ORSP - Examples IRB Review

EXAMPLES OF PROJECTS THAT DO AND DO NOT
REQUIRE IRB REVIEW

Research is defined in 45 CFR 46 as, "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Human subject is defined in 45 CFR 46 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."

Research involving human subjects that requires IRB review:

1. A researcher asks children (i.e. human subjects) questions about the qualities they admire in adults. The questions are asked in a systematic way and the researcher intends to draw conclusions from analysis of the data (i.e. research).
2. A researcher asks school personnel (i.e. human subjects) about their impression of how their classroom and school size compares with other facilities in the area. The identical questions are asked of personnel in various schools in a specified area. The researcher intends to compare teachers' impressions of facility size with actual measurements of the schools, and test a hypothesis (i.e. research).
3. A medical doctor designs a study with objectives and a set of procedures to test his hypothesis regarding an unapproved use for an approved device (i.e. research). His patients (i.e. human subjects) will provide informed consent and the study conforms to FDA guidelines.
4. An internal evaluation of several departments of a health care facility will be conducted. Usual quality assurance methods will be supplemented by collection of personal data, interviews, and administration of additional tests to department personnel (i.e. human subjects). The objective is to provide sufficient data to enable conclusions to be drawn that can be applied to other departments at the institution (i.e. research).
5. A teacher compares two different methods of teaching spelling to provide the best instruction to her students. For one month, the teacher uses the traditional methods that she has used for several years. For the next month, she uses sign language techniques to teach the spelling words to her students (i.e. human subjects). If test scores indicate that the novel method is more effective than the traditional technique, as she expects it will be, then the teacher plans to discuss it at teacher conventions (i.e. research).
6. Observations will be conducted in high school classrooms during open house activities to describe how teachers (i.e. human subjects) greet parents (i.e. human subjects). The researcher is interested in determining whether parents are greeted differently based on their gender, race, ethnicity, and how they arrive (alone or in pairs). Data will be compared with the academic performance of students based on gender, race, and ethnicity in an effort to determine whether the qualities of parent - teacher interaction is one of the factors affecting student performance (i.e. research).
7. A Cooperative Extension Department is affiliated with an academic institution, and routinely performs evaluations of its programs for the purpose of dissemination of results and conclusions to other departments and institutions (i.e. research). Depending on the particular project, methodology includes surveys, interviews, focus groups, or questionnaires administered to, or conducted with, participants (i.e. human subjects).
8. A preschool for children with developmental disabilities that is affiliated with an academic institution routinely collects data about the progress of its students. Permission to collect the data and analyze it for research purposes is obtained for all students upon enrollment. IRB review is not required for routine analysis of the data that is conducted to evaluate the progress of individual students because it is not research (i.e. not intended for dissemination). However, after review of the data, the educational staff notices that a particular group of children with whom a specific educational intervention was performed are progressing at an extraordinary rate. The staff members want to perform further analyses of these data with the intention of testing their hypothesis and presenting the results at an educational conference (i.e. research). IRB review is required at this point because the purpose of the data analysis has changed from measurement of student progress to research.
9. As part of course work requirements, an undergraduate student at Rutgers must conduct a research project that involves interviews with children (i.e. human subjects). Although this project is not research according to the definition contained within 45 CFR 46, because there are no plans to disseminate the results, IRB review is required according to Rutgers policy. This exception for student course work is provided because student research utilizes standard research methods, may present risks to human subjects, and has the potential for dissemination if developed and conducted in accordance with sound scientific principles.

NOTE: Federal requirements postulated in 45 CFR 46 pertain only to federally funded research. However, in order to receive federal funds, an institution must maintain an assurance with the Office for Human Research Protections (OHRP). Most assurances, including the Multiple Project Assurance between Rutgers University and OHRP, extend the federal regulations to ALL human subjects research conducted by individuals affiliated with the institution, regardless of the funding source of the project. In addition, institutions that hold assurances are required to have procedures in place to review human subjects research that falls within one or more of the six categories of research that are "exempt" from 45 CFR 46 (review the categories at: http://orsp.rutgers.edu/humans1.html). At Rutgers, these procedures currently require review of the protocol by the IRB Exemption Subcommittee.

Research involving people that does NOT require IRB review:

1. Researchers want to test the strength of different models of rock climbing harnesses. Subordinate project staff members wearing the harnesses - attached to bungee cords - will jump off a bridge over a river, and data will be collected about the frequency and type of harness failures. IRB review is not required because data bout human subjects is not collected. (Example from Ivor Pritchard's presentation at IRB 101, San Diego, California, October 2000.) NOTE: IRB review would be required if the researcher collected data about the staff members' reasons for participating in such a risky activity.
2. A researcher telephones various schools to ask personnel about the actual physical dimensions of their school, playground, and classrooms. IRB review is not required because the purpose is to collect data about a physical structure, not about living individuals. NOTE: IRB review would be required if the researcher asked the personnel what their opinion was about the size of the facility.
3. A medical doctor develops a novel intervention, involving a combination of various therapies, that he believes will benefit an individual patient and has a reasonable chance of success based on past experience or data collected about each of the therapies involved. IRB review is not required because the purpose of medical practice is to provide diagnosis, treatment, or therapy to particular individuals. NOTE: IRB review would be required if the doctor developed a protocol to test his hypothesis about the combination therapy in a systematic way, with the intention of publishing the results in a medical journal.
4. Data is gathered for classroom training in research methods for which the only foreseeable purpose is teaching. In this case, neither the instructor nor the student teacher can foresee or anticipate any dissemination of the data gathered beyond the classroom situation. (Example from Washington University Medical Center website.)
5. Data is gathered for administrative purposes alone within the context of the normal efforts of a department or an institution to find out what is happening or how to assure quality services or operations. In other words, no dissemination of this information outside the unit or institution is foreseen or anticipated. (Example from Washington University Medical Center website.)
6. Institution A is conducting a study of 50 institutions that involves contacting faculty members at each institution and asking them to complete a questionnaire. The study was submitted to the IRB at Institution A and approval was obtained. IRB approval is not required from the 50 institutions from which faculty members will be contacted; however, Institution A must obtain authorization from each facility to conduct the study at their facility. Most IRBs at the study sites require a copy of the protocol and approval notice from Institution A.
7. A researcher plans to interview a famous person in preparation for writing a biography of this individual. In addition, the researcher will review past articles about the person, and possibly use surveillance to record his behavior. This project is not subject to IRB review because it is journalism and does not employ systematic research methods to test a hypothesis and draw conclusions.
8. A preschool for children with developmental disabilities that is affiliated with an academic institution routinely collects data about the progress of its students. Permission to collect the data and analyze it for research purposes is obtained for all students upon enrollment. IRB review is not required for routine analysis of the data that is conducted to evaluate the progress of individual students because it is not research (i.e. not intended for dissemination).
9. Samples from deceased individuals are collected for analysis related to the condition from which the individual expired. IRB review is not required because living individuals are not involved. NOTE: IRB review would be required if the condition that was being investigated had a genetic component and the family members of the deceased person were interviewed, or samples were obtained from them.

NOTE: At times it may be difficult to determine whether IRB review is necessary. For clarification, please contact Michelle Gibel, CIM, IRB Administrator, by phone at 732-932-0150 x 2104 or by email at gibel@orsp.rutgers.edu.

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