by Farah Moulvi, MSPH, Institutional Animal Care and Use Program Manager and Biosafety Officer at the University of South Flordia

In sunny Florida, as summer sizzles on, I keep reminiscing about the buzz surrounding the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) at the 2012 Institutional Animal Care and Use Committee (IACUC) Conference, including a very fruitful discussion on the new “harm/benefit” statement.

Page 27 of the Guide indicates that animal use protocols with a potential for unrelieved pain or distress or other animal welfare concerns should be scrutinized thoroughly and evaluated by the IACUC. More specifically, the Guide states that “the IACUC is obliged to weigh the objectives of the study against potential animal welfare concerns.” This seems to indicate that, for studies involving potential for pain and distress, the IACUC should conduct a harm/benefit analysis.
A harm/benefit analysis is analogous to cost/benefit and risk/benefit analyses, both of which are not new to the IACUC world, and is conducted through the application of the three R’s (replacement, reduction, and refinement).

A well-designed IACUC application requires a principal investigator (PI) to provide a rationale for the proposed research that explains the potential scientific benefit and the study’s relevance “to human or animal health, the advancement of knowledge, or the good of society,” as stated in the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.

Although not specifically stated as harm/benefit analysis, the Animal Welfare Regulations, Public Health Service Policy, and the Guide all instruct IACUCs to evaluate protocols by weighing the potential for scientific gains (“benefits”) versus potential animal welfare concerns, pain, distress and discomfort (“harm”).

IACUCs must also consider the magnitude and severity of harm, and the significance of the scientific benefit. If the potential benefit is significant and potential harm minimal, the IACUC may consider approval. If, on the other hand, the potential benefit is significant and potential harm significant, the IACUC should consider implementing contingencies for the protocol’s approval, such as guidance from experts, a pilot study to assess outcomes increased frequency of observations, periodic progress reports, , post-approval monitoring, increased frequency of IACUC review of the protocol, or retracting “approval” based on outcomes.

Additionally, if the potential benefit is minimal, and potential harm is significant, the IACUC can withhold approval or require significant modifications to adjust the potential for harm to more reasonable levels.  These modifications should address factors such as assessment for humane endpoints through frequency of observation, criteria for monitoring severity of pain and distress, defined point(s) and nature of intervention, and training of individuals assigned for animal pain assessment and monitoring. The IACUC must not approve research in which the risks are judged unreasonable in relation to the anticipated benefits.

An IACUC’s harm-benefit review should evolve over time as new procedures and techniques are developed, as old ones are refined, and as set precedents are adjusted. What are the innovative enhancements or fine-tuning that your organization has developed in order to comply with and document the harm/benefit evaluative process? Please share with us before you head off for the summer sizzle, the barbecue grill, and, hopefully, the sunscreen.