Exempt projects, please confirm that the other IRB has been contacted and that the Non-KSU investigator has followed their policies and procedures regarding Exempt research.","required":false,"helpText":"","compoundType":"radio","label":"","type":"question","dependencies":[{"targetId":1932288,"type":"displayed"}],"children":[{"dataId":1932514,"name":"Radio8","text":"Yes, the Non-KSU investigators have contacted their IRB office and are complying with the policies and procedures of that IRB.","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1932520,"name":"AttachButton4","text":"","description":"If there are any communications with the other IRB(s) or determination letter(s), please attach ","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":1932514,"type":"displayed"}]}]},{"dataId":1932515,"name":"Radio9","text":"No, the Non-KSU investigators have not contacted their IRB.","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1932516,"name":"Label1","text":"Please inform the Non-KSU investigators to reach out to their IRB office and inform of their involvement in this project. Based on the policies of the other IRB, the Non-KSU investigators may need to submit to their IRB for it's Exempt determination. KSU does not enter into reliance agreements for Exempt research. It is the responsibility of the PI to ensure all compliance approvals are in place prior to beginning the research.","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1932515,"type":"displayed"}]}]},{"dataId":2121950,"name":"Radio12","text":"Clear","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1932517,"name":"Label7","text":"Non-Exempt projects with Non-KSU study personnel will require an agreement either with the individual investigator or with the affiliated institution.  If the study personnel is not affiliated with an institution with a  Federalwide Assurance, KSU can extend its FWA to cover them by entering into an Individual Investigator Agreement. Please have Non-KSU study personnel who are not affiliated with an institution with a FWA sign the Individual Investigator Agreement and attach below. 

(The Office for Human Research Protections maintains a database of all institutions with FWAs which can be found by following this link: Active FWA)","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1932288,"type":"displayed"}]},{"dataId":1932521,"name":"AttachButton7","text":"Individual Investigator Agreements","required":false,"helpText":"","label":"","type":"attachment","dependencies":[{"targetId":1932288,"type":"displayed"}]}]},{"dataId":1801443,"name":"Section4","text":"Funding","label":"1.4","type":"question","dependencies":[{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"},{"targetId":1801364,"type":"displayed"}],"children":[{"dataId":1801444,"name":"Group7","text":"Funding","description":"Is this study funded or intended to be submitted for funding?","required":false,"helpText":"Linking your IRB submission to Sponsored Projects","compoundType":"radio","label":"1.4.1","type":"question","children":[{"dataId":1801445,"name":"Radio2","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1801446,"name":"SponsorFinder1","text":"Please identify the sponsor below.  Please also visit the Study Details page and link this submission to the sponsor protocol. ","required":false,"helpText":"","label":"","type":"sponsorfinder","assignmentType":"IRB_SPONSOR","hasMultiple":true,"dependencies":[{"targetId":1801445,"type":"displayed"}]}]},{"dataId":1801447,"name":"Radio3","text":"No","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":1932403,"name":"Section17","text":"Conflicts of Interest","label":"5.1","type":"question","dependencies":[{"targetId":1801364,"type":"displayed"},{"targetId":1801366,"type":"displayed"}],"children":[{"dataId":1932404,"name":"Group1","text":"Are there any study personnel who have a financial conflict of interest?","required":false,"helpText":"","compoundType":"radio","label":"5.1.1","type":"question","children":[{"dataId":1932405,"name":"Radio1","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1932406,"name":"Radio6","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1932407,"name":"TextArea15","text":"Identify the study personnel with a financial conflict of interest.","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1932405,"type":"displayed"}]}]},{"dataId":1801399,"name":"Section9","text":"Reliance Request","label":"3.1","type":"question","dependencies":[{"targetId":1801366,"type":"displayed"}],"children":[{"dataId":1801400,"name":"Label12","text":"This form is made available for researchers at KSU who are collaborating on a project in which there is another IRB who has or will review and act as the IRB of record and are requesting KSU IRB to rely on the review conducted by the other IRB. This includes commercial IRBs who are contracted to review research in which KSU is engaged. (see help text regarding \"engagement\")

Please note: 
*If your project is Exempt: The KSU IRB will normally not enter into reliance agreements for studies we deem exempt. If another IRB wants to provide review for such a study or to rely on KSU IRBs exemption determination, consultation with the IRB Office Director is required.
*If you are the PI on a federally funded multi-site project requiring Single IRB review, please contact the IRB Office Director. 
","required":false,"helpText":"An \"engaged\" institution is one whose agents (faculty, students, or staff) recruit and secure consent from subjects, conduct research procedures, or who receive or share private, identifiable information. This definition parallels the federal definition of research with human subjects. The activities listed need IRB review.

Institutions are not engaged if their employees only:
","label":"","type":"label"},{"dataId":1801403,"name":"TextBox2","text":"Identify the external IRB who has or will review the project","description":"","required":false,"helpText":"","label":"3.1.3","type":"textbox"},{"dataId":1801404,"name":"TextBox1","text":"Provide the name of the PI on the project that has been or will be reviewed by the external IRB.","description":"","required":false,"helpText":"","label":"3.1.4","type":"textbox"},{"dataId":1801405,"name":"TextBox11","text":"Provide the ID # and Study Title on the external IRB submission","description":"","required":false,"helpText":"","label":"3.1.5","type":"textbox"},{"dataId":1801407,"name":"AttachButton17","text":"Attach protocol","required":false,"helpText":"","label":"3.1.7","type":"attachment"},{"dataId":1801408,"name":"AttachButton18","text":"Attach approved recruitment and consent documents","required":false,"helpText":"","label":"3.1.8","type":"attachment"},{"dataId":1801409,"name":"AttachButton19","text":"Institutional Authorization Agreement  and other supporting documents","required":false,"helpText":"An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the Single IRB reviewing. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover another institution.","label":"3.1.9","type":"attachment"}]},{"dataId":1801410,"name":"Section1","text":"Class Projects","label":"1.3","type":"question","dependencies":[{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"},{"targetId":1801364,"type":"displayed"}],"children":[{"dataId":1801411,"name":"Label11","text":"Class projects or assignments involving human subjects are generally conducted for educational purposes or training solely to fulfill a course requirement; as such, an element of the definition of research - the intent to develop or contribute to generalizable knowledge - is missing.  For this reason, these activities often do not meet the regulatory definition of research.  Projects that do not meet the regulatory definition of research do not fall within the purview of the IRB and do not require IRB review.  Student class projects or assignments that that are conducted solely for training or educational purposes to fulfill a course requirement and are not intended to develop or contribute to generalizable knowledge can be excluded from the requirement to submit an Institutional Review Board (IRB) application for review and approval; however, there are specific parameters listed below that must be reviewed and followed to confirm exclusion from review.

If a class project or activity is a systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge (outside of the classroom), it meets the definition of research and will require IRB review and approval.

Thesis and dissertation projects are typically conducted to develop or contribute to generalizable knowledge and, therefore, meet the definition of research. If these projects involve human subjects (including identifiable written material or samples removed from human subjects), IRB review and approval will be required. Visit IRB Review Classifications for additional information on what types of projects need to be submitted or email us at irb@kennesaw.edu to discuss.
","required":false,"helpText":"","label":"","type":"label"},{"dataId":1801412,"name":"Group15","text":"Is this a Class Project?","description":"","required":false,"helpText":"If this is a Class Project, please choose \"yes\" to determine if it requires IRB review.","compoundType":"radio","label":"1.3.1","type":"question","children":[{"dataId":1801413,"name":"Radio7","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1801414,"name":"Label3","text":"Please complete the Determination of Human Research worksheet found on the next page to determine whether your project requires IRB review. ","required":false,"helpText":"If you have already spoken with the IRB Office and have been advised to submit your class project for review, you are not required to complete the Determination of Human Research worksheet. ","label":"","type":"label","dependencies":[{"targetId":1801413,"type":"displayed"}]}]},{"dataId":1801415,"name":"Radio19","text":"No","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":1801416,"name":"Section8","text":"Determination of Human Subjects Research","label":"2.1","type":"question","dependencies":[{"targetId":1801365,"type":"displayed"},{"targetId":1801413,"type":"displayed"}],"children":[{"dataId":1801417,"name":"Label2","text":"This is a guide to help investigators determine if their project is considered human subjects research as defined by the Department of Health and Human Services (DHHS).
","required":false,"helpText":"","label":"","type":"label"},{"dataId":1801418,"name":"Label15","text":"Is this Research?
HHS regulations define research at 45 CFR 46.102(d) as follows: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.","required":false,"helpText":"","label":"","type":"label"},{"dataId":1801419,"name":"Group19","text":"Is the proposed activity a systematic investigation?
","description":"A systematic investigation is an activity that involves research development, data collection, analysis, and evaluation to answer a question.","required":false,"helpText":"","compoundType":"radio","label":"2.1.1","type":"question","children":[{"dataId":1801420,"name":"Radio20","text":"Yes ","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1801421,"name":"Radio21","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1801422,"name":"Group20","text":"Will conclusions contribute to generalizable knowledge?
","description":"Generalizable knowledge is when knowledge gained is applicable outside of the local research context/entity. (CE, course/ internal program evaluations, many QA/QI programs, course requirements, or classroom exercises do not usually qualify as contributing to generalizable knowledge.)","required":false,"helpText":"","compoundType":"radio","label":"2.1.2","type":"question","children":[{"dataId":1801423,"name":"Radio22","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1801424,"name":"Radio23","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1801425,"name":"Label5","text":"**If you answered \"No\" to either of these questions, STOP here, do not submit to the IRB. Please delete this submission and the study. You are not doing human subjects research according to the federal definition (see above) and thus do not require the oversight of the IRB.","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1801421,"type":"displayed"},{"targetId":1801424,"type":"displayed"}]},{"dataId":1801426,"name":"Label16","text":"Does the proposed activity involve Human Subjects?
HHS regulations define human subject at 45 CFR 46.102(f): A living individual about whom an investigator (whether professional or student) conducting research (refer to definition above) obtains data through intervention or interaction with the individual, or identifiable private information.

Data which describe organizational dynamics, external trends, environmental factors or other non-human factors, even if collected from humans, does not itself constitute human subjects research, unless primarily opinion-based.
\"About whom\"= the information being elicited for the research is about the [living] individual (the \"Whom\"). The focus of the investigation is the opinions, characteristics, or behavior of the individual(s).","required":false,"helpText":"","label":"","type":"label"},{"dataId":1801427,"name":"Group21","text":"Will you collect data through intervention or interaction with an individual, including interviews, surveys, physical procedures manipulations of the subject's environment, and any other direct contact or communication with the subject (regardless of whether resulting data is identifiable or not)?","description":"Intervention: Includes both physical procedures by which data are gathered, and manipulations of the subject or subject?s
environment performed for research purposes.
Interaction: Communication or interpersonal contact between investigator and subject.
","required":false,"helpText":"","compoundType":"radio","label":"2.1.4","type":"question","children":[{"dataId":1801428,"name":"Radio24","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1801429,"name":"Radio25","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1801430,"name":"Group22","text":"Will you obtain, view or otherwise handle any private information which identifies individual subject(s) through the use of either direct identifiers (name, address, etc.), or indirect identifiers in the form of a code that links back to the identity of subject through an existing key?","description":"Private information includes (but is not limited to): Medical records and charts, specimens, data or tissue repositories,  Employment or educational records, and observations of behavior which the subject could reasonably expect no observation to be taking place, personal thoughts, feelings, opinions, attitudes, beliefs, etc.
Direct identifiers include (but not limited to) name, street address, audio/ video-recordings, telephone, fax, email, SSN, medical record # (other potential identifiers evaluated on a case by case basis) **If codes & key exist: check \"N\" here, and submit official correspondence from the holder of the key which states that researcher will not be given access to the key under any circumstances.","required":false,"helpText":"","compoundType":"radio","label":"2.1.5","type":"question","children":[{"dataId":1801431,"name":"Radio26","text":"Yes","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1801432,"name":"Radio27","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1801433,"name":"Label8","text":"**If you answered \"No\" to both of these questions, STOP here, do not submit to the IRB. Please delete this submission and the study. You are not doing human subjects research. ","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1801429,"type":"displayed"},{"targetId":1801432,"type":"displayed"}]},{"dataId":1801434,"name":"Label9","text":"If you answered \"Yes\" to either of these questions, you are doing human subjects research.  Please navigate to the next page and proceed to complete the Initial IRB Review Request Form","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"}]},{"dataId":1801435,"name":"Group23","text":"If you are requesting verification from the IRB, please complete the questions below.","description":"","required":false,"helpText":"","compoundType":"radio","label":"2.1.6","type":"question"},{"dataId":1801438,"name":"TextArea1","text":"Provide a 3-5 sentence, clear summary of the proposed activity. Please include the purpose and aims of the activity.","description":"","required":false,"helpText":"","label":"2.1.7","type":"textarea"},{"dataId":1801439,"name":"TextArea2","text":"Briefly describe all activities that will be performed by or conducted under the supervision of the KSU faculty, staff, or students.","description":"","required":false,"helpText":"","label":"2.1.8","type":"textarea"},{"dataId":1801440,"name":"TextArea3","text":"Briefly describe or list all study procedures to be conducted related to study subjects (i.e., screening, recruitment, consenting, enrollment, procedures, etc.), types of data being collected, anonymous/identifiable information, and how you will be obtaining data from or about study subjects
","description":"","required":false,"helpText":"","label":"2.1.9","type":"textarea","children":[{"dataId":1801441,"name":"AttachButton22","text":"attach any survey, interview, or focus group questions, if applicable","required":false,"helpText":"","label":"2.1.10","type":"attachment"}]},{"dataId":1801442,"name":"Label14","text":"Click \"Complete Submission\" now in the left-hand panel to request determination from the IRB.  

If, based on your responses, you have concluded that this is human subjects research, navigate to the next page and proceed to complete the rest of the submission. ","required":false,"helpText":"","label":"","type":"label"}]},{"dataId":1801448,"name":"Section2","text":"Research Design","label":"1.5","type":"question","dependencies":[{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"},{"targetId":1801364,"type":"displayed"}],"children":[{"dataId":1801449,"name":"Group2","text":"Level of Review","description":"","required":false,"helpText":"","compoundType":"checkbox","label":"1.5.1","type":"question","children":[{"dataId":1801450,"name":"CheckBox1","text":"Exempt","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":1801451,"name":"Group5","text":"Exempt human subjects research is a subset of minimal risk research involving human subjects that does not require approval by an IRB; however, it does require a review and a final determination by a member of the Human Research Protection Program.  The IRB Office is responsible for reviewing and granting all determinations of Exempt human subjects research.  

*NOTE: Research involving prisoners cannot be Exempt
*NOTE: Limited IRB Review is conducted for Exempt Category 2 (iii), 3 (iii), and 4(iii);
*NOTE: KSU does not enter into IRB Authorization Agreements (IAAs) for Exempt research.

","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","dependencies":[{"targetId":1801450,"type":"displayed"}],"children":[{"dataId":1801452,"name":"CheckBox8","text":"Category 1 - Education research
Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801453,"name":"CheckBox9","text":"Category 2  - Surveys, Interviews, Educational Tests, and Observations of Public Behavior 
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 46.111(a)(7).

*Applies to studies that collect data using one or more of the following research methods ONLY:
Surveys; Interviews (including cognitive interviews); Focus groups; Educational tests (e.g., cognitive, diagnostic, aptitude, achievement); Observation of public behavior (i.e., behavior that occurs in a public place where there is no expectation of privacy and where no special permission is required to observe others such as a public venue)

*What's NOT allowed: Interventions, collection of bio-specimens, research with children 

*NOTE: Limited IRB Review is required for Exempt 2(iii), when sensitive identifiable data are collected, to ensure that adequate protections are in place to protect subject privacy and the confidentiality of data. This means that the IRB must review and approve procedures for data management and security where sensitive information is collected with direct identifiers (e.g., name, address, email, phone number, social security number, student ID, patient ID) OR indirect identifiers, such as a code that can link back to a subject, or data elements that could be combined to readily re-identify a subject (e.g., dates, employment history, etc.).

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801454,"name":"CheckBox10","text":"Category 3 - Benign behavioral interventions
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a Limited IRB review to make the determination required by 46.111(a)(7).

*Examples: Benign behavioral interventions could include having participants play an online game, having them solve puzzles under various environmental conditions, or having them decide how to allocate a nominal amount of cash between themselves and others.

*What's NOT allowed: research with children, deception (unless prior agreement from participants is obtained), physiological data collection methods that touch participants (e.g., EEG; wearable devices; blood pressure monitors)

*NOTE On use of Deception: If the research involves deceiving participants regarding the nature or purposes of the research, this Exemption is not applicable unless the participant consents to the deception. This should occur through a participant being informed through the consent process that there are portions of the study that they will be unaware of or not fully described. Debriefing participants about the nature of the deception is required, unless a waiver is specifically requested and granted.

*NOTE: Limited IRB Review is required for Exempt 3(iii) - when sensitive identifiable data are collected to ensure that adequate protections are in place to protect subject privacy and the confidentiality of data. This means that the IRB must review and approve procedures for data management and security where sensitive information is collected with direct identifiers (e.g., name, address, email, phone number, social security number, student ID, patient ID) OR indirect identifiers, such as a code that can link back to a subject, or data elements that could be combined to readily re-identify a subject (e.g., dates, employment history, etc.).

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801455,"name":"CheckBox11","text":"Category 4 - Secondary Research (Identifiable Private Information/Biospecimens
Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under HIPAA for the purposes of \"health care operations\" or \"research\" as those terms are defined at 45 CFR 164.501, or for \"public health activities and purposes\" as described under 45 CFR 164.512(b). **(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

*What's NOT allowed:  Collection and analysis of protected health information (PHI) and personally identifiable information (PII). If you intend to collect both PHI and PII, the research could not be reviewed under an Exempt category. This study would likely fall under an Expedited Category 5.

*NOTE: Since HIPAA does not apply to biospecimens, Exempt 4(iii) applies only to the secondary use of PHI (which can include information obtained from biospecimens), not the biospecimens themselves.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801456,"name":"CheckBox12","text":"Category 5 - Public Benefit / Service Program Research 
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801457,"name":"CheckBox13","text":"Category 6 - Taste / Food Quality Evaluation & Consumer Acceptance 
","required":false,"helpText":"","label":"","type":"checkbox"}]}]},{"dataId":1801458,"name":"CheckBox2","text":"Expedited","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":1801459,"name":"Group6","text":"","description":"Expedited review is conducted on research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the below categories. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

*The categories apply regardless of the age of subjects, except as noted.
*The standard requirements for informed consent (or its waiver, alteration, or exception) apply.
*The expedited review procedure may not be used for classified research involving human subjects.
*The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

","required":false,"helpText":"","compoundType":"checkbox","label":"","type":"question","dependencies":[{"targetId":1801458,"type":"displayed"}],"children":[{"dataId":1801460,"name":"CheckBox14","text":"Category 1 - Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required; or
(b) Research on medical devices for which (i) an investigational device exemption application (21CFR812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

*NOTE: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801461,"name":"CheckBox15","text":"Category 2 - Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801462,"name":"CheckBox16","text":"Category 3 - Prospective collection of biological specimens for research purposes by noninvasive means.

Examples:
(a) hair and nail clippings in a non-disfiguring manner;
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
(c) permanent teeth if routine patient care indicates a need for extraction;
(d) excreta and external secretions (including sweat);
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue;
(f) placenta removed at delivery;
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
(j) sputum collected after saline mist nebulization.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801463,"name":"CheckBox17","text":"Category 4 - Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.

*NOTE: Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.

Examples:
(a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
(b) weighing or testing sensory acuity;
(c) magnetic resonance imaging;
(d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
(e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801464,"name":"CheckBox18","text":"Category 5 - Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

*NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human research participants. 45 CFR 46.101(b)(4). This category refers only to research that is not exempt.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801465,"name":"CheckBox20","text":"Category 6 - Collection of data from voice, video, digital, or image recordings made for research purposes.

","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801466,"name":"CheckBox21","text":"Category 7 - Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

*NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human research participants. 45 CFR 46.101(b)(2) and (b)(3). This category refers only to research that is not exempt.

","required":false,"helpText":"","label":"","type":"checkbox"}]}]},{"dataId":1801467,"name":"CheckBox7","text":"Full Committee","required":false,"helpText":"","label":"","type":"checkbox"}]},{"dataId":1801468,"name":"TextArea7","text":"Provide background/scientific rationale for the project.","description":"","required":false,"helpText":"","label":"1.5.2","type":"textarea"},{"dataId":1801469,"name":"TextArea8","text":"Describe the objectives/aims of the project.","description":"","required":false,"helpText":"","label":"1.5.3","type":"textarea"},{"dataId":1801470,"name":"Group12","text":"Check all that apply
","description":"","required":false,"helpText":"","compoundType":"checkbox","label":"1.5.4","type":"question","children":[{"dataId":1801471,"name":"CheckBox19","text":"Audio","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801472,"name":"CheckBox22","text":"Video","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801473,"name":"CheckBox23","text":"Medical Records/HIPAA","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801474,"name":"CheckBox25","text":"Educational Records/FERPA","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801475,"name":"CheckBox27","text":"Urine","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":1801476,"name":"TextArea6","text":"","description":"Analysis to be conducted on specimens","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801475,"type":"displayed"}]},{"dataId":1801477,"name":"TextArea4","text":"","description":"When will unused specimens be disposed?","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801475,"type":"displayed"}]}]},{"dataId":1801478,"name":"CheckBox30","text":"Saliva","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":1801479,"name":"TextArea48","text":"","description":"Analysis to be conducted on specimens","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801478,"type":"displayed"}]},{"dataId":1801480,"name":"TextArea5","text":"","description":"When will unused specimens be disposed?","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801478,"type":"displayed"}]}]},{"dataId":1801481,"name":"CheckBox28","text":"Blood","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":1801482,"name":"TextArea41","text":"","description":"Amount of blood to be collected
(if more than one collection occurrence, include the amount of each collection and total)","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801481,"type":"displayed"}]},{"dataId":1801483,"name":"TextArea42","text":"Frequency of blood collection","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801481,"type":"displayed"}]},{"dataId":1801484,"name":"TextArea43","text":"","description":"Method of blood collection","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801481,"type":"displayed"}]},{"dataId":1801485,"name":"TextArea44","text":"","description":"Identify study team who will be involved in collection of blood
(study team who will collect blood should be appropriately trained in the method of blood collection) ","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801481,"type":"displayed"}]},{"dataId":1801486,"name":"TextArea45","text":"","description":"How will the blood be labeled and stored?","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801481,"type":"displayed"}]},{"dataId":1801487,"name":"TextArea46","text":"","description":"Analysis to be conducted on specimens","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801481,"type":"displayed"}]},{"dataId":1801488,"name":"TextArea47","text":"","description":"When will unused specimens be disposed?","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801481,"type":"displayed"}]}]},{"dataId":1801489,"name":"CheckBox29","text":"Other","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":1801490,"name":"TextBox3","text":"","required":false,"helpText":"","label":"","type":"textbox"}]}]},{"dataId":1801491,"name":"Label4","text":"(If you will be collecting biological samples, please contact the KSU Biosafety Office to seek guidance on their requirements https://research.kennesaw.edu/ibc/index.php)","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1801475,"type":"displayed"},{"targetId":1801478,"type":"displayed"},{"targetId":1801481,"type":"displayed"},{"targetId":1801489,"type":"displayed"}]},{"dataId":1801492,"name":"Group13","text":"Will genetic analysis be conducted?","required":false,"helpText":"","compoundType":"radio","label":"1.5.5","type":"question","dependencies":[{"targetId":1801475,"type":"displayed"},{"targetId":1801478,"type":"displayed"},{"targetId":1801481,"type":"displayed"},{"targetId":1801489,"type":"displayed"}],"children":[{"dataId":1801493,"name":"Radio13","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1801494,"name":"TextArea9","text":"Describe the genetic analysis","description":"","required":false,"helpText":"","label":"","type":"textarea","dependencies":[{"targetId":1801493,"type":"displayed"}],"children":[{"dataId":2035396,"name":"Label10","text":"Include in the consent form if genetic or genomic testing is possible:

\"Even without your name or identifiers, genetic information is unique to you. The results of genetic research apply to both you and your family members. Genetic information used improperly to discriminate or support negative stereotypes could cause you or your family distress. We do not know whether future technology will make it possible for someone to trace your genetic information back to you.
There is a federal law called the Genetic Information Nondiscrimination Act (GINA). Generally, GINA makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that GINA does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. It also does not prohibit discrimination on the basis of an already known genetic disease.\"

","required":false,"helpText":"","label":"","type":"label","dependencies":[{"targetId":1801493,"type":"displayed"}]}]}]},{"dataId":1801495,"name":"Radio14","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1801496,"name":"Date3","text":"Tentative study start and end dates","description":"Start Date","required":false,"helpText":"","label":"1.5.6","type":"datepicker"},{"dataId":1801497,"name":"Date4","text":"","description":"End Date","required":false,"helpText":"","label":"","type":"datepicker"},{"dataId":1801498,"name":"TextArea10","text":"Research Methods and  Procedures","description":"Provide a thorough, sequential description of all research procedures, interventions, assessments, and subject activities. Include time commitments for each activity. Describe how information will be captured (e.g. hard copy forms, audio and/or video recordings, note taking, computer task, etc.). Attach data collection forms, surveys, etc. 
","required":false,"helpText":"","label":"1.5.7","type":"textarea","children":[{"dataId":1801499,"name":"AttachButton2","text":"Attach data collection forms, surveys, etc here
Do NOT upload links to surveys or other study materials as links are not static. The IRB requires an actual document to be a permanent part of the file.
","required":false,"helpText":"","label":"1.5.8","type":"attachment"}]},{"dataId":1801500,"name":"TextArea40","text":"External Sites
","description":"Identify any external sites where recruitment or research activities will take place (Leave blank if n/a)

For Multi-Site Research: Detail the responsibilities of each site with regard to protections of participants, such as reporting of findings or adverse events. For research conducted outside of KSU and its affiliates, describe any site-specific regulations or customs affecting the research and any local scientific and/or ethical review requirements.

International research: In addition to describing specific laws, regulations, and customs, also describe researcher safety; data/sample safety, storage, and transfer; relationship with the communities; other information as appropriate.
","required":false,"helpText":"","label":"1.5.9","type":"textarea","children":[{"dataId":1801501,"name":"AttachButton5","text":"Attach letter(s) of authorization/permission provided by the external site","required":false,"helpText":"","label":"1.5.10","type":"attachment"}]},{"dataId":1801502,"name":"TextArea11","text":"Data Analysis","description":"Describe methods and assumptions such as loss to follow-up, as appropriate. Describe arrangements for data analysis. If a project incorporates qualitative rather than quantitative methods, describe qualitative analysis. Describe how the data will be examined and statistically analyzed to answer project objectives. Describe how missing or incomplete information will be handled in analysis.
","required":false,"helpText":"","label":"1.5.11","type":"textarea"}]},{"dataId":1801503,"name":"Section5","text":"Subject Selection","label":"1.6","type":"question","dependencies":[{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"},{"targetId":1801364,"type":"displayed"}],"children":[{"dataId":1801504,"name":"TextArea12","text":"Describe the targeted subject population including age range, gender and other criteria, as relevant
If there are multiple populations involved (e.g., when there are multiple arms for a project, whenever there would be a need for multiple consent forms), please list separately. ","description":"","required":false,"helpText":"","label":"1.6.1","type":"textarea"},{"dataId":1801505,"name":"TextArea13","text":"Inclusion Criteria
If there are multiple populations, please list inclusion criteria for each separately . ","description":"","required":false,"helpText":"Inclusion criteria concern properties of the target population, defining the population to which the study's results should be generalizable. These are the characteristics that prospective participants must have if they wish to join the study. Inclusion criteria may include factors such as type and stage of disease, the subject?s previous treatment history, age, sex, race, ethnicity.","label":"1.6.2","type":"textarea"},{"dataId":1801506,"name":"TextArea14","text":"Exclusion Criteria
If there are multiple populations, list exclusion criteria for each separately . ","description":"","required":false,"helpText":"Exclusion criteria concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. These are the characteristics that disqualify prospective participants from joining a study. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used for assessment of outcomes), or to eliminate factors that may limit the interpretability of study results (e.g., comorbidities). ","label":"1.6.3","type":"textarea"},{"dataId":1801507,"name":"TextBox18","text":"Provide the maximum number of subjects to be enrolled or maximum number of records to be accessed.
If there are multiple populations, please list sample size for each separately. ","description":"
","required":false,"helpText":"","label":"1.6.4","type":"textbox"},{"dataId":1801508,"name":"Group14","text":"Vulnerable Populations

","description":"Check any or all vulnerable populations who will be targeted for research participation, if applicable 

Subjects\tare vulnerable\twhen\tthey\tare\tnot\tconsidered as\tautonomous\tagents\tand/or\ttheir\t voluntariness\tis compromised.
There\tare\ttwo\timportant\ttypes of\tvulnerability:\t
(1)\tDecisional\timpairment,\twhereby\tpotential\tsubjects\tlack\tthe\tcapacity\tto\tmake\tautonomous\tdecisions\t in\ttheir\town\tinterest,\tperhaps\tas\ta\tresult\tof\tundue\tinfluence/inducement
(2)\tSituational/positional\tvulnerability,\twhereby potential\tsubjects may\tbe\tsubject to undue influence or\tcoercion","required":false,"helpText":"Individuals in these groups may be considered potentially vulnerable because they may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.
Four common types of abuses in human research are:
A subject or subject group may be considered vulnerable for one or more vulnerable traits that fall into the following types:
","compoundType":"checkbox","label":"1.6.5","type":"question","children":[{"dataId":1801509,"name":"CheckBox31","text":"Children ","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801510,"name":"CheckBox32","text":"Students ","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801511,"name":"CheckBox33","text":"Employees","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801512,"name":"CheckBox34","text":"Individuals with Cognitive Impairment ","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801513,"name":"CheckBox36","text":"Prisoners","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801514,"name":"CheckBox37","text":"Pregnant Women","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801515,"name":"CheckBox38","text":"Fetuses ","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801516,"name":"CheckBox39","text":"Neonates","required":false,"helpText":"","label":"","type":"checkbox"},{"dataId":1801517,"name":"CheckBox40","text":"Other","required":false,"helpText":"","label":"","type":"checkbox","children":[{"dataId":1801518,"name":"TextBox19","text":"","required":false,"helpText":"","label":"","type":"textbox"}]}]},{"dataId":1801519,"name":"TextArea16","text":"Explain the rationale for using these particular vulnerable populations (Leave blank if n/a)","description":"","required":false,"helpText":"","label":"1.6.6","type":"textarea"},{"dataId":1801520,"name":"TextArea17","text":"Describe the additional protections in place for these groups (Leave blank if n/a)

The cornerstones of vulnerable participant safeguard comprises of comprehensive Informed Consent process, authorized substitute decision makers, addressing privacy and confidentiality concerns, justified benefit versus risk assessments, equitable justice and methods of subject selection.","description":"","required":false,"helpText":"Additional protections include methods to mitigate the nature of the vulnerability.  For example: Students are vulnerable when their instructor conducting research seeks to enroll them as participants due to the nature of the power dynamic between instructor and student.  The students may feel that if they do not participate, their instructor will be upset with them and grade them more harshly, affecting their grade in the course. This represents undue influence. The researcher (instructor) may reduce this potential for undue influence by  proposing a recruitment method in which the instructor has removed him/her/themselves from the process and/or incapable of knowing who has chosen to participate until after the course is completed and grades have been posted. ","label":"1.6.7","type":"textarea"}]},{"dataId":1801521,"name":"Section6","text":"Subject Recruitment ","label":"1.7","type":"question","dependencies":[{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"},{"targetId":1801364,"type":"displayed"}],"children":[{"dataId":1801522,"name":"TextArea18","text":"Compensation (Leave blank if n/a)","description":"If compensation will be offered, describe here. (this includes extra credit that may be offered for student participation)  Include the amount of compensation, method of payment, method of pro-ration if the subject withdraws from the research. If study personnel will be required to collect any information in order to provide the compensation (name, address, email address, SSN), include those details which should also be included in the consent form.
If you will use a drawing/raffle/lottery, please see related guidance https://research.kennesaw.edu/irb/participant-ince...","required":false,"helpText":"","label":"1.7.1","type":"textarea"},{"dataId":1801523,"name":"TextArea19","text":"Recruitment Process","description":"Describe the plan (when, where, how) to identify potential subjects, including database review, if applicable. Describe how the population will be identified, and how initial contact will be made. Provide information regarding access to the population that will allow recruitment of the necessary number of subjects.

Specify if any advertising/recruitment materials will be used, including verbal/electronic announcement of the research. Upload recruitment material(s) as supporting documents with your submission.","required":false,"helpText":"","label":"1.7.2","type":"textarea","children":[{"dataId":1801524,"name":"AttachButton10","text":"Attach all materials related to Subject Recruitment (email templates, flyers, in-person script, social media posting)","description":"","required":false,"helpText":"","label":"1.7.3","type":"attachment"}]},{"dataId":1801525,"name":"TextArea20","text":"Screening Process (Leave blank if n/a)","description":"Describe the screening process (how researchers will confirm that potential subjects meet inclusion/exclusion criteria). Explain what happens with screen failures and any data obtained from screen failures, if applicable.
","required":false,"helpText":"","label":"1.7.4","type":"textarea","children":[{"dataId":1801526,"name":"AttachButton14","text":"Attach screener here, if applicable","description":"","required":false,"helpText":"","label":"1.7.5","type":"attachment"}]}]},{"dataId":1898147,"name":"Section14","text":"Consent","label":"1.10","type":"question","dependencies":[{"targetId":1801364,"type":"displayed"},{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"}],"children":[{"dataId":1898148,"name":"TextArea54","text":"Describe the process (when, where, how) for obtaining informed consent including considerations for privacy. If research involves minors, describe assent process and how parent permission will be obtained. Upload consent/assent/parental permission documents/scripts. If applicable, detail the process to ensure ongoing consent throughout the duration of the project and for ensuring that the subjects understand the research. Describe steps taken to minimize the possibility of coercion or undue influence, the method used for documenting consent, the use of comprehension quizzes, and, if applicable, who might be asked to provide permission or consent on behalf of the subject. If minors who are recruited will turn 18 during the research, provide a process for consenting them as an adult when they turn 18.

Informed Consent FAQs
https://www.hhs.gov/ohrp/regulations-and-policy/gu...


","description":"","required":false,"helpText":"The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject?s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds and documents that informed consent can be waived (45 CFR 46.116(c) or (d)); or (3) the IRB finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings. When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117.

Assent means a minor's (e.g., child, youth, adolescent under the age of 18) affirmative agreement to participate in research (45 CFR 46.402(b)). To assent, the minor must actively demonstrate a continued willingness to participate in the research, and not just comply with participation directions.

Parental Permission in Research involving Children, Focusing on
?Not Reasonably Available?
SACHRP Recommendation, October 17, 2018

1. Parental Permission in Research Involving Children

HHS and FDA regulations for the protection of human subjects (45 CFR Part 46, Subpart D, 21 CFR Part 50 Subpart D) require that when research involves children, the IRB must ensure that ?adequate provisions are made for soliciting the permission of each child?s parents or guardian (46.408 (b); 50.51). The permission in writing of one or both parents is required for the child to participate unless the IRB has waived the requirement for parental permission or a method other than written permission is approved. The responsibility of the institutional review board is to review the research in light of the regulatory requirements and determine the most appropriate category to support approval of the research. An IRB may approve research involving children that falls into one of these three categories: research no greater than minimal risk (46.404, 50.51(a)); research greater than minimal risk but presenting the prospect of direct benefit (46.405, 50.52); or research greater than minimal risk, with no prospect of direct benefit, but likely to yield generalizable knowledge about the underlying condition or disorder (46.406, 50.53). HHS must consult with a panel of experts for review of research that does not fit into one of these three categories but presents the opportunity to understand, prevent or alleviate a serious condition affecting the health or welfare of children (46.407, 50.54).

Once the IRB determines which regulatory provision applies to the research under review, reference is then made to 46.408 and/or 50.55 which sets out the requirements relating to the permission of the parent or guardian. The permission of one parent is sufficient for the first two categories (46.404, 46.405, 50.51,50.52). For research falling under 46.406/50.53, if permission is to be obtained from parents, permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

Both IRBs and investigators have expressed confusion about how the term ?reasonably available? should be applied and interpreted. We start with the premise that determining whether one parent is reasonably available necessarily begins from the assumption that both parents are known and legally competent, and both have legal responsibility for the care and custody of the child.

There exists a broad, varied and inconsistent spectrum of opinion as to what may be considered an appropriate determination whether a parent is or is not reasonably available. Generally, IRBs do not review the circumstances of whether a second parent is reasonably available for each enrolled subject; this is a task for the investigator. The IRB determines the requirement for parental permission at the time of IRB review of the research, based on the regulatory category that is most appropriate to the nature of the research under review and with regard to the entire population of prospective subjects. It is not until the investigator meets the parent (s) and child and discusses the particulars of the research and enrollment that information about the availability of both parents becomes apparent. While the IRB may certainly be consulted by investigators for guidance on a particular situation, it is ultimately the responsibility of the investigator to adequately assess, document and decide whether a parent is not reasonably available given the specific facts and circumstances of each situation, including the level of that second parent?s participation in the life of the child.

When the IRB requires that permission be provided by two parents, and both parents provide permission, there is no issue. The problem arises when both parents are known and competent and have legal responsibility for the child but the permission of the second parent is not obtainable. Here, the absence of permission by a second parent could be because the second parent:

1. does not want to participate in the informed consent process;
2. is not reasonably available; or
3. is reasonably available to provide permission for the child?s participation but is not reasonably available in terms of providing a signature.

In this recommendation, we provide guidelines on how to determine whether a parent is not reasonably available, and on management of situations in which a parent may be reasonably available to provide permission but not reasonably available to provide a signature.

2. OHRP Guidance on Not Reasonably Available

An OHRP Q&A provides the general guidance for permission from parents:

Do both parents need to provide permission for their child to participate in research?

It depends. In general, permission should be obtained from both parents before a child is enrolled in research. However, the Institutional Review Board (IRB) may find that the permission of one parent is sufficient for research to be conducted under 46.404 or 46.405. When research is to be conducted under 46.406 and 46.407 permission must be obtained from both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

Reasonably available is not defined in regulation or regulatory guidance. There are varying IRB interpretations that result in either the ability to more easily enroll children with one parent?s permission or more stringent interpretations that impose more limitations on the ability to enroll children in research. Since subpart D was developed, the concept of reasonably available has been affected by the advent of new forms of communication that can lead to more easily reaching and communicating with a parent who might otherwise not be available for discussion about a child?s participation in research. These methods include, but are not limited to: video-conferencing, e-consent, communication via an app, as well as scanning or faxing documents. These tools enable communication, permission and documentation of consent without requiring a parent to be physically present. That said, not all individuals will have access to these mentioned forms of communications or other appropriate ones not herein listed.

3. Overarching Principles

Families present in a variety of configurations and experiences. Researchers should be sensitive to this variability in making determinations about whether a second parent is ?reasonably available? to consent. In some cases, such as cases of domestic violence or abandonment, it may be inappropriate, or disrespectful to the first parent, to solicit consent from the second parent. Researchers may need to inquire about parental relationships ? including whether two parents live in the home or are otherwise involved in the child?s life (e.g., participates in decisions about health, education, etc., visits regularly, provides financial support) in making their evaluation. In doing so, they must rely on the information provided by one parent.

? When an IRB determines that the permission of both parents, if reasonably available, is required, the permission process with each parent can occur independently, at different times, and by different methods prior to involvement of the child in research.
? When children are in the shared legal custody of two parents or guardians, each parent?s right of decision-making is to be respected. If one parent agrees to be contacted and declines to give permission, in other words affirmatively says no to participation by the child in research, that does not mean the parent is not reasonably available. It means that parent has decided not to provide permission, and that therefore, the child should not be enrolled in the research.

The term reasonably available should be applied both to (1) locating a parent and (2) the mechanism that can be used to secure that parent?s permission. For example, parents may be reasonably available because they have been located; however, there may be no reasonably available mechanism to obtain the second parent?s signature on a permission form.

4. Application of ?Reasonably Available? to Locating a Parent

Overall, if a parent's role in the care of and/or decision-making about the child, even if limited, is such that his or her involvement and location may be readily ascertained, the parent is considered reasonably available and attempts at contact should be pursued. ?Not reasonably available? is not intended to mean that a parent is temporarily unavailable, unless there are specific circumstances where time is of the essence. There are numerous specific situations that could support a determination that a parent is not reasonably available. In general, however, a parent who is not reasonably available is one whose whereabouts are unknown; who should not be contacted because of the nature of the relationship between the parent and child; whom there is no way to reach by phone, mail, email, fax or any type of videoconferencing; or who has not responded to multiple contact attempts. ?Not reasonably available? does not apply to situations when a parent is at work, traveling, not immediately available by electronic means, or living in another state or country, without more to justify the investigator?s inability to reach the parent and seek permission.

Examples of situations when one may reasonably conclude that a parent is not reasonably available could include the following situations:

? The parent is incarcerated and not contactable.
? The parent is on active military duty and not contactable.
? The parent?s whereabouts are unknown.
? The parent is known and contactable but chooses not to be involved in the child?s care.
? The parent is known but, upon inquiry, there is reason to believe that requesting permission would be inconsistent with the parent/child relationship, such as where there is reason to believe there is or has been domestic violence or other situations involving harm to the health or welfare of the child.

5. Application Of ?Reasonably Available? to Documentation of Permission by a Parent

A determination that a parent is ?not reasonably available,? per the regulations, may include circumstances in which a parent is available to participate in the consent process and has given permission for the child?s participation, but is not able to provide a valid signature. A second parent?s inability to provide a signature must not be used as a reason not to involve that parent in the consent process, or as a reason not to respect that parent?s decision. SACHRP recommends that OHRP and FDA produce joint guidance that describes types of documentation that would satisfy the requirements of 45 CFR 46.117 / 21CFR50.27 in addition to the traditional mechanism of physically signing a document. However, SACHRP recommends that a parent?s inability to provide a signature or other accepted form of permission in writing, confirming the decision to permit the child to enroll in the research would be acceptable under the regulations as an application of the ?not reasonably available? criterion, and thus would not require a waiver of documentation of informed consent. This analysis permits recognizing the importance of obtaining permission from both parents if available, without violating 45 CFR Part 46.117(c), which would not allow a waiver of documentation of consent in a situation involving greater than minimal risk research.

","label":"1.10.1","type":"textarea"},{"dataId":1898149,"name":"AttachButton1","text":"Attach consent, minor assent, parental permission here.  Please use templates provided. 
Do NOT upload links to consent forms or other study materials as links are not static. The IRB requires an actual document to be a permanent part of the file.","required":false,"helpText":"","label":"1.10.2","type":"attachment"},{"dataId":2122039,"name":"TextArea22","text":"Non-English Speaking Subjects (Leave blank if n/a)","description":"If target population is non-English speaking, indicate what language(s) is/are the primary language(s) of prospective subjects and will be used by those obtaining informed consent. The informed consent discussion must be conducted in language in which the subject is proficient. If subjects are expected to be non-English speakers, describe the process to ensure that the verbal/written information provided to those subjects (including recruitment materials, surveys, etc.) will be in the appropriate language. All applicable consent forms and project materials should be translated. Include the Translation Certification form with translated documents.","required":false,"helpText":"https://www.hhs.gov/ohrp/regulations-and-policy/gu...

Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented \"in language understandable to the subject\" and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117).

Where informed consent is documented in accordance with §46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them. OPRR strongly encourages the use of this procedure whenever possible.

Alternatively, §46.117(b)(2) permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.

When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document (see sample attached) should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.

At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.

The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.

It is the responsibility of the IRB to determine which of the procedures at §46.117(b) is appropriate for documenting informed consent in protocols that it reviews.
","label":"","type":"textarea","children":[{"dataId":2122040,"name":"AttachButton8","text":"Attach translated versions of all study materials, if applicable","required":false,"helpText":"","label":"","type":"attachment"}]},{"dataId":2122041,"name":"TextArea23","text":"Cognitively Impaired Adults/ Use of a Legally Authorized Representative (LAR) (Leave blank if n/a)","description":"If the target population includes cognitively impaired adults, describe the process (how, who) to determine whether an individual is capable of consent. Describe how the subjects? decisional capacity will be assessed as the project proceeds in order to evaluate any deterioration or improvement in the ability to consent. Describe the process for obtaining assent from the research subjects and consent from the LAR, and how the authority to provide consent will be confirmed.","required":false,"helpText":"Recommendations Regarding Research Involving Individuals with Impaired Decision-making

https://www.hhs.gov/ohrp/sachrp-committee/recommen...
","label":"","type":"textarea"},{"dataId":2122069,"name":"TextArea24","text":"Withdrawals","description":"Describe procedures that will be followed when subjects withdraw during data collection. Describe the process for subjects to withdraw from the project after participation is complete, if applicable. Describe conditions under which the researcher might withdraw a subject from the project. Describe what will happen to data obtained from withdrawn subjects.
","required":false,"helpText":"Withdrawal of Subjects from Research Guidance

https://www.hhs.gov/ohrp/regulations-and-policy/gu...
","label":"","type":"textarea"}]},{"dataId":1898117,"name":"Section13","text":"Consent Waivers","label":"1.9","type":"question","dependencies":[{"targetId":1801458,"type":"displayed"},{"targetId":1801467,"type":"displayed"},{"targetId":1801364,"type":"displayed"},{"targetId":1801431,"type":"displayed"},{"targetId":1801428,"type":"displayed"}],"children":[{"dataId":1898118,"name":"Group24","text":"Are you requesting a Waiver of Documentation of Consent?

A Waiver of Documentation of Consent is used when: 
","required":false,"helpText":"","compoundType":"radio","label":"1.9","type":"question","children":[{"dataId":1898119,"name":"Radio5","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1898121,"name":"Group27","text":"Select one of the following and then provide a rationale explaining why this Waiver of Documentation of Consent will not adversely affect the rights and welfare of the participants. ","required":false,"helpText":"","compoundType":"radio","label":"1.9.1","type":"question","dependencies":[{"targetId":1898119,"type":"displayed"}],"children":[{"dataId":1898122,"name":"Radio39","text":"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 will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern. ","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1898123,"name":"Radio40","text":"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. ","required":false,"helpText":"","label":"","type":"radio"},{"dataId":1898124,"name":"Radio41","text":"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 documentating that inform3ed consent was obtained. ","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1898125,"name":"TextArea49","text":"How will the rights and welfare of participants be protected even though you will not be obtaining documentation of informed consent from the participant?","description":"","required":false,"helpText":"","label":"1.9.3","type":"textarea","dependencies":[{"targetId":1898119,"type":"displayed"}]}]},{"dataId":1898120,"name":"Radio38","text":"No","required":false,"helpText":"","label":"","type":"radio"}]},{"dataId":1898126,"name":"Group28","text":"Are you requesting a Waiver or Alteration of Consent or will you be altering or removing any of the required Elements of Consent?","description":"A Waiver of Consent is used when you will not be obtaining any informed consent from participants. This is a rare occasion, typically used when a signature would normally would be required, but contacting each potential participant would be impactable. Alteration of Consent is applicable if deception or incomplete disclosure is part of the study design. ","required":false,"helpText":"","compoundType":"radio","label":"1.9.4","type":"question","children":[{"dataId":1898127,"name":"Radio42","text":"Yes","required":false,"helpText":"","label":"","type":"radio","children":[{"dataId":1898129,"name":"TextArea50","text":"","description":"Describe how the research involves no more than minimal risk to participants. ","required":false,"helpText":"","label":"1.9.5","type":"textarea","dependencies":[{"targetId":1898127,"type":"displayed"}]},{"dataId":1898130,"name":"TextArea51","text":"","description":"Describe how the research could not practicably be carried out without the waiver or alteration. 

If research involves using identifiable private information or identifiable biospecimens, this rationale should include a description of why the research would not be practicable without access to the identifiable information or biospecimens under a waiver of consent. ","required":false,"helpText":"","label":"1.9.6","type":"textarea","dependencies":[{"targetId":1898127,"type":"displayed"}]},{"dataId":1898131,"name":"TextArea52","text":"","description":"Describe how the waiver or alteration will not adversely affect the rights and welfare of the participants. ","required":false,"helpText":"","label":"1.9.7","type":"textarea","dependencies":[{"targetId":1898127,"type":"displayed"}]},{"dataId":1898132,"name":"TextArea53","text":"","description":"Describe how, whenever appropriate, participants will be provide with additional information after participation. ","required":false,"helpText":"","label":"1.9.8","type":"textarea","dependencies":[{"targetId":1898127,"type":"displayed"}]}]},{"dataId":1898128,"name":"Radio43","text":"No","required":false,"helpText":"","label":"","type":"radio"}]}]},{"dataId":1898166,"name":"Section15","text":"HIPAA","label":"1.11","type":"question","dependencies":[{"targetId":1801364,"type":"displayed"},{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"}],"children":[{"dataId":1898167,"name":"Label13","text":"If your project does not involve the use of PHI, please skip this section
","required":false,"helpText":"","label":"","type":"label"},{"dataId":1898347,"name":"Label25","text":"The HIPAA Privacy Rule (effective since April 14, 2003) introduced standards covering allowable uses and disclosures of health information, including to whom information can be disclosed and under what circumstances protected health information can be shared.

The HIPAA Privacy Rule permits the sharing of health information by healthcare providers, health plans, healthcare clearinghouses, business associates of HIPAA-covered entities, and other entities covered by HIPAA Rules under certain circumstances. In general terms, permitted uses and disclosures are for treatment, payment, or health care operations.

HIPAA authorization is consent obtained from a patient or health plan member that permits a covered entity or business associate to use or disclose PHI to an individual/entity for a purpose that would otherwise not be permitted by the HIPAA Privacy Rule. Without HIPAA authorization, such a use or disclosure of PHI would violate HIPAA Rules and could attract a severe financial penalty and may even be determined to be a criminal act.
","required":false,"helpText":"","label":"","type":"label"},{"dataId":1898287,"name":"Label24","text":"","required":false,"helpText":"","label":"","type":"label"},{"dataId":1898169,"name":"TextArea56","text":"HIPAA Authorization


If you are collecting Protected Health Information (PHI) from a covered entity, include a detailed list of all PHI, including identifiers, to be collected. Provide justification for use of the PHI. If you will you be obtaining HIPAA authorization for access to and/or collection of PHI, indicate whether you will be using a separate HIPAA Authorization form OR a consent document that includes a HIPAA Authorization section .

If you are requesting a waiver of HIPAA or a waiver of HIPAA for recruitment purposes only, indicate so and provide appropriate justification for the waiver.

","required":false,"helpText":"","label":"1.11.1","type":"textarea"},{"dataId":1898173,"name":"AttachButton3","text":"Attach Authorization form here, if applicable.","description":"HIPAA Authorization can be incorporated in the research Informed Consent Document or a separate, stand alone document. The authorization document must be written in plain language to ensure it can be easily understood and as a minimum, must contain the following elements:

Specific and meaningful information, including a description, of the information that will be used or disclosed
Statements must also be included on the HIPAA authorization to notify the individual of:
","required":false,"helpText":"","label":"1.11.2","type":"attachment"},{"dataId":1898286,"name":"Label23","text":"HIPAA Waivers
","required":false,"helpText":"","label":"","type":"label"},{"dataId":1898285,"name":"TextArea59","text":"When PHI is needed for recruitment purposes only, Waiver of the Authorization is not required provided that:
  1. Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research;
  2. No protected health information is to be removed from the covered entity by the researcher in the course of the review; and
  3. The protected health information for which use or access is sought is necessary for the research purposes.

","description":"Provide study specific documentation for each 1-3 if not seeking HIPAA authorization and PHI is used only for activities preparatory to research.  Leave blank if n/a","required":false,"helpText":"","label":"1.11.3","type":"textarea"},{"dataId":1898284,"name":"TextArea58","text":"When PHI will be collected and used for additional research purposes beyond preparation for research, and the requirement for HIPAA Authorization is to be waived or altered, the following criteria must be met:
(A) The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements;
  1. An adequate plan to protect the identifiers from improper use and disclosure;
  2. An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
  3. Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;
(B) The research could not practicably be conducted without the waiver or alteration; and
(C) The research could not practicably be conducted without access to and use of the protected health information.","description":"Provide study specific documentation for each A-C  if HIPAA Authorization will not be obtained or will be altered and PHI will be used for research purposes beyond preparation for research. ","required":false,"helpText":"","label":"1.11.4","type":"textarea"}]},{"dataId":1801543,"name":"Section7","text":"Protection of Subjects","label":"1.8","type":"question","dependencies":[{"targetId":1801428,"type":"displayed"},{"targetId":1801431,"type":"displayed"},{"targetId":1801364,"type":"displayed"}],"children":[{"dataId":1801544,"name":"TextArea28","text":"Risks to Subjects","description":"State any possible psychological, physical, social, economic, or legal risk of harm to subjects including their likelihood and seriousness.

Examples:
","required":false,"helpText":"","label":"1.8.1","type":"textarea"},{"dataId":1801545,"name":"TextArea29","text":"State the plan for preventing or minimizing risk of harm (e.g. screening to assure appropriate selection of subjects, sound research design, appropriate project team training, prompt de-identification of data, safety monitoring and reporting). Include details regarding additional protections for vulnerable populations. Include provisions for psychological or medical attention, if required as a result of research procedures or the means for referral for such services.","description":"","required":false,"helpText":"","label":"1.8.2","type":"textarea"},{"dataId":1801546,"name":"TextArea30","text":"Benefits","description":"Describe the potential direct benefits that individual subjects may experience from taking part in the research. Clearly indicate if there is no direct benefit to participating. 
","required":false,"helpText":"","label":"1.8.3","type":"textarea"},{"dataId":1801547,"name":"TextArea31","text":"Describe the benefits to society that will/may result from this research.","description":"","required":false,"helpText":"","label":"1.8.4","type":"textarea"},{"dataId":1801548,"name":"TextArea32","text":"Privacy","description":"Describe procedures to protect subjects privacy including privacy considerations during recruitment, informed consent, and data collection (such as access to private rooms, closed doors, etc.) Describe the setting in which the subject will be interacting with a researcher. Privacy refers to an individual and their right in controlling the extent, timing, and circumstances of access of others to themselves. Individuals have greater concerns about privacy whenever the requested information is considered to be of a sensitive nature. 
","required":false,"helpText":"","label":"1.8.5","type":"textarea"},{"dataId":1801549,"name":"TextArea35","text":"Data Management","description":"Considerations for securely storing data include:
","required":false,"helpText":"","label":"1.8.6","type":"textarea"},{"dataId":1801550,"name":"TextArea36","text":"If greater than minimal risk, briefly describe the data and safety monitoring for the project and upload supporting documents.
Describe whether researchers have obtained or will apply for a federal Certificate of Confidentiality.
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