Current Issues
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Research Education
The Office of Research supports research activities of Texas Tech University Health Sciences Center campuses and schools. The Research Integrity Office (RIO) serves to oversee the protection of human research participants and investigators. Information regarding the RIO is available at: http://www.ttuhsc.edu/research/hrpo/
Training
All Prinicipal Investigators, Co-Investigators and research staff are required to recieve training in the protection of human research subjects prior to beginning activities related to human-research. Information regarding training is available at: http://www.ttuhsc.edu/research/hrpo/irb/edurequirements.aspx
The Institutional Review Board (IRB) Policies and Procedure Manual is available at:
http://www.ttuhsc.edu/research/hrpo/irb/files/2009_IRB_PPs.pdf
Other Online Resources
NIH has an online course called “Protecting Human Research Participants” –provides very basic, very quick information. The website is http://phrp.nihtraining.com/users/login.php
TTUHSC IRB website http://www.ttuhsc.edu/research/hrpo/irb/ has other information, including the IRB policies, procedures and Investigator’s Guide with the essential information investigators want to conduct research with human subjects.
Brochure
The Research Integrity Office has a brochure about the TTUHSC Human Research Protection Program. Virginia Smith can send one or a hundred of the brochures to anyone who asks.
Classes
There are two “sit and listen to us talk to you” classes on human research issues TTUHSC. The first is an informal 45-minute (or so) presentation various groups of faculty or students entitled, “What is an IRB and why should I care?” Information covered includes some of the history of ugly things that occurred in the name of research over the years, provides some definitions of research and of human subjects, talks about the regulations governing IRBs in the US, and discusses some of the “nitty gritty” about submitting research to the TTUHSC IRB. The class has only been offered in Lubbock, but IRB Administrators at the other campuses could provide the same class. If anyone is interested in attending, send an email Beth to arrange it.
A longer and more formal (5 hours— lunch provided) course is provided. Training is primarily geared toward faculty members, but staff and residents attend as well. The course is conducted jointly by the Research Integrity Office and the Division of Clinical Research. In class, all of the requirements not just from the “submitting to the IRB” side, but also, everything required to actually DO the research correctly is discussed. The program is offered at least once a year at each campus, and typically has been offered 4-5 times per year in Lubbock. The course can be tailored for specific groups (Surgery faculty, Urology Faculty, Ophthalmology Faculty) if asked, and availability is publicized on the HSC website for anyone to sign up. If anyone wants more information about this class, contact Beth Taraban.
Books and Other Resouces
The Research Integrity Office (soon to be in HSC 1C165 in Lubbock) also has a small but growing library of books and CDs about human research protection concerns. The RIO is happy to share.
The ROI staff are happy to assist faculty and students with their research questions!
Consulting on Projects
TTUHSC IRB review is required unless the investigator has a strict consulting relationship in which:
- The investigator is hired on his/her own time (refer to TTUHSC OP 50.27);
- The investigator holds no rights in the work; and
- Neither the investigator nor TTUHSC obtains, receives, or possesses identifiable private information or receive coded data while at TTUHSC.
All three of these criteria must be met or the IRB must review the project.
Resident and Student Research Projects
In accordance with federal regulations, TTUHSC requires that all human research be prospectively reviewed by the IRB. Accordingly, resident research projects, theses, research practica, and Master�s or Doctoral theses involving human subjects must be submitted for IRB review. TTUHSC IRB policy requires that only faculty member must serve as the principal investigator on resident/student research projects.
EXEMPT STATUS
The IRB makes the determination of exempt status. The Principal Investigator does not have the authority to make this determination. To be exempt, an application must fit into one of six specific categories of activities summarized below (Federal regulations 45 CFR 46.101(b)). Exempt status does not apply to research involving prisoners.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices
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Research involving the use of educational tests, surveys or questionnaires, provided that human subjects cannot be identified and that responses by the subjects will not place them at risk of liability or be damaging to financial standing or reputation.
An example of a study that might be exempt is one conducting a survey on all graduate students by stopping them in the hallway but not asking for their names or any other identifying information.
- Research involving the use of educational tests or observation of public behavior that is not exempt under the previous category if (1) the human subjects are elected or appointed public officials or candidates for public office or (2) the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the PI in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. An example of this category is a retrospective chart review where no identifiers are taken. Remember that this is research and that the exemption must be granted by the IRB office prior to the research taking place.
- Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads in order to review public service programs; procedures for obtaining benefits under those programs; possible changes to those programs or possible changes in methods or levels of payment for benefits under those programs.
- Taste and food quality evaluation and consumer acceptance studies.
If the research application meets the criteria for exemption, approval will be provided to the Principal Investigator in writing and shall include the citation of the specific category justifying the exemption. If the research application does not meet the criteria for exemption, the IRB Office will provide written notice to the Principal Investigator specifying the additional information needed and stating the appropriate category for review (e.g., expedited or full Board).
The RIO has the right to audit exempt status research.
Bylaw Revisions Input
Faculty are asked to review the draft of the revised bylaws and provide feedback via e-mail to one of the representatives from your School ( (see addresses under the Members link). The link to the bylaw revision draft is available here.
Constitution Revision Input
Faculty are asked to review the draft of the revised constitution and provide feedback via e-mail to one of the representatives from your School ( (see addresses under the Members link). The link to the bylaw revision draft is available here.
Faculty Related HSC OP Review Sections
Faculty Senate included in REVIEW SECTIONS OF EACH FACULTY RELATED HSC OP. The Senate will be reviewing faculty related HSC OPs each year. All faculty are encouraged to e-mail (see addresses under the Members link) one of the representatives from their School to submit suggestions or raise questions.
Employee Tuition Assistance Program
The Faculty Senate is working with TTUHSC to provide Faculty with information about the Texas Tech Employee Tuition Assistance Program. Please go to Human Resources OP 70.03 for more information. The Tuition Certification form is available here.
Strategic Space Study
Another issue the TTUHSC Faculty Senate is reviewing is the Strategic Space Study. We are asking the Faculty to take a few minutes to explore the link on this page to review the PowerPoint presentation.
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All faculty are encouraged to email (see addresses under the Members link) one of the representatives from their School to submit suggestions or raise questions. Representative suggestions/questions will be posted periodically on this page prior to the meeting. Some that have already been addressed are currently posted on the Frequently Asked Questions link.