TEXAS DEPARTMENT OF CRIMINAL JUSTICE

The Full Research Proposal should be the document which is presented to the Principal Investigator’s Institutional Review Board. At a minimum, the Full Research Proposal should include the following:

• A project overview
• A short review of the literature
• Project details
• Purpose, goals, and objectives
• Research design and methodology
• Participant recruitment strategy (if applicable)
• Clinical Trial Protocol (if applicable)
• Data management plan
• Harm mitigation strategy (for projects with human subjects)
• Proposed timeline
• Expected publications, presentations, and outward facing documents
• Benefits to the Texas Department of Criminal Justice

Informed Consent is an individual’s express, written permission to participate in a research project after being provided sufficient information on a project, including the expectations of their participation and all possible consequences of participation.

Requirements for informed consent will vary from project to project and across institutions. While the components listed below will be required at a minimum for all research with human subjects under the employment or supervision of the Texas Department of Criminal Justice, it is likely that biomedical projects will require additional information in the informed consent process.

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of any benefits to the subject or to others that may reasonably be expected from the research (financial or otherwise).
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject. This will necessarily include contact information for both the Principal Investigator and sponsoring organization.
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

More information on informed consent can be found in Code of Federal Regulations Title 45, Part §46 section 116 General Requirements for Informed Consent at U.S. Department of Health & Human Services.

An Institutional Review Board (IRB) is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in all research in accordance with Code of Federal Regulations Title 45 Part §46 as well as organizational standards and practices. This includes determining if research involves human subjects in accordance with 45 CFR and providing either a written approval or exemption for research projects that meet federal guidelines.

The Texas Department of Criminal Justice requires that projects receive a new Institutional Review Board approval or exemption annually. Expedited review boards for initial approval are only acceptable if projects are deemed to not involve human subjects.

The Texas Department of Criminal Justice does not offer IRB approval/exemption services for projects.

Due to the sensitive nature of much of the information provided and obtained in research projects, the Texas Department of Criminal Justice requires that all members of the research team who collect, analyze, or otherwise may have access to the data submit an Application to Conduct External Research (ER 22.01) to facilitate the background investigation process.

Yes. Upon sending in your research application materials, please designate if you desire an individual to be the primary point of contact for a project and their contact information.

Neither compensation nor incentives are allowed for participating in a research project. This policy applies to both inmates and staff of the TDCJ. The informed consent submitted by the principal investigator must include this stipulation.