RESOURCES AND REQUIRED FORMS
Welcome to the Heartland IRB Resource Hub. Here, you’ll find everything you need to start your submission with confidence.
Before applying for your Heartland IRB review, ensure you have all the required documents prepared and completed. These forms are essential to ensure your submission meets ethical and regulatory standards.
HOW TO USE THIS PAGE
01
Identify Your Needs
Each research project is unique. Review the descriptions below to determine which forms apply to your study.
02
Download & Complete Forms
Click the download button for each applicable form. Fill them out completely and save them for submission.
03
Prepare Additional Documents
Refer to the form details for any supporting documents required, such as a copy of your survey or your curriculum vitae.
04
Certification Assessment
All applicants must complete the Heartland IRB Assessment before submission (If they don’t have proof of completed Human Subject Training not older than 2 years). Don’t worry—you can access it on this page.
05
Seasoned Expertise
After you’ve found what you needed and completed all prior steps, it’s time for submitting your application.
IMPORTANT NOTICE
Our resources are divided
into two key sections:
Mandatory Documents
These are required files that must be completed and submitted for your protocol review.
Bonus Resources
Additional templates and guides designed to simplify your research process.
Mandatory Documents for
Protocol Review
Ensure Compliance and Expedite Your Application
Before applying for a protocol review, make sure to download, complete, and prepare these essential documents. These are required to meet ethical and regulatory standards and ensure a smooth review process.
- Protocol Review FormThe foundation of your application. Use this form to outline your research protocol in detail.Download Protocol-Review-Form.doc
- Criminal Background Check RequirementAnswering these first without looking if you already made the changes so sorry if it gets repetitive.Download Criminal_background_assurance-and-form.doc
- Investigator Review FormProvides critical details about the principal investigator(s).Download Investigator-Review-Form.doc
- Waiver Request for HIPAA AuthorizationFor studies requiring a HIPAA authorization waiver.Download Waiver-Request-for-HIPPA-Authorization.doc
- Request for Project ExtensionExtend the timeline of your approved research project.Download Request-for-Project-Extension.doc
- Request for RevisionsSubmit updates or changes to an already approved study.Download Request-for-Revisions.doc
- Section 14: Research Projects Using Secondary DataRequired for studies using pre-existing data. Ensures compliance with ethical standards for secondary data use.Download Research-Using-Secondary-Data.pdf
When you download and fill out these documents, you
can start your submission process below. If you’ve
already completed this click below to enroll.
Bonus Resources from
Heartland IRB
Templates and Guides to Simplify Your Research
These resources are optional but highly recommended. Use them to enhance your research process, ensure compliance, and save time.
- Consent/Cover Letter Required ElementsLearn the essential elements required for informed consent documents.Download Consent-Cover-Letter-Required-Elements.pdf
- Sample Participant Consent FormA ready-to-use template to guide your participant consent documentation.Download Sample_Participant-Permission_Parent__child.doc
- Formally Closing Your Research Study or Program EvaluationThe final document needed to officially close your study.Download Formally-Closing-Your-Research-Study-or-Evaluation.doc
- Sample School Teacher Consent FormA template to streamline obtaining teacher consent.Download Sample_Permission_ltr_Teacher.doc
- Sample School Administrator Consent FormFor obtaining consent from school administrators in education research settings.Download Sample_Permission_ltr_School_Admin.pdf
Valuable Links
These links lead to information important to human subjects research. We advise you to review these links to update your knowledge of research protocols and considerations critical to research and program evaluation involving human subjects or participants. The links below are here for your convenience.
Human Subject Protection and Ethical Principles
- The Nuremberg Code involves human experimentation ethics developed during the Nuremberg Military Tribunals (OHRP).
- Declaration of Helsinki – Recommendations from the World Medical Association on ethical principles for research involving human subjects.
- Belmont Report – Basic ethical principles involving human subjects in research issued by the National Commission for the Protection of Human Subjects in 1978 (FDA).
- HIPAA regulations
HIRB Assessment
Complete Your Assessment
As stated previously, if you don’t have proof of completed Human Subject Training that’s not older than 2 years, then before submitting your application, you must complete the Heartland IRB Assessment.
This ensures you understand the ethical and regulatory responsibilities of your research. The Assessment is very short and can be completed almost in a single breath.
Note: This Assessment is meant stricly for Principal Investigators to verify their user account. While the proof of Human Subjects training for the team members (other researchers) included in the given project has to be uploaded when submiting the project documentation for review.
Ready to Begin Your
Research Journey?
Heartland IRB is here to guide you every step of the way. Whether it’s your first protocol review or the next in a long line of groundbreaking studies, we’re ready to help you succeed. Let’s protect human subjects and push the boundaries of knowledge together.