Getting Started

All personnel involved in human subjects research must complete CITI Human Research training before a study can be assigned for pre-review.

• Complete one of the following:
  • Biomedical Research Investigators and Key Personnel
  • Social/Behavioral Research Investigators and Key Personnel
• A minimum score of 80% on each module is required to pass
• Training is valid for 4 years
• Investigators should retain completion certificates for all study personnel

Purdue adheres to federal definitions of research and human subjects. If your activity will utilize data collected from human participants for research purposes, your project must be reviewed by the Purdue HRPP/IRB.

Some examples:

• Graduate work such as a thesis or dissertation involving the use of human study participants
• Exploratory or feasibility studies involving human feedback or opinion data
• Use of a non-public dataset with identifiable data.
• Data collected for research projects intended for publication or presentation

An algorithm for determining whether an activity is Human Research can be found in HRP-310 - WORKSHEET - Human Research Determination. Use this document for guidance as to whether an activity meets either the DHHS or FDA definition of Human Research, keeping in mind that the HRPP office or IRB makes the ultimate determination in questionable cases as to whether an activity constitutes Human Research subject to IRB oversight.

If your study does not seem to be like those listed above, it may not meet the definition of “human research”. If it is not “human research”, it does not need to be reviewed by the HRPP for exemption or by the IRB.

Some low-risk studies may qualify for Exemption from IRB Review, including:

• Surveys and interviews
• Benign behavioral interventions
• Educational research
• Secondary data analysis

Exempt studies still require submission in PERA and must comply with Purdue policies and ethical principles (Belmont Report).

The HRPP uses HRP-312 - Worksheet - Exemption Determination to confirm exemption.

Before submitting in PERA:

• Complete the appropriate protocol template:
  • HRP-503a - Protocol Non-Exempt Research
  • HRP-503c - Protocol - Exempt Research
  • HRP-503b - Human Research Determination Template
• Complete all applicable appendices (e.g., children, devices, consent waivers)
• Prepare required documents:
  • Consent forms
  • Recruitment materials
  • Letters of collaboration
  • Agreements (if applicable)

All templates, forms, and guidance documents are available in:

• PERA Library
• HRPP Toolkit on the IRB website

All submissions must be completed through the PERA IRB module.

Create a New Study in PERA:

1. Complete the SmartForm (use built-in help text as needed)
2. Upload all required documents
3. Submit the study (PI must submit)

You will know the study is submitted when it reaches Pre-Review status.

The level of IRB review depends on study risk:

Exempt Review

• Determined by HRPP staff

Expedited Review

• Reviewed by a designated IRB reviewer
• Rolling submissions (not tied to meeting dates)

Full Board Review

• Required for greater than minimal risk research
• Reviewed at a convened IRB meeting

You can log into PERA IRB to check the status of your study at any time.

• Pre-Submission: The study has not been submitted to HRPP/IRB for review. The study still sits with the PI/research team.
• Pre-Review: The submission is with the HRPP/IRB office for review.
• Clarification Requested: Clarification is requested by the Analyst/Coordinator, and the submission is open to the study team for a response.
• IRB Review: The study has been assigned for review by either an IRB Designated Reviewer of the IRB Committee.
• Modifications Required: Modifications are requested by the reviewer(s) prior to final determination.
• Post-Review: The study has been reviewed and the determination letter will be generated shortly by the Analyst/Coordinator.
• Review Complete: The review of the submission is complete and the study is now active and approved.

• Respond promptly to requests for revisions or clarification
• All communications are sent to the Principal Investigator and Primary Contact
• Timely responses help reduce review delays