PRIM&R’s 2008 Advancing Ethical Research Conference: Balancing the Needs of Human Subjects and Science began with an inspiring Keynote Address by Ivor Pritchard, Senior Advisor to the Director of the Office for Human Research Protections (OHRP).*

Dr. Pritchard spoke about finding the balance between adhering to the requirements of ethical principles and regulations and responding to the distinctive features and needs of research projects. He pointed out that the regulations have sufficient flexibility to permit discretion in their application (for example, they permit variability in how exemption determinations are made or in how frequently continuing reviews must be conducted). However, the structure provided by these rules and standards are also helpful, as they provide consistency and inform decision-making. The challenge we face is “walking the line” between blind adherence to the rules and research without oversight or guidance.

Dr. Pritchard remarked that it is arguable that some of our current regulations are too flexible. Consider the ongoing debate over what constitutes “research.” The regulations include a definition of “research,” yet the application of this definition is frequently debated. An example of this is the controversy raised in the now well-known case of the Johns Hopkins University Keystone Initiative, which concerned the use of a checklist for ICU staff to follow to avoid infections in the placement of catheters. Cases also exist in which the flexibility of the regulations may not be fully realized. The differing levels of discretion that institutions exercise in overseeing large, multi-site research reviews is evidence of this.

Dr. Pritchard noted that, as human subjects professionals, we are obliged to follow the rules to the extent that they represent the best judgment for how we conduct research activities. However, some rules become inapplicable or ill-suited to circumstances that evolve over time and as a result of technological advances. In such cases, there may be justification for defying the rules. Open defiance of rules that no longer seem to fit within the ethical framework should prompt the regulators to change the rules.

Dr. Pritchard ended his address by reminding those present to always be guided in their work by the interests of subjects who volunteer to participate in research. Their sacrifice furthers our knowledge and benefits us all.

Look for more from the 2008 Advancing Ethical Research Conference tomorrow!

*Dr. Pritchard spoke in his capacity as a private citizen. His views may not be those of OHRP, DHHS, or the United States government.