Protection of Human Research Subjects
Pursuant to federal law and University policy, all research involving human subjects conducted by IU East investigators must be reviewed and approved by the Indiana University East Institutional Review Board (IRB). These policies and procedures are designed to provide an efficient avenue for the processing of applications. The smooth flow of applications is the only way to ensure that each research protocol is provided the level of review it deserves. Cooperation by faculty, students, and staff with the Board is essential if we are to comply with federal and University regulations. The Board recognizes that the federal regulations and our interpretations of the regulations can be daunting to an investigator on first encounter. The Board will provide whatever assistance it can to investigators or departments to explain our procedures and to secure compliance with a minimum of delay or disruption of research. We welcome suggestions for improvement of the information that is provided here on the Web.
Feel free to contact us through the Office of Academic Affairs.
The Collaborative Institutional Training Initiative (CITI) program replaces the IU Human Subjects Protection Course and Test and Investigator 101. All principal investigators, co-investigators, (anyone involved in the design, conduct, or reporting of the research, or having significant interaction with subjects) including personnel obtaining informed consent listed on an IU East IRB application will need to complete CITI training. This includes graduate and undergraduate student researchers. The CITI portal is found on the IU Office of Research Administration Research Education, Ethics and Policy (REEP) site: http://www.researchadmin.iu.edu/REEP/reep_edu.html. There are nine base modules. Modules can be added for specific research tracks. Each module takes approximately 10-30 minutes to complete. The training can be taken in sections and can be re-taken as many times as needed. Investigators need an overall score of 80% to pass. Investigators that have already completed CITI modules with other organizations can log-in through the main CITI site (www.citiprogram.org) using their CITI log-in and password and affiliate with the IU campus that applies. Upon completion, investigators will be issued a certificate that can be submitted to the IRB with study submissions. Additionally, IRB staff can look up investigators to verify completion of CITI. Investigators will be asked to complete refresher courses every three years.
Do I Need Institutional Review Board (IRB) Approval?
All research that involves human subjects, including some student projects, conducted under the auspices of IU East must be reviewed and approved by the IU East Institutional Review Board.
The IRB committee meets on a regular basis for review of submitted protocols. The deadline for protocol submission is the first working day of every month.
If submitting protocols electronically, please print one complete set of materials (with appropriate signatures) and submit to Dr. Jerry Wilde, Raper Hall 344 or Dr. Karen Clark, Hayes Hall 269/271. Electronic submissions should be sent to either Dr. Jerry Wilde (firstname.lastname@example.org) or Dr. Karen Clark (email@example.com). If submitting paper copies, please submit 7 complete sets of materials (including the originals with signatures) to either Dr. Wilde or Dr. Clark.
Is it Research?
The Department of Health and Human Services (DHHS) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”Intervention includes “both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.”
Does it Involve Human Subjects?
Human subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
What About Student Projects?
Some student projects require Institutional Review Board review. However, classroom assignments that do not involve risk, and are not intended to, nor likely to, lead to generalizable results, may not need to be reviewed.
Student studies that fit ANY of the descriptions below must be reviewed:
- Student projects that may place subjects at risk,
- Student projects that are undertaken with the intent of adding to generalizable knowledge, including:
- ANY public presentation beyond the classroom type setting
- Funded studies
- Written presentation beyond the classroom/peer setting
- Student studies that are undertaken involving special populations including:
- pregnant women
- human in vitro fertilization
Instructors are responsible for screening individual student research projects and making an initial determination as to whether the project may fall in the category of research. Institutional Review Board approval must be obtained prior to initiation of the research.
- Federal Code 45 CFR 46. This document is the section of the federal code that pertains to the protection of human subjects and the creation of IRBs and their duties.
- The Belmont Report. This document outlines the philosophical thinking behind the work of the IRB and provides the principles that all researchers using human subjects must uphold.