The resource toolbox contains a listing of regulations, reports,
documents and websites that researchers may need when
conducting human subjects research.
The TTU Electronic Data Policy Statement provides requirements needed to protect information of human subjects collected by electronic means. This includes online surveys, blogs, avatars and virtual environments. Private and sensitive information collected from human subjects must be protected.
The Memorandum of Understanding between TTU and TTUHSC is an agreement that stipulates the need for only one IRB review when collaborating research between the two institutions is proposed.
The policy in place states:
"Research being conducted jointly by faculty at Texas Tech University Health Sciences Center (TTUHSC) and Texas Tech University (TTU) campuses may be reviewed by a single IRB. The TTU IRB designates the TTUHSC IRB as its IRB of record for projects originating at TTUHSC that use faculty, facilities, staff, and/or students of TTU. TTU studies containing medical interventions will normally be referred to the TTUHSC IRB. TTU studies containing only psychological interventions will normally be reviewed by the TTU IRB unless TTUHSC is involved in the research. If the most appropriate assignment of an application is in doubt, the administrators and chairs of the two IRBs should reach consensus on which IRB is most appropriate" (2012-2014 IRB Manuall).
FWA - Federalwide Assurance
The FWA (Federalwide Assurance) is the agreement between Texas Tech University and the federal government. The TTU identification number is: FWA 00001568 and is approved until 11/29/2017. The TTU IRB is also registered with the federal government and identified as IRB 00000276 and IORG0000166. These identification numbers can be used to search for more details on the OHRP website.
Federal Regulations: 45 CFR 46
Federal regulations mandate how research with human subjects is conducted. The Code of Federal Regulations (CFR) provides the definition of research and human subjects. These definitions determine if IRB review is needed. The IRB itself also is defined in the federal regulations.
The Belmont Report provides guidelines to researchers as they design and conduct their research studies. The three principles highlighted include respect for persons, beneficence, and justice.
The Office of Human Research Protections (OHRP) is the leadership body within the U.S. Department of Health and Human Services that looks after the rights, welfare, and well-being of human subjects participating in research. OHRP provides clarification and guidance, education, regulatory oversight, and ethical advice on biomedical and behavioral research. It is OHRP that oversees the TTU IRB.
OHRP works to ensure that human subjects outside of the United States who participate in research projects conducted or funded by DHHS receive the same level of protections as research participants inside the United States. To that end, the OHRP International Activities program offers consultation services, disseminates pertinent reports, and provides research ethics training.
Texas Tech University has specific policies and procedures for the establishment and operation of the TTU IRB. The TTU IRB institutional official is Dr. Taylor Eighmy, vice president for research. Dr. Alice Young is associate vice president for research (research integrity) for Texas Tech University and supervises the operations of the IRB. Dr. Rosemary Cogan is chair of the IRB and is broadly engaged with the HRPP staff. The HRPP staff and the IRB are directly accountable to the Office of Human Research Protections of the Department of Health and Human Services federal agency.
Texas Tech University has specific policies and procedures for paying research participants. These policies and directions apply only to funds filtered through a TTU account and do not apply to personal funds provided by the researchers. For additional information or questions, contact the Office of Tax Compliance and Reporting at (806)742-3255.
Annotated Bibliography by Rosemary Cogan, Ph.D., ABPP, CIP; and Patricia Pujals, B.A. Texas Tech University