Human Subjects Protection Education Requirements

A. Purpose

Northwestern Health Sciences University (NWHSU) strives to facilitate research, scholarship, and dissemination of knowledge while fostering a scholarly community committed to sound, ethical teaching and learning experiences. This policy affirms NWHSU’s commitment to safeguard and respect the rights and welfare of human subjects in research.

NWHSU’s Institutional Review Board (IRB) is responsible for conducting initial and continuing review of all research that involves human subjects to ensure that all research involving human subjects is conducted in accordance with ethical principles and federal guidelines. Education of those involved in the research process is considered essential to achieving this purpose. The IRB provides guidance on approval process and on the education requirement for the protection of human subjects involved in research.

B. Revision History

Originally issued: December 2014
Updated: October 2017

C. Persons Affected

All Northwestern Health Sciences University faculty, staff, students, and external partners involved in the protection of human subjects and human subjects’ research.

D. Policy

Northwestern Health Sciences University ensures that its research investigators, research advisors, students, IRB members, staff, and external partners maintain continuing knowledge of and comply with legal and ethical obligations to protect human subjects in conducting research.

The IRB requires individuals involved in human subjects’ research to complete mandatory online, peer-reviewed learning modules covering the historical development of human subjects’ protections, as well as current information on regulatory and ethical issues. NWHSU’s online research compliance education provider is the Collaborative Institutional Training Initiative (CITI). Requirements include:

  • Individuals participating in research involving human subjects must complete the required CITI modules with an overall pass rate of 80% before a project will be receive final IRB approval.
  • Certification must be renewed every four years. CITI refresher courses are available to renew certification.
E. CITI Program

The CITI program offers two learning tracks: one for biomedical investigators and another for social, behavioral, and educational investigators. The core content for both tracks is similar; however, the case examples are relevant to the different research discipline areas. Reviewing the two course offerings may provide guidance in determining the most appropriate track.

Biomedical Research Track

Required Modules:

  • Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research
  • Populations in Research Requiring Additional Considerations and/or Protections
  • Basic Institutional Review Board (IRB) Regulations and Review Process
  • Informed Consent
  • History and Ethics of Human Subjects Research
  • Social and Behavioral Research (SBR) for Biomedical Researchers
  • Records-Based Research
  • Genetic Research in Human Populations
Social & Behavioral Research Track

Required Modules:

  • Defining Research with Human Subjects – SBE
  • Assessing Risk – SBE
  • History and Ethical Principles – SBE
  • The Federal Regulations – SBE
  • Informed Consent – SBE
  • Internet-Based Research – SBE
  • Privacy and Confidentiality – SBE

Note: The Responsible Conduct of Research (RCR) courses do not qualify for Human Subjects training. You may, however, wish to take one or more of these courses to get an overall view of responsible and ethical conduct of research. It includes information about plagiarism, data, mentoring, authoring, publishing, copyright, and other research issues. RCR courses may be required for sponsored research.

HIPAA and research

If your research involves the use of protected health information, you must complete the Information Privacy Security course.

Required Modules:

  • Basics of Health Privacy
  • Health Privacy Issues for Clinicians
  • Basics of Information Security, Part 1
  • Basics of Information Security, Part 2
F. CITI Registration

Research investigators, advisors, IRB members, and others completing the human subjects education requirements should complete steps 1-10 to create a profile in CITI and affiliate with Northwestern Health Sciences University:

Select your organizational affiliation: select — Northwestern Health Sciences University — from the dropdown menu

Click Continue to Step 2

Complete Personal Information

Click Continue to Step 3

Create your Username and Password

Click Continue to Step 4

Complete Gender, Ethnicity and Race

Click Continue to Step 5

Respond to the CEU credit questions

Click Continue to Step 6

Complete the information for NWHSU

Click Continue to Step 7

Select Curriculum

  • Click Complete Registration
  • Click Finalize Registration

Once registration is finalized, you may complete the required and optional modules as described in the policy. After completing the modules, you may save your completion report.

Note: the NWHSU IRB administrator is able to look up your account and verify course completions and scores.

For questions about CITI registration and courses, please contact:

Institutional Review Board
irb@nwhealth.edu