Application for Approval of Research with Human Participants

Institutional Review Board

Application for Approval of Research with Human Participants

Primary Investigator (PI): Click or tap here to enter text.

PI Phone: Click or tap here to enter text.

PI email: Click or tap here to enter text.

Status of PI: Click or tap to choose an item from the pull-down list.

Supervising Faculty member (if PI is a student): Click or tap here to enter text.

Are there additional researchers? ☐Yes ☐No

Project Title:Click or tap here to enter text.

Research Determination Survey ID#: Click or tap here to enter text.

Proposed initiation date:Click to enter a date. Proposed completion date:Click to enter a date.

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Signature of PI Date Signature of Supervising Faculty Date
(if PI is a student)

My signature above certifies that all statements made in this application are complete and accurate; that if I receive IRB approval for this investigation, I agree to inform the IRB in writing of any emergent problems and to request permission to make any changes in the protocol (with the exception of changes made to eliminate immediate hazards to participants). I agree not to proceed with the investigation until the problems have been resolved or the IRB has reviewed and approved the changes. It is the explicit responsibility of the research and supervising faculty to ensure the wellbeing of human participants.

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Signature of Department Chair Date Signature of Dean Date
The signature(s) above indicate(s) that the Department Chair (if applicable) and Dean have read the research proposal above and support its contents, pending IRB approval.

Checklist

All materials and signatures must be submitted or the IRB application will not be accepted.

Yes No N/A

☐ ☐ Completed IRB Application form, including all signatures

☐ ☐ ☐ Appendix A: Additional Researchers, with all signatures (including all students conducting research)

☐ ☐ ☐ Appendix B: Interinstitutional Research Authorization (for research that has been approved by another IRB)

☐ ☐ ☐ Appendix C: Application for Waiver of Documentation of Informed Consent

☐ ☐ Appendix D: Copy of CITI course completion certificate (faculty/staff or student researcher module)

☐ ☐ Appendix E: Copy of Consent and/or Assent Form (if minors involved)

☐ ☐ Appendix F: Copy of all recruiting materials and screening tools

☐ ☐ ☐ Appendix G: Copy of all instructions(verbal and/or written) to participants, including debriefing explanation after survey is completed

☐ ☐ ☐ Appendix H: Copy of all survey instruments

☐ ☐ ☐ Appendix I: Copy of HIPAA Release Form and/or compliance documentation to other federal regulations (e.g., Department of Defense)

☐ ☐ ☐ Other Appendices: (please describe)

Funding

Name of financial sponsor (if any):

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Intentions for Investigation

Will the data collected during implementation of the study/project be used for: (check all that apply)

☐Dissemination to anexternal audience

☐CCGA Class project for which results will not be disseminated outside the classroom

Application

I. Rationale for study/project and hypothesis

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II. Human Participants involved in the study/project

1. Description of participants (check all that apply):

☐CCGA Employees ☐CCGA Students ☐ Volunteers not affiliated with CCGA

1. Projected number of participants to enroll: Click or tap here to enter text.

1. Description of participant recruitment process: (submit all flyers or scripts in appendix F)

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1. Screening tools used to meet participant enrollment. Please explain in relation to inclusion and exclusion criteria for the study/project: (submit the screening tool in appendix F)

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1. Approximated time involvement of participants: Click or tap here to enter text.
2. Are participants receiving compensation with money, course credit, or any other type of incentive? ☐ Yes ☐No

If yes, describe the incentive process and if the participant will receive compensation if they withdraw from the study/project.

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1. Do your potential participants include any of the following? (Please mark the appropriate column and provide details when requested)

Yes No N/A

a. ☐ ☐ ☐ Infants or children under the age of 7-years old?

b. ☐ ☐ ☐ Participants under the age of 18?

c. ☐ ☐ ☐ Participants under the age of majority? (if research is taking place in a state/country where the age of majority is other than 18)

If yes, specify location: Click or tap here to enter text.

If yes, what is the potential age range of participants? Click to enter text.

d. ☐ ☐ ☐ Individuals or institutionalized patients in which legally informed consent cannot be granted without a guardian (e.g., cognitive or developmental disabilities)?

e. ☐ ☐ ☐ Students enrolled in your own course?

f. ☐ ☐ ☐ Prisoners?

g. ☐ ☐ ☐ Wards of the state?

h. ☐ ☐ ☐ Pregnant women?

i. ☐ ☐ ☐ Older adults/geriatrics (over the age of 65-years old)?

j. ☐ ☐ ☐ Other special (vulnerable) populations? If yes, please specify.

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III. Research Procedures(Checking one of the boxes in this sectionmayresult in full board review)

A.Please check the appropriate box if your procedures involve the following:

Yes No N/A

☐ ☐ ☐ Introducing substance(s) into the body.

☐ ☐ ☐ Activity which could lead to physical discomfort or injury.

☐ ☐ ☐ External application of a device or instrument which could lead to physical discomfort or injury.

☐ ☐ ☐ Use of deception.

☐ ☐ ☐ Other interventions which could lead to distress.

☐ ☐ ☐ Changes to an already existing IRB approved protocol that may increase participant risk.

If you checked “yes” to any procedure that may elevate risk of distress, discomfort, or injury, please describe the course of action that will be used to neutralize the effects.

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B. Describe in concise terms the proposed research protocol. The description should be arranged in chronological order the steps the researcher(s) will take, including recruitment, participant involvement, intervention, proposed time frame, number of participants, confidentiality, measurement instruments, consent and/or waiver of signature of informed consent (attach as an appendix), and any scripts or fliers used during the study.

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C. Specific questions about research procedure(s):(Please mark the appropriate column and provide details when requested)

Yes No N/A

☐ ☐ ☐ 1. Will information be obtained about behavior, economic status, sexual preferences, religious beliefs, or other information that, if made public, may cause damage to participant self-esteem, psyche, or reputation? If yes, provide a description of how confidentiality will be maintained. Include security in the storage of data.

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☐ ☐ ☐ 2. Will any personal or identifying information (i.e. names, phone numbers, addresses, email, place of employment, etc.) be collected from participants at any point during the research? If yes, describe how identifying/personal information will be de-identified, secured, and kept separate from study data to protect anonymity.

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☐ ☐ ☐ 3. Does the research protocol involve a form of deception? If yes, explain why deception is necessary to the study, what the nature of the deception will be, and how debriefing will occur. Provide a copy of the debriefing script (attached as an appendix) and the timeframe in which it will be provided to participants.

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☐ ☐ ☐ 4. Will the researcher or research team allow participants to withdraw from the study after debriefing and remove all responses/results from data obtained through participant involvement? If no, describe the rationale.

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☐ ☐ ☐ 5. Are there prospective participants who might be vulnerable to risk due to the nature of protocol procedures? If yes, discuss the screening process to eliminate those who may be at risk.

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☐ ☐ ☐ 6. Will procedure interventions involve asking questions or viewing material which may induce anxiety or stress? If yes, describe the plan for debriefing and referral to counseling/behavioral health services.

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☐ ☐ ☐ 7. Will study procedures include data collection via questionnaires or interview format? If yes, provide a description of the instrument or interview questions.(Attach all questionnaire items as appendices.)

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☐ ☐ ☐ 8. Will the study use external scientific devices or instruments (e.g., MRI, cardiac monitor, or blood pressure cuff)? If yes, provide a description of all instrument protocols that may affect study participants.

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☐ ☐ ☐ 9. Will the study use any proprietary materials or instruments(e.g., clinical assessments, software, or equipment)? If yes, attach the approved permission(s).

10. Describe the process of obtaining informed consent and, if applicable, assent. Indicate if planning to submit for waiver of signed consent. (Attach all forms used as appendices)

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11. Describe the process for data storage and protection. Indicate how participant data will be destroyed after time allotted following study completion. Who will be in charge of data storage and disposal? Student researchers: specify the faculty or staff who will be responsible for retaining data after leaving CCGA. (Note, the CCGA IRB requires researchers to retain all study data for a minimum of 3 years following study completion/closure).

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12. Describe your emergency plan if an unforeseeable adverse event would occur. Please describe the precautions to be implemented should such an event occur.

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For CCGA IRB Members ONLY:

Application Status:

☐Approved with no changes

☐Approved with the following minor changes:

☐Returned for significant revision (application must be resubmitted).

Application approved as:

☐Exempt☐Limited☐Expedited☐Full

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Signature of CCGA IRB reviewer Date
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Signature of IRB Chair/Vice Chairapproval* Date
*If research requires full board review, the signature of the IRB Chair is required. If the IRB Chair is the submitter, then the IRB Vice-Chair must sign.

*Application adopted from Armstrong Atlantic State/Georgia Southern University with approval

IRB Application for Approval of Research with Human Participants

Appendix A: Additional Researchers

This appendix should only be included if there are multiple researchers, including students. To insert additional signature lines, click on the signature line, then select the plus button that appears on the bottom right.

Names of Additional Researchers / Status / Signatures
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IRB Application for Approval of Research with Human Participants

Appendix B: Interinstitutional Research Authorization

This appendix should be completed for IRB applications that have already been approved by another institution’s IRB.

Revised 7/25/20181

Primary/Originating Institution

Institution Name:

IRB Registration #:

Federal Wide Assurance (FWA) #:

IRB Contact Information:

College of Coastal Georgia

ORG #: IORG0006081

IRB #: IRB00007326

FWA #: FWA00015213

Office of Academic Affairs,

One College Drive,

Brunswick, GA 31520

912-279-5965/

Revised 7/25/20181

The Officials signing below agree that College of Coastal Georgia may rely on the primary institution’s/organization’s designated IRB for review and continued oversight of the human participants research described below: (check one)

☐ This agreement is limited to the following specific protocol(s):

Name of Research Project:Click or tap here to enter text.

Primary IRB Tracking Number:Click or tap here to enter text.

Expiration Date:Click or tap to enter a date.

ATTACH A COPY OF THE IRB APPROVAL LETTER

Name of Principal Investigator: Click or tap here to enter text.

Name of CCGA Investigator(s): (if applicable)

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☐ Other (describe):

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The review performed by the primary institution/organizations designated IRB will meet the human research participants’ protection requirements of the CCGA OHRP-approved FWA. The IRB at the primary institution/organization will follow written procedures for reporting its findings and actions to appropriate officials at CCGA including minutes of meetings that address any process relating to actions required in continuing review of the project. The primary institution remains responsible for ensuring compliance with the IRB’s determinations and with the Terms of its OHRP-approved FWA. This document must be kept on file by both parties and provided to OHRP upon request.

Signature of Primary Institution Signatory Official (IRB Chair):

______Date: ______

Print Full Name: Click or tap here to enter text.

Institutional Title: Click or tap here to enter text.

Signature of CCGA Official for Specific Data (if applicable):

______Date: ______

Print Full Name: Click or tap here to enter text.

Institutional Title: Click or tap here to enter text.

Signature of CCGA FWA Signatory Official:

______Date: ______

Print Full Name and Academic Title: Ms. Kay Hampton, FWA Designee

Institutional Title: Provost and Vice President for Academic Affairs

(Appendix modeled after Georgia Southern University IRB policy and materials)

IRB Application for Approval of Research with Human Participants

Appendix C: Waiver of Documentation of Informed Consent

In accordance with 45 CFR part 46.116-117, this appendix should only be submitted if the PI(s) is/are requesting waiver of documentation of informed consent.

Documentation of consent means that participants are required to sign a consent form, thereby documenting their consent. A Waiver of Documentation of Consent means that the CCGA IRB is waiving the requirement to obtain the participant's signature. Even if this waiver is granted, a process of informed consent must still be in place. The consent form must still contain all the required elements of consent - 46.116>.

Participants must indicate their informed consent by checking a box on paper or on an electronic form.

In order for the CCGA IRB to grant this waiver, your investigation much meet one of the following conditions. Check the appropriate condition and explain why your research/class project meets the condition in the space provided below:

☐ Condition 1- The only record linking the participant and the research/class project would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality. Each participant will be asked whether she/he wants documentation linking the participant with the research, and his/her wishes will govern.

Explanation:

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OR

☐ Condition 2- The research/class project presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. This refers to procedures such as electronic surveys or brief interviews over the telephone or at public events/venues that elicit non-sensitive information.

Explanation:

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Signature of Principal InvestigatorDate

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Signature of Faculty Advisor (if applicable)Date

(Appendix modeled after Georgia Southern University IRB policy materials)

Revised 7/25/20181