Institutional Review Board for the Protection of Human Subjects

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. How long will I wait for approval of my 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?

Before starting a project at NAU, nearly all proposed research focused on human participants must be evaluated and approved by the Institutional Review Board (IRB). 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 that all research be conducted within the highest possible legal requirements and ethical principles.

Participation in projects must be voluntary. In addition, 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. Often, additional ethical standards are applied in many disciplines.

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.

3. Are some projects not reviewed by the IRB? Yes, projects are not reviewed that 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:

• All 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.
• All research projects that may present risk to participants, including physical, social, or psychological risk.
• All dissertations or theses researching human participants.
• All research initiated by faculty or staff focused on human participants.
• All training programs with a research component, regardless of the source of funding.

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 following checklist is used by the IRB:

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. Is the application 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.

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. How long will I wait for approval of my application?

If your project qualifies for exempt and expedited review, expect to hear from the IRB within 10 working days of submitting your application.

Response to applications depends on:
(a) the degree of risk,
(b) the sensitivity of the topic researched,
(c) any special or vulnerable groups or situations that may be involved, and
(d) the soundness of research design.

If your project requires Full Board review, you will hear about this status within 10 working days of submitting your application. Then, you will hear back from the IRB within 2 days after the board meeting in which your application was reviewed.

See detailed information:
Calendar of IRB meetings
Instructions for Students, Faculty, and Researchers Applying for Approval from the NAU IRB

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.

American Psychological Association

NHGRI Ethical, Legal, and Social Issues Program

Office of Medical Bioethics, Univ. of CA at Calgary

NAU Sites: