Office Of Human
Research Protection Program

National University Campus

The Office of Human Research Protection Program (HRPP) is a comprehensive system designed to ensure the protection of the rights and welfare of participants in human research. The HRPP is comprised of institutional leadership; Human Research Protection Program Administration, which includes the Institutional Review Board (IRB), investigators and their study staff, department chairs, and other relevant offices.

Human Subject Research

Does my project need IRB review?

Are you planning a research project involving people or their personally identifiable information as the basis of your analysis? If you answered “yes” then you need to figure out if your project has to be written up for review by National University’s Institutional Review Board (IRB) before you commence research activities.

Research in any field of study can be designed in such a way that it meets the criteria for “research involving human subjects” or not. Research that is involving human subjects requires review by an IRB before research commences.

Some research designs do not require IRB review, so you must first determine if your project is or is not “research involving human subjects” per the Code of Federal Regulations Title 45, Part 46 (45CFR46), and Title 21, Parts 50, 56, 312 and 812 (21CFR50, 56, 312 & 812).

This determination can be made by initiating a new submission in Cayuse. Follow the Quick Start Guide to get your project started. The IRB will respond within 5 business days.

Elements of Human Subjects Research

There are two critical elements to figuring out if your research project meets the criteria for requiring review:

  1. Does your research design require an IRB to review it?
  2. AND
  3. Does your research involve “Human Subjects?”

Research Designs Requiring IRB Review

The Code of Federal Regulations (45CFR46 & 21CFR50, 56, 312 & 812) requires an IRB review of projects which are systematic investigations, including research development, testing and evaluation, or designed to develop or contribute to generalizable knowledge. What does that mean?

Systematic Investigation

This refers to the components of a research design including your procedures, methods and instruments.

Indicators

  • Your project is designed to explore cause-and-effect relationships among a set of factors (e.g., independent variables) and your topic (dependent variable)
  • Your project is systematically organized in such a way that you can test your hypothesis/research question

If your project doesn’t do either of the above, then your research probably doesn’t meet the criteria for a systematic investigation.

Development, Testing, and Evaluation

Indicators

  • You are using an existing, valid, and tested instrument
  • If you’re developing your own instrument (e.g.: questionnaire), you intend to test it, evaluate it, improve it, and repeat the data collection

If not, then your research probably doesn’t meet the criteria for development, testing, and evaluation.

Develop or Contribute to Generalizable Knowledge

It is widely accepted that this refers to making the components of your research design (procedures, methods, and instruments) as well as your analyzed findings available for other professionals and/or academics to peer review, replicate, and utilize.

Indicators

  • Publishing in a peer-reviewed journal or publication
  • Presenting at a peer-reviewed venue or conference
  • Presenting at a professionally refereed competition (including student research competitions)
  • Sharing through new-media methods of professional discourse

Research Subjects Requiring IRB Review

The Code of Federal Regulations (45CFR46 & 21CFR50, 56, 312 & 812) defines a “Human Subject” as a living individual about whom an investigator (whether professional or student) conducting research obtains a data through intervention or interaction with the individual or identifiable private information. What does that mean?

Intervention

Common forms of data collection that involve intervention with human subjects include:

  • Physical procedures (e.g., fatigue stress tests)
  • Manipulations of the subject’s environment that are performed for research purposes (e.g., response induction techniques)

Interaction

Common forms of data collection that involve interaction with human subjects include:

  • Observing (in places where an individual could reasonably expect not to be)
  • Surveying (by instrument or questionnaire)
  • Interviewing (systematically across all participants)

Identifiable Private Information

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Common forms of data with identifiable private information involving human subjects include:

  • Student or health records with identifiers
  • Immigration status records with identifiers
  • New media forms of individual disclosure which are not made public but you have access to by privilege or accident

What Doesn’t Meet The Criteria

  • Data from deceased individuals
  • Irrevocably de-identified data made publicly available (e.g., public health data)
  • Coded data made available by authorized institutions and the researchers have no way of ascertaining any individual subject’s identity

Additional Precautions

Some research (whether Human Subject Research or not) may pose a special risk if it:

  • Involves protected or vulnerable populations
  • May cause participants harm (e.g., psychological, physical, legal, social, and/or economic) during data collection or if it’s ever revealed
  • If the research activities pose a risk to you as the researcher

In these circumstances, you must contact the university’s Risk Management Department regarding “Special Risk” assessment.

Next Steps

If you are unsure whether your research requires IRB review, you can submit an initial submission in Cayuse. By answering a few questions under the General Information and Study Objectives and Background tabs, the IRB will be able to determine whether you need IRB oversight for your project. You can expect a response within five business days.

If you think your research requires IRB review, continue on to Training and Certification below. If you’re a student, talk to your faculty advisor about submitting your project for IRB review. If you know your certification in the protections of human subjects is current and valid, continue on to Prepare and Submit.

Human Subjects Research Training

Who Needs Training?

The NU IRB requires all students, staff, and faculty who will be conducting research with human subjects, supporting research (e.g., faculty sponsor or co-investigator), or teaching a research related course to be certified in human subjects protections prior to submitting a protocol or teaching a research class.

Online Training

Collaborative Institutional Training Initiative (CITI)

National University subscribes to the Collaborative Institutional Training Initiative (CITI) online training program. Any researcher affiliated with NU may complete CITI Program training. CITI training is recognized by the NU IRB and professionally for exceeding minimum standards of training in the protection of human subjects.

When you complete the modules, you should save the CITI certification. You will be required to upload it to your IRB protocol document during your review. You may also log back into CITI at any time to reprint your certificate, add training in other areas we subscribe to (e.g., Responsible Conduct of Research, etc.), or change affiliation to another subscribing institution (e.g., graduate school).

If you are new to NU from another CITI-subscribing institution/university, follow these instructions to transfer your CITI certification credits to NU. Each institution/university subscribes to the modules of their choice so you may be required to complete additional modules in order to meet NU’s certification standards (but you will not have to repeat modules we have in common).

Social-Behavioral-Educational (SBE) Modules

At a minimum, CITI Basic Course modules must be completed. Additional Human Subjects Research (HSR) training may be required at the discretion of anyone signing off on the protocol, including the IRB.

Note: Researchers proposing to use or collect HIPPA-protected, personally identifiable private health information may also be required to complete Information Privacy Security training (see below).

Additional Training for Use of Private Health Information

Researchers proposing to use or collect HIPPA-protected, personally identifiable private health information may be required to complete Information Privacy Security training at the discretion of anyone signing off on the protocol, including the NU IRB.

CITI Training Login

https://www.citiprogram.org/

CITI Knowledgebase (Help)

http://citiprogram.desk.com/

Prepare and Submit

Prepare Your Application

Download and follow the Quick Start Guide to get started. You will need to begin gathering the necessary materials for submission.  These include consent forms, recruitment forms (e.g., flyer, script, etc.), and site permission forms. See Site or Population Access Authorization below.

Site or Population Access Authorization

NU researchers (student, staff, and faculty) conducting research off campus in any place other than public space will need to obtain permission to collect data from the site(s). This may be documented in the form of an email with the person who has the authority to grant access.  For example, if a researcher is interested in surveying employees of an organization, permission must be granted from someone at the director-level position or above.

For NU researchers (student, staff, and faculty) conducting research on campus with NU populations (student, staff, or faculty), permission must be obtained through the Provost’s Office. Please download the proper form.

IRB Support

The IRB office is here to help.  Please feel free to contact us with any questions you have.

Brianne Mongeon, MA, MS, CIM
Assistant Director, Academic and Research Integrity
bmongeon@nu.edu(858) 642-8384

Jenessa Eberhardt
IRB Analyst
jeberhardt@nu.edu(858) 642-8134