Q: What is the UCA policy regarding the use of human participants in research?
A: All research involving human participants conducted by faculty, staff, or students of the University of Central Arkansas (UCA) must be reviewed and approved by the UCA Institutional Review Board (IRB). The UCA IRB operates according to the guidelines in the Code of Federal Regulations (45CFR46) and other state and institutional guidelines.
Q: What does the IRB do?
A: It is the responsibility of the IRB to review research protocols involving human participants to ensure that the rights of the participants are protected, that they are not subject to unreasonable harm (physical and emotional), and that information about them is kept confidential.
Q: What is research?
A: Research means a systematic investigation, including pilot research, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy.
Q: What is a human participant?
A: Human participant means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or through identifiable private information.
Q: How do I know if I should submit a research protocol to the IRB?
A: If your research project (including observation, interviews and surveys) involves human participants, you must submit an IRB Application.
Q: When should I submit my Application to the IRB?
A: You may submit your request at any time, but you must receive IRB approval before you begin recruiting participants or collecting data. For a full board review, please submit your request 2 weeks prior to the next scheduled IRB meeting date.
Q: What do I submit?
A: You should submit an IRB request that includes the appropriate request form, an informed consent form or survey cover letter, training certifications for all researchers involved, and any tests, surveys, or interview questions you will be using in your study.
Q: What is informed consent?
A: Both written consent and verbal consent for participation in research must involve an informed consent process. Informed consent involves an education and information exchange that takes place between the researcher and the potential subject.
Sometimes the information to be imparted to potential subjects is complex or possibly distressful and may require some time for it to be absorbed and appreciated. In these circumstances, the researcher should present the information and discuss the issues with potential subjects on more than one occasion, or allow a period of time to elapse between imparting the information and requesting a signature on the consent form. During this waiting period, potential subjects should be encouraged to discuss their possible participation with family members, close friends, or trusted advisors. With IRB approval, other approaches to communicating complex information can be used, including the use of audio-visual materials and brochures.
Informed consent is not merely a document to be signed or handed to the research subject. It is an ongoing process meant to keep your subject informed of the risks and expectations of your research.
Q: What happens after I submit my IRB Application?
A: Once your study has been submitted, an email will be sent acknowledging your submission with an assigned internal routing number. Your submission will be reviewed for completeness. If there are documents missing you will be informed via the email so that you may revise and resend the necessary documents. Once it is deemed complete, it will be reviewed for compliance with Federal regulations and a determination made. You will receive an email with either suggestions for further revision, or a determination (exempt, approved, not approved, etc.) with an attached approval letter. Print a copy for your records.
The type of IRB review dictates the length of time necessary for a decision. If your study is eligible for an ‘Exemption from Full Board Review’ submission, you will receive a decision within one week after the submission. An ‘Expedited Review’ submission decision is made within two weeks after submission, and a ‘Full Board Review’ submission decision is made within one month after submission.
Q: How will I be notified of the status of my request?
A: You will receive an email from the Research Compliance Office either asking for revisions, or explaining the determination (exempt, approved, not approved, etc.). Once a determination is reached, a letter will be emailed. Print a copy for your records.
Q: What is the best way to prepare my IRB Submission?
A: You should work closely with your faculty advisor (if you are a student) well in advance of beginning the actual research. It will be important for all researchers to apply what you learned in the CITI online training course when you complete your IRB proposal.