Human Subjects Protection Training Program & Educational Resources
As a prerequisite for IRB approval, all human subjects researchers, including staff, students, postdocs and others, must complete Human Subjects Protection (HSP) training, and the HIPAA Privacy Training. A list of Frequently Asked Questions about Human Subjects Protection Training can be found here.
Educational opportunities such as IRB 101 (a basic course for all coordinators, researchers and any interested staff) and Monthly Investigator Meetings (MIMs) are scheduled regularly. Materials from the meetings are posted below.
Additional Education Opportunities
Monthly Investigator Meeting (MIM) and IRB 101 Presentations (click to view)
2024
September 19, 2024 MIM Presentation (click below to view slides)
March 7, 2024 MIM Presentation
- Reliance! (Part 1): Explaining IRB reliance situations, the process for requesting them, and the forms that are used.
March 21, 2024 MIM Presentation
- Reliance! (Part 2): Explaining IRB reliance situations, the process for requesting them, and the forms that are used.
2023
August 24, 2023 MIM Presentation
- Rascal Appendix R: Review Process for Protocols involving MRI
August 24, 2023 MIM Presentation
- MRSC and IRB Review
May 25, 2023 MIM Video
2022
June 30, 2022 MIM Presentation
- IRB Submissions: Common Reasons for Returns
March 17, 2022 MIM Presentation
- Research with Medical Devices/ In-Vitro Diagnostic Tests (IVDs)
2021
November 18, 2021 MIM Presentation
- HRPO Updates
- Q&A Session
October 28, 2021 MIM Presentation
- HRPO Updates
- Common reasons for returns
- Common noncompliance findings
August 19, 2021 MIM Presentation
-
Reliance agreements
June 17, 2021 MIM Presentation
- Electronic consent and remote consent
April 15, 2021 MIM Presentation
- Response to feedback from the research community
March 18, 2021 MIM Presentation
- Remote Monitoring
- Important updates on select research policies and guidance documents
2020
December 17, 2020 MIM Presentation
- Home Study Visits
- Guidance for the evaluation of research versus quality assurance/improvement activities in healthcare settings
September 24, 2020 MIM Presentation
- E-consent and REDCap
February 6, 2020 MIM Presentation
- Update on consent form language and addendum
- Notifications to past, present, future participants
- Pre-consent status
January 16, 2020 MIM Presentation
- 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
2019
December 12, 2019 MIM Presentation
- 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
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Topics include updates on GDPR, “Approval” letters, Reliance processes, Expanded Single IRB requirements, Certificates of Confidentiality, and Informational sessions.
May 9, 2019 IRB 101 Presentation
April 18, 2019 MIM Presentation: Research Ethics
- Research Ethics: Where are we, How did we get here, and Where are we going?
March 21, 2019 MIM Presentation: Research with Medical Devices
- Presentation includes information from both the Clinical Trials Office and the Human Research Protection Office about conducting research using medical devices.
February 21, 2019 MIM Presentation: Informed Consent (includes 2018 Regulatory Requirements for Informed Consent)
- Informed Consent Basics
- Review of the Process
- Documentation of Informed Consent
- Waivers
- 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
2018
- 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.
IRB Rascal Workshop: New Protocol - More than Minimal Risk
Mon, January 22, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: Renewal - Annual Report - Modification
Mon, February 26, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: New Protocol - Minimal Risk
Mon, March 25, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: Consent Form Builder
Mon, April 22, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: Consent Form Builder
Mon, Aug 26, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: New Protocol - More than Minimal Risk
Mon, Sept 23, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: Renewal - Annual Report - Modification
Mon, Oct 28, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: New Protocol - Minimal Risk
Mon, Nov 18, 2024 3:00 PM - 4:00 PM
IRB Rascal Workshop: Consent Form Builder
Mon, Dec 16, 2024 3:00 PM - 4:00 PM
Newsletter #10 released on 9/27/2024
- New Policy on Resolution of Queries after Study Closure
- Information on Renewals and Annual Reports, including regulatory and institutional requirements, the IRB and HRPO review process, the calculation of the expiration or due date, the recommended timeline for submission of renewals, and instructions on how to submit renewals and ARs
- Updated TruCentive Instructions for research participants
- Requirements to obtain prospective IRB approval before implementing protocol deviations, and to report protocol violations to the IRB.
Newsletter #9 released on 8/12/2024
- Updated Policy on Incidental Findings from Imaging Procedures for Research Studies
- Changes in the conduct of research studies: Submission of a new protocol versus a new modification
Newsletter #8 released on 4/19/2024
- Description of the Administrative Modifications
- Concurrent Review of certain Human Research Protocols by other Research Offices or Committees than the IRB (i.e. Ancillary Review)
Newsletter #7 released on 3/11/2024
- Updated Guidance for the Classification of Quality Improvement Activities versus Research with Human Subjects
- Lyft Car Concierge Program for Research Participants
- New feature in Rascal: Algorithm incorporating the IRB training requirements integrated into the Rascal Human Subjects Module
Newsletter #6 released on 12/19/2023
- Guidance on Changes in PI
- Payment Options for Reimbursement and Compensation of Research Participants: guidance/consent Form language and TruCentive instructions
- Review of Annual Reports
- Follow up to the “IRB Submission of IBs” Topic addressed in the October 2023 newsletter
Newsletter #5 released on 10/19/2023
- New Guidance on International Research
- Description of the "118" review for federal funding applications
- IRB Submission of Investigator’s Drug Brochures (IBs) and/or Device Manuals
Newsletter #4 released on 08/02/2023
- Policy on Resubmission of New Protocols after 60/90 days
- Rascal Resource: Accessing and responding to researcher Tasks – Process for stamping IRB-approved documents
- Review involving the Enrollment of CU affiliates
- Time Period to submit Renewals
- Documents attached in Rascal should not include direct individual identifiers
Newsletter #3 released on 10/17/2022
- Collaborative Research with a non-CU Investigator: new information available on HRPO website
- New Guidance on Changes in Principal Investigator (PI)
- Rascal Resource: Protocol Tracker Report
- IRB Training Requirements
- HRPO Office New Location
Newsletter #2 released on 5/17/2022
- Human Subjects Module in Rascal:
- Update of the “Human Embryos or Human Pluripotent Stem Cells” question and addition of the link to the new “Stem Cell Research” web page.
- Update of the “Drug and Device” pages to include the “CTO form of notice” template
- Reminders: Documents to be stamped should be in pdf format – A correspondence to address responses to research tasks should be added in Rascal.
- Recruitment of CU/NYPH Employees/Residents/Fellows/Interns/Students: requirements for submission
- Change in Principal Investigator (PI) modifications: Information to be provided in the modification
Newsletter #1 released on 4/15/2022
- New Guidance on Risk to Subjects from Skin Biopsies
- Available in Rascal: Statement of ICH-GCP compliance - Rascal 2.1 tutorial (video)
- Current Review Process: list of items that are prioritized for review