Getting on the same page: Submission and Review of Human Subjects Research Applications (A 3-part lecture series)
The Human Subjects Office (HSO), Division of Sponsored Programs (DSP), and Institute for Clinical and Translational Science (ICTS) have partnered on a three-part series of presentations about how to achieve the most efficient review of human subjects research applications by the Human Research Protection Program (HRPP). These presentations are intended to help researchers be “on the same page” as the HRPP committees that review their research submissions.
Part 1: Complete Submission Materials
- How researchers can ensure complete submission materials for HSO/IRB, DSP, and other HRPP committees reviews.
- What “starts the clock” for the HSO/IRB, DSP, and HRPP committee reviews
- How human subjects research application reviews can occur in parallel to facilitate a faster review
[NOTE: Part 1 of this lecture series is part of the ICTS Clinical Lecture Series. The Zoom link will be sent to people on the ICTS distribution list. If you are not on that list, please contact Dori Hinson to request the link.]
|Thursday, February 4, 2021
12:00 PM - 1:00 PM
Part 2: Case examples of Parallel Review Process
We will provide examples of UI researcher submissions to HRPP committees to highlight when the HRPP reviews occurred in parallel, and when this did not occur. This presentation will include suggestions for how to submit research applications that provide the information needed for the HRPP committees to conduct their review.
|Friday, February 19, 2021
12:00 PM - 1:00 PM
Part 3: Human Subjects Research Financial Budget Best Practices
This presentation will focus on the most common reason HRPP reviews do not get finalized in parallel – the human subjects research financial budgets. This presentation will cover budget best practices and offer template budget examples.
[NOTE: Part 3 of this lecture series is part of the ICTS Clinical Lecture Series. The Zoom link will be sent to people on the ICTS distribution list. If you are not on that list, please contact Dori Hinson to request the link.]
|Thursday, February 25, 2021
12:00 PM - 1:00 PM
Use of eConsent: A Look at the Regulatory Guidance
This presentation will focus on the regulatory requirements for the use of electronic consent (eConsent). Attendees can expect to learn more about
- The Office of Human Research Protection (OHRP) & The Food and Drug Administration (FDA) shared guidance on “Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers”
- UI tools for researchers setting up an electronic consent (eConsent) process
- What to expect when using an external eConsent tool for FDA regulated research
|Wednesday, February 17, 2021
10:00 AM - 11:00 AM
The Data Security Mystery Machine: Study Data, Where Are You?
This presentation will review the options and remove the mystery from establishing adequate data security plans for research study data. Researchers typically need assistance from an IT professional to establish appropriate data security plans for electronic records. This joint presentation by the IRB Education & Outreach Program and ITS Research Services will provide both the IRB and IT perspective.
Data security and confidentiality protections are an essential aspect of the ethical conduct of research. And they must comply with federal regulations for the protection of human subjects and institutional policies regarding the protection of data. Researchers must have adequate confidentiality protections for storage and transmission of paper and electronic records and biospecimens. And there must be more stringent data security protections when data are more sensitive.
(To the Saturday morning cartoon fans from the 70’s who get the reference in the title: There may be a surprise appearance by Scooby Doo!)
|Tuesday, March 16, 2021
1:00 PM - 2:00 PM
The Boomerang Application: Best Practices for Managing Workflow Questions and Requests
You answered every question in the HawkIRB form. You put a lot of time into editing the Informed Consent Document template to describe your study. You checked your attachments page--twice. You crossed every T and dotted every I. Yet, the HawkIRB application was returned to your Inbox for you to address questions and provide clarification. The truth is, this is a very common scenario for many researchers, and the Human Subjects Office (HSO) wants to help.
In this presentation, we will show you IRB-side of the application review process. We will look at the most common Workflow questions and requests and provide strategies for addressing them to keep the IRB review process moving along. Ideally, we want you to know how to anticipate and avoid having these application issues altogether. Finally, we will share insights about the review process from HSO staff reviewers. This presentation will be beneficial to anyone who works with HawkIRB applications.
|Wednesday, April 14, 2021
10:00 AM - 11:00 AM
Student PIs and Faculty Advisors: Know Your Responsibilities
The UI is one of the few academic institutions that still allows student researchers to serve as the Principal Investigator (PI) of their own project involving human subjects research. But this is only possible if the student has adequate training and expertise to serve as the PI AND has an engaged Faculty Advisor who agrees to oversee the project, from study design and HawkIRB submission through to completion of the project
This presentation will provide an overview of the expectations for students who plan to conduct research and the responsibilities of Faculty Advisors of student research projects. You must know the responsibilities for whichever position you hold to ensure the ethical conduct of research and the protection of human research subjects.
|Thursday, April 29, 2021
2:00 PM - 3:00 PM