Human Subjects Used in Research

Handbook of Operating Procedures 7-1320

Human Subjects Used in Research

I. Policy Statement 

It is the policy of The University of Texas at Austin (“University”) to assure the use of human subjects in University research is done in accordance with applicable federal and state laws and regulations, and The University of Texas System Board of Regents Rules and Regulations. This applies to research conducted in University facilities or by faculty, staff, or students on behalf of the University. Failure to comply may result in disciplinary action, up to and including, termination of employment.

II. Reason for Policy 

To set forth administrative guidance to comply with relevant laws and regulations governing the protection of human research participants including Title 45 CFR Part 46 and Title 21 CFR Part 56.

III. Scope & Audience 

This policy applies to University employees, students, and affiliates who utilize human subjects for research. It is applicable to activities that occur in University facilities and at other locations whenever projects involve University funding, faculty scholarship, or staff/student effort as part of University activities.

IV. Definitions (specific to this policy) 
Human Subjects:

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

 

  1. The Department of Health and Human Services (DHHS) defines a human subject as a living individual about whom the principal investigator conducting research obtains

 

  • data through intervention or interaction with the individual, or

 

  • identifiable private information.

 

  1. The Food and Drug Administration (FDA) defines a human subject as an individual who is or becomes a participant in research, either as a recipient of a test article (investigational drug, biologic, or device) or as a control and may be either a healthy human or a patient. The definition also includes an individual on whose specimen a device is used.
Human Subject Research:

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

 

  1. DHHS defines human subject research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge and includes a living individual about whom the investigator conducting research obtains

 

  • data about the subjects of the research through intervention or interaction with them, or

 

  • identifiable private information about the subjects of the research.

 

  1. FDA defines human subject research as

 

  • a clinical investigation on one or more individuals who are or become participants in the investigation, either as recipients of a test article (drug, biologic, or device) or as controls and may be either patients or healthy non-patients.

 

  • the data obtained from participants (and controls) that will be submitted to, or held for inspection by, the FDA in support of a marketing or research application for an FDA-regulated product, or data obtained from the use of a device (in vitro diagnostic device) on tissue specimens that will be submitted to, or held for inspection by, the FDA in support of a marketing or research application for an FDA-regulated product.
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.

 

  1. Obtaining identifiable private information about living individuals for research purposes.

 

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

 

  1. Studying, interpreting, or analyzing identifiable private information or data 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.

 

  1. FDA defines research as an activity that involves a drug or device, other than use of a market 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.
V. Website (for policy) 
https://policies.utexas.edu/policies/hop/7-1320
VI. Contacts 
Contact Details Web
Office of Research SupportPhone:512-471-8871Website:
VII. 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 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.
  • directing an annual review of 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.
  • directing an annual review of the University’s participant outreach program.

The IO 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.
  1. 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 research demonstrations, development, or other activities involving the use of human subjects must be reviewed and approved by the IRB prior to initiation of the project.

 

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.

 

All suspected protocol deviation or non-compliance should be reported to the Office of Research Support.

 

  1. Principal Investigator (PI) and Investigator Responsibilities

A significant burden of responsibility rests with the Principal Investigator (PI) when using humans in research.   

The PI’s responsibilities include, but are not limited to:  

  • Completing proposals for funding in accordance with requirements of the funding agencies.
  • Assuring projects are performed in accordance with funded proposal and IRB approved protocols.
  • Ensuring IRB approvals have been obtained.
  • Providing annual updates to the IRB.
  • Ensuring significant changes to protocols have been approved by the IRB in accordance with IRB policies.

Investigators using human subjects must comply with the following and assure:

 

  1. All personnel involved with a research project utilizing human subjects are trained in ethical principles, relevant federal regulations including the FDA’s guidance related to adequacy of supervision by researchers, and institutional policies governing human subject research.
  1. Human subjects give voluntary consent to participate in research unless the requirement to obtain consent is waived by the IRB.
  1. All subjects are provided with pertinent information, e.g. risks and benefits, contact information for investigators and IRB chair, etc.

Note: In the case of research involving protected classes or individuals with diminished capacities to consent, the investigator assures the consent and assent is obtained, as appropriate.

  1. Human subjects will be selected equitably, so the risks and benefits of the research are justly distributed.
  1. The IRB will be immediately informed of any information regarding incidents of non-compliance with approved research protocols, stipulations of the IRB, federal or state regulations and guidelines, or local policies and procedures, as well as unanticipated problems that would increase risk to human subjects.
  1. The IRB will be immediately informed of any complaints from participants regarding their risks and benefits.
  1. The privacy of the subjects and confidentiality of subjects’ research data will be maintained appropriately to ensure minimal risk to subjects.
XI. History 

Last review date: December 12, 2013

Next scheduled review date: December 2015