Research FAQs

Research

Human Subjects

(Answer provided by Dr. Leody Bojanowski, Oct 2017)

Prospective IRB review is required for research involving human subjects or human participants of research. Human subjects research are activities that include both a systematic investigation designed to develop or contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research obtains data from identifiable private information or through intervention or interaction with the individual(s). Human subjects research protocols must be submitted in the iRIS electronic IRB submission System (eIRB) in order for it to be reviewed by the IRB.

Only the Exempt Determination Official (EDO) at USU may make an official determination if a research does not meet the regulatory definition of Human Subjects Research. A Not Human Subjects Research (NHSR) determination can be obtained by submitting an application in the eIRB. Please use the Human Research Decision Charts and refer to the OHRP Guidance link for additional information.

https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html

1.   The Human Research Protections Program (HRPP) Office will accept the submission documents via the eIRB system- iRIS. To access the system, please go to: https://dmrncac.dhhq.health.mil 

2.   Make sure your email address associated with your CAC is current by updating your Enterprise Profile (on the left).

3.   To establish an eIRB account, initiate the request directly from the eIRB web page to apply on-line for a new account. Reference the EIRB Quick Reference- System Access guide for steps on how to request an account as a new user. 

4.   Applicant will receive an email from IRIS (eIRB) contractor requesting a copy of the applicant’s Cybersecurity Training certificate - “Cyber Awareness Challenge”. You can take the training here: https://iatraining.disa.mil/eta/cyberchallenge_v4/launchPage.htm

5.   After receiving the verification of Cybersecurity Training, IRIS contractor will send the USU IRB office an email to verify that applicant is USU billeted or a USU student.

6.   Once verification is done and account is established, the applicant is notified.

The process is generally between 5-10 days. Please note that all new user accounts are created with the role/permissions of "Researcher."

In order for USU to conduct an administrative review of a protocol that was reviewed and approved by an external IRB*, the PI will need to submit a protocol modification in the eIRB to add USU as a participating site. For legacy protocols with only the shell in eIRB, you will need to complete the Protocol Application in order to submit a modification. This means each section must be completed, section by section using the Save and Continue button in the upper left at the end of each section.  Once the Protocol Application is complete, then go into the modification form and select the Protocol Application in section 4.  That will allow you to process the modification to add USUHS as a site.

*This applies only to projects in which there is an existing DoD Institutional Review Board Agreement for IRB Review (IAIR).

Participating sites engaged in human subject research must have a Human Research Protections Program (HRPP) and a federal wide assurance (FWA) and/or a DoD Assurance of Compliance. Consult with the HRPPO staff early in the planning stages because there might already be a DoD Institutional Agreement for IRB Review (IAIR) in place with some sites that are not organizationally or legally part of USU.

Quality Assurance and Research both involve a systematic approach in data collection and analysis. The main difference is in how the results will be used. Quality Assurance, also referred to as "quality improvement" refer to activities that use the results for the improvement of current practices or to determine best practice for implementation at the local level. This type of activity does not require IRB review. IRB approval is required for QA research that results in generalizable knowledge aimed at changing current common perceptions or adding new knowledge across a wider population other than for internal use only. Research related activities are reviewed by the IRB to assess the risk to participants.

Research involving surveys conducted by any DoD Component on members of the public or that REQUIRE participation of personnel from more than one DoD Component must be reviewed and recommended for approval or disapproval by the Washington Headquarters Services, Defense Manpower Data Center’s Research, Surveys, and Statistics Center. The purpose of this review is to comply with the Office of Management and Budget (OMB) guidance on Federal surveys.

The DoD Information Collections Program oversees the management, control, approval processing, and tracking of DoD Internal and Public Information Collections.  For information about the Information Management Control Officer (IMCO) requirements to approve and license with a report control symbol (RCS) DoD internal information collections and approve DoD public information collections, go to: http://www.esd.whs.mil/Directives/collections/resources/

The DHA Privacy Office serves as the main point of contact for data sharing requests, data sharing arrangements with private entities, and research projects. A DSA is requested by submitting a Data Sharing Application Agreement (DSAA) endorsed by both an Applicant and a Government Sponsor (the “requestors”) which must be approved before a DSA will be executed. Once the DSAA is approved it becomes part of the final agreement provided to the requestors.

See link for more information on DSA and the required forms: https://health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application

The USU IRB/HRPP and the USU Office of Research are operationally independent with separate functions. The IRB/HRPP is mainly responsible for the ethical and regulatory review of the research. Human research projects should only be submitted for IRB review once the PI has received approval and recommendation for IRB review from the Office of Research including a fully signed USU Form 3208 or 3202.

All inquiries/requests for agreement assistance start by completing the USU Agreement Request Form online:   https://docs.google.com/a/usuhs.edu/forms/d/e/1FAIpQLSeopQ76mSccLO2w-27RGcnnfaXBcAx77DWUlrKf0wskDxU7CQ/viewform.  

The Agreements office is within Finance located in the main office in Building A. The POCs are jennifer.stecklein@usuhs.edu or helen.hocknell.ctr@usuhs.edu

Anatomical Materials

USU Form 3213 or 3214 should be used for requesting the use of anatomical materials and cadavers for Teaching or Research, respectively.  This form is then submitted to the Regulatory Affairs Administrator (Ms. Melanie Hazzard, melanie.hazzard@usuhs.edu)

Animal Use

No, funding is required before a USU Form 3206 for animal use can be submitted.

 Please contact Finance to ensure your LAM task Line was created successfully. 

This meeting is required.  It must be completed after you have received IACUC approval and before you need to order animals. Please contact MAJ Anna Mullins.

To place an animal order in RATS, you will need to complete the Post Approval Meeting with LAM and have funds available in DAI. 

  https://sites.google.com/a/usuhs.edu/iacuc/forms

To ensure you are using the most up-to-date form, please download each time from the website 

Main Contact

The Office of the Vice President for Research (VPR)

Uniformed Services University of the Health Sciences

Building A, Room A1032

4301 Jones Bridge Road

Bethesda, Maryland 20814

(301) 295-3303

Email Research Office