Frequently Asked Questions

Researchers should thoroughly read and understand the HCC IRB process, including the Federal IRB regulations, particularly focusing on whether the proposed project meets the Federal definition of research. The Federal definition of research is a systematic investigation that is intended to develop or contribute to generalizable knowledge. If the activity meets this definition, then an IRB application should be submitted.

 

 

HCC interprets this to be when the intent is to use the outcomes of an activity to contribute to an action that is broad in scope. Examples include: submitting an article for publication (including dissertations), developing and delivering a conference or workshop presentation, or contributing to a process that ultimately would impact a decision made by HCC regarding major programs and services. It usually would not include routine classroom assignments or the performance of regular job duties.

 

HCC Board policy EDA (LOCAL) stipulates that researchers must submit any project that involves HCC students, faculty, or staff for IRB review. The individual self-determines whether to submit an application to HCC's IRB based on his/her understanding of IRB regulations and the HCC IRB process. The HCC IRB Chair and the IRB members may offer guidance, but the individual makes the final decision to submit an application.

 

 

Open records requests are made through the Office of General Counsel. Information is located here.

 

No, unless the projects meet the Federal definition of research

 

No. The application is designed to ensure that the IRB has sufficient information to make a judgment regarding compliance with Federal regulations. Researchers who submit incomplete applications will be informed that their applications will not be reviewed until all the information is received. Researchers are encouraged to build sufficient time for IRB review into their research timetable.

 

Participants cannot be recruited or data collected until official IRB determination for the application is received.  However, there are certain steps in the research process that may be completed prior to submitting an application to the HCC IRB.  For example, if the project will require recruiting a specific group of faculty or students, the Dean may be contacted to discuss the logistics of the contact.

 

When an application is not approved, the researcher may make modifications and re-submit the proposal. Should an application be subject to review by the IRB, and the Board issues disapproval, the determination cannot be overridden based on Federal regulations.  HCC's IRB does not have an appeals process.

 

In most cases, four to six weeks will be required to review an application. The timing of the determination will vary based upon the completeness of the application, HCC schedule, and other factors. Determinations for some applications involving complex protocol, needing input from special resources, and/or requirements as the second review could take longer. Researchers should not begin the participant recruitment process or data collection until they receive their official IRB determination, but they may work on other aspects of their research while waiting.

 

Regulations require that investigators administering research that has been approved via either expedited or full review must complete training in a timely manner as a condition of the approved research. However, individuals may complete training even if no research is currently planned.

 

HCC recommends completing the training provided by the National Institutes of Health.

 

Maybe.  If you are uncertain if your research needs IRB review, please feel free to contact the IRB at irb@hccs.edu.  

 

Research is a systematic investigation designed to develop knowledge that can be generalized. If it is planned 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: the project is not considered research and does not require IRB review. 

If YES: the project is considered research and requires IRB review. It may, however, be exempt. 

If the 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, it is advisable 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 the 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
• data on students that are not part of directory information 

If NO: The project most likely does NOT need IRB approval
If YES: The 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 HCC administrative purposes (e.g. teaching evaluations, course evaluations, institutional surveys like CCSSE) 
• Research that is a class project or term paper and will not be published in any form at any time. 

If you are uncertain, please contact the HCC IRB at irb@hccs.edu.

Use the following guidelines to determine if the 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 or put them at risk of criminal or civil liability (Revised Common Rule).
• The research will not be likely to adversely impact the student’s opportunity to learn required educational content of the assessment of educators who provide the instruction (Revised Common Rule).
• 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. prisoners, minors, cognitively impaired individuals). 

• The collected data does not leave the classroom setting.
• 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, the project will require IRB notification and formal IRB approval before the project can be started.

 

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 does not need IRB review.

If you are uncertain, please contact the HCC IRB at irb@hccs.edu.

Exceptions that 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

 

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 individually identifiable data from HCC’s PeopleSoft or other student data systems are to be used, the project will need 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.

 

In accordance with federal regulations and board policy, HCC’s IRB committee must review all research involving human subjects prior to the start of the study/project. Use the following questions to determine if your project needs to be submitted to the IRB committee for review/approval.

Initial Screening of your Project:
If you are doing research with people, then you must submit your research project to the IRB.

 

Emails to the IRB may be sent to the irb@hccs.edu.