FAQs / Comments
For additional information please contact the IRB office at April.M.Odell@LoneStar.edu
What is the purpose of the LSCS Institutional Review Board (IRB)?
The IRB is the LSCS committee that reviews and approves protocols for the use of human subjects in research. Federal regulations require that the IRB have at least five members representing a variety of backgrounds, training and experience. At least one member must have no formal or family connection with the System and be invited to serve as community representative.The IRB reviews research proposals to ensure that the rights and welfare of human subjects used in research studies are protected. The IRB assures that
- Risks have been considered and minimized.
- Benefits have been identified and maximized.
- Subjects only volunteer to participate after being provided with legally effective informed consent.
- That all research is conducted in an ethical manner and in compliance with established standards.
- That all private information is handled with confidentiality.
How do I know if I am doing research?
Research is a systematic investigation including research development, testing and evaluations, designed to develop or contribute to generalizable knowledge. If you plan to present, publish, or otherwise share results of the study outside of the Lone Star College System, it is generally considered research.
How do I know if I am using human subjects?
Human participants are defined as living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual; or obtains data through identifiable private information. A researcher is considered to be using human subjects/participants when:
- Individuals are asked to complete questionnaires, participate in interviews, or whose behavior is observed in daily activities
- Oral history interviewees are studied to get their subjective impressions
- Students and teachers are observed in the classroom for the study of various teaching methods or development of curricula
- A researcher asks for data on students or staff from the Office of Institutional and Research Effectiveness at LSCS
How do I know if I must submit my project for review?
If you are doing research that involves people, then you should submit your project for review to the LSCS Institutional Review Board. You might ask yourself if you are planning on:
- presenting the data of my project (using humans as test subjects) at an academic conference?
- publishing the data in an academic journal?
- using the research data in a master's thesis or doctoral dissertation?
- presenting the data at the annual Honors Day Program, and planning to present statewide if you are a winner?
If you answered YES to any of the above, your project is considered research and requires IRB review. If you answered NO to all of the above, your project is probably not considered research and will not require IRB review.
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 research begins.
How do I submit my proposal?
Once you have determined that you are indeed doing human subject research, you must fill out an IRB Research Application Form. Submit an electronic copy, with all other necessary documentation, to the IRB office by emailing to: April.M.Odell@lonestar.edu. Once the application is submitted, the IRB will make a determination on the status of the project, which will be Approved, Conditionally Approved, Tabled or Not Approved.
No research may be conducted prior to receiving approval from the IRB. Any unapproved or conditionally approved research proposals will be presented in writing to the investigator along with any recommendations or suggestions.
What other documentation might need to be submitted with my proposal?
- Informed Consent Form (first page on letterhead of organization sponsoring study)
- Surveys, questionnaires, or other data gathering forms
- Any disclosures explaining risks or procedures
- Letters of approval from cooperating entities
- Any approvals or documentation from external IRBs
- Letters, flyers, questionnaires distributed to subjects or posted to recruit
- NOI-IRB: Notice of Intent is required, to be signed by president(s) of LSCS college(s) at which you will collect data or conduct research
Principal Investigators are also required to submit a Human Subject Protection Training certificate with their application. NIH offers a 1-2 hour online training course, which can be found at http://phrp.nihtraining.com/users/login.php. Applications without training certificates will not be reviewed until the training is complete. Training from NIH must be renewed every year, so please be sure your certificate is up-to-date.
What is informed consent?
Informed consent is generally thought of as informing participants of the risks, benefits and methods of the research they are participating in. Informed consent means insuring that potential subjects and/or their legally authorized representatives are fully informed of all aspects of their participation in a research project. Informed consent must enable them to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. Data collected on students by LSCS is also subject to the rule of informed consent: this means that students must sign a consent form before access is allowed to their contact information.
Does research conducted as an LSCS employee require review?
If an LSCS faculty member or employee is investigating how to improve educational practice at LSCS, then it is generally not considered "research" as this IRB defines it. However, if research is done NOT as a part of that educator's work at LSCS, is funded from an external funding source, is research is for dissertation or thesis, or otherwise is not part of their work at LSCS, then that project would need to be reviewed.
Do classroom projects require IRB review?
Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review. For example:
- Data collected for internal departmental, school, or other administrative purposes (e.g. teaching evaluations, course evaluations)
- Class project or term paper and will not be published in any form at any time
- Reviews and searches of existing literature and research involving a living individual, such as a biography, that is not generalizable beyond that individual
If ALL of the following criteria are met then IRB review is NOT required on the classroom project.
- 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, etc. contain no sensitive personal questions or other personal information that could stigmatize and individual
- No identifying information is recorded to link a person with the data such that it could reasonably harm the individuals 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
- The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data is shared only with that entity
- No LSCS employee or student receives financial compensated for collecting, organizing, analyzing or reporting the data
Your project will require IRB notification and formal IRB approval if you do not meet ALL of the above requirements.
Do student research projects require IRB review?
Undergraduate research is to be encouraged, and learning the IRB review process is an important part of a college education. All undergraduate research will be submitted to the IRB for review. Undergraduates are to be strongly discouraged from engaging in research that poses more than minimal risk to subjects, as they are unlikely to have received sufficient training to safely conduct such research. Faculty members can encourage course research activities such that students become familiar with developing research proposals that can fall into the exempt or expedited categories.
Do class activities need review?
Students may be involved in course activities such as questioning, participation in minimally physically stressing classroom exercises, observing and/or interacting with other individuals. The course instructor is responsible for determining whether such activity is classified as those kinds of activities that require IRB approval. If the instructor has any doubt concerning the classification of these activities, he/she is encouraged to complete a Research Application Form and submit it along with the project and any accompanying consent forms and/or questionnaires in order to obtain the guidance of the IRB.
Can students be principal investigators?
No. The sponsoring faculty member must serve as the Principal Investigator (PI) and submit the application to the IRB. The student should be identified as the Co-PI. A sponsoring faculty member is responsible for student research. Faculty will inform students of human subject guidelines and take measures to enforce compliance to those guidelines. It is the responsibility of the supervising instructor/faculty member to determine whether projects are subject to review. It is always best to err on the side of caution and seek consultation from the IRB Office if a question arises regarding human subject research and classroom activities.
Do research studies involving children require IRB review?
ALL research with children including adolescents must be reviewed by the IRB committee. Children are considered a vulnerable population. They are less able to give fully-informed consent with respect to the research involved. Safeguard procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children. In most cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18.
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