IRB/Human Subjects Protection

IRB/Human Subjects Protection Program
Revised: August 2008

Whenever a university employee, student, or affiliate intends to conduct a study for purposes of presentation or publication of research that involves human beings (including, but not limited to, interviews, surveys, observation of behavior, or analysis of writing), they must seek the approval of an Institutional Review Board (IRB) before the research begins.  Researchers who fail to obtain permission to conduct research before the research begins are often denied permission to use any data they may have obtained prior to gaining IRB approval.  Casual observations of classroom behavior or student writing that later seem to be worthy of research and research conducted for a graduate seminar involving human participants can be approved after the fact by the IRB because the researcher had not intended to conduct a study for purposes of presentation or publication at the time the potential data was collected.  The University of Arizona's IRBs are administered by the Human Subjects Protection Program (www.irb.arizona.edu).  Permission of the IRB is not needed for research that is conducted solely for the sake of internal evaluation (e.g., a survey administered in the Writing Program that will never be published or presented to anyone other than staff).  In all other cases, federal law stipulates that the researcher must contact their IRB to learn whether their research involving human participants is subject to IRB oversight.  The RCTE Program strongly recommends that all faculty and graduate students complete the training to conduct human subjects research (further information is available at www.irb.arizona.edu); the Program also recommends that all faculty and graduate students become familiar with the National Council of Teachers of English Position Statement on Guidelines for the Ethical Conduct of Research in Composition Studies (available at www.ncte.org).

This section serves as a reminder and clarification of the human subjects review process for graduate student research. Established University policy requires that any research involving human subjects (not only clinical work but also surveys, interviews, etc.) must be reviewed prior to study conduct in order to fulfill the University's obligation to protect human subjects. Each student who wishes to conduct research with human subjects must have his/her own approval. Students are the lead investigators on theses and dissertations and obtaining the necessary clearance constitutes responsible research conduct and forms a part of the professionalization process. Please note the following:

1. Responsibility
It is the responsibility of the faculty member (graduate student's thesis/dissertation adviser or committee chair) to advise the student about obtaining clearance from the Human Subjects Protection Program (HSPP) prior to the start of the research. If the thesis or dissertation involves human subjects, the approval or exemption notice from the HSPP
must be attached to the relevant Graduate College form (Master's/Specialist Plan of Study form or the doctoral Advancement to Candidacy form).

2. No "Grandfathering"
Student research carried out via another individual's approved project, such as a work conducted on a faculty member's research grant or use of data obtained from an existing project is not automatically "grandfathered" for approval. Separate approval is required for Master's thesis and PhD dissertation projects. Please refer to the HSPP web site at www.irb.arizona.edu for the required application form.

3. Exemptions
The HSPP web site includes a decision-tree tool  (http://www.irb.arizona.edu/decisiontree/index.htm) to help determine if a research project meets the Federal definition for exemption from federal regulations. However, all research conducted with human subjects must be reviewed and approved by the Human Subjects Protection Program office. This includes projects that might be determined to be exempt from Federal Regulations.

4. Continuing Review
Federal Regulations require that existing projects involving human subjects, which include theses and dissertations as outlined above, be reviewed by an Institutional Review Board (IRB) no less than annually. The annual review process is explained on the HSPP web site and covers re-approval as well as conclusion or withdrawal of projects. For example, this applies to students that have not concluded their dissertation research projects within one year of receiving approval.

We raise the above points because the Graduate College and the Human Subjects Protection Program have recently had the unfortunate duty of denying or delaying graduation to a number of graduate students who did not obtain the necessary human subjects approval in advance of the thesis or dissertation research. Please be advised that there is no way to obtain retroactive approval for a research project. A particularly distressing situation occurs when a student's faculty adviser signs a Graduate College form stating that human subjects are not involved, and upon submission of the thesis or dissertation it becomes clear that this was not the case.

We urge graduate students and faculty members to consult the HSPP website (http://www.irb.arizona.edu) as part of the thesis and dissertation proposal development process, as well as in research design and professionalization courses. For further assistance, please call the HSPP office at (520)626-6721.

Human Subjects Review

Chronology

1.  If you are proposing to do a project that involves human subjects (interviews, oral
histories, observation studies, and/or experiments), you should begin the process of receiving review and approval from the Human Subjects Protection Program now.  Please visit the Human Subjects Protection Program (HSPP) website to familiarize yourself with the process. http://www.irb.arizona.edu.

2.  The first thing you should do is to determine if your project uses human information or is actually research on humans. 

3.  Copies of Protecting Study Volunteers in Research: A Manual for Investigative Sites (Dunn and Chadwick, 2001) are located with the Program Assistant.  Read through this book to familiarize yourself with the issues before you take the online training. Their definition of research is the one used by the Code of Federal Regulations and The University of Arizona:

 Research means a systematic investigation, including research development,
 testing and evaluation, designed to develop or contribute to generalizable
 knowledge. Activities which meet this definition constitute research for purposes
 of this policy, whether or not they are conducted or supported under a program
which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (200)

4.  Students who use human information and/or conduct research on humans for any purpose other than seminar papers (done within a graduate course) must take the Collaborative Institutional Training Initiative (CITI) with a Social Behavioral Science focus [CITI-SBS].  This is an online training module with self-paced lessons and exams.  The entire training will take 6 or more hours for most people (and students can take the modules over several days).  After completing the CITI-SBS, students must print off the verification of the training and the dates when the exam was passed. 

5.  The next step is to complete the Project Review Form and the Verification of Training Form (VOTF).  It is necessary to have an adviser for both the PRF and VOTF who has completed CITI-SBS training.  Important: this adviser does not have to be the dissertation director or even a committee member. 

6.  Students must also obtain a “site authorization letter” for the location where the research (including recruitment) will occur (Writing Program, high school, community organization, church, etc.).  The letter needs to come from the principal or director or minister of the site.

SCENARIOS

For the purposes of research, information from student writing/experiences/interviews is considered human data or information.  What matters to the HSPP is
• what you are using it for,  and
• whether you are gathered it for research purposes

What is research? Ultimately, the decision on whether the use of human information meets the definition of research is up to the researcher.  For example, researchers get ideas about research by being in the genre of their environment.  We use our senses to absorb information that may or may not turn into a theory that then turns into a research project.  Always ask yourself what your purpose is in using human information.  If you have human information to support a theory, if you have a collection mode to talk about, then you have probably conducted research. 

What if you are giving an oral presentation or writing a paper for a graduate course at UA and you cite student work, conduct student interviews, or cite student experiences or incidents in your own class to support your own argument?

This use of data falls under the purview of educational work and does not require that you take
CITI nor that you get Human Subjects Protection Program (HSPP) approval.  However, 
if you change your mind and you ever want to use this data for a conference or publication paper you would then need approval from the Institutional Review Board (IRB) of the Human Subjects Protection Program for use of that information for research purposes.

What if you quote a student conversation, narrate an incident, summarize something a student wrote – all anonymously – in a conference presentation or publication?

If the use of this data is a single event, it is probably not research.  If, however, your observations are
becoming part of a research agenda, then you should set up an open project with HSSP that will
allow you to collect narrative observations, take notes, audiotape, etc. over a course of 5 to 10 years.
You would get disclaimer forms approved, take the CITI, and thereby enable the use of this
kind of human information over time.

What if you are giving a paper at a professional conference or sending a paper off for publication and you plan on using anonymous samples of student work/interviews/experiences with students in your paper?

You need to take the CITI training because you are “using human information.” 
At this point, however, you are conducting research.  You do not need to get
consent from the students to cite their work because the information (data) is now
anonymous. However, you do need to get Human Subjects Protection Program
(HSPP) approval.

In other words, you can collect the information for non-research purposes and then
decide later to use the information in a publication or for presentation. This is called
pre-existing data.  If you want to do this you would complete the Project Review Form
and indicate that the data was collected for another purpose and that you would like to
use it now for research.

What if you are giving a paper at a professional conference or sending a paper off
for publication or writing a dissertation and you are using student work to support research you conducted (e.g., comparing two groups of students with different variables, collecting all student writing over one or more semesters in order to understand some aspect of writing, etc.)?

You need to take the CITI training.  In addition, you must complete the Project Review
Form and the Verification of Training Form (VOTF) prior to conducting your research. Because you are a graduate student, you must have an adviser who has CITI training and who will sign off on your work (this individual does not have to be your dissertation director or even a member of your committee).  In addition, you need to complete the application before you gather the data.  Finally, you must obtain a site authorization letter from the principal, director, or administrator of the site in which you conduct your research.  If minor children are involved (under age 18), you will also need parental permission from parents and child assent from the children.

Program(s): 

College of Social and Behavioral Sciences