Texas Tech University

IRB Policies and Procedures

Section 4: Background for Preparing Proposals

4.0 General

The Principal Investigator submits the human subjects research proposal in Cayuse IRB and is responsible for the proposal and for the design, conduct, and reporting of the research. Only full-time or tenured Texas Tech University faculty or a full-time employee with the terminal degree in their discipline (Ph.D., Ed.D., J.D., or M.D.) may be the Principal Investigator on proposals. Proposals for research by students, other personnel, or people from outside of Texas Tech University must be submitted with a Texas Tech University eligible Principal Investigator (PI). All other investigators (students, other personnel, or people from outside of TTU) must be listed as Co-Investigators.

Investigators should be aware that consent may be required on legal, ethical, or practical grounds that do not involve the protection of research subjects.

IRB proposals may be considered to be public information in accordance with the Texas open records statute.

Proposals should be submitted to the IRB through the Cayuse IRB system.

4.1 IRB Approval from TTUHSC and other Institutions.

Projects that involve human subjects research at both Texas Tech University and another institution need to be reviewed and approved by the other institution's IRB as well as the TTU IRB. For projects where another institution is the primary institution, that institution's complete IRB proposal and approval letter should be submitted in the Cayuse IRB system. It is possible that an Institutional Authorization Agreement can be created that allows TTU IRB to rely on the other institution.

Research being conducted jointly by faculty at Texas Tech University and the Texas Tech University Health Sciences Center (TTUHSC) 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 the faculty, facilities, staff, and/or students of TTU. If the most appropriate assignment of an application is in doubt, the administrators and chairs of the two IRBs should reach a consensus on which IRB is most appropriate. The Memorandum of Understanding between TTU and TTUHSC is in Appendix E.

4.2 Proposals Involving External Funding

When research involving external funding involves work with human subjects, funding from federal and some private sources cannot be expended until an IRB proposal has been approved (see 45 CFR 46.122). The Office for Human Research Protections has noted (May 31, 2000) that some agencies require IRB review before a project can be funded. Regulations require that the IRB review the grant application or proposal to be certain that the grant and IRB proposals are in agreement. The IRB must have a complete copy of the grant proposal for this purpose and for records.

It takes 10 working days before the IRB can complete a proposal review and more than that when changes are necessary or special populations are involved. Some proposals will require a review by the Full Board, which meets once a month. For several years, some federal funding awards have been made with very short time frames required for funds to be awarded. This has led to situations in which the investigator had very little time to document IRB approval. In other words, an investigator had to write an IRB proposal and submit it to the IRB and the proposal had to be reviewed and necessary changes made, sometimes within 24-hours. This is an impossible situation for the TTU IRB and for IRBs across the country. It is in the researchers best interest to submit an IRB proposal along with a grant proposal or soon after.

Occasionally a project already approved by the IRB is submitted for external funding. In such a case, the Office of Research Services will require verification from the IRB that the proposed research protocol is the same as the one previously approved by the IRB. The investigator should submit the grant proposal to the IRB in the form of a modification to the original IRB proposal. The grant proposal and the approved IRB proposal will be forwarded to an expediting reviewer who will verify that the two protocols match.

4.3 Payment to Research Subjects

The TTU O.P. 62.25 concerns Payment to Research Participants. This area is complex and goes beyond the work of the IRB.

4.4 Recruitment of Subjects by Subjects

Referral fees paid to research participants to recruit other research participants introduces possibilities of coercion in recruitment. The TTU IRB will not approve these recruitment procedures.

4.5 Risk

Minimal risk "means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (45 CFR 46.102).

The definition of "risk" is determined by assessing the probability of harm and the magnitude of harm. Consideration is given to both aspects of potential harm. In some cases, (perhaps research in physical exercise) one of the possible risks could be death. However, this would be an extremely rare occurrence which is likely to never occur. Thus, the probability of harm would be exceptionally low. Therefore, although the potential magnitude of harm could be high, the probability of that occurring is so low that the research does not necessarily need to be considered high risk.

4.6 Electronic Data Policy

The Electronic Data Policy Statement is in Appendix F.

4.7 Subject Pools

Departments that have written procedures for organizing pools of research subjects must submit the procedures for IRB approval. The procedures should describe the methods for recruiting and compensating subjects. If credit toward meeting a course requirement is offered to students in the pool, the nature of that credit should be specified. Non-research alternatives for earning the same credit with similar time and effort must be available and should be described. If the subject pool procedures are approved by the IRB, the details of subject recruitment and compensation need not be reported in detail in projects proposing to use the subject pool. It is sufficient to refer to the procedures on file with the IRB. The IRB reviews existing procedures once each year and considers new procedures and modifications as they are submitted.