Several preliminary steps must be completed before the IRB can review any application. Completing these steps as described can help investigators avoid delays in receiving review by the IRB.
UAB policy gives each departmental chair responsibility for determining that proper scientific and department approvals have been obtained and that the hypothesis and procedures are consistent with generally accepted scientific principles in the discipline. Therefore, the principal investigator obtains review and approval from the department in which he or she holds a primary appointment. Most departments use the Protocol Oversight Review Form to document this review. If the project involves gene transfer or the administration of recombinant materials in humans, then review by the Gene Therapy Project Review Panel must be documented on the Report of the Project Review Panel.
UAB policy requires review by the Conflict of Interest Review Board (CIRB) for all research when the principal investigator (including immediate family) or any individual (including immediate family) associated with the design, conduct, or reporting of the research described in this protocol submission has any of the relationships listed below regardless of whether the research is extramurally or intramurally funded.
Immediate family is the spouse or a dependent of the employee. Dependent is any person, regardless of his or her legal residence or domicile, who receives 50% or more of his or her support from the public employee or his or her spouse or who resided with the public employee for more than 180 days during the reporting period.
The CIRB provides relevant information on study personnel to the OIRB to assist the IRB in its review. The IRB will determine
Notably, the IRB can require measures in addition to any required by the CIRB to manage an identified conflict (actual, potential, or in appearance only). Visit www.uab.edu/cirb for more information.
Investigators whose studies involve human subjects and who have subcontracts with collaborating non-UAB investigators for human subjects research must obtain the IRB approval from the subcontractor’s institution and submit a copy to the UAB IRB. The subcontracting institution should have a FWA with DHHS. If it does not, then either a Memorandum of Understanding (MOU) or an Individual Investigator Agreement (IIA) is required. Investigators should call the OIRB for specific instructions. Subcontract investigators may also need to provide certification of human subjects protection training. These documents must be submitted to the IRB before any participants are enrolled or research involving human subjects begins at any subcontract site. Coordination of subcontracts is facilitated through the Office of Sponsored Programs (OSP), which maintains a web site at www.uab.edu/osp.
Whenever an investigator becomes involved in the transfer of tangible research materials, outbound or inbound, the University requires you work through The UAB Research Foundation (UABRF) to put a Material Transfer Agreement (MTA) in place to facilitate the transfer because these transfers involve important rights and obligations. MTA’s address ownership of the transferred materials, and ownership of modifications or derivatives made by the recipient from the materials. They also address limits on the use of the materials by the recipient institution, confidentiality of information related to the materials, liability issues, publication rights, and rights to inventions and research results.
Materials that are commonly transferred under MTA’s are culture, cell lines, plasmids, nucleotides, proteins, bacteria, transgenic animals, pharmaceuticals, and other chemicals. Intangible research materials, such as data and software, are generally transferred under Confidentiality Agreements (CDAs and are processed by UAB’s office of Grants and Contracts Administration, unless an Intellectual Property Disclosure (IPD) has been filed with UABRF. If an IPD has been filed, then the Agreement would be processed by UABRF. More information may be found at the following web sites:
If the research involves a device or invention developed by the investigator, the investigator should contact the UAB Research Foundation at 934-9911. For more information please visit the UABRF web site at www.uab.edu/uabrf.
The investigator should also determine which, if any, of the approvals described in the section on Special Approvals apply to the protocol. All special approvals must be obtained and documented as described before the OIRB will issue an Approval Form.
The IRB recommends investigators obtain approval of any message text prior to taping to avoid re-taping if reviewers determine that inappropriate wording is used. The advertisements for recruiting into investigational studies should not mislead participants.
Data and safety monitoring is often required to provide regular reports about the continuing safety of participants, as well as the continuing validity and scientific merit of the project. Data Safety Monitoring Board (DSMBs) and Data Safety Monitoring Plans (DSMPs) may not be necessary or appropriate for many studies when the intervention is low risk. For example, expedited protocols rarely need such monitoring because they are minimal risk studies.
A DSMP is sufficient for many types of studies, such as most Phase I and Phase II trials or investigator-initiated studies conducted at UAB. A DSMP details how the study investigator, along with a colleague or medical monitor, will provide continuous, close monitoring as well as prompt reporting of toxicities to the IRB, FDA, and sponsor, as applicable. The DSMP should include the name of the individual(s) who will be reviewing the data so that the IRB can assess their qualifications and assure there is no conflict of interest.
The DSMP should also describe data “stopping rules,” which include
A DSMB is required for federally funded Phase III studies and may be needed for Phase I or II trials that are high-risk, blinded, and/or multi-center. A DSMB may also be needed for protocols that involve, for example, a large study population, a multi-center study, use of high-risk therapies or procedures, study populations with potential for increased rates of mortality or morbidity, or a high probability that the study may be terminated early under the stopping rules. For the IRB to determine whether the members of the DSMB are qualified and appropriate, the investigator must provide the names and the qualifications of the members in the IRB application.
DSMBs are formed under a charter. Their members typically include clinical experts, statisticians, someone knowledgeable about conduct of clinical trials, ethicists, and an advisory panel member (lay member). Each member has a contractual agreement to serve on the board, to declare any relevant conflict of interest, and to sign the appropriate confidentiality agreement(s).
A DSMB has the authority to stop a trial if there is