Institutional Review Board

• Only research involving living human subjects is subject to IRB review. Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Living human subjects means a living person about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (obtained directly or indirectly from a source entrusted with human subject information).
  • Use the IRB Review Decision Flow Chart to determine whether your project requires IRB approval.
  • If you are unsure whether your study requires IRB review, please contact the HFC IRB at hfcirb@hfcc.edu
• The IRB conducts multiple types of reviews depending on the nature and scope of the research project presented. The timeframe for review varies depending on the type of review being conducted.
• HFC Student Research: The decision to submit to the IRB is up to the faculty advisor. It is recommended that all research involving human subjects be submitted to the IRB for review.

• Compliance training for all members of the research team must be completed prior to submitting an application. Evidence of completion should be submitted with your IRB application.
• Prior to submitting your application to the IRB for review, please make sure that all study materials are prepared and attached to your submission email.
• If your study has already been reviewed by another school’s IRB, you must submit your IRB application, approved study materials, and approval letter.
• If you are affiliated with another school which has an IRB, you must receive IRB approval from that IRB prior to submitting to HFC’s IRB.
• HFC Student Research: Student research must be overseen by a faculty advisor or mentor. This advisor must be on all email communication and provide their signature attesting to their approval of your application.

The IRB safeguards individuals involved in research by ensuring that:

• The prospective subject population is appropriate in terms of characteristics and number.
• The recruitment of subjects is free of coercion.
• The design of the study is sound.
• Any risks associated with the research project are minimized to the greatest extent possible.
• The potential benefits are maximized to the greatest extent possible.
• The risk to the subject are outweighed or balanced by the potential benefits.
• The level of subject compensation (if any) is fair and non-coercive.
• The degree to which confidentiality is maintained is acceptable.
• The method used to obtain informed consent is ethically and legally acceptable.
• The investigator has the appropriate qualifications, experience and facilities to conduct the research.
• The informed consent process is appropriate for the study.

• External researchers must obtain HFC IRB approval before any human subjects are recruited.
• For all research activities conducted by external researchers, an HFC employee must be willing to serve as a local sponsor for the duration of the project and act as a contact for questions regarding the research.
• External researchers must obtain IRB approval from the IRB at their own institution and provide documentation of IRB approval. Researchers who do not have an IRB at their own institution must follow all HFC IRB guidelines and submit using HFC IRB materials.
• Any external researchers desiring to conduct research at HFC or use HFC students as research subjects must also obtain permission from the Vice President of Strategy and Human Resources after receiving approval from the HFC IRB.
• When reviewing external requests, the HFC IRB and the Vice President of Strategy and Human Resources take into consideration how external research would be of benefit to HFC.
• In general, HFC cannot provide facilities of any type for external research projects.
• External researchers interested in conducting research at HFC should start by contacting the HFC IRB at hfcirb@hfcc.edu.

The IRB will determine what level of research your study falls under based on your IRB application and study materials.

• Exempt research
  • Exempt reviews are provided for research studies that are minimally invasive and that pose no potential threat to participants. Examples include education research, surveys, interviews, or secondary data analysis.
  • Exempt categories
• Expedited research
  • Studies that qualify for expedited review must present no more than a minimal risk to participants. Examples include collection of noninvasive biological specimens, collection of audio or video data, clinical studies of drugs and medical devices.
  • Expedited categories
• Full Board research
  • Research that presents greater than minimal risk and/or does not qualify for exempt or expedited review will require a full Institutional Research Board review.