study and deliberation at the national level by the research community, federal policy makers, and professional associations before implementation in a formal or mandatory manner.

Relevant Potential Conflicts of Interest

As an investigator conceives research questions and designs a study to answer those questions, there are multiple points at which unintentional self-interest may bias his or her decision making. The consideration of potential conflicts of interest at this very early stage in the research process is important, as early decisions may significantly affect participant protections provided down the road.

Formulating the research question, for example, may seem to be straightforward if the main considerations are perceived to be only scientific in nature. However, the importance of the research question should demonstrate sufficient possibility of adding to the fund of useful knowledge in order to consider involving volunteers. Merely adding to a company portfolio or to the publications on an investigator’s curriculum vitae, for example, are not useful expenditures of human capital, let alone sufficient reasons to subject research participants to the risks inherent in any research protocol (including instances in which no physical or psychological harm would result). The issue in these cases is a simple balance between the participant’s interests and those of the investigator or institution.

Personal biases and conflicts also can emerge during protocol development. For example, the addition of a placebo arm in a drug study may enable the investigator to use fewer participants, and thus obtain results (and a publication) more quickly than a comparison with an existing drug. However, such a design may or may not be in the best interests of participants, and participants’ rights should trump scientific considerations.7

Conflicts of interest could also lead an investigator to seek out a population simply because it is easy to reach or to seek out individuals because they consciously or subconsciously feel pressure to volunteer. An example is the recruitment of employees, students, or trainees who are in any way associated with the investigator. Rigorous scientific review and appropriate training in the ethics of research with humans can often prevent or identify trouble spots before damage is done. Furthermore, strong organizational leadership and the promotion of a culture based upon ethical norms (as


The committee notes that reducing the number of participants who should be exposed to protocol risks in order to sufficiently answer a scientific question also serves overall participant protection needs. The point in this instance is that individual participants’ rights should not be sacrificed in doing so (Katz, 1993).

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