Training and Tools
If you are engaged in human subject research, all study personnel who interact with subjects, participate in an intervention with subjects, or who access information about subjects which could reasonably identify the subjects must complete required training. At Purdue, required training is administered through CITI.
The Collaborative Institutional Training Initiative (CITI) Human Research Protections Training Course is a self-paced web-based training program covering core ethical concepts and regulatory requirements. Purdue University requires all individuals engaged in the conduct of human subject research to have current CITI certification, which may be updated by a refresher course after 4 years.
IRB Monthly Training
IRB trainings are available via WebEx for faculty, staff, and students. Human Research Protection Program (HRPP) staff will demonstrate how to submit an Institutional Review Board (IRB) protocol application in the Cayuse IRB system, followed by a question-and-answer session.
Advance registration is required within 48 hours of the scheduled session. To register, fill out the form here. Those who register will be provided with a confirmation email and later a message that includes the virtual meeting participation link (typically Microsoft Teams or Zoom). Please direct questions to irb@purdue.edu. "
2024 Dates and Times are as follows:
Date | Time |
---|---|
Tuesday, January 16, 2024 | 11:00 a.m. - 12:00 p.m. |
Thursday, February 8, 2024 | 11:00 a.m. - 12:00 p.m. |
Wednesday, March 6, 2024 | 11:00 a.m. - 12:00 p.m. |
Wednesday, April 17, 2024 | 4:00 - 5:00 p.m. |
Thursday, May 16, 2024 | 11:00 a.m. - 12:00 p.m. |
Wednesday, June 19, 2024 | 11:00 a.m. - 12:00 p.m. |
Thursday, July 18, 2024 | 4:00 - 5:00 p.m. |
Wednesday, August 28, 2024 | 4:00 - 5:00 p.m. |
Thursday, September 19, 2024 | 11:00 a.m. - 12:00 p.m. |
Thursday, October 17, 2024 | 4:00 - 5:00 p.m. |
Wednesday, November 13, 2024 | 11:00 a.m. - 12:00 p.m. |
Tuesday, December 3, 2024 | 3:00 - 4:00 p.m. |
To schedule a group training or classroom presentation, email irb@purdue.edu or call the HRPP office at 765-494-5942.
Online CITI Training
The CITI Human Subjects Research Basic Course is required for all investigators and study personnel (i.e., Users) who have not previously completed a CITI human subjects research course.
At a minimum, Users must select and complete the curriculum (called Learner Groups) that corresponds with their role in the research. However, we strongly recommend all Users, regardless of their role or type of research conducted, choose to complete on of the following Learner Groups to fulfill their CITI certification requirement.
- Biomedical Research for Investigators and Key Personnel Learner Group
- Social Behavioral Research for Investigators and Key Personnel Learner Group
- Use this CITI Registration Instruction Sheet to assist you in registering with CITI.
You do not need to complete the entire Course in one session. Re-enter as often as you like, using your username and password, to complete the training.
You must complete all required modules with a cumulative score of 80% or better to pass the course.
Assistance with Protocol Development
The Human Research Protection Program offers regular campus trainings throughout the academic year. Please watch for specific opportunities in electronic publications like the Dimensions of Discovery, Purdue Today, or through posts on our website.
To schedule a virtual appointment please use the form on our contact page or call the HRPP office at 765-494-5942. For class or large group trainings, please fill out the form here.
Protocol Writing Guidance
Purdue IRB Protocol Guidance Document
This guidance document breaks down the categories of the Cayuse application into descriptive sections. Please utilize this document side-by-side with the application when writing a new protocol for the HRPP/IRB.
Researcher Guide
In addition to its Standard Operating Procedures, the Purdue HRPP provides guidance to researchers in the form of a researcher guide to clarify best practices and promote our shared goal to protect human participants in research. Please check back for more topics as they are added.
Researcher Responsibilities
Clarifies the expectations of a Principal investigator and all research personnel during the conduct of a research project with human subjects research.
Download Researcher Responsibilities Guide
Training and Education
Describes personnel types used by the HRPP/IRB and defines training expectations prior to conducting research with human subjects.
Download Training and Education Guide
Is your work Human Subjects Research?
Provides a step-by-step assessment that researchers may use to assess applicability ofthe definition of Human Subjects Research.
Download Human Subjects Research Determination Guide
Datasets Available to the Public
Describes parameters of IRB review when publically available datasets are utilized.
Download Publicly Available Datasets Guide
Recruitment
Guidance to provide researchers with information about the material an IRB must review related to recruitment for a proposed study involving human subjects research.
Compensation
Provides guidance on practices utilized when participants will be compensated for enrolling or completing a research study.
Deception and Debriefing
Provides information related to processes related to incomplete disclosure of research and proper practices associated with these studies.
Tools for Protocol Development
Understanding Study Inclusion and Exclusion Criteria in Human Subjects Research Protocols
Proper eligibility criteria help to ensure that the correct population is recruited and that those with additional needs or considerations are protected. Use this infographic as a way to think about how to write these important items into an IRB protocol.
Study Inclusion and Exclusion Criteria Infographic
FERPA Applicability to Research Data
Data related to Education Records at Purdue or other educational institutions could be subject to the Family Educational Rights and Privacy Act (FERPA). Review this information before submitting a protocol for review.
FERPA Applicability Infographic
Infographic Representation of the IRB Review Process
Use this infographic to walk through the submission requirements of an IRB protocol application.
Submitting to the IRB Infographic
Applications Proposing to Use Protected Health Information (PHI) for Research
Use this chart to determine what the IRB requires in an application prior to review or approval when Protected Health Information is involved in research.
Applications Proposing to Use Protected Health Information (PHI) for Research
Working with External Collaborators
This flowchart will help you determine the type of agreement required when non-Purdue researchers will serve as key personnel on an IRB protocol.
External Collaborator Sites Flowchart
International Research with Human Subjects
Purdue University researchers proposing to conduct human subjects research outside of the US must confirm that their research fits within the applicable national laws and cultural norms of their study population. All international research studies must adhere to recognized Ethics Codes such as Title 45 CFR 46, the Declaration of Helsinki, the Nuremberg Code, and/or the Belmont Report.
Recruitment Flyer Guidance
This document will assist your efforts to include the required content when making a recruitment flyer for your IRB protocol.
Considering Privacy, Confidentiality, and Anonymity in Human Subjects Research
Researchers are asked to describe the protections related to keeping research data private and confidential. This document is intended to guide researchers on what to consider when writing an IRB protocol.
Guidance on Privacy and Confidentiality
Standardized Consent Form Language
Provides Researchers with standardized text for risks associated with common research procedures and techniques.
Standardized Consent Form Language
Guidance on Writing Consent Forms by Reading Level
An excerpt from the New England Journal of Medicine giving guidance on consent form language by readability level.
Examples of Informed-Consent Text
How to Access Protocols in CoeusLite
The HRPP/IRB no longer uses Coeus for IRB protocols. However, PIs or designated personnel can access protocol records in the system using these instructions.