Frequently Asked Questions for IRB
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What is human subjects review?
Federal, state and university regulations require that the use of human subjects in research be reviewed and approved by an Institutional Review Board (IRB). Federal regulations addressing the protection of human subjects can be found in 45 CFR 46, at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. The Regent University policy on the Protection of Human Subjects in Research is published in the Faculty & Academic Policy Handbook. -
What is considered research?
The definition of research, per 45 CFR 46.102(d) is: "Research means a systematic investigation, including research development, testing evaluation, designed to develop or contribute to generalized knowledge." -
Does my research require review?
If you are a faculty, staff, or student at Regent University and your research involves the use of human subjects (either directly or through records or other data), your research requires human subjects review. -
What about course assignments that involve surveys or other contact with human subjects?
Any such activities that involve human subjects should go through the IRB application process. If the IRB determines that the class assignments do not fall under these policies, they will notify the professor accordingly. In such cases, however, the instructor of the course will be responsible for informing students of proper procedures regarding the conduct of such research and for monitoring the work done by students. Note, however, that human subjects related data collected in class assignments may not be used in future publications if the effort did not receive prior IRB approval. -
Does all research go through the same review process?
The depth of the review process is dependent upon the type of research that you are proposing. IRB reviews are classified as exempt, expedited, or full board review. Each of these categories requires a submission to the Institutional Review Board, although the review time and procedures vary. -
How do I know in which category (exempt, expedited, full) my application belongs?
The IRB application has a checklist to help you determine which category your application belongs, although the IRB will review your submission and make the final determination of the application type. The criteria used to determine exempt review are found in 45 CFR 46.101 and exempt review in 45 CFR 46.110. These are available online at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm -
How do I begin the review process?
Complete an Institutional Review Board Application form online and submit it to the Chair of the Institutional Review Board. Be sure to include all relevant information (grant proposals, consent forms, questionnaires, test instruments, advertisements, debriefing statements, contact letters, etc.) in accordance with the requirements of your research category. If you are a student working under the guidance of a faculty member (e.g., sponsored research, thesis, or dissertation), you must secure the approval of your faculty advisor before submitting your application to the board. -
What will happen to my application?
When the Institutional Review Board receives your application, they will examine it to determine whether it warrants exempt, expedited, or full board review. After completing the review process, the IRB will reply with a letter of approval, request for further information or revisions, or a letter of rejection. The Board reviews the proposed purpose, procedures, and subject populations to be used and determine if the benefits of the activity outweigh the risks to subjects. Issues considered in this analysis include ensuring that risks to the subjects are reasonable in relation to anticipated benefits, selection of subjects is equitable, informed consent is properly sought and documented, adequate preparation is taken to protect the privacy and confidentiality of subjects, and adequate provisions are made for the ongoing monitoring of the subjects' welfare. -
Is a research request ever denied?
Yes. If the IRB determines that the risks of a proposed activity outweigh the benefits or that the proposed research is not in alignment with the guidelines found in 45 CFR 46 for the protection of human subjects in research, they will reject the application. However, in most situations, the IRB will present the concerns to the researcher and provide an opportunity for modifications rather than simply denying the request. -
How long does this process take?
The estimated review timeframes are one week for exempt reviews, two weeks for expedited reviews, and one month for full board reviews. -
When can I begin data collection?
You will receive a letter from the Board responding to your application and you are required to wait for approval before beginning any research. -
How do I change my research after it has been approved?
You must notify the IRB if you wish to change your research. You can make minor and administrative changes by submitting a written summary describing the proposed changes. Substantial changes in the focus, procedures, or subject population of the research may require submission of a new or revised application. -
How long is approval valid?
Approval is good for one year. If your will be collecting data after the one-year anniversary of your approval, you will be required to submit a renewal request using the IRB Application to secure an additional twelve month extension. You may repeat this process for as many years as necessary just as long as you don't substantially alter your original research request. -
Do I need to submit anything to the IRB after the research has been completed?
Yes; please submit a final report using the Research Final Report form. -
Who do I contact if I have more questions?
If you have additional questions, please contact the Chair of the Institutional Review Board, the IRB member from your school, or the IRB website.
