Human Subjects Protection Training Program & Educational Resources
Additional Education Opportunities
Monthly Investigator Meeting (MIM) and IRB 101 Presentations (click to view)
- IRB Submissions: Common Reasons for Returns
- Research with Medical Devices/ In-Vitro Diagnostic Tests (IVDs)
- HRPO Updates
- Q&A Session
- HRPO Updates
- Common reasons for returns
- Common noncompliance findings
- Electronic consent and remote consent
- Response to feedback from the research community
- Remote Monitoring
- Important updates on select research policies and guidance documents
- Home Study Visits
- Guidance for the evaluation of research versus quality assurance/improvement activities in healthcare settings
- E-consent and REDCap
- Update on consent form language and addendum
- Notifications to past, present, future participants
- Pre-consent status
- Certificates of Confidentiality for federally funded research (beyond NIH)
- Annual/Progress Report for certain research approved on or after Jan. 21, 2019
- Posting of consent documents for federally funded clinical trials
- Consent form confidentiality language for “Epic” studies
- Reliance aka Single IRB updates/tips
- New initiative to decrease the need for review at multiple convened meetings
- New Rascal feature, the Protocol Tracker
- Explanation of Annual Report requirements and demonstration how it works in Rascal
- Clarification about personnel on IRB protocols
Topics include updates on GDPR, “Approval” letters, Reliance processes, Expanded Single IRB requirements, Certificates of Confidentiality, and Informational sessions.
- Research Ethics: Where are we, How did we get here, and Where are we going?
- Presentation includes information from both the Clinical Trials Office and the Human Research Protection Office about conducting research using medical devices.
- Informed Consent Basics
- Review of the Process
- Documentation of Informed Consent
- e-Consent and Remote Consent
- Special Situations
- Common Noncompliance Findings Involving Informed Consent
January 24 MIM Presentation: New Rule Information Session - 2018 Regulatory Requirements
- Regulatory Changes General Compliance: January 21, 2019
- What you need to know
- Current Regulations (Pre-2018 Requirements)
- Regulatory Changes (2018 Requirements)
- Rascal Changes
- Regulatory Changes Effective January 21, 2019
- Revisions to the Incidental Findings from Imaging Procedures Conducted for Research Studies Policy
- General Data Protection Regulation (GDPR)
- Update on Columbia Human Research Protection Program reaccreditation
Introduced in 2003, the Monthly Investigator Meetings provide regular educational opportunities that address current human subjects protection topics.
The objectives of these meetings are:
- To help ensure that all human subjects research is conducted in accordance with the federal regulations, in an ethical manner, and with high standards of excellence;
- To improve the quality of submissions to the IRB; and
- To form a network among researchers, the IRB, and the Office of Clinical Trials for the purposes of facilitating human research.
Selected MIM presentations are posted in Informational Materials
A quarterly informational session for our human subjects research community.
- Click here for a slide deck of the February 5, 2021 IRB 101
- Click here for a slide deck of the July 25, 2019 IRB 101
- Click here for a slide deck of the May 9, 2019 IRB 101
This session provides:
- A history of human subjects protection and the ethical principles that guide human subjects research;
- An overview of the federal regulations for the protection of human subjects in research;
- Criteria for IRB review;
- Tips for submitting complete and understandable new protocols, modifications, renewals, and adverse event reports;
- An overview of the RASCAL system and process;
- Special considerations for vulnerable populations; and
- The IRB Review process, continuing review and oversight monitoring at CU.
Who should attend?
- New research personnel
- Research Personnel new to Columbia
- Researcher personnel who have not yet attended Part I of the IRB 101 series in the past
- All those who wish to gain a historical perspective and learn the ethical and regulatory guidelines for Human Subjects Research
These sessions are intended to focus on both the technical aspects and required content for different types of RASCAL submissions ranging from the creation of consent forms to the submission of specific types of events. These workshops will be hands on, held in a computer lab, and researchers are encouraged to bring their own current submissions to work on during the session. Workshop topics will be rotated every two weeks, focusing on the Consent Form Builder or Protocol Submissions. Space is limited because of the nature of these workshops.