Thus, in order to protect potential research participants, any proposed investigator should, through his or her training, professional commitment, and moral judgment, be able to review what has been done prior to his or her involvement and either accept it, urge modification, or decide he or she cannot be part of it. Faculty members in academic health centers or private physicians may be asked to undertake research initiated in this way.
In contrast, the typical project initiated by an academician is more often motivated primarily by a scientific question rather than by drug development. For biomedical studies, a drug may be involved, but more likely as a probe or perturbation to the system than as an element of proving efficacy and market potential. The investigator in this case is likely to be seeking support from the National Institutes of Health (NIH) or a foundation (or drug company), but the study will not have the elaborate developmental and group participation described for industry. Similarly, NIH will not be monitoring each step of preparation, but will first be involved when a grant application is submitted. The individual investigator is therefore responsible for arranging the same features of research design referred to above and for considering the elements of participant protection.
It should be clear that the investigator working on his or her own to develop a human research protocol needs extensive education and preparation for that role. This is the subject of further discussion below.
The different perspectives between investigators from distinct fields are less important than their commonalities. Anyone studying human beings requires mentoring that is grounded in the science of the discipline, the integrity of research, and the ethics of human investigation. For this reason, the committee believes that formal education, for which numerous programs are now available, with a measured learning achievement should be required of all investigators. The committee does not endorse any single approach, but believes that the research organization should establish standards by which investigators’ initial preparedness, their continuing education, and their adherence to institutional policies and procedures can be assessed. However, it is critical that federal agencies require such education as a basic precondition for carrying out research (Box 4.2) and encourage others research sponsors to do the same.
Educational opportunities within a research organization may include attending seminars, workshops, or Internet-based training. These programs should offer continuing education credits and, when appropriate, a certificate of completion. Topics can be derived from a variety of sources,