Institutional Review Board (IRB)
Houston Christian University (HCU) provides our students with A Higher Education through the pursuit of the Ten Pillars. Specifically, Pillar Five states that the institution has a mandate to understand the world. To this end, HCU is committed to the pursuit of excellence in teaching, research and public service.
In the pursuit for excellence, the university strives to protect the welfare of every person who may be involved in research and training projects in accordance with the federal regulations, and the ethical principles established by the Belmont Report.
Review and oversight of research involving human subjects or identifiable data derived from human subjects is the charge of a federally mandated committee called an Institutional Review Board, or IRB. The IRB is tasked with the responsibility of safeguarding the rights and welfare of all persons participating in research projects.
Prior to proposing research to the IRB, please review the regulations applicable to your project. 45 Code of Federal Regulations (CFR) 46 (“The Common Rule”) specifically addresses the protection of human study subjects as promulgated by the Department of Health and Human Services (DHHS). Regardless of funding, all research at HCU is held to the DHHS standard. 21 CFR 50 and 21 CFR 56 are the general regulations that govern U.S. Food and Drug Administration (FDA)-regulated research. FDA regulations 21 CFR 312 and 21 CFR 812 govern research involving drugs and devices, respectively.
All HCU faculty, staff or students proposing to engage in any research activity involving the use of human subjects must have approval from the IRB prior to the recruitment for and initiation of research procedures. Any questions regarding IRB or the research categories and policies found on this website should be directed the Dr. Lisa Ellis, the Chair of the IRB Committee at firstname.lastname@example.org. The submission of applications to the IRB is currently handled through the faculty primary investigator emailing a completed application to email@example.com.
Applications to IRB
*If you are from another institution, seeking participants for your research, please read the instructions found in the Research Approved by Other Institutions section below.
- Complete your CITI Training Requirement. All researchers are required to complete the CITI training prior to submitting a research application at Houston Christian University. All researchers are required to submit proof of completion of the CITI training with the application to conduct research to the IRB.
- Understand if your proposal qualifies for exemption, expediated review, or a full board review. The IRB Chair will determine if your research proposal is exempt from review, qualifies for an expedited review, or requires a full board review following the OHRP guidelines. Any research directly involving vulnerable populations (e.g. children or prisoners) will require a full board review.
- Make sure the application is complete; answer all questions thoroughly and ensure appropriate attachments have been uploaded. All applications will undergo a preliminary administrative review to determine if they are complete and meet the basic requirements for compliance with IRB policies and procedures. In addition to answering the questions, the researchers’ CITI training must be attached and they must sign the application. Digital signatures are allowed. Any application that is incomplete will be returned for correction and resubmission before being assigned to the IRB review process.
- Submit early to ensure enough time for routing. Once the application is submitted, the review process will be initiated. Applications submitted by the deadline (4th Friday in September, February, or June for the Fall, Spring, or Summer semester, respectively) are guaranteed a 2-week turnaround on the initial review. Applications from Ed.D. candidates submitted by the 2nd Friday of April or November are also guaranteed a 2-week turnaround. The initial review process for applications submitted after the deadline may take up to 4 weeks.
- Allow time for feedback and resubmission. IRB review will elicit a determination letter, which will be sent approximately 5-8 business days following the completed review process. Most require at least minor corrections and/or stipulations to be addressed. When submitting your protocol, please budget time for addressing stipulations and the IRB review of responses.
- Ensure that all human subjects procedures listed in a grant proposal are contained within the protocol reviewed by the IRB.
- Ensure that the proposal accounts for and follows HCU’s Data Policy. You must include specifics regarding the location of the data and storage type.
- All data used for either publicly published graduate theses or dissertations must be turned in to the Center for Research and Doctoral Studies (CRDS) at the time of uploading the thesis to ProQuest. This data will be kept by the CRDS for no more than five years. The purpose of this storage is to make sure there is a record of the research in case any questions are raised regarding it. If you are writing a publicly published graduate theses or dissertations then one of your three storage locations will be the CRDS.
- If, for any reason, you modify your research procedures, surveys, forms, or any other aspects of your research, the faculty principal investigator must submit an IRB Proposal Modificationto firstname.lastname@example.org for review.
Research Approved By Other Institutions
If you wish to have HCU faculty, staff, or students participate in your research project you must email the IRB approval letter from your parent institution to email@example.com. HCU’s IRB committee’s role is to not review the research proposal, but to review the approval already granted by the parent institution. Thus, upon receipt of the approval letter, the IRB chair will send a letter granting the researcher the right to recruit research participants at HCU. The researcher should make accommodations to recruit participants, as HCU’s IRB does not aid in recruitment and will not solicit information on behalf of the researcher.
- Dr. Lisa Ellis, Chair IRB Committee, Associate Professor of Biology