This five-part lecture series is sponsored by the Institute for Clinical and Translational Research (ICTS) and the Human Subjects Office (HSO). These are stand-alone lectures about common aspects of the research process. Recordings will be posted in the IRB ICON Course for Researchers.
Pre-registration is not necessary. Request the Zoom link from Dori Hinson (email@example.com or 319-384-5282) or the IRB Education & Outreach Program (firstname.lastname@example.org). People who attend the lectures via Zoom can request Continuing Medical Education (CME) credits.
NOTE: These lectures address processes for a submission to the UI IRB, not for a single IRB model or commercial IRB.
Use a Sample Protocol to Create a HawkIRB Application
Prior to the lecture, attendees can use a sample protocol (Phase II/III, Randomized, Double-Blind, Placebo-Controlled Trial of Snapeacillium for Quidmort) to draft an application in the HawkIRB Training platform. All are welcome to attend even if you are not able to prepare a draft HawkIRB application in advance. Attendees will learn:
- How to collect everything you need to prepare a draft HawkIRB application
- Where to put elements in the protocol in the HawkIRB application
- Aspects of the HawkIRB application that are study-specific (not specified in a protocol)
- When and how to request additional information from the Principal Investigator (PI), sponsor, coordinating center, or Other UI Committees involved in the review process.
The Recruitment Process: Plan, Describe, Implement
This lecture will provide best practices for this often overlooked, yet essential, aspect of a research study. A study is doomed to fail without effective recruitment and retention of subjects. We will answer the following questions, and more!
- Why should I plan multiple recruitment methods?
- What should I include (or not include) in the recruitment message?
- Do I need IRB approval for a “Dear Doctor” letter requesting referrals?
- How do I send a UI mass email?
- When does the IRB grant a partial waiver of HIPAA authorization?
- What is ResearchMatch.org?
- What support does the UI offer for study recruitment?
- Do I need an IRB-approval stamp on recruitment materials?
- Where do I attach recruitment materials?
The Informed Consent Process: An effective and ethical description of the study
Technically, the consent process begins with the recruitment message. In this lecture, we will start after a potential subject has agreed to learn more about the study. We will discuss how to use the Informed Consent Document to conduct the consent process with a “real” subject.
- Using the IRB-approved Consent Summary and Informed Consent Document as a guide to conduct the consent process - best practices for the verbal description
- The Gold Standard Consent Process: Read the Document, Verbal Description, Ask Questions, Think about it/Discuss with Family, Sign, Receive a Copy
- Consent process with a Parent/Legal Guardian or Legally Authorized Representative (LAR)
- Proper documentation on the Informed Consent Document and of the consent process
- Record storage requirements for signed Informed Consent Documents
Reportable Events: Being Clear About What, When and How to Report
During this panel discussion, representatives from the Human Subjects Office, Institutional Review Board and the UI research community, will share best practices for submitting reportable events:
- Recognizing the five types of events
- Identifying these events during the course of a study
- Reportable Event Forms (REFs) in HawkIRB
- IRB review process for REFs
Pre-requisite: The Reportable Event Forms (REFs) portion of the Part 3 HawkIRB Training: Forms Submitted After IRB Approval (Modifications, Continuing Reviews, Reportable Events Forms and Project Close Forms). This HawkIRB Training is offered monthly. A recording is available in the IRB ICON Course for Researchers (in the module “HawkIRB Trainings Part 3, Part 4 and Part 5”).
Use a Sample Protocol to create an Informed Consent Document (ICD) and Consent Summary
Attendees will use the same sample protocol (Phase II/III, Randomized, Double-Blind, Placebo-Controlled Trial of Snapeacillium for Quidmort) and the UI IRB templates in the HawkIRB Training platform to create an Informed Consent Document and Consent Summary. During the lecture we will discuss:
- The process of translating the protocol into lay language
- Where to include elements of the protocol in the Informed Consent Document and Consent Summary
- Best practices for creating a clear, concise Informed Consent Document and Consent Summary