Human Subjects Protection Training Program
Human Research Required Training
Before a protocol will be approved by a CU IRB, the PI must review the Human Subjects Protection Training course and receive a passing score of 80 or greater on the relevant exams. Research personnel other than the PI who have contact with subjects, contact with confidential study data, or are otherwise engaged in the research (i.e., key personnel) must also complete training in the protection of human subjects prior to participation in the research. The course is available in Rascal here. Instructions for accessing the course are available here.
A list of Frequently Asked Questions about Human Subjects Protection Training can be found here.
The CRC Training Program is open to all research personnel who are involved in work with human subjects or collection and maintenance of study data. It is mandatory for individuals who participate in clinical human subjects research that involves more than minimal risk and who are designated under “Personnel Staff” on any Rascal Human Subjects Protocol Data Sheet as having one of the following roles:
- Study Coordinator
- Research Coordinator
- Research Nurse
- Regulatory Coordinator
- Data Manager
- Research Assistant
If you have any questions, please email email@example.com.
The FDA-regulated research module required for researchers involved in a study that involves a drug, device, biologic, or other biomedical intervention in a study of its potential therapeutic use, or a diagnostic test or procedure to study its potential clinical utility. This module is accessible within the CITI Human Subjects Protection Training Program, in the RASCAL Training Center. Information on adding FDA-regulated research to Rascal training can be found here.
Columbia University faculty members who serve as the sponsor and Principal Investigator (i.e., Sponsor-Investigator or S-I) of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) must also complete RASCAL Training Course TC0096 with 80% of the questions answered correctly.
If the study population includes children, completion of the CITI Research with Minors module is required. This module is accessible within the CITI Human Subjects Protection Training Program, in the RASCAL Training Center. Information on adding Research with Minors module to Rascal training can be found here.
Training in Good Clinical Practice (GCP) is required by some sponsors and is recommended for all clinical research personnel. As of January 1, 2017, NIH requires GCP training every 3 years for individuals on clinical trials funded in whole or in part by the NIH, regardless of the study phase or type of intervention. Please see the Good Clinical Practice Training page for more details.
Additional Education Opportunities
Monthly Investigator Meeting (MIM) Presentations (click to view)
- 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. 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.