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Part 11. Research
Section B. Research Ethics and Compliance
Policy Number 11.B.5
Date Issued: July 6, 2009
Approved By: Vice President for Research

USE OF HUMAN SUBJECTS IN RESEARCH

Section I. General Policy Guidelines

A. Policy Statement

It is the policy of The University of Texas at Austin to assure that the use of human subjects in all research or teaching activities conducted in University facilities or by faculty, staff or students of the University will be done in accordance with applicable federal and state laws and regulations and the Rules and Regulations of the UT System Board of Regents. Failure to comply may result in disciplinary action up to and including termination of employment.

B. Purpose

This policy sets out relevant laws and regulations governing the protection of human research participants including 45 CFR 46 and 21 CFR 56.

C. Scope

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

D. Definitions

1. Human Subject Research:

   Human Subject Research is defined as any activity that either:

   • Meets the Department of Health and Human Services’ (DHHS) definition of “Research” and involves “Human Subjects” as defined by the DHHS;

     or

   • Meets the Food and Drug Administration’s (FDA) definition of “Research” and involves “Human Subjects” as defined by the FDA;
   
   
2. Human Subject:

   A human subject is defined by the DHHS as a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information.

   • “Intervention” as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.[45 CFR 46.102(f)]
   • “Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
   • “Private information” as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
   • “Identifiable information” as defined by the DHHS means information that is individually identifiable (i.e., the identity of the subject is or may be ascertained readily by the investigator or associated with the information).

   A human subject is defined by the FDA as an individual who is or becomes a participant in research, either as a recipient of a test article or as a control who may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject according to the FDA includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]

3. Investigator:

   An Investigator is each faculty member, principal investigator, or other researcher responsible for the design, conduct, or reporting of the research or other educational activity proposed for funding. In some cases, graduate students and postdoctoral fellows may be responsible for the design, conduct (including, for instance, obtaining voluntary informed consent of individuals to be research subjects), or reporting of research such that the graduate student or postdoctoral fellow is considered to be an Investigator under this policy and may be required to complete a financial disclosure statement. The principal investigator on each grant or contract should insure that all researchers on the project are aware of and comply with this policy.

4. Research:

   Research as defined by the DHHS is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

   Research as defined by the FDA means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms: research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]

   • "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act" are any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
   • "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act" are any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]

Section II. Authority and Responsibility for Ensuring Compliance

A. Institutional Official

The Vice President for Research is the Institutional Official responsible for the human research protection program at The University of Texas at Austin with specific responsibilities and authorities delineated below. To achieve that end, he or she is responsible for the delegation of authority for the establishment and enforcement of relevant University policies and procedures.

Responsibilities include:

• Ensuring the protection of all 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 the activities under its jurisdiction;
• Ensuring that the number of IRB members is adequate to address the volume and types of human research to be reviewed, so that reviews are accomplished in a thorough and timely manner;
• Conducting an annual review of the human research protection program, including but not limited to, reviewing the number and composition of the IRB depending on the volume and types of research, and the performance of IRB researchers and staff; and
• Conducting an annual review of the organization’s participant outreach program.

In order to complete these responsibilities, the Institutional Official is granted the following authorities:

• To create and approve policies and procedures, including those dealing with conflicts of interest, governing the human research protection program that have institutional authority;
• To establish or modify IRB(s);
• To provide resources, including budgetary authority, for the IRB(s);
• To take action if persons responsible for the protection of human participants are unduly influenced;
• To suspend or terminate research including disapproving a protocol or research activity that has been approved by the IRB;
• To provide access to legal counsel on behalf of the IRB(s); and
• To 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.

B. Institutional Review Board

The IRB reports to the Vice President for Research. The IRB is charged with reviewing and approving all teaching and research activities involving the use of human subjects. All research demonstrations, developments, 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 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.

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:

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

In order to allow the human research protection program to function independently of other organizational entities in its role in protecting research participants, officials of the organization may not approve a protocol that has not been approved by the IRB(s).

C. Principal Investigator and Investigator Responsibilities

Although institutional policies are designed to provide the IRB and the Institutional Official, and his or her designee(s), the necessary resources to assure compliance, a significant burden of responsibility also rests with the Principal Investigator. Not only is the Principal Investigator charged with completing the proposal for funding in accordance with the requirements of the funding agency, but he or she also must assure the project is performed in accordance with the funded proposal and the IRB-approved protocol. It is also the Principal Investigator's responsibility to ensure that IRB approvals have been obtained, annual updates to the IRB have been submitted, and any significant changes to the protocol have been approved by the IRB in accordance with IRB policies.

Investigators using human subjects must comply with the following:

1. The Investigator assures that all personnel involved with a research project utilizing human subjects are trained in the ethical principles, relevant federal regulations including the FDA’s guidance related to adequacy of supervision by researchers, and institutional policies governing human subject research;
2. The Investigator assures that human subjects will voluntarily consent to participate in the research when appropriate (e.g. surveys, interviews) and will provide subjects 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 secured, as appropriate;
3. The Investigator assures that human subjects will be selected equitably, so that the risks and benefits of the research are justly distributed;
4. The Investigator assures that the IRB will be immediately informed of any information regarding incidents of non-compliance with the approved research protocol, stipulations of the IRB, federal or state regulations and guidelines or local policies and procedures as well as unanticipated problems that would increase the risk to the human subjects and cause the category of review to be upgraded to a higher level of review;
5. The Investigator assures that the IRB will be immediately informed of any complaints from participants regarding their risks and benefits; and
6. The Investigator assures that confidentiality and privacy of the subjects and the research data will be maintained appropriately to ensure minimal risk to subjects.

Section III. Miscellaneous

A. Reporting Suspected Noncompliance

Any person may contact (anonymously, if he or she wishes) the Director of Research Support (512) 471-8871 or the IRB Chair [irbchair@austin.utexas.edu] if there are concerns regarding the use of human subjects at or by faculty, staff, or students at the University.

University Compliance Services may also be used. See details regarding reporting options at http://www.utexas.edu/compliance, including a toll-free, anonymous help line at 1-877-888-0002. Anyone reporting concerns may not be retaliated against for a good-faith report of suspected wrongdoing.

All such concerns will be referred to the IRB for review and inquiry. If warranted, an investigation will be conducted to determine if corrective action is appropriate.

B. Retaliation Prohibited

A student, faculty, or staff member who retaliates in any way against an individual who has brought a complaint pursuant to this policy or participated in an investigation of such a complaint, is subject to disciplinary action, up to and including dismissal from the University.

C. Filing of False Complaints

Any person who knowingly and intentionally files a false complaint under this policy is subject to disciplinary action, up to and including dismissal from the University.

D. Media or Public Inquiries

Members of the media or the public may contact the University to make inquiries about the conduct of research involving human subjects. All such inquiries are to be directed to the Office of Vice President for Research at (512) 471-2877, and will be directed to the appropriate office for response.

For Assistance: If you have questions regarding this policy, you may contact the Director of Research Support (512) 471-8871.

Source: 45 CFR 46. 21 CFR 56. The Belmont Report. This new policy was developed in accordance with recommendations of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).