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Clinical Trials And Research

Clinical Trials and Research at Memorial Hospital

Physicians interested in clinical trials at Memorial Hospital: null Listen to the

podcast interview with Debi O'Connor, IRB (.mp3/5:37)

The institutional review board (IRB) at Memorial Hospital updates its policies/procedures and submission forms annually to improve the review of research and protection of human subjects. Please be sure to use the most current version on this site when you prepare to submit research for review. If you have any questions or suggestions about our forms, please call our office at 719-365-5042.

Application for NEW protocol review - FULL BOARD REVIEW (.pdf/56K)
The intent of these forms is to provide the IRB with all required documentation at the point of submission. Please note that there is a check list at the end of the application to ensure your submission packet is complete.

Application for NEW protocol review - Expedited Review (.pdf/92K)
This application is intended for those research projects that are of minimal risk, student research, or those projects that are data collection only.

Conflict of Interest/Disclosure (.pdf/32K)
Every new study must be accompanied by a Conflict of Interest form for each investigator.

Study Summary (.pdf/52K)
All new studies should have a study summary. This gives the IRB at Memorial Hospital an idea of how research will be conducted locally.

Fee Waiver ? Reduction Request (.pdf/32K)
If there is a financial hardship or no funding for the research project, the investigator may fill out the attached form requesting that fees be reduced / waived.

Waiver of HIPAA Authorization (.pdf/92K)
Researchers should use the Memorial Hospital IRB Waiver of Authorization form to request approval of access to Protected Health Information (PHI) for your research project.

Continuing Review Report Form (.pdf/64K)
Per Federal and Memorial policies and procedures, every research project must complete a CR report form and be approved to continue the research. Memorial Hospital reviews research projects every 10 months unless otherwise stated.

Serious Adverse Event Report Form - Local?(.pdf/40K)
Serious Adverse Event Report Form - External (.pdf/56K)
Federal Regulation 21CFR §56.108 (b) (1) requires the IRB to "follow written procedures for ensuring prompt reporting to the IRB…any unanticipated problems involving risk to human subjects or others."

HIPAA Template (.pdf/32K)
An example of a HIPAA Authorization form that is to be used in conjunction with the patient-informed consent.

Protocol Template (.pdf/28K)
Attached is an example of how to write a research protocol.

Consent Form Template (.pdf/40K)
Attached is an example of how to write a patient informed consent.

Glossary of Terms (.pdf/60K)
Attached is a glossary of terms commonly used in research.