Do I need an IRB?

Research is a systematic investigation designed to develop knowledge that can be generalized. If you plan to present or publish the work or otherwise share the results of the study, it is probably research.

Are you planning on presenting the data of the project on human subjects at an academic conference, publish the data in an academic journal, or use the human subjects research data in a master's thesis or doctoral dissertation?

• If NO: your project is not considered research and does not require HCC IRB review.
• If YES: your project is considered research and requires HCC 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 the 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 participants are defined as: living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Does your project involve subjects/participants or data identifiable to specific human subjects?

Some examples of subjects/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 HCC IRB approval
If YES: Your project most likely needs HCC IRB review.

Certain activities have the characteristics of research but do not meet the regulatory definition of research needing HCC IRB review.

Examples of activities that may not need HCC IRB review are:

• Data collection for internal departmental or other HCC administrative purposes (e.g. teaching evaluations, course evaluations, institutional surveys like CCSSE) 
• Research is a class project or term paper and will not be published in any form at any time.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

HCC 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 HCC 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 HCC IRB notification and formal HCC 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 HCC IRB prior to the start of such a project since the decision on the exempt status is the sole responsibility of the HCC 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.
• 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. The purpose is to refine data collection procedures and research design on a small scale.

The questions asked usually do not contribute to generalizable knowledge and as such do not qualify as research and do not need IRB review.

Exceptions that require HCC 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

Existing data are also called secondary data. Such secondary data analysis involves using existing data from sources to answer new questions.

HCC 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.

HCC 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 individually identifiable data from HCC’s PeopleSoft system is to be used, the project will need HCC IRB review.

If the data collected via the Internet and computers involves human subjects 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 subjects involved.