1. How do I know if I am doing research?
2. How do I know if I am using human participants?
3. How do I know if I must submit my project for review?
4. Do research studies involving children require IRB review?
5. Does research conducted as a Blinn College employee require review?
6. Do classroom projects require IRB review?
7. Do student research projects require IRB review?
8. Do class activities need review?
9. Can students be principal investigators?
10. What types of projects might receive an expedited review?
11. Does "Existing Data" Analysis require IRB review?
12. Do Internet/Online based projects require IRB review?
13. How do I submit my proposal?
14. What other documentation might need to be submitted with my proposal?
15. What is informed consent?
16. What are the requirements for outside researchers not affiliated with Blinn College?
17. Do I need my Dean’s approval to conduct research?
In accordance with federal regulations, the Blinn College IRB committee must prospectively review all research involving human participants. Use the following questionnaire to answer whether your projects needs to be submitted to the IRB committee for approval prior to the start of your project.
Initial Screening of your Project
If you are doing research with people, then you must submit your research project to the IRB.
1: 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 Blinn College, it is generally considered research.
2: How do I know if I am using human participants?
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 participants when any of the following or similar conditions are met:
3: 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 Blinn College IRB. You might ask yourself if you are planning on:
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.
4: 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. This section is especially important if you have any Dual Credit students in your class.
5: Does research conducted as a Blinn College employee require review?
If a Blinn College faculty member or employee is investigating how to improve educational practice at Blinn College and that information will NOT be disseminated beyond Blinn College, then it is generally not considered "research" as the IRB defines it. However, if research is done NOT as a part of that educator's work at Blinn College, is funded from an external funding source, is research for dissertation or thesis, is not part of the employee’s work at Blinn College, or will be disseminated in any mode or manner beyond Blinn College then that project would need to be reviewed.
If ALL of the following criteria are met then IRB review is NOT required on the classroom project.
Your project will require IRB notification and formal IRB approval if you do not meet ALL of the above requirements.
7: 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 participants, 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.
8: Do class activities need review?
Students may be involved in course activities such as questioning, participation in minimally physically stressing classroom exercises, or 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.
9: 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 if a question arises regarding human subject research and classroom activities.
10: What types of projects might receive an expedited review?
The following are examples of projects that require IRB notification but may be exempt from a full IRB review, referred to as an expedited review. A completed Research Application Form must be submitted to the IRB prior to the start of such project since the decision on the expedited review process is the sole responsibility of the IRB committee.
Research projects that might qualify for expedited review include
11: Does "Existing Data" Analysis require IRB review?
Existing data are also called secondary data. Such secondary data analysis involves using existing data from other sources to answer new questions. Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and to ensure that the objectives of the secondary analysis are in keeping with those for which consent was obtained.
12: Do Internet/Online based projects require IRB review?
If the data collected via the Internet and computers involves human participants, 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.
13: How do I submit my proposal?
Once you have determined that you are indeed doing human subject research, you must fill out a Research Application Form. Submit an electronic copy, with all other necessary documentation, to the IRB office by emailing to: IRB@blinn.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.
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.
15: 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 participants 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 Blinn College 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.
16: What are the requirements for outside researchers not affiliated with Blinn College?
Outside researchers not affiliated with Blinn College, but conducting studies targeting Blinn College faculty, students, or staff, must find a collaborator at Blinn College such as a Co-Principal Investigator. The Co-Principal Investigator will be responsible for providing the IRB with all the necessary documents such as a completed IRB Application form (from Blinn College), appropriate Informed Consent form, recruitment flyer or ads, instruments or measures to be used, CV of the Co-Principal Investigator, letter of IRB approval from the collaborating institution, consent from the appropriate Vice President for the conduct of research within their area of supervision, and any other supporting documentation.
Do I need my Dean’s approval to conduct research?
Although the IRB does not require you to obtain the approval of your Dean prior to submitting your Research Application Form, having your Dean confirm that he or she is aware that you are conducting research is preferred. Please have the Dean initial the Notice of Intent to Conduct Research on the designated line.