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Human Subject Research and the IRB

IRP Processes and Procedures

Library Subject Guide

Human Subject Research and the Institutional Review Board

Subject Guide

Introduction to Human Subject Research

According to Title 45 Code of Federal Regulations Part 46 (45 CFR 46),  (a-j), research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.”

National American University's (NAU) Institutional Review Board (IRB) is an authoritative body to ensure the protection of human subjects through the review, approval, modification, or disapproval of research applications submitted by faculty, staff, student, and/or external investigators. Therefore, any research project involving human subjects which is conducted by NAU faculty, staff, students, or external persons (or that takes place on any NAU campus or as a part of an academic affiliation agreement) is subject to review and approval by the NAU IRB. The IRB is further responsible for communication, recordkeeping, reporting, monitoring, education of the university community about ethical issues, and oversight of all research activities involving human subjects.  The IRB is guided by ethical principles outlined in the Belmont Report (1979), the Declaration of Helsinki, and the Nuremberg Code. and legal mandates outlined in the Title 45 Code of Federal Regulations Part 46 (45 CFR 46), (2017).  

NAU's Institutional Review Board (IRB) is guided by National Institutes of Health Regulations and Ethical Guidelines and underlying principles established by Title 45 Code of Federal Regulations Part 46 (45 CFR 46), the Belmont Report, the Declaration of Helsinki, and the Nuremberg Code.  NAU's IRB will review all research proposals in accordance with the policies and procedures outlined in the NAU Institutional Review Board Procedures Manual.  

There are two questions you must answer prior to moving forward on the decision of if you will need IRB approval: Is it research and is the research on human subjects?

1. Is it research? According to 45 CFR 46.102 (a-j), research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.”

a. Are you conducting an investigation, an inquiry to gather facts, an experiment, or an examination of a specific phenomenon?

b. Is it systematic, involving a method, system, or plan that will be used consistently throughout data collection? 

c. Will your results be presented as representing a larger population than the sample you recruited? 

d.Will your findings be presented beyond a class setting such as presenting at a conference, publishing in a peer-reviewed journal, or used in a graduate-level thesis or dissertation?  

If you answered NO to EVERY question, you are not doing research.  However, if you answer YES to ANY question 1a-d, you are conducting research.  

2. Is human subject research? According to 45 CFR 46.102 (f), “Human subject” means a living individual about whom an investigator (whether professional, faculty, or student) is conducting research to obtain data through intervention or interaction with the individual or collects identifiable private information.

a. Does the research involve human subjects or said another way, does your research involve living human individuals in any way, even previously collected data from any source on a living human? 

NO? If you can answer no to question 2.a. IRB approval is not necessary. 

YES? You need an IRB review.  

Training

All research on human subjects requires IRB application and CITI training. 

The training is available at https://about.citiprogram.org/en/homepage/ 

All Human Subject Research requires IRB application and CITI training. You should take the training as recommended in CITI and listed under National American University.   However, you must as a minimum complete the "student version minimal risk research" to get started.  

The training is available at https://about.citiprogram.org/en/homepage/ 

Choose “REGISTER” tab on the CITI home page. 

If you have already registered, even with a different institution, click “LOG ON” tab.  Do NOT choose “LOG IN THROUGH MY INSTITUTION” as NAU does not use a single sign-on with CITI.  

Once you are in the program.  Choose “COURSES” tab.  

All institutions that you are affiliated with will show.  

If you do not see NAU as a choice, you will click on “Add an Affiliation.”  Choose “National American University” as your affiliation.  We recommend that you do NOT remove an affiliation as all previous training you have taken anywhere can be shared between the affiliation records.  

Once you have added NAU as your affiliation, select the course or courses you need to take.  

If you are uncertain, answer the quiz that will get you started. 

 

Click the title of a course to begin or continue the course.
 

  • Your must first complete the Integrity Assurance Statement presented at the top after clicking a course title. The system will not allow you to start the course modules until you have clicked the "accept" boxes.
     
  • To complete and pass a course, you must achieve an average minimum passing grade on (1) the quizzes associated with Required modules set by your institution; and (2) the quizzes associated with the minimum number of Elective modules the institution has specified, if any.
     
  • Note that for some courses the institution has specified a required minimum grade per quiz, in addition to the minimum average score for the quizzes overall. If set, you must also meet this requirement to pass.
     
  • Institutions may also include Supplemental (optional) modules with a course. These are entirely optional, and scores on the associated quizzes do not affect passing requirements. You may return to the course at a future time to review these modules if you prefer.

When you meet the course passing requirements, you will be presented with a menu of options for what to do next:

 

Possible IRB Outcomes

EXEMPTED IRB:  If the research DOES involve living human subjects and yet qualifies for an exemption from an IRB review, complete the exemption checklist in the course. Possible reasons for exemption are identified Title 45 Code of Federal Regulations Part 46 (45 CFR 46). Students MUST submit all paperwork to the IRB. think of it as exempted from the necessity of an IRB meeting to review but not exempted from submission.  Reasons for exemption currently include the following:

• Specific educational practices and setting involving normal educational practices such as instructional strategies, effectiveness, and instructional techniques, curricula, or classroom methods and the and the research is not FDA-regulated or involving special populations such as prisoners (not likely to be used in strategic security studies)

• Anonymous educational tests, surveys, interviews or observations unless information obtained by recording, discloses the responses, involves special populations such as children and prisoners or is FDA regulated (not likely to be used in strategic security studies)

• Special circumstances of educational tests, practices, and settings not addressed above if the human subjects are elected or appointed for public office or the federal state(s) require without exception confidentiality of personally identifiable information and the research is not FDA-regulated or involving prisoners (not likely to be used in strategic security studies)

• Collection or study using existing data, documents, records, pathological specimens, or diagnostic specimens if those sources are publicly available or if the information was recorded in such a way that the subjects cannot be identified, directly, or through identifiers linked to the subject and the research is not FDA- regulated or involving prisoners (most likely exemption for strategic security studies)

• Public benefit or service program which is conducted by and subject to the approval of a federal department or agency head and are designed to study, evaluate, or otherwise examine federal public benefit or service programs, procedures for obtaining those benefits, alternatives or changes of those benefits, or methods of payments or levels of payments for those benefits. Additionally, they must be conducted under federal statutory authority, have no statutory requirement for an IRB, do not involve significant physical invasions upon privacy, have federal funding, are not FDA-regulated or involving prisoners

• Taste and food evaluations as approved by the FDA but not involving prisoners

EXPEDITED IRB: If the study proposed involves living human subjects but does not fall into one of the federally specified exemption categories, it must meet one of the nine expedited review categories or have a full IRB approval. Expedited and full reviews require the candidate to take the CITI training. Expedited review may be used if the study falls into one of the following nine categories and is found to be of minimal risk (low probability and magnitude of harm and discomfort anticipated are no greater in and of themselves than those ordinarily encountered in daily life):

  • Clinical studies of drug and medical devices under certain circumstances (not likely to be used in strategic security studies)
  • Collection of blood samples by finger stick, heel stick, ear stick or venipuncture under certain circumstances (not likely to be used in strategic security studies)
  • Non-invasive collection of biological specimens for research purposes under certain circumstances (not likely to be used in strategic security studies)
  • Non-invasive collection of data from clinical practice excluding x-ray and microwaves for research purposes under certain circumstances (not likely to be used in strategic security studies)
  • Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research means such as medical treatment or diagnoses (not likely to be applicable to dissertation candidates)
  • Collection of data from voice, video, digital or image recordings made for research purposes under certain circumstances
  • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies (most likely exemption for strategic security studies)
  • Continuing review of research previously approved by the convened IRB where the research is permanently closed to the enrollment of new subjects, all subjects have completed the intervention, and the research remains active for long-term follow- up or where no subjects have been enrolled and no additional risks are identified or where the remaining research activities are limited to data analysis (not likely to be applicable to H-PSSS dissertation candidates).

  • Continuing review of research where categories 2-8 above do not apply but the IRB has determined and documented at a convenes meeting that the research involves no greater than minimal risks and no additional risks have been identified (such as a candidate needs more time than the original full IRB granted)

FULL IRB: A full IRB must be conducted if data is collected on any special or vulnerable population, including children and minors 17 years of age or younger, adults 65 years of age or older, medically or psychologically vulnerable persons, institutionalized persons, prisoners, parolees, probationers, economically vulnerable populations, military or veteran persons, non-English speakers, international persons, pregnant women, or any other special population covered by the law.

The IRB determines if the criteria for IRB approval have been met and may take one of the following actions:

  • APPROVE: the research procedures as being adequate to protect the rights and welfare of human subjects and to meet the standards for informed consent;
  • APPROVE SUBJECT TO MODIFICATIONS: regarding the treatment of human subjects to protect their rights and welfare;
  • DISAPPROVE: research procedures as violating the rights and welfare of human subjects; or
  • DEFER ACTION on the proposal pending receipt of more information or further clarification of specific items.
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