Human Research Protections Office (HRPO)
Helpful BRAAN Information
BRAAN Passwords
A feature for notifying all BRAAN users of the date their password will expire has been added to the system. BRAAN passwords expire every 90 days. Upon logging into BRAAN, the date and time your BRAAN password will expire can be found on the Welcome Screen, under your name.
Please make a note of this date, as you will be required to change your password BEFORE it expires. To change your password, simply click on the "Click here to change your password" hyperlink and follow the instructions.
If you have problems using this feature in BRAAN, or if you have issues with your password or login, please contact the SOM help desk at 410-706-3998 or help@som.umaryland.edu for assistance.
BRAAN User's Guide
The HRPO will no longer offer monthly BRAAN Training Sessions effective November 7, 2005. However, we are providing the "BRAAN User's Guide" for you to download and read. This guide is an excellent source of information on maneuvering around in BRAAN, crafting protocol submissions, etc. We encourage new and veteran BRAAN users to download the guide.
Instructions To Investigators For Amendment Submissions:
To help the IRB review protocol amendments other than pure administrative, the amendment form should:
- State what was formerly done and what is being proposed.
- Provide the rationale for the change.
- State what impact the change has on patient safety, (i.e. either positive or negative or no impact).
- State whether the change has an impact on the scientific integrity of the study, (i.e. decreases or increases or no impact).
If necessary, due to space limitation on the Amendment Form, this information can be provided in a separate document as an attachment.
Please note: Federal regulations require that all revisions be approved by the IRB prior to their implementation. Revisions that increase the risk of research participation MUST be approved by the full IRB committee.
Amendment Information
When you create an amendment to an active protocol, the first section you see is the amendment information section. ALL the text input from this section is automatically inserted in the IRB approval letter AND in the IRB minutes. The section has two input fields. Please be sure that the correct reason for the amendment is chosen from the drop-down list. The "description" box should contain a concise summary of the change(s) requested. If many changes are requested, please put at the top of the list those that impact risk or significantly affect study design.
Please be sure that the text that you enter into the "description" box is clear and that there are no grammatical or spelling errors.
Federally Funded Protocols
HHS regulations at 45 CFR 46.103(f) require that an institution with an approved Federal Wide Assurance (FWA) shall certify that each application or proposal for research covered by the assurance has been reviewed and approved by the IRB. Therefore, in accordance with 45 CFR 46.103(f) all research proposals that are federally funded are required to have a copy of the grant application attached in section S of the BRAAN protocol for review and approval.
Adverse Event Reporting
Investigators and sponsors conducting human gene transfer trials will now be able to report adverse events to NIH using a secure electronic interface on the GeMCRIS system.
The NIH and the FDA announced that they have launched a new Genetic Modification Clinical Research Information System (GeMCRIS) - a Web-accessible database on human gene transfer. GeMCRIS, developed collaboratively by the two agencies, is an important new electronic tool to facilitate the reporting and analysis of adverse events on these trials. The new system will improve the government's ability to monitor adverse events in gene transfer research, also known as gene therapy.
With this tool, reports can be submitted instantaneously to the NIH. Investigators and sponsors can save their NIH submission on their own computer and send a copy to the FDA in accordance with 21 CFR 312.32 together with a FDA Form 1571.
How the HRPO Prioritizes the Workload
The HRPO has been receiving frequent inquiries about when something will be approved. Currently, we have 400 items in our inbox to triage, review, respond to and/or approve. The order in which the HRPO prioritizes the workload is (1) renewals, (2) amendments, and (3) new protocols. Business is attended to daily. Please try to limit the number of status inquires regarding your protocol.
If you have a question regarding your protocol, please email the IRB coordinator (analyst) assigned to your study at HRPO@som.umaryland.edu. To find the IRB coordinator (analyst) assigned to your study, please look on the demographic page of your study in BRAAN (the page with the "what would you like to do" question on it).
If you have a question specific to working in BRAAN, please email BRAAN-help@som.umaryland.edu.
Meeting Dates
All protocols submitted through BRAAN are reported out in the meeting minutes of a fully convened IRB, even if the protocol is expedited and not being reviewed at that IRB meeting. Therefore, all protocols will have a meeting date associated with it. If the protocol not fully approved by its assigned meeting date, you will see the meeting date change to allow for approval of the study.
Verification Stamps
The HRPO has received numerous requests for a verification stamp on the HIPAA authorization forms and on recruitment materials. Please note that HIPAA authorization forms and recruitment materials are not required to have a date or verification stamp on them. Since these documents are included in the original IRB proposal, they are considered approved under the IRB's official approval of the "entire submission." HIPAA authorization forms and recruitment materials do not have an expiration date. Therefore, if revisions to either of these documents are required, an amendment must be submitted for review and approval by the IRB prior to its implementation.
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