Approval Process - Human Subject Research

NOTE: The approval process is summarized in HRP 01.05 - Flowchart Guidance on R&D Submissions (not available online).

The University of Maryland Baltimore IRB is the IRB of record for the VAMHCS. The VAMHCS R&D Committee will not consider any protocol or amendment until the protocol or amendment has received IRB approval.

1. Submit materials (new protocols or amendments) to the University of Maryland IRB using the BRAAN system accessed through the Human Research Protections Office (HRPO) website* (https://medschool.umaryland.edu/hrpo/default.asp). Answer the questions and guidelines in BRAAN in order to complete your submission. There is also a BRAAN tutorial available on the BRAAN/HRPO website. See further details in the table below.
   
   
2. After IRB approval has been obtained, submit the protocol or amendment to the VAMHCS R&D Committee. Begin this process by contacting Mary Pope at ext. 7131 or mpope001@umaryland.edu.
   
   
3. The completed submission packet will automatically be sent to the Human Studies Subcommittee of the R&D Committee.
   
   
4. Human Studies Subcommittee will either send the submission to R&D Committee or will send it back to the PI for modifications.
   
   
5. It may also be necessary to submit materials to other VAMHCS Committees (Subcommittee on Research Safety, Hospital Radiation Safety Committee, etc.). You will be told of this when you submit your materials to the R&D Committee.
   
   
6. No protocol or amendment may be initiated at the VAMHCS until it has been approved by the R&D Committee.

Tools and checklists to assist research staff with writing and submitting protocols and informed consent documents are available through the Research Service and the UMB Human Research Protection Office.

A detailed description of the approval process is in Section IV.A. of the Human Research Protection Plan (HRP 01.02).

During the course of a study, it is often necessary to amend the protocol, the informed consent form, the logistical details provided in the BRAAN submission, or other aspects of the study. In this case, investigators must submit a "Modification Request" to both the IRB and the R&D Committee. The IRB and the R&D Committee review and approve modifications in similar fashion to that described for initial submission.

Please note that forms listed below are to be printed and manually completed.

VAMHCS Process for Protocol Approval
IRB Approval (BRAAN)
Requirement	Process / Reason
BRAAN Protocol (electronic submission to the IRB) accessed though: Human Research Protections Office (HRPO) BRAAN Login*	Collects information on the investigators, I/E criteria, requirements for subjects, risk-benefit analysis, justification for the project, description of recruitment and consent processes, study/vulnerable populations, study design & schedule, drugs/devices to be used, advertisements, etc. Subjected to departmental review and the IRB "Deferral Prevention Program" as part of the approval process.
Protocol	Provides committee with greater detail on scientific merit, potential risks to subjects, pre-clinical findings, etc.
Investigators Brochure
Informed Consent Document	Must have all essential elements of Informed Consent and applicable additional elements; BRAAN automatically provides template, including VA format; investigators must use HRPO checklist "General Requirements for Informed Consent" or a similar checklist to confirm that all requirements are in place.
Link to DSMP Worksheet/Forms	Determines level of safety monitoring that will occur and the process of the monitoring; assist the PI in development of the DSMP.
Link to HIPAA worksheet and authorization	HIPAA form is submitted as an attachment; must be submitted unless a waiver is requested.
Amendments (to protocol, to the ICF, to the BRAAN information, etc): There must be IRB approval before R&D will consider an amendment. Must have R&D approval before it can be activated at the VAMHCS.	Submit "Modification Request" to the IRB and R&D committee; forms and process are on HRPO website (IRB) and via the Research Service (R&D Committee). The process is similar to that for submission of new protocols.
R&D Committee Approval (Human Studies Subcommittee and other subcommittee submissions will be done automatically)
Requirement	Process / Reason
Worksheet for Submissions to R&D Committee (Human Studies)	Ensures that all paperwork and sign-offs are provided.
Investigational Device Attestation	Requires the PI to take responsibility for proper training of staff and storage/operation of devices/equipment; protects patient safety by notifying the Research Compliance Officer of research-related devices, equipment and procedures to be used in studies (even if they are not investigational), arrangements for storage & dispensing, training of staff, etc.
Attestation for the Use of Equipment in the Conduct of a Research Study	Required R&D form for equipment
Attestation for the Performance of Procedures in the Conduct of a Research Study	Required R&D form for performing procedures
Training, Licensing & Credentials	Credentials and documentation of required trainings may need to be submitted by PI if not already on record in the Research Service Office
Confirmation of Required Trainings of Research Staff	Validates staff training is current; required for R&D submission
Data Security Packet	Data Security Plan Data Security Checklist for PIs (VA) PI's Certification: Storage & Security of VA Research Information (VA)
Clinical Research Hazards Screening Form
Amendments (to protocol, to the ICF, to the BRAAN information, etc): There must be IRB approval before R&D will consider an amendment. Must have R&D approval before it can be activated at the VAMHCS.	Submit "Modification Request" to the IRB and R&D committee; forms and process are on the HRPO website (IRB) and via the Research Service (R&D Committee). The process is similar to that for submission of new protocols.

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