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 |
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| New Protocol Submission | Submit to request new protocol IRB Review for Registration by FLEX, Exempt, Expedited, or Full review. |
(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 | l | |
| Progress Report Submission | Submit prior to the protocol expiration date to request an extension of the protocol’s expiration date. | ||
| 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 |
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| 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. | ||
| Reportable Event Submission | Submit to report to the IRB any unanticipated problems or events (e.g., protocol deviations, non-compliance, etc.) | ||
| Undergraduate Classroom Human Subjects Research for Educational Purposes Only | For professors teaching undergraduate classroom research For students conducting undergraduate research projects |
| 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 | ||
| 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 | ||
| 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 |
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| IRB Authorization Agreement (IAA) Request | Include with new protocol & amendment submissions when 91直播 is deferring IRB review to another institution | ||
| Investigator-Attestation for Ceded Projects | Include with new protocol submissions when 91直播 is deferring IRB review to another institution | ||
| 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 | ||
| Letters of Support from External Sites | Include with new protocol and amendment submissions when working with or conducting research at non-Campbell sites | ||
| Data Use Agreement | For use when transferring of identified data | Contact the IRB Office for the appropriate template | |
| Recruitment Email聽 | For use when recruiting participants via email | ||
| 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 |
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Title |
Use/Description |
Form/Templates |
|---|---|---|
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Institutional Consent for Research 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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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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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. | |
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Student Classroom Project Information/ Permission Sheet |
For use in undergraduate classroom research 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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HIPAA Consent Form |
For use in projects which involve the use of Protected Health Information (PHI). |
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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 |