IRB/Ethics and Project Proposal Forms and Instructions

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    Instructions and Information    - FAQ

    Required Forms

    Forms for Use in Ongoing Projects

    Policies

IMPORTANT: Applications to be made to the Institutional Review Board must include a completed Project Proposal form, an IRB Application, and an Informed Consent document. Prior to submission to the IRB, this material must be sent to the Human Protections Administrator (HPA) for determination whether the research is exempt from IRB consideration. A copy of the HPA Certification Form and the IRB Exemption Request form should be submitted to the Human Protections Administrator with all IRB applications material. If you believe your research is not exempt, you do not need to complete and submit the IRB Exemption Form, but should still include the HPA Certification Form with the material you submit to the HPA.

        Required Forms

• New Project Proposal Template
This template may be used as a guideline whenever you develop a new project that will be submitted to the PCCR research council for evaluation of scientific merit prior to applying to the IRB, or for a practicum project that will be submitted to your committee for approval

• IRB Application Form
This form is to be used when preparing your application to the IRB for evaluation of human protection in your approved research project.

• Informed Consent Template
This is a model template for developing your informed consent document. It provides the general framework for a consent document, and it includes a set of tips for each section of the document.

• HPA Certification Form
Please note: All research proposals must be submitted to the Human Protections Administrator for initial ethics consideration. Please use the accompanying form as the cover page to your submitted proposal

• IRB Exemption Request
If you believe your project is exempt from full IRB review, please complete this form and submit it to the Human Protections Administrator. This document explains the circumstances under which your research may be exempt from review by the IRB.


        Instructions and Information

• IRB Application Instructions
These instructions provide detailed guidance on how to complete the application to the Institutional Review Board.

• IRB Application Checklist
This documents the series of steps you need to follow to make sure your project is approved for merit and is then submitted for ethics review.

• IRB Frequently Asked Questions
This set of pages discusses what constitutes human subject research, what is required in an IRB review and what you can expect to occur when you submit your application for review. You will find answers to many question about the IRB process in these three pages.

• Informed Consent Checklist
This checklist provides you with a set of criteria to ensure that you included all the necessary information in your informed consent document, which is part of your IRB application.

• Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO)                     This provides information on new federal rules regarding reporting unanticipated risks for participants in research studies or for others involved in those studies. This is in addition to requirements for reporting adverse events.
       

        Forms for Use in Ongoing Projects

• IRB Adverse Event Form
This is an example of a form that is to be used for reporting any adverse event that takes place during human subjects research. You will need to prepare such a form as part of your IRB application and as part of your research plan.

• IRB Progress Report
All projects must undergo IRB re-review on an annual basis. This form is to be completed at that time.


        Policies

• PCC Policy for Protection of Human Subjects
This is the policy used by Palmer College of Chiropractic pertaining to the use of human subjects in research. It is recommended that you read this prior to initiating any research involving humans and that you become conversant with its stipulations.

• PCCR Policy Handbook
This handbook provides information on all policies in effect in the Palmer Center for Chiropractic Research.

• OHRP Website: http://www.hhs.gov/ohrp
This links you to the United States Office of Human Research Protections. On this site, you will find links to a significant amount of information addressing human subject research, including material about IRBs, educational resources, reports and more. We recommend you spend time perusing the information contained here.

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