The Graduate School
Human Research
Students sit at laptops waiting for class to begin. Isolated from other students located in various rooms, these students are able to communicate with each other and the instructor only online. The instructor monitors the students responses and studies how they react to the online environment. Are they able to comprehend the material? Are they distracted by the technical problems? How well do they communicate with her and each other? Live sessions and evaluations will help her gather this information.
Studies with human subjects are going on all around campus. They range from basic observation to more direct intervention. In order to protect the participants and the researchers data, all of these studies must obtain the approval of a Departmental Review Committee (DRC) and the Institutional Review Board (IRB). These entities ensure that the investigators observe all ethical policies in regard to their human subjects. Every student, faculty, and staff member who wishes to study with human participants needs approval before the work begins.
Your proposal may require additional discussion at a full-board meeting of the Institutional Review Board if your study includes:
- participants that may feel compelled to participate such as prisoners
- the use of drugs, including over the counter medication
- any study that posses more than a minimal risks to the participants.
The DRC and IRB will determine the risk and general quality of the study. We will discuss more about the DRC's and IRB's roles in a few moments but first it is important to examine the reasons why this strict ethical review is necessary.
Historically, participants' human rights have not always been a priority. Many unethical and inhumane studies have occurred in the name of science: The Nuremberg trials brought the world's attention to the atrocities committed by Nazi physicians in concentration camps. The evidence in these trials was so horrifying to the international community that it became a catalyst for the foundation of our current ethical codes.
In our own country, the rights of 400 African American men were violated when they were injected with syphilis bacteria in Tuskegee, Alabama. between 1933 and 1972. When treatment was available they were denied a cure to further the results of the study. Our own military conducted studies with U.S. Army recruits by exposing them to intense psychological stress. Young men in one study were led to believe they had caused harm or death to other recruits.
These extreme examples of ethical violations have had an impact on the formation of our current international laws and scientific ethical standards. The basic code of research ethics followed by UT follows these laws and standards. This code includes:
- the right to free and informed consent,
- calculation of risk,
- and the equitable selection of subjects.
The right to free consent ensures that all subjects were not coerced into participating in the study. Students should not be pressured to support the studies of their professors and participants have the right to withdraw from a study at any time.
The participants also have the right to informed consent. They must clearly understand the details of their role. Are there any risks, psychologically or physically? The IRB must review all consent forms to ensure that all participants were properly informed of their rights.
The IRB will also determine if the investigators have properly calculated the risk of the study versus the expected benefits to society. A study that is expected to yield small benefits should have only a small impact on participants. A study that poses a high risk to participants should, if successful, yield larger benefits.
Equitable selection assures that there is no bias against any particular group or population. According to the National Institute for Health, "research should not involve persons from a group that are unlikely to benefit from subsequent applications of the research" . An investigator should not choose subjects because they are convenient or vulnerable but rather because their particular participation is needed for the study.
Your primary responsibility is to protect your human subjects and the data gathered. The ethical guidelines set by the university you will help you provide the appropriate protection for your subjects and produce respectable scientific data.