1996 OPEN FORUM Abstracts
Ethics of Human Research and Institutional Review Boards
Dean R. Hess, PhD, RRT Wednesday, November 6,1996
Research ethics relates to the principles governing investigator conduct during the design, implementation, data analysis, and reporting of studies.
An ethical study begins with an appropriate design. A study that addresses a hypothesis of questionable value may be unethical--particularly if subjects are placed at risk. The study should be designed to minimize potential risk to subjects and adequate pilot testing should be conducted using models or animals before the human study is implemented. The study must be designed with adequate attention to sample size. If the sample size is too small, subjects may be placed at risk for inconclusive results. On the other hand, a sample size that is too large may needlessly place subjects at risk or deprive others of the superior treatment.
New treatments are scientifically judged from the results of controlled clinical trials, which are conducted to determine whether one treatment is superior to another. By nature of their design, half of the subjects in the controlled clinical trial receive the new therapy and the other half receive conventional therapy or a placebo. To control bias, subjects are randomly assigned to the treatment group or the control group. Further, blinding is usually performed such that the subject (and often the investigator) do not know which treatment is used. Thus, therapy is driven by the rules of the experiment rather than the moment-to-moment wishes of the patient or those providing care for the patient. Human studies may be of direct benefit to some participants or be of no direct benefit to the individual participants but ultimately help others. It is very important that the investigation is structured to minimize the risk for harm and maximizes the potential for benefit.
Three primary principles govern conduct of research involving human subject. First of these is freedom of harm. Every effort should be made to minimize the risk of harm resulting from the participation of in a study. Second, the confidentiality of subjects must be assured. Third is the issue of informed consent, discussed in more detail below.
Federal funding to an institution can be withheld for failure to conform to ethical research principles. Responsibility for research conduct is assigned to the Institutional Review Board (IRB) of the hospital. The IRB reviews all research proposals involving human subjects. Some research activities are exempt from review. An example might be research conducted in established or commonly accepted educational settings involving normal educational practices. Other research activities may receive expedited review if only minimal risk is involved. An example might be recording of data using noninvasive procedures routinely employed in clinical practice. All other research requires review and approval by the full IRB.
The IRB will determine that an appropriate written consent form is used for recruiting subjects. A consent form should include the title of the research, an overview of the research project, a description of risks and benefits of participation, how discomfort or injury will be handled, how confidentiality will be assured, who to contact for more information, a statement that participation is voluntary, and appropriate signatures. Of particular concern is the process of consent for subjects who are not competent to provide consent on their own behalf (e.g., critically ill patients).
Research ethics are also important in the analysis and reporting of the data. Appropriate statistical testing must be used and the results must be reported in a balanced and unbiased manner.
The role of the IRB in activities such as continuous quality improvement is not well defined. When uncertain, it is always best to consult the chairperson of the IRB for guidance.