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

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
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
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 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  
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
Research Personnel

Include with all new protocol and continuing review submissions

Include with amendments when changes to personnel are proposed

  
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 Authorization Agreement (IAA) Request Include with new protocol & amendment submissions when 橙子影院 is deferring IRB review to another institution
Investigator-Attestation for Ceded Projects Include with new protocol submissions when 橙子影院 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听 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

Title

Use/Description

Form/Templates

Guidance

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).

Biomedical Consent Form

For use in projects involving biomedical research activities and are reviewed under federal regulations.

Multi-Site Biomedical Consent Template For use in projects when research activities are conducted at multiple sites.

Social, Behavioral & Educational听Consent Template

For use in projects involving social, behavioral or educational research activities are reviewed under federal regulations听

Academic Banking Consent Form

For use in projects with research activities involving banking of student records are reviewed under federal regulations

Biomedical Banking Consent Form

For use in projects with research activities involving banking of health information/biospecimens.

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.

 

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.

Assent Form 7-10 yrs Form

For use in minors between 7-10 yrs of age, in addition to the Consent/Assent.

Assent Form 11-13 yrs. Form

For use in minors between 11-13 yrs of age, in addition to the Consent/Assent.

Verbal Consent Script

For use when obtaining verbal consent

Online Survey Consent Form

For use when obtaining consent online.

Project Information Sheet For use when in no greater than minimal risk projects as determined by the IRB.

FERPA Consent Form

For use when obtaining consent sent for access & use of student records.

Consent Modules

For use when appropriate information applies and is required in informed consent.

听

Student Classroom Protect Information/

Permission Sheet

For use in undergraduate classroom research projects for educational purposes only.

HIPAA Authorization Form

Use this template form to develop a HIPAA Authorization for use or disclosure of protected health information.

Translation Declaration Forms

Use these template forms to provide verification of translations and translator credentials to the IRB when using translated documents