1. When and why do I need to be concerned about research review at NAU?

2. What is the definition of research?

3. Are some projects not reviewed by the IRB?

4. What kinds of projects are reviewed and what standards are used?

5. Why is Informed Consent required from human participants?

6. What are the responsibilities of the Institutional Review Board (IRB)?

7. What happens after I submit my IRB application?

8. If I obtain all the data from collaborators, do I need to obtain IRB review of my initial (new) research proposal and reviews of ongoing research?

9. Where on the Internet can I find help and additional information about researching human participants?

1. When and why do I need to be concerned about research review at NAU?

All proposed research focused on human participants must be evaluated and approved by the Institutional Review Board (IRB). (See definition of human subjects research below in 2.) In addition, some classifications of ongoing research are reviewed by the IRB at least every 364 days, or when certain changes are made to the research's scope or activities. The University requires all research to be conducted within the highest possible legal requirements and ethical principles.

Participation in projects must be voluntary. Informed Consent must be obtained from all participants or their legal representative, unless this requirement is waived by the IRB. Legal requirements to protect human participants apply to a much broader range of research than you may realize. Additional ethical standards may also be applied depending on the circumstances of the research.

Required Tutorial Module:

NAU student, faculty, and other researchers are required to have completed the NAU IRB tutorial within two years of their IRB initial application. The NAU IRB uses The Collaborative Institutional Training Initiative (CITI) program as its required tutorial. All NAU faculty, staff, and students planning to conduct research or work on a research project as key personnel must successfully complete (80% or better) the tutorial. Please refer to the instructions on how to register for the CITI course and take the IRB tutorial.

If you are not certain about the need for IRB approval, you should discuss your questions with your professor, faculty sponsor, department chair, dean, and/or institute/center supervisor. You may contact Paula Garcia at 928-523-4236 or 928-523-4340 to ask about this.

2. What is the definition of human subject research?

"Research" means a systematic investigation, including research development, testing, and evaluation, designed to devleop or contribute to generalizable knowledge.

"Human subject" means a living individual about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.

If your project does not fit both of these definitions, your project may not require IRB approval.

3. Are some projects not reviewed by the IRB? Yes, projects that do not require IRB approval are similar to the following examples:

• Gathering or asking only opinions about political candidates or issues, without recording or revealing any details that could identify the person.
• Gathering or asking only opinions regarding American-made vs. foreign made products, without recording or revealing any details that could identify the person.
• Gathering or asking only opinions concerning environmental issues or policies, without recording or revealing any details that could identify the person.
• Gathering or asking only opinions/preferences about the participant's favorite television show, preferred vacation spot, musical preference, etc., without recording or revealing any details that could identify the person.

These examples reveal nothing about a person's experiences, behaviors, and/or identity. Therefore, no IRB review is required.

4. What kinds of projects are reviewed and what standards are used?

4.A. Projects that require IRB review:

• Projects that gather or ask for an individual participant's name, social security number, description, ethnicity or other voluntary or involuntary group membership, or any other substantial identifier.
• Research projects that may present risk to participants, including physical, social, or psychological risk.
• Dissertations or theses involving human participants.
• Research initiated by faculty, students, or staff focused on human participants.

4.B. Review of proposed research is conducted to meet all ethical guidelines, insure the protection of research participants, and provide compliance with University and international research guidelines.

For example, research focused on human participants often involves:

Private information, such as survey responses, educational records, medical information, etc., that can be identified with an individual - even if the information was not specifically collected for your research.

Legal permission from adults, minors, and children, such as the need for Informed Consent, the kind of consent(s) needed, and the manner of obtaining consent.

Safeguards, such as plans that must be put into place for protecting the confidentiality of the participants and their relatives.

Materials that are obtained from the participants - even if you did not directly collect the materials. This includes:
(a) audiotapes, videotapes, computer technology, or photography of any type, and
(b) cells, blood, urine, tissues, organs, hair or nail clippings, etc.

4.C. The IRB considers the following when reviewing your application:

Research requirements
1. Are risks to participants less than, equal to, or greater than minimal risk?
2. Are risks minimized?
3. Are risks reasonable in relation to the anticipated benefits?
4. Is the selection of participants equitable (e.g., in recruitment, are participant populations included or excluded; is there a risk of coercion or excessive compensation)?

Language used
5. Are the application and informed consent documents written simply enough that an 8th grade student can understand it?

Informed Consent
6. Is the process of obtaining Informed Consent appropriate? (adult consent, child and minor assent)
7. Are the Informed Consent Documents (download from IRB homepage) appropriately written for the participants' age level, reading level, and native language?
8. Are the Informed Consent documents appropriately written for the participants' age level, reading level, and native language?

Safety and Confidentiality
9. Are the provisions for monitoring data adequate to insure the safety of the participants?
10. Are there adequate safeguards to protect the privacy of the participants?
11. Are the provisions for maintaining confidentiality adequate?

Monitoring and Expertise
12. For either an Expedited or a Full Board Review: will a periodic Continuing Review once a year be sufficient?
13. Do the Principal Investigators and Key Personnel have appropriate expertise to perform their responsibilities?

5. Why is Informed Consent required from human participants? To insure that all people:

• Voluntarily agree to be a part of the research,
• Are fully informed of the research process and procedures,
• Are fully informed of the risks and benefits, and
• Are protected against any possible violation of privacy or confidentiality that could cause harm to themselves or their relatives.

When implementing informed consent, be sure to have 2 copies of your consent form per participant - one for them to keep and one for them to sign and return to you.

6. What are the responsibilities of the Institutional Review Board (IRB)?

A. Education, training, and assistance for faculty, staff, and students who are involved in research.
B. Periodic Continuing Reviews of ongoing research are held at least every 364 days (Federal rule), or when changes are made to a project's scope or activities that may result in a different classification.
C. Review of each Application for IRB Approval through one of these processes:

Exempt from Periodic Continuing Review. Research that
(1) poses no risk (physical, social, or psychological), but information is gathered or obtained about personal experiences, behaviors, and/or identity. These projects
(2) begins with an Initial Application for Approval of Research,
(3) uses the Informed Consent Process if applicable,
(4) safeguards the confidentiality of all participants, and
(5) has no periodic Continuing Reviews.

Expedited Review. Research that
(1) meets the Minimal Risk criteria,
(2) uses the Informed Consent Process,
(3) safeguards the confidentiality of all participants, and
(4) involves only procedures and activities similar to those listed in Section 5.B.1. - 5.B.9 of the IRB Reference Document.

Full Board Review. The evaluation process used whenever there is:
(1) a possible risk greater than minimal risk (physically, socially, or psychologically); or
(2) a sensitive topic area is being researched; or
(3) research with participants who are in special or vulnerable groups or situations similar to those listed in IRB Reference Document, Section 5.C.3.

7. What happens after I submit my IRB application?

Once your application is submitted to the IRB (after approval from your faculty sponsor if you have one), the IRB has 10 working days to respond to your application with either 1) notification that your project will be reviewed by the fully convened board; 2) a request for revisions, or missing elements or documents; 3) approval under exempt or expedited review; or 4) a determination that your project does not require IRB review.

Once your project is approved, you will recieve an approval letter from the IRB and, if your project included signed informed consent, consent forms stamped and dated with IRB approval. Research protocols involving human research subjects may not be implemented prior to written notification of IRB approval. Also, researchers should not begin to recruit participants prior to securing IRB approval.

When you receive your approval letter and stamped informed consent forms (if applicable), you may begin your research.

8. If I obtain all the data from collaborators, do I need to obtain IRB review of my initial (new) research proposal and reviews of ongoing research?

Yes, both you and your collaborators must have approval from the IRB at your respective institutions - unless:
(a) the IRB classifies your research proposal as Exempt from Periodic Continuing Reviews (those conducted at least every 364 days by Federal rule), and
(b) no changes are made to the ongoing research that alters the Exempt classification.

9. Where on the Internet can I find help and additional information about researching human participants?

Office for Human Research Protections (OHRP) The Federal agency that oversees research in the U.S.

The Belmont Report lists safeguards for protecting the rights of all human participants.

The Declaration of Helsinki provides ethical principles for medical research involving human subjects.

45CFR46 outlines the federal laws, guidance, and regulations on human subjects research.

American Psychological Association provides guidelines for ethical human subjects research in the field of psychology.

NHGRI Ethical, Legal, and Social Issues Program provides guidance from the National Human Genome Research Institute.

NAU Sites: