The US Department of Health and Human Services Office for Human Research Protections is the federal agency governing research in the United States. The law relating to researchers’ responsibility for the protection of their human subjects is stated in the Code of Federal Regulations (45 CFR 46.102) found at this link: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102. 

This document defines human subject-related research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” on human subjects. A human subject is defined as “…a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” As a researcher using human subjects, you must seek and receive documented approval for your proposed research through the Purdue Global Institutional Research Board, or IRB. 

The IRB reviews Purdue Global-affiliated research proposals involving human subjects to ensure the welfare and rights of subjects are not placed at risk. The IRB is focused on the prevention of harm to human subjects in all research. Harm to subjects is defined as any disclosure of the human subjects’ responses outside the researchthat could reasonably place the subjects at risk of criminal or civil liability, or can be damaging to subjects’ financial standing, employability, or reputation.

Any research that involves human subjects must be reviewed and approved by the IRB. When in doubt, please submit a proposal.

Please review the Guidelines for Submission. We also provide templates and suggested verbiage , as well as checklists, to help you as you develop your proposal.

Once submitted, the request will first go to your thesis advisor, consultant/instructor, or supervisor for approval.

When that approval is secured, the IRB reviewers will review your proposal and respond in one of three possible ways:

1. They determine that your protocol is Exempt and approved. If so, you are approved to proceed with your research as outlined.

2. They may require additional information or modifications before they can approve the proposal. They will provide you with specific recommendations for revisions or additions that must be made before your proposal is reviewed again.

3. They may determine that your proposal requires a full review. 

The typical timeline for the IRB review process is 2-4 weeks, though this is just an estimate. The process may take more or less time, depending on the need for additional information and the thoroughness of the proposal.

Yes. The Purdue University Global IRB is obligated to adhere to the terms of its Federal Wide Assurance with OHRP, which strongly recommends that the designated IRB establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, the following:  

• relevant ethical principles; 

• relevant federal regulations;

• written IRB procedures;

• OHRP guidance;

• other applicable guidance, state and local laws; and 

• institutional policies for the protection of human subjects. 

Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subjects’ research; and b) research investigators complete appropriate institutional educational training before conducting human subjects’ research.

Compliance with the training standard may be met by completion of any ONE of the following three options: 

Training Option #1:  CITI Basic Course in Social/Humanistic/Behavioral Research (SBR)

Accessible from:   https://www.citiprogram.org/default.asp 

Stringent adherence to the directions in the instruction set is strongly recommended.  If an individual does not follow the instructions, and therefore completes a course other than the basic course in SBR (14-15 content modules) then it is the individual's responsibility to take the correct course.    

Certification in a “Refresher” course or a “Responsible Conduct in Research” course, or any course other than the basic course in Social/Humanistic/ Behavioral Research, will not be accepted.   When in doubt, the IRB staff should be contacted for further direction in taking the basic SBR course.

Training Option #2:  PHRP Computer-Based Training (CBT)

Accessible from:  https://phrptraining.com/#!/

The very first page of the PHRP CBT Website includes clear and brief instructions for registering and completing the training.  The training is straightforward and brief in comparison to the CITI training. 

Training Option #3:  

A certificate from another institution providing similar certification as Training Option #1 or Training Option #2 will also be accepted.  However, Purdue Global will not accept training documentation that is more than 7 years old.