Any researcher conducting a study involving human subjects has a responsibility to make certain that subjects come to no harm as a result of the research. In recent years, the research environment in the United States has placed increasing emphasis on this issue. To assure that researchers do not conduct experiments that might result in harm to subjects, research methodologies are presented to Institutional Review Boards (IRBs) which review the proposed methodology and determine whether the study can be conducted as proposed. Some methodologies that might yield a clear picture of the effects of alcohol on motorcycle operation would likely be considered too dangerous and would be disallowed by an IRB. More information on human subjects’ protection and IRBs can be obtained from the U.S. Department of Health and Human Services, Office for Human Research Protections (http://ohrp.osophs.dhhs.gov).
In addition to concerns about the safety of subjects, research methodologies must consider the safety of the researchers themselves. For example, studies that require researchers to work near traffic place those researchers at risk. This issue must be considered when designing research protocols.
In many cases, surveys require clearance from the Federal Office of Management and Budgets (OMB) which may add significantly to the time and complexity involved in performing the study. Survey work performed for NHTSA is subject to OMB approval.
Many potential methodologies will require researchers to obtain cooperation from agencies such as law enforcement and hospitals. Because these agencies are primarily concerned with other functions, and because they may not be familiar with research, effort must be taken to assure that agency staff will be cooperative and remain cooperative throughout the project. Staff from other agencies may require training to perform the tasks required by the project. They will also require supervision. Because of their regular duties, it may be difficult to gain access to staff in order to conduct training and provide supervision. In some cases it may be necessary to pay staff of other agencies to do some or all of their research work while they are officially off duty. It may be necessary to provide other financial compensation or incentives to the agencies in exchange for cooperation.
Some research methodologies hold potential risk for subjects, researchers, or other parties. Researchers need to consider their potential legal liabilities as well as their potential for being sued when designing study methodologies. The best defense against lawsuits obviously is to not create research situations where a risk exists and for which the research agency could be held liable. Additionally, given the potential costs of defending against even frivolous lawsuits, researchers should endeavor to design and conduct studies in ways that minimize if not eliminate methods and situations that could be construed by the average person to put them at risk and invite a potential lawsuit.
Given that effective research methods sometimes involve a degree of risk, researchers should use previously tested methodologies and safeguards that have been shown in the literature to be the standard and most accepted practices providing the greatest documented legal protection and the least exposure.
Alcohol dosing of subjects can help provide valuable data on the effects of alcohol as part of a controlled experiment, however the process of dosing subjects must be approached carefully, with a great deal of control. Issues to consider when dosing subjects include prescreening of subjects, measurement of BAC, dosing schedules, monitoring of subjects, protecting subjects during and after the experiment, arranging transportation, and methods of administration of alcohol.
Researchers will need to consider what incentives will be used to obtain participation and/or cooperation from research subjects. Incentives have the advantage of increasing the likelihood of cooperation. However, incentives can create problems. There can be concern from IRBs that an inordinately high incentive would be coercive; it would cause people to do things that might be detrimental that they would not ordinarily do. There is also the possibility that subjects who agree to participate only for the incentive will not be interested enough in the study to provide valuable data. For example, a subject might quickly create a false diary to satisfy the requirements for payment, rather than making the effort to maintain a factual daily diary.
The cost of incentives can be a very large part of the cost of doing research. Researchers must consider this when planning a study. It is possible that the amount of monetary incentive necessary to obtain cooperation may raise the cost of a study to the point that it is not economically feasible to do.
Researchers can also consider other ways to provide incentives beyond paying cash to individual subjects. Organizations may provide subjects from its membership in exchange for donations or contributions in kind to the organization. Individuals may participate in exchange for gift certificates or a chance at getting an incentive (e.g., drawing tickets for a door prize).