Forms & Consent Templates

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 Research Form

New Protocol Electronic Application Form

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 Submission Form

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

Amendment (AME) Submission Form

Amendment Electronic Application Form

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.

Closure Submission Form

Closure Electronic Application Form

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

Reportable Event Submission Form – All-Other Types

Reportable Event Electronic Application Form

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 IRB 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 IRB SOP: Requirements and Qualifications to Serve as a Principal Investigator
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 Investigator Attestation for Ceded Projects Form

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

IRB SOP: Advertisements

IRB SOP: Recruitment Methods

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