Human Subjects Research (IRB)
The Institutional Review Board must review all programs (externally funded, internally funded, or unfunded) that include any form of research involving human subjects (e.g., surveys, evaluation instruments, pre- and post-tests, baseline data collection, etc.) In some cases IRB approval is required prior to proposal submission; in EVERY case, IRB approval or exemption is required prior to the conduct of any research involving human subjects.
It may also be helpful to review the following sets of Frequently Asked Questions (FAQs) published by the Office for Human Research Protections. This information may help clarify assurance and IRB registration issues.
- Assurance page -- http://www.hhs.gov/ohrp/assurances/assurances_index.html
- IRB registration page -- http://www.hhs.gov/ohrp/assurances
- Policy and Guidance page -- http://www.hhs.gov/ohrp/policy/index.html
These and other FAQs may also be accessed from the HHS homepage (http://www.hhs.gov), by selecting "Questions" at the top right of the page and then on the 'Questions and Answers" page under the "Category" drop-down menu, selecting "Human Research."
Additional Training:
- All IRB Committee Members and faculty who intend to use the classroom assignment review process must complete this federal IRB training module. All researchers are encouraged to complete it: http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp
- The National Institute of Health (NIH) online tutorial: http://phrp.nihtraining.com
- The Collaborative Institutional Training Initiative (CITI) online tutorial: www.citiprogram.org
For instructions on the CITI web site, please click here.
- To view a power-point presentation on the IRB focused toward students, please click here.
The UTC IRB Training Manual is now available in PDF format for reference and download. The manual includes answers to frequently asked questions, guidelines for selecting the appropriate level of review, a step-by-step walk-through of the application and approval process, and explicit instructions on obtaining informed consent. Also included in the manual are links to all IRB forms and the UTC IRB Policy. Please click here to download the manual.
HIPAA Guidelines:
The Health Insurance Portability and Accountability Act (HIPAA) establishes conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes [45 CFR §§ 164.501, 164.508(f), 164.512(i) ]. The Privacy Rule outlined in HIPAA defines the means by which individuals/human research subjects are informed of how medical information about them will be used or disclosed, and their rights with regard to gaining access to information about them when such information is held by covered entities. In the course of conducting research, researchers may create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose PHI for research with individual authorization, or without individual authorization under limited circumstances.
For additional information on HIPAA regulations, please reference the HIPAA section on the IRB website.
Specific information about the UTC IRB policy and procedures may be found on the IRB website. For additional information, please email instrb@utc.edu or contact Lindsay Pardue, Director of Research Integrity.
