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Researcher Materials (Forms & Templates)


HRP-103: Investigator Manual 

This manual outlines the submission process throughout the life cycle of a study and should be referred to when you have questions.


APPLICATION FORMS:

HRP-211 FORM: Initial Review   This form is REQUIRED for a new study submission for IRB review.

HRP-212 FORM: Continuing Review   This form is REQUIRED for all continuing review and final review (closure) submissions.

HRP-213 FORM: Modification   This form is REQUIRED for all modifications/amendments to IRB-approved studies.

HRP-214 FORM: Reportable New Information   This form is REQUIRED for any new information submission to the IRB, such as a report of an unanticipated problem or adverse event.  Refer to page two of the form for specific examples.

A note on HSPP application forms that require a "signature":  There is no requirement to provide a hand-signed, scanned copy on any IRB submission materials.  Your typed name is sufficient for all application materials in the submission process, and the form is associated with your (the Principal Investigator's) unique profile and access in IRBNet.

A note on multiple requests for the same study:  For approved research, a modification request, continuing review, and new information report require separate IRB review processes and different forms.  Modifications and Continuing Review applications must be submitted as separate packages in IRBNet for processing and review.


TEMPLATES:

Templates are tools that may be used to develop materials for your study.  There is no requirement to use these exact formats for your submission.  However, all researchers are encouraged to review the templates for content and language that may be relevant to your research and may be considered during IRB review.

HRP-503a TEMPLATE PROTOCOL: Social-Behavioral   This template can help you build a research protocol that includes information considered by the IRB during the review process.  Your research protocol is the key document in your submission package that should be supported by all supplemental materials.


HRP-502a TEMPLATE CONSENT DOCUMENT: Social-Behavioral   This template can help you draft a consent document for your study and includes the required elements of consent and contact language for the HSPP/IRB.  The template should be adapted to best fit your research and your subject population.

HRP-502b TEMPLATE CONSENT DOCUMENT: Anonymous Survey   This template may be used to develop a simple consent statement that precedes an anonymous survey.

HRP-502c TEMPLATE CONSENT DOCUMENT: Release Form for Images and Recordings   For some studies, a separate release form may be appropriate to gain specific permissions for data collection through photography, video-recording, and/or audio-recording.  This template may be edited to fit your research.  In other studies, the researchers may integrate language and permissions for this type of data collection into their consent form.

HRP-502d TEMPLATE CONSENT DOCUMENT: Assent Templates   This template provides guidance on drafting verbal scripts and/or written assent forms for gaining permission from child participants.

HRP-502e TEMPLATE CONSENT DOCUMENT: Parental Consent   For studies that involve child participants, this template can be used to develop a consent document for parents.

HRP-502f TEMPLATE CONSENT DOCUMENT: Adult Unable to Consent   For studies that involve adult participants who are unable to consent, this template may be used to develop a consent document for legally authorized representatives (LAR).

HRP-507 TEMPLATE CONSENT DOCUMENT: Short Form   A short form is required when gaining consent from subjects who cannot read an English consent form.


 HRP-504 TEMPLATE LETTER: School Permission to Conduct Research   This templates provides example language for permission to conduct research in a school setting.


IRB forms and templates are also available in the IRBNet Library.  Researchers are encouraged to review the HSPP Policies & Procedures and reviewer checklist and worksheets (For Reviewers) for further guidance and relevant information.  All faculty, staff, and students should read MSU Denver's Human Research Protection Plan.

 HRP-430 CHECKLIST: Investigator Quality Improvement Assessment  This checklist can aid researchers in assessing their study documentation and consent information/process for IRB-approved projects.

Please Note:  The IRB website and IRBNet library contains forms and templates most commonly used by MSU Denver investigators, primarily for social-behavioral research.  The HSPP staff can provide you with forms and templates for biomedical research (clinical trials, research with drugs or devices, etc.) if needed.


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