Institutional Review Board
The St. David’s HealthCare Institutional Review Board (SDH IRB) provides ethical overisght for all research activities at St. David’s HealthCare facilities in Austin and hospitals within the Central & West Texas Division of HCA. The jurisdiction of SDH IRB shall include the following:
- All research involving St. David’s HealthCare hospitals or stand-alone medical centers, and research involving hospitals in the Central and West Texas Division of HCA.
- All research involving or conducted by St. David’s HealthCare employees.
- All research involving or conducted by providers (MDs, DOs, RNs, NPs, APNs, etc.) who are members of St. David’s HealthCare medical staff.
The IRB can provide oversight to hospital or clinic-based research studies. If you are outside of the jurisdiction of the IRB, please contact the Office of Research before submitting your study.
The SDH IRB uses IRBNet (www.irbnet.org) for managing all study submissions, ongoing reviews and actions, and all correspondance with Investigators. It is free for researchers to create an account and submit/manage studies. Please use the link to the right to get started. Registration instructions for using IRBNet to manage your studies are available in the document library below.
Submit New Study
Understanding the timeline and status of your proposed and ongoing research projects is of key importance to the Office of Research. The IRB meetings usually take place on the second Wednesday of each month. New study submissions must be submitted to the IRB via IRBNet at least two weeks prior to the Board meeting. See our calendar on the home page to view to current deadlines.
Board action documents for new research studies will usually be provided no longer than one week after the meeting. For expedited review of study documents, the Board action documents will generally be provided within three business days of submission.
Please log into IRBNet to access the complete forms library at www.irbnet.org. All of the current forms for both St. David’s HealthCare Institutional Review Board and St. David’s Division Research Council can be found there. Forms should be submitted to the IRBNet once completed in order to obtain IRB review.
Below are some of the most commonly requested documents for SDH IRB:
- IRBNet Energizers (Step-by-Step Submission Instructions) [Part 1] [Part 2]
- IRB Net Manual
- IRB Roster
- SDH IRB SOP Manual
- Fee Schedule
- Protocol Template [DOCX]
- Informed Consent Form Template [DOC]
- Exempt Determination Form [DOC]
- Chart Review Template [DOC]
Forms should be submitted to the IRB through our web portal at www.irbnet.org. If you have questions about which forms to use, please give us a call at 512-544-2626.
How do I sign-up (“register”) to use IRBNet?
You must create a free, new-user account before using IRBNet. Register by clicking on “New User Registration”
at the top right corner of the IRBNet website. When the IRBNet asks your site affiliation, choose “St. David’s HealthCare.” This will ensure that your submission goes to the St. David’s HealthCare IRB and will also give you access to our IRB forms.
Why can’t I see my studies in IRBNet?
If you have registered for a profile in IRBNet, next you will need to log in and affiliate with St. David’s HealthCare as an institution. For existing studies that have already been approved by the IRB, you will need to ask someone at your research facility who has access to IRBNet to share or transfer the appropriate projects with you. If this is a new study that has not yet been approved, you will want to choose the “Create Project” button on the left so you can begin the submission process. If you have any questions, please give us a call and we can walk you through the process.
Where can I find your submission forms?
Once you have registered for a profile in IRBNet, you will log into IRBNet and click on the button on the left side of the page labeled “Forms Library.” Here, you should be able to see all of our submission forms and you can click on the links to download.
Why can’t I submit to the St. David’s HealthCare IRB?
Once you have registered, you need to affiliate your account with St. David’s HealthCare.
How do I do a Chart Review Study?
See our Guidance Doc for Chart Review Studies.
Is my study exempt ?
Please create an account on www.irbnet.org and download our Exempt Determination Form (see Forms section above). You can follow the algorithm on the form to understand whether your study is Exempt or not. You can also look at the easy-to-follow flowchart provided by OHRP on their website. Please see Chart 02 at their website here. You should submit the form via IRBNet once completed in order to obtain IRB review.
What are your deadlines?
The deadline for submissions to be reviewed at full board meetings is two weeks prior to the meeting. SDH IRB generally meets the second Wednesday of each month.
What are your turnaround times?
For new studies, you can expect to receive your decision documents within approximately five business days of the board meeting. For other items that are reviewed by the full
board (i.e., Continuing Review Site Reports), you should receive documents within approximately three business days. Turnaround time for all other items is typically three business days from the date your submission was complete in IRBNet. If you need
a special accommodation, such as if a subject is waiting on the information, please let us know and we will do our best to meet your needs.
Where can I find your roster?
Please see the link to our Membership Roster listed above under the Document Library section.
Where can I find the current version of the informed consent form?
You should be able to find the currently approved consent form in IRBNet, which can be viewed at www.irbnet.org. When viewing packages in IRBNet, look for the most recent package first and then move backwards until you find it. Since all revisions to the consent form must be marked in Track Changes, you will want to be certain that you have the locked Word version of the informed consent form that was most recently approved by the Board. If you are uncertain, please send us a quick email and we can ensure that you have the correct one.
How do I submit a Continuing Review Submission?
Please log into IRBNet, www.irbnet.org, and click on the button on the left labeled “My Projects.”
Choose the appropriate study from the list. After you click on the study, you will be directed to a new page with all of the information about the project. Next, you will click on the “Create Project” button on the left side of the screen. Here, you will
be able to download and complete the “Site Report Form.” Once complete, please upload the form, then use the buttons on the left side of the screen to sign and then submit the project. Once you submit the project, we will receive a notification that the
documents are ready for review. If you are unsure if we received it, please feel free to follow up by email or phone.
How do I submit revisions to a currently approved study (such as protocol amendments, revised drug/device information, new or revised consent forms, ads, etc.)?
Please log into IRBNet, www.irbnet.org, and click on the button on the left labeled “My Projects.” Choose the appropriate study from the list. After you click on the study, you will be directed to a new page with all of the information about
the project. Next, you will click on the “Create Project” button on the left side of the screen. Here, you will be able to download and complete the “Document Review Form.” This form will help you to determine what attachments need to be submitted. Once
complete, upload the form along with all required attachments, then use the buttons on the left side of the screen to sign and then to submit the project. Once you submit the project, we will receive a notification that the documents are ready for review.
If you are unsure if we received it, please feel free to follow up by email or phone.
How do I submit a Final Close-out Report?
Please log into IRBNet, www.irbnet.org, and click on the button on the left labeled “My Projects.”
Choose the appropriate study from the list. After you click on the study, you will be directed to a new page with all of the information about the project. Next, you will click on the button labeled “Create Project” on the left side of the screen. Here,
you will be able to download and complete the “Site Report Form.” Once complete, please upload the form, then use the buttons on the left side of the screen to sign and then to submit the project. Once you submit the project, we will receive a notification
that the documents are ready for review. If you are unsure if we received it, please feel free to follow up by email or phone.
How much does IRB review cost?
This depends on whether or not the study is funded. Typically, fees are less costly if the study is not funded. Access our fees by clicking here.
Do advertisements need to be approved prior to use?
Yes! All advertisements must be submitted to SDH IRB for review and approval prior to use. If you are unsure about what types of items must be reviewed, please
send them to us via email and we can preview your documents to assist in making this determination and ensure compliance.
Do questionnaires or other materials to be given to study subjects need to be approved prior to use?
Typically, any documents that will be seen or heard by subjects should be submitted to SDH IRB for review
and approval prior to use. However, if your questionnaires are widely used and are standard in the industry (such as DSM-V), you do not need to submit them for approval. If you are unsure about what types of items must be reviewed, please send them to
us via email and we can preview your documents to assist you in making this determination to ensure compliance.
Where should I send my payment for IRB review services?
Please make checks payable to “St. David’s HealthCare Partnership, LP, LLP.” Payments should be mailed to: St. David’s HealthCare Institutional Review Board, 919 East 32nd Street, Austin, TX 78705.
Research Policies and Procedures
Patient safety is our top priority. The Office of Research can help to ensure that you are compliant with all of the regulatory requirements associated with clinical research. The Office of Research can help coordinate IRB review, which will ensure compliance with FDA and DHHS regulations and with ICH Good Clinical Practice Guidelines. Once the IRB review is complete, the Office of Research can help you coordinate administrative approvals to ensure feasibility and compliance with hospital policies. Our goal is to help increase efficiency by streamlining the study start-up process.
General Ethical Principles
ICH GCP: Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Learn more.
The Belmont Report: The Belmont Report is a statement of basic ethical principles and guidelines for the conduct of research with human subjects. Learn more.
Office of Human Research Protection (OHRP)
- 45 CFR Part 46 (aka “The Common Rule”)
Food and Drug Administration (FDA)
- Human Subjects Protections (Informed Consent) and Additional Safeguards for Children in Clinical Investigations
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- 21 CFR Part 56 Institutional Review Boards
- 21 CFR Part 312 Investigational New Drug Application (INDs)
- 21 CFR Part 812 Investigational Device Exemptions (IDEs)
St. David’s HealthCare is a member of the Collaborative Institutional Training Initiative (CITI) Program. CITI is dedicated to providing high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organizations and individual learners.
Researchers that wish to complete CITI training must first create a (free) account with CITI and affiliate with St. David’s HealthCare. The list of assigned courses will reflect the training requirements, depending on the researcher’s role and research type. Completing the courses involves reviewing written materials and passing a short exam to ensure comprehension. Courses are self-paced and may be completed from any computer with a web browser and Internet connection. Courses are portable across institutions, meaning that credit is granted for identical courses previously taken by multiple institutions. Completion of all courses is required to obtain a certificate.
Are you new to CITI? To sign-up for CITI and affiliate with St. David’s, please use the link to the right and click the “Register” button on the top-right corner. Be sure to add “St. David’s HealthCare” to your list of affiliated organizations.
Already have a CITI account? Log into your account and add “St. David’s HealthCare” to your list of affiliated organizations.
For technical support (i.e., problems with the CITI website, registration etc.), please contact CITI support.
CITI FAQ’s: https://support.citiprogram.org/
Additional Training Resources
Public Responsibility in Medicine and Research: (PRIM&R) is an industry organization that advances the highest ethical standards in the conduct of biomedical and social science/behavioral research through education, membership services, professional certification, and public policy initiatives.
Association for Clinical Research Professionals: (ACRP) is an industry organization that supports professional development for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. Many of our clinical research coordinators are members of ACRP. St. David’s HealthCare encourages clinical research coordinators to seek certification from ACRP or similar organizations.
Society of Clinical Research Associates: (SoCRA) is a non-profit, educational membership organization that provides education and certification for professionals involved in clinical research activities. SOCRA is also the premier educational organization for oncology site coordinators and is a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia.