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Review of the history of human subjects research provides us with many examples of unethical and inhumane treatment of human research subjects. Perhaps the most infamous examples were perpetrated by Nazi physicians during World War II, but there are several other examples of unethical research activities that took place in the United States.

As a result, several international codes arose that addressed the issues of ethical treatment of research subjects. In 1947, the Nuremberg Code established ten major ethical principles for human subjects research and later the World Medical Association established its own code of research ethics at a meeting in Helsinki, Finland and revised it several times over the years to keep pace with the changing technologies and types of human subjects research.

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1.2.1 The University of Texas at AustinThe mission of The University of Texas at Austin (University) is to achieve excellence in the interrelated areas of undergraduate education, graduate education, research and public service. The University provides superior and comprehensive educational opportunities at the baccalaureate through doctoral and special professional educational levels.

The Office of Research Support and Compliance provides the interface between the various components of the HRPP as needed to ensure human subject research is conducted with integrity and in compliance with applicable regulations.

In general, however, it is the responsibility of all faculty and research staff, IRB members, IRB staff, University staff negotiating with research sponsors, and anyone else involved in human subjects research to uphold the ethical standards delineated in the Belmont Report and assure that the highest level of human subjects protections are in place and implemented at all times.

The Office of the Vice President for Research, Scholarship and Creative Endeavors (VPR) is responsible for the administration and oversight of research integrity at the University. The IO oversees the functioning of the IRB. The ORSC Director is responsible for provision of IRB administrative support. Supervisors periodically evaluate administrative support staff regarding their knowledge and interpretation of relevant policies and procedures regarding human subjects protections. In addition, and as part of the overall oversight function, in order to maximize compliance with regulations, guidelines, and policies and procedures of the institution, the ORSC Director relies on an internal QI monitoring program to assess research activities and documentation.

This manual contains a current compilation of federal, state, The University of Texas System (UT System) and the University rules, regulations, policies and procedures applicable to the protection of human research subjects, sets forth appropriate mechanisms for their implementation and is regularly updated to reflect new standards, regulations and the University policy.

The policies and procedures set forth in this manual are applicable to all faculty, staff, employees, and students at the University who propose to use human subjects in research, development, and related activities including research for which investigational devices or drugs are used, as well as to the IRB, ORSC staff who support the HRPP, and the Institutional Official.

Compliance with this policy or the procedures set forth herein will in no way render inapplicable pertinent laws of the State of Texas, any local law which may bear upon the proposed activity or the Rules and Regulations of the Board of Regents of the UT System.

The ORSC is responsible for maintaining and updating this manual. All new or revised manual materials will be published on the ORSC website by the IRB office at -subjects/policies-and-guidance. Updates to the manual will be communicated to the research community electronically via newsletter and listserv communications.

Agent of the Organization is a faculty member or non-faculty employee, who may also be a principal investigator of a research protocol or an Institutional Review Board member, or non-employees who perform institutionally designated activities or who exercise institutionally delegated authority or responsibility such as research or teaching activities. Examples would include community IRB members, University faculty who are conducting research at another institution, a faculty member performing research while on sabbatical or a University student conducting research at another institution as part of a course requirement.

Anonymity means that the identity of a research subject cannot be readily ascertained by anyone, including the Principal Investigator, either directly or through the use of coded data.

Applicable Clinical Trial means any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause and effect relationship between the intervention and a health relationship. The definition includes surgical procedures, behavioral treatments, and FDA regulated studies with drugs, biological products, or devices.

Approved Assurance means a document that fulfills the requirements of 45 CFR Part 46 and is approved by the Secretary of Department of Health and Human Services (HHS). The University of Texas at Austin has an approved Federalwide Assurance on file with HHS.

Approved with Explicit Conditions or Modifications Required to Secure Approval means the protocol is approved with explicit conditions for minor changes or simple concurrence of the Principal Investigator that will be identified to the Principal Investigator and must be completed and documented prior to beginning the research. In most instances, the Institutional Review Board (IRB) Program Coordinators will review and approve but explicit conditions deemed as significant or are directly relevant to regulatory criteria must go back to the convened IRB for review and approval.

Assent means an affirmative agreement to participate in research or clinical investigation. Mere failure to object an absence of affirmative agreement may not be construed as assent. This most often is applicable to children and decisionally impaired adults.

Authorized deception means that a Principal Investigator has intentionally not described certain aspects of a research study but subjects are informed that certain information will be withheld until the subject completes the study tasks.

Basic community partnership research is a project that involves a relationship with a community partner in which the researcher makes the key decisions in the project, but considers the needs and interests of the community in how the research is conducted and how the outcomes are disseminated.

Children are persons who have not attained the legal age for to treatments or procedures involved in research or clinical investigations. In Texas, where federal regulations and state law both apply, individuals under the age of 18 are considered to meet the definition of children. For research conducted outside Texas, children are defined under the applicable law of the jurisdiction in which the research or clinical investigations will occur. Some funding agencies may define children differently.

Clinical Trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Close community partnership research is an ongoing collaborative project in which goals are co-defined in ways that balance benefit to the PI and utility of the findings for the community. There is some sharing of decision making between the Principal Investigator and the community, but the research methodology is primarily determined by the Principal Investigator.

Coded Information/Data means that identifying information that would enable the Investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

Coercion is an overt or implicit threat of harm that is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that his or her grades might suffer if they do not participate in the research.

Community-based research is research that takes place in or involves a community. The more precise definitions below reflect the degree of engagement of the community in the research, which can take place along a spectrum of engagement and shared governance.

Community-placed research is a researcher-initiated project involving a one time or short-term relationship between the PI and the community, with limited community involvement beyond being a venue for recruiting research subjects or for implementing research procedures.

Community-based participatory research (CBPR) is a project defined by co-creation of project ideas and procedures by Principal Investigator and a community, active and substantive participation by the community in all or nearly all stages of the research, and shared power and decision-making responsibilities. There is an expectation that findings will be used to change systems or solve community problems. CBPR sees research subjects as both individuals and as a community comprised of individuals. Issues of confidentiality in CBPR should be viewed differently than with individual subjects and decisions made as to what may or may not be appropriate.

Confidential pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission or in ways that are inconsistent with the understanding of the original disclosure. For example, there may be a legal responsibility to divulge information and that should be stated in the consent form. The words anonymous" and "confidential" do not have the same meaning and are not interchangeable.

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