Templates, Forms, and Guidance Documents

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Templates, Forms, and Guidance Documents

HRPO Templates

Research Protocol Submission Template	To be used by TMA staff and whenever non-TMA staff members submit a study that has not already been reviewed and approved by an IRB
TMA Protocol Contact Information Template	To be used for all protocols that are not submitted using the TMA Research Protocol Submission Template
Protocol Modification Request Template	To be used when requesting a modification to a previously approved and still current study.
Protocol Continuing Review Template	All approved studies have a corresponding approval expiration date. If the investigator wishes to continue work beyond that expiration date, then this template must be used to request the continuation
Gatekeeper Template	TMA uses the information provided on this template to identify if the proposed study duplicates efforts already underway within TMA or the MHS
Researcher Responsibilities Form	A standard form that must be signed by each investigator (PI and Associate Investigators) attesting to their understanding of and adherence to the special protections afforded to our beneficiary population

Exempt Determination

Exempt Determination Request Template	Investigators who believe that their studies qualify for one of the exemptions from IRB review found in 32 CFR 219 should use this template to request a determination from the TMA Exempt Determination Officer
Exempt Categories	An excerpt of 32 CRF 219.101(b) that describes the Categories of research that are of minimal risk and do not require IRB review. The investigators conducting these studies must still comply with Common Rule protections

Protocol Submission Guidance Documents

Protocol Submission Guidance Documents	Explains the TMA HRPP requirements for protocol submission for each type of review requested and provides timelines for the reviews
Instructions for Submitting Protocols for Review in IRBNet	Explains in a stepwise fashion the process of submitting studies for TMA HRPP review using the online tool called IRBNet. IRBNet is accessed through Army Knowledge Online (AKO)
Instructions for Obtaining an AKO Account	For individuals outside of the DoD environment who require an AKO account for submitting protocols, this guide provides stepwise instructions for obtaining that account
Instructions for Affiliating with OUSD(P&R)	Protocols to be reviewed by TMA HRPP must be submitted directly to our office. To find our office, investigators must “affiliate” themselves with the OUSD(P&R) in IRBNet. This guide explains that process
HRPO Review Checklist	This should be used to confirm that you have a complete protocol package before submitting it in IRBNet for TMA HRPO review

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