There are several things to consider in determining whether a research project needs a human participants review or not. A good starting place is the federal decision chart, which poses several questions to determine what level of review might be necessary. Below are several frequently asked questions which can also guide decision-making about an IRB review.
Research is defined as the systematic investigation designed to develop knowledge that can be generalized. Are you planning on presenting the data of the project on human participants at an academic conference, publish the data in an academic journal, or use the human participant research data in a master's thesis or doctoral dissertation ?
If NO: your project is not considered research and does not require IRB review.
If YES: your project is considered research and requires IRB review. It may however be exempt.
If your project is not hypothesis-driven, does not use research protocols and methodologies, and the anticipated data are not intended for publication of an article in a newspaper or magazine, no IRB review is needed.
If no public dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, you are advised to submit the project for IRB review and approval before initiating the research project.
Human Subject refers to a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.
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.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical or school record). In order to meet the above definition, private information must be individually identifiable (i.e., the identity of the subject is known or may readily be ascertained by the investigator or associated with the information) in order for the investigation to constitute research involving human participants. In general, private information is considered to be to be individually identifiable when it can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of individuals. Does your project involve participants or data identifiable to specific human participants?
Some examples of participants include:
Individuals who are asked to complete surveys, participate in interviews, or whose behavior is observed in daily activities oral history interviewees whose subjective perceptions are studied students and teachers observed in the classroom for the study of various teaching methods or development of curricula.
If NO: You do NOT need IRB approval.
If YES: Your project most likely needs IRB review.
Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review.
Examples of activities that may not need IRB review are:
Data collection for internal departmental or other RTC administrative purposes (e.g. teaching evaluations, course evaluations, institutional surveys)
Research that is a class project or term paper and will not be published in any form at any time.
Use to following guidelines to determine if your activities in the classroom are subject to IRB review. IRB review is NOT required if all of the following are true:
- The project is limited to surveys/questionnaires/interviews/observations of public behavior directly related to topics being studied in an official college course.
- The above surveys/questionnaires/activities, etc. contain no sensitive personal questions (e.g., no questions about drug use, sexual behavior or attitudes, criminal activity, grades, medical history) or other personal information that could stigmatize an individual.
- No identifying information is recorded to link a person with the data such that it could reasonably harm the individual's reputation, employability, financial standing, or place them at risk for criminal or civil liability.
- The participants in the project are not from a vulnerable or special population (e.g., pregnant women, prisoners, minors, cognitively impaired individuals).
- The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data are shared only with that entity.
- No RTC employee or student is receiving compensation for collecting, organizing, analyzing, or reporting the data.
If not ALL of these conditions are met, or if your project does not fall into any of these categories, your project will require IRB notification and formal IRB approval before you can start with your project.
The following are examples of projects that DO require IRB notification but are exempt from IRB review. Nonetheless, formal paperwork needs to be submitted to the IRB prior to the start of such project since the decision on the exempt status is the sole responsibility of the IRB committee.
- The study of or comparison among instructional techniques, curricula, or classroom management methods.
- The use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless this involves anyone under the age of 18 (in which case a full review is necessary).
- The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is collected in a way that cannot be linked either directly or through identifiers to an individual
Pilot projects are preliminary investigations performed to determine if a study is feasible. If the questions asked will not contribute to generalizable knowledge, then they do not qualify as research and does not need IRB review.
Exceptions that DO require IRB approval PRIOR to the start of the pilot project:
- Vulnerable populations, methods with more than minimal risk, or sensitive data will be used.
- The possibility exists that the collected data will be used in some form or another for publication purposes at a later date.
Existing data are also called secondary data. Such secondary data analysis involves using existing data from sources to answer new questions.
IRB review and approval is not needed if the source of the data is public (data from public libraries, newspapers, publications) and analysis of the data will not make the data individually identifiable.
IRB review and approval is needed if the source of the data is not public (government and private data bases) and the existing data has not been previously received IRB approval.
If the data collected via the Internet and computers involves human participants and is intended for eventual publication purposes, then it requires IRB review and approval.
All such studies involving internet technologies must ensure compliance with the principles of voluntary participation and informed consent, the anonymity and confidentiality of the participants, and address the potential risks to the human participants involved.