What is Human Subjects Research?

Human Subjects Research (HSR) is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge that involves human subjects, or an individual or individuals about whom an investigator is conducting research.

This informative video from the U.S. Department of Health and Human Services reviews Social and Behavioral Research studies and the impact they can have on human subjects who participate in them. It's good to look at this topic from the perspective of someone who might participate in a research study, because that way people who propose studies can better understand how to structure their research in an ethical way.

What is the IRB?

IRB stands for Institutional Review Board. To learn more about what an IRB is and what it does, watch the video (below) from the U.S. Department of Health and Human Services.

Please note that IRB approval MUST BE SOUGHT AND OBTAINED BEFORE BEGINNING ANY RESEARCH ACTIVITY OR STUDY PROCEDURES, including:

• Identification of potential subjects (who will you be researching)
• Recruitment efforts (how will you get people to participate)
• Data collection (how you will collect AND where you will store any data)

The IRB CANNOT RETROACTIVELY APPROVE research activity.
 

The University of Iowa has its own Institutional Review Board (IRB) office. 

What do I need before I start working with the IRB?

CITI Training is not required to complete an HSRD form, but will be required to complete an exempt or IRB approval applications. If you're submitting an HSRD form, go ahead and complete the Student PI Training.

Does it need IRB approval?
 The Human Subjects Research Determination Form!

If you are doing a research study that involves individuals, the HSO and IRB must review your proposed study and say that a.) it does not require IRB approval b.) it requires an exempt application or c.) it requires a full IRB application.

You cannot do or start the study then ask for approval. 

To start the process, complete the Human Subjects Research Determination Form that the IRB evaluators will use to determine your approval status.

Three Examples

Here are three examples of studies, either fabricated or real-life examples used with permission, that illustrate how the IRB process could or has been applied to School of Music research applications. 

Example #1: The composer interview

A student is planning their dissertation project, which will be an audio recording of repertoire by a living composer. There are few written resources about this composer, other than a scant Wikipedia entry, a few recording reviews, and a biography posted to the composer's website. The student would like to interview the composer about their life and work, with particular attention to the works they are recording for their project. 

1. At the proposal stage, the student includes that they plan to interview the composer, pending IRB approval. 
2. After their proposal passes, the student completes the Student PI Training.
3. The student completes the Human Subjects Research Determination Form in the HawkIRB system.
4. IF the student receives notification that their project is not considered human subjects research: The student contacts the composer and arranges for the interview to take place. DESPITE not needing IRB approval, the student has the interview subject sign a statement of consent as to how the interview will happen, be recorded and how the content will be used by the student. For more information on consent forms, contact the music librarian. 
5. IF the student receives notification that their project is considered human subjects research: The student will complete either the exempt or full form, as instruction by the UI IRB office. 

Example #2: Surveying the discipline

A researcher is interested in the attitudes of faculty, staff, and students in the School of Music concerning performance and study of music by composers from historically underrepresented groups, in particular those living and working today. They would like to recruit participants via email and administer the survey online. They would like to invite survey participants to be interviewed with a set of follow-up questions via an online video or audio call. The goal would be to present the data at conferences, to School faculty, staff, and students, and to publish an article of the findings. 

1. If the researcher is a student, they complete the Student PI training.
2. The researcher completes a Human Subjects Research Determination Form in HawkIRB.
3. The researcher received notification that the study is considered human subjects research, but can proceed through the exempt application because it presents minimal risks to the study participants.
4. The researcher completes the CITI training.
5. The researcher completes an Exempt application in HawkIRB. The following decisions about the study are of particular note.
   • The researcher selects Qualtrics as the online survey tool. This software is hosted and managed by the University of Iowa, and therefore meets a desired threshold of privacy and security for the data gathered.
   • The research elects to use University managed email lists targeted at undergraduate music students, graduate music students, music minors, and music faculty and staff for distributing the invitation to participate. No public forums, such as social media, are utilized to maintain the integrity of the targeted population.
   • The researcher selects Zoom for conducting the post-survey interviews. All participants are brought into the meeting with video off and are allowed to decide whether or not to turn the camera on. 
   • The researcher stores all their data in their University-managed OneDrive account, and therefore meets a desired threshold of privacy and security for the data gathered.
   • The researcher uses the various document tools available in the IRB application to craft their invitation email, consent forms, and other documents required for the application. 
6. The researcher receives comments from the IRB with required revisions. The researcher makes all needed revisions. Completion of revisions may involve more than one round of edits.
7. The researcher's application is approved. They conduct the study as outlined in the application.

Location

The HSO office is located in the Hardin Library for the Health Sciences, first floor (Suite 105).

Hours

Monday to Friday, 8:00am-4:30pm
Saturday to Sunday: CLOSED

Contact

Phone: (319) 335-6564

Email: IRB Directory