Human Research Protections Program Office

Human Research Protections Program Office

Welcome to the USU HRPPO Home Page!

In an effort to keep the USU research community informed of upcoming events and process/policy changes, this page will have a "News" section to keep you current on what is happening, what is changing, and new personnel.  Our contact information is listed below, please do not hesitate to reach out for questions or concerns.  Please bookmark this page!

 

News 

New Drop-in Hours: Tuesdays and Thursdays 1330 - 1500

Limited Services:  The USU HRPPO will have limited services Monday, November 18 through Wednesday, November 20, 2019 for PRIM&R.

Updates on the implementation of the new Common Rule:  The revised Common Rule went into effect on January 21, 2019.  The USU HRPP staff will be standing down on January 9 and 10 to attend a two day meeting on implementing the new regulations.  Once the staff is educated on implementation, more information will be available on how this effects you.  Please continue to refer to this site and the Research Compliance Update for information as it becomes available. Please be advised, these new regulations will affect research teams, especially in the area of exempt research (category changes and additions), research eligible for expedited review (no continuing review required for these), and informed consent (new template, new structure, new elements).

Assistant Vice President for Research Initiatives and Compliance (AVP-RIC)  Dr. Laura Brosch has joined USUHS as the AVP-RIC as of March 4, 2019.  She comes to USU with a deep background in human subjects protection and has been a DoD leader in this area.  She currently serves as the Director for the Office of Research Protections and the Director of the Human Research Protections Office at the United States Army Medical Research and Materiel Command.  Since  beginning her nursing career, Dr. Brosch has been a tireless advocate for high-quality care for recipients of military medicine and a champion for the protection of human subjects in research.  We look forward to her arrival to help advance our USU mission.

Changes in Protocol Submission Processes - Amendments:  Starting January 14, 2019, in order to maintain version control of protocols, research teams will only be allowed to have 1 amendment in process at any given time within eIRB.  Please note, an amendment submission can have multiple changes within it.  For example a single amendment submission could request a personnel change, a change in inclusion criteria, and expanding a follow-up window; there is no need to create three separate amendment submissions for a situation like this.  If you have any questions regarding this change, please don't hesitate to contact us.

Changes in IRB Timelines and Processes

   IRB Meetings:  We have implemented a new process to improve communication with PIs during IRB meetings.  As is currently being done, each team will be given a projected time on the agenda for IRB review. In addition the HRPP staff will text teams when we estimate the review will occur during the meeting.  We anticipate that this commuication will decreas wait times for the teams on the day of the meeting.

   PI responses to reviewer questions prior to IRB meeting:  We are projecting changes in the IRB timeline process by the end of January 2019.  This will not impact submission deadlines for investigators (see IRB meeting schedule here for deadlines).  However we will be adding a formal process to communicate questions from the reviewers to the PIs two days prior to the IRB meeting.  We will ask that PIs respond back to the questions in writing prior to the meeting.  While not required to respond prior to the meeting, we believe this process will help to resolve many of the questions/concerns prior to the formal meeting time.

Multi-site Protocols:  If you are planning a multi-site project that will need review by the IRB and involves DoD or civilian institutions, please let the HRPP staff know as early in the planning process as possible - we are implementing single IRB review at the direction of our Component Office and may need to negotiate a reliance agreement for your study.

 

Hours of Operation: Monday through Friday, 8:00 a.m. to 4:30 p.m.

Office Hours:  Tuesdays and Thursdays, 1:30 pm - 3:00 pm

Main Office Phone Number: 301-319-4730 (direct) and 301-295-3303 (main VPR office) 

 

HRPPO Mission

The Human Research Protections Program Office supports the USU research community conduct human subjects research in accordance with applicable regulatory and ethical standards. The HRPPO operational processes are primarily dedicated, but not limited, to the administrative support and related activities of the USU IRB.

 

Frequently Asked Questions and associated links:

 

Department of Defense and Federal Wide Assurance Information

The USUHS IRB operates under both: 

Department of Defense (DoD) Assurance: P60001

Health and Human Services (HHS) Assurance: FWA00001628