Q: How do I register and login to the new Collaborative Institutional Training Initiative (CITI) website?
A: If you are a new learner at a participating organization (i.e., SHSU), you must register to create your own username and password and gain access to the site:
- For those who are new to the CITI website, go to: CITI Registration and Login Page
- Click on Register Here
- Choose Sam Houston State University as the Participating Institution
- Complete questions 1-7
- Click Submit
- Complete the necessary required Member Information
- Select your Curriculum: i.e., SHSU Human Subjects if conducting research involving work with Human Subjects or SHSU Animal Welfare if conducting research involving work with Animal Subjects
- Click Submit
- Check No to continue with your current institution
- You should be at your Main Menu at this point, and you can begin your course(s)
Q: Who do I contact with questions regarding Compliance (CITI, IRB, IACUC, or Biosafety?
A: Sharla Miles, or phone (936) 294-4875
Q: Who is required to complete CITI training?
A: Any PI (faculty, staff, or student) who is applying for and/or receiving federal funding
Q: Who do I contact to regarding ORSP workshops offered during the academic year?
Q: I have an agency/company/individual interested in funding my work. What is the first step?
- Assistance in developing the written portion of the proposal, formulating ideas, as needed: Delia Gallinaro, or phone (936) 294-3760
- Assistance with budget development, proposal routing, proposal submission: Dee Myall, or phone (936) 294-4032 (Due to the fact that the award will be made to the University and not to the PI, University policy requires the proposal to be reviewd and approved before it is submitted.)
Q: Why am I required to submit my proposal through ORSP?
A: Proposals must be routed so that the signatures of the researchers and the Chair/Dean can be obtained. Your Chair/Dean provides the technical review of the proposal. Your Chair/Dean also needs to know how much time you are proposing to commit to research and to approve any release time or reduction in teaching load. Your Chair/Dean must approve any cost-sharing or matching funds prior to submission.
In addition, the federal government has rules that educational institutions must follow in the costing of their proposals. Some costs are allowable and others are not. There is also a requirement to be consistent in the way that costs are proposed and reported. ORSP will prepare your proposal budget according to the federal or other sponsor's general guidelines, the specific requirements of the program and according to SHSU policies and procedures.
Q: Why do I need ORSP to prepare/verify my budget?
A: ORSP will verify that proper salaries/wages, fringe and indirect are appropriately calculated before a proposal is submitted. This should prevent any miscalculations affecting your bottom dollar. In addition, ORSP will identify which standard budget categories are appropriate for your proposed funding. This will ensure accuracy when post-award personnel are notified of your award and loads your funds into the Grant Accounting System.
Q: What is the signature process for the proposal routing form?
A: The signature process for the proposal routing form is as follows:
- PI(s)' and Co-PI(s)' Department Chair(s) Dean(s)
B: ORA will obtain the remaining signatures:
- ORSP (applies to all proposals)
- Provost (if matching funds are involved)
- President (if over $750K)
Q: What is the procedure for IRB application submissions?
A: The SHSU in-house application system for Institutional Review Board (IRB) reviews, which can be accessed from any computer, is found on SamWeb. The pathway for accessing the system follows: SamWeb > Miscellaneous > Forms > IRB Application.
The following documentation could potentially be required for IRB review:
Ethics Training (CITI) certificate Involving Prisoners in Research form Consent Form Assent Form Cover Letter Parental Consent Letter Support Letters* Survey Interview Phone Interview Media advertising Internet postings Psy PerP system (what participants will see) Emails Telephone text (including introductory remarks) Mass Mailing
Q: How can I tell the status of my IRB application?
A: To inquire about application status, contact Sharla Miles, or phone (936) 294-4875.
Q: How do I make changes/corrections to my application when it is sent back to me?
A: Revise your saved application, resave in the following format: Protocol number_PI Last Name_revised, and email back to SHSU IRB office via email at: Sharla Miles.
Q: How can request an extension to my IRB approval?
A: You will need to submit a Continuing Review form. Click on the link below to start the process:
CONTINUING REVIEW FORM [FILLABLE PDF] - to be completed ONLY AFTER your initial IRB application has been approved, and you are requesting an extension.
Q: What documentation is required for a continuing IRB review of my research?
A: For the IRB to meet its regulatory obligations (45 CFR §46.109), SHSU’s IRB requires the following documentation for a continuing IRB review of research:
- A brief project summary (this could be included (a) as part of a progress report described in the next bullet, (b) provided as a separate document, or (c) be addressed by referencing other documents made available to the IRB, including the informed consent document(s));
- A progress report [NOTE: the following information is requested in the SHSU IRB Continuing
Review form] that includes the following:
- The number of subjects accrued (for multicenter research studies, the number of subjects accrued at the local institution and the number accrued study-wide, if available, should be provided);
- A brief summary of any amendments to the research approved by the IRB since the IRB’s initial review or the last continuing review;
- Any new and relevant information, published or unpublished, since the last IRB review, especially information about risks associated with the research;
- A summary of both any unanticipated problems and available information regarding adverse events (the amount of detail provided in such a summary will vary depending on the type of research being conducted; in many cases, such a summary could be a brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol and the informed consent document)
- A summary of any withdrawal of subjects from the research since the last IRB review, and the reasons for withdrawal, if known; and
- A summary of any complaints about the research from subjects or others since the last IRB review;
- The latest version of the IRB-approved protocol and informed consent document(s);
- Any proposed modifications to the informed consent document or protocol;
- Any other significant information related to subject risk.
Q: What is the procedure to follow for informing the IRB of significant changes to my already-approved IRB protocol?
A: You will need to submit an Amendment to your already approved IRB protocol. Click on the link below to start the Amendment process:
Q: How can I close out my IRB protocol once my research and subsequent data analysis are complete?
A: You will need to submit a Final Report. Please click below to begin the Final Report process:
Q: How can a PI view all protocols submitted to the IRB in the last three years?
A: PIs must email Sharla Miles to request any past IRB applications submitted within the last three years. The turnaround time for expediting these requests is 24-48 hours.