Investigator:

An individual performing various tasks related to the conduct of human subject research activities such as:

1. Obtaining information about living individuals by intervening or interacting with them for research purposes.

2. Obtaining identifiable private information or biospecimens about living individuals for research purposes.

3. Obtaining voluntary informed consent of individuals to be subjects in research.

4. Studying, interpreting, or analyzing identifiable private information, data, or biospecimens for research purposes.

Research:

Two definitions are applicable in this policy depending on the federal agency overseeing the research.

1. DHHS defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

2. FDA defines research as an activity that involves a drug or device, other than use of a marketed drug in the course of medical practice, or the use of a device to evaluate safety and effectiveness of that device, and data from the activity will be submitted to, or held for inspection by, the FDA in support of a marketing or research application for an FDA-regulated product.

5. Website (for policy)

https://secure4.compliancebridge.com/utexas/public/getdoc.ph?file=7-1320
 

6. Contacts

7. Responsibilities & Procedures

1. Institutional Official (IO)

The vice president for research is the institutional official (IO) responsible for the human research protection program at the University with specific responsibilities and authorities delineated below. The IO, or appropriate delegate, is responsible for establishing and enforcing relevant University policies and procedures including but not limited to:

• ensuring the protection of research participants.
• ensuring ongoing compliance with state and federal law.
• ensuring the autonomy of the Institutional Review Board (IRB).
• ensuring the human research protection program has sufficient resources for conducting activities under its jurisdiction.

• ensuring the number of IRB members is adequate to address the volume and types of human research to be reviewed.
• periodically reviewing the human research protection program, including but not limited to, reviewing number and composition of the IRB depending on volume and types of research, and performance of IRB researchers and staff.

The IO, or appropriate delegate is granted the following authorities:

• create and approve policies and procedures, including those dealing with conflicts of interest, governing the human research protection program that have institutional authority.
• establish or modify IRB(s).
• provide resources, including budgetary authority, for the IRB(s).
• take action if persons responsible for the protection of human participants are unduly influenced.
• suspend or terminate research including disapproving a protocol or research activity approved by the IRB.
• provide access to legal counsel on behalf of the IRB(s).
• place administrative sanctions on investigators for non-compliance, such as requiring investigators or researchers to undergo additional training as a condition of continuing research, or appointing independent persons to monitor ongoing research.

2. Institutional Review Board (IRB)

The IRB reports to the vice president for research. The IRB is charged with reviewing and approving all research activities involving the use of human subjects. The IRB is responsible for safeguarding the rights and welfare of subjects who participate in the research activity as well as ensuring University policies and procedures are adhered to during human subject research. All activities meeting the definition of research involving the use of human subjects must be reviewed and approved prior to initiation of the project. Research qualifying for an exemption may be approved by Human Research Protection Program staff.

The IRB is responsible for the general oversight, evaluation, and assurance of compliance of the institution's human research protection program. In addition to protocol review, the IRB has additional authority in these areas:

• Approve, require modifications to secure approval, or disapprove all human subject research activities overseen and conducted by the organization.
• Suspend or terminate approval of research not being conducted in accordance with IRB requirements or associated with unanticipated events related to research involving human subjects.
• Observe, or have a third party observe, the consent process.
• Observe, or have a third party observe, the conduct of research.

In order to assure the human research protection program functions independently in its role to protect research participants, officials of University units/departments conducting the research may not deviate from protocol approved by the IRB nor may research not approved by the IRB be approved by any University official. However, those officials may decide not to approve/proceed with research previously approved by the IRB.