If you have questions or any issues downloading or accessing a form or template, contact us at irbadmin@campbell.edu.
| Title | Use/Description | Form/Templates | Guidance |
| Not-Human Subjects Research Submission | Submit to request a Not-Human Subjects Research Determination | Not Human Subjects (NHSR) Categories | |
| New Protocol Submission | Submit to request new protocol IRB Review for Registration by FLEX, Exempt, Expedited, or Full review. |
New Protocol Electronic Application Form (See Submission Attachment Forms for Research Plan Template) |
New Protocol Submissions (see Research Plan Guidance Document) |
| Amendment Review Submission | Submit to request a change in the previously approved protocol | IRB SOP: Amendment to Approved IRB Protocol | |
| Progress Report Submission | Submit prior to the protocol expiration date to request an extension of the protocol’s expiration date. |
IRB Progress Report Submission Progress Report/Continuing Review Electronic Application Form |
IRB SOP: Continuing Review or Progress Report of IRB Approved Protocols |
| Continuing Review Submission | Submit 45 days prior to protocol expiration to request continuation of previously approved protocols that were determined to require continuing review (i.e., Full Review, some Expedited Review and, if applicable, Exempt-Limited Review) |
Contact the IRB for this form |
IRB SOP: Continuing Review or Progress Report of IRB Approved Protocols |
| Project Closure Submission | Submit 45 days prior to protocol expiration to request previously approved protocols be closed as human subject research activities are complete. Applies to Full Review and Expedited Review IRB approved protocols. | IRB SOP: Closure of IRB Approved Protocol | |
| Reportable Event Submission | Submit to report to the IRB any unanticipated problems or events (e.g., protocol deviations, non-compliance, etc.) |
Reportable Event Submission Form – Non-Compliance, Deviation or Violation |
IRB SOP: Requirements for Reporting to the IRB |
| Undergraduate Classroom Human Subjects Research for Educational Purposes Only | For professors teaching undergraduate classroom research For students conducting undergraduate research projects |
Cover Sheet for Undergraduate Classroom Submission Form Undergraduate Classroom Human Subjects Research Submission Form |
IRB SOP: Undergraduate Classroom Projects for Educational Purposes Only |
| TITLE | USE/DESCRIPTION | FORM/TEMPATES | GUIDANCE |
| Appendix A -HIPAA/Use of Protected Health Information | Use this appendix to your Research Plan when your research involves use of Protected Health Information (PHI) under the HIPAA Privacy Law | Appendix A – HIPAA/ Use of PHI | HIPAA and Human Subjects Research |
| Appendix B – Banking Projects |
Use this appendix to your Research Plan to provide the IRB with information when your research involves banking of information/biospecimens |
Appendix B – Banking Projects | IRB SOP: Banking Projects |
| Appendix C – Research Involving Genetic Information/Tests | Use this appendix to your Research Plan to provide information to the IRB when your research involves genetic information/tests | Appendix C – Genetic Materials/Information/Tests | |
| Research Plan | The Research Plan is a narrative of the project and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted to the IRB | IRB Research Plan Template | Research Plan Guidance |
| Research Personnel |
Include with all new protocol and continuing review submissions Include with amendments when changes to personnel are proposed |
Research Personnel Form | |
| Funding and Sponsorship |
Include this form with a new protocol submission if your project is funded Include with an amendment submission when funding has changes or is being added |
IRB Funding and Sponsorship Form | |
| IRB Investigator Agreement |
Include in all new protocol submission Include with amendments when changes to Principal Investigator is proposed |
IRB Investigator Agreement Form | IRB SOP: Responsibilities for Investigators Conducting Human Subjects Research |
| IRB Authorization Agreement (IAA) Request | Include with new protocol & amendment submissions when Campbell University is deferring IRB review to another institution | IRB Institutional Authorization Agreement Request Form | IRB SOP: Reliance Agreements for Multi-Site Projects |
| Investigator-Attestation for Ceded Projects | Include with new protocol submissions when Campbell University is deferring IRB review to another institution | IRB SOP: Reliance Agreements for Multi-Site Projects | |
| Individual Investigator Agreement (IIA) | Include with new protocol and amendment submissions when a member of the research team is independent and unaffiliated with an institution | IRB Individual Investigator Agreement Request Form-Campbell IRB of Record | IRB SOP: Reliance Agreements for Multi-Site Projects |
| Letters of Support from External Sites | Include with new protocol and amendment submissions when working with or conducting research at non-Campbell sites | Letters of Support from External Sites Guidance | IRB SOP: Reliance Agreements for Multi-Site Projects |
| Data Use Agreement | For use when transferring of identified data | Contact the IRB Office for the appropriate template | |
| Recruitment Email | For use when recruiting participants via email | Recruitment Email Template | |
| Conflict of Interest in Human Subjects Research Disclosure | Include with new protocol and amendment submissions for all project staff members that have a conflict of interest | IRB Conflict of Interest Disclosure Investigator Form | IRB SOP: Conflict Of Interest in Human Subjects Research |
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Title |
Use/Description |
Form/Templates |
Guidance |
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Institutional Consent Form |
For use in minimal risk research that is NOT federally funded or require review under the federal regulations (Registration Projects for FLEX Review). |
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Biomedical Consent Form |
For use in projects involving biomedical research activities and are reviewed under federal regulations. |
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| Multi-Site Biomedical Consent Template | For use in projects when research activities are conducted at multiple sites. | Multi-Site Biomedical Consent Template | Conducting Collaborative or Multi-site Research |
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Social, Behavioral & Educational Consent Template |
For use in projects involving social, behavioral or educational research activities are reviewed under federal regulations |
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Academic Banking Consent Form |
For use in projects with research activities involving banking of student records are reviewed under federal regulations |
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Biomedical Banking Consent Form |
For use in projects with research activities involving banking of health information/biospecimens. |
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Consent/Assent Biomedical Consent Form |
For use in projects that involves biomedical research activities with minors and requires both parental permission and minors (over the age of 14) assent. |
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Consent/Assent Social, Behavioral & Educational Consent Form |
For use in projects that involves S/B/E research activities with minors and requires both parental permission and minors (over the age of 14) assent. |
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Assent Form 7-10 yrs Form |
For use in minors between 7-10 yrs of age, in addition to the Consent/Assent. |
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Assent Form 11-13 yrs. Form |
For use in minors between 11-13 yrs of age, in addition to the Consent/Assent. |
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Verbal Consent Script |
For use when obtaining verbal consent |
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Online Survey Consent Form |
For use when obtaining consent online. |
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| Project Information Sheet | For use when in no greater than minimal risk projects as determined by the IRB. | Project Information Sheet Template | Informed Consent & Waivers of Informed Consent |
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FERPA Consent Form |
For use when obtaining consent sent for access & use of student records. |
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Consent Modules |
For use when appropriate information applies and is required in informed consent. |
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Student Classroom Protect Information/ Permission Sheet |
For use in undergraduate classroom research projects for educational purposes only. |
Student Class Project Information/Permission Sheet Template Form |
IRB SOP: Undergraduate Classroom Projects for Educational Purposes Only |
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HIPAA Authorization Form |
Use this template form to develop a HIPAA Authorization for use or disclosure of protected health information. |
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Translation Declaration Forms |
Use these template forms to provide verification of translations and translator credentials to the IRB when using translated documents |
IRB SOP: Recruitment and Enrollment of Non-English Proficient or Limited-English Proficient Subjects |