NIH Recipients Conducting Biospecimen Research: Gaps in Emergency Planning and Reporting

Why OIG Did This Review

• As emergencies (e.g., hurricanes, flooding) become more frequent, important medical research using biospecimens and NIH funds may be at risk. Each year, NIH invests billions of dollars in extramural cancer research, which is often dependent on high-quality biospecimens (e.g., blood, tissue).
• In emergencies, biospecimens can be damaged or ruined if, for example, freezers unexpectedly shut down due to power outages. Biospecimens often have specific temperature storage requirements, and even small temperature fluctuations can damage or ruin sensitive samples.
• NIH recipients are not required to have emergency plans. However, NIH directs recipients to guidance on how to plan for emergencies. NIH also has some requirements and guidance for recipients on how to report negative effects of emergencies on their research.

What OIG Found

All 23 recipients in our review were located in areas that were higher risk for emergencies, and all recipients reported having emergency plans. However, most (16) recipients’ efforts were not informed by risk assessments, which could result in ineffective planning or wasted resources.

Recipients that experience an emergency may not be submitting timely or complete information to NIH. Five out of six recipients that experienced negative effects of an emergency may not have reported them to NIH in a timely manner, and the completeness of the reports could also be a concern. This could hinder NIH’s ability to (1) assist recipients after an emergency; and (2) estimate and report the financial and programmatic impacts of emergencies to stakeholders.

What OIG Concludes

While our sample size was small, our findings identify gaps in recipients’ emergency planning and reporting that may apply beyond our sample. Additional planning guidance could help recipients better protect their biospecimens and the important NIH-funded research that relies on them. More specific guidance for recipients on how and when to report negative effects from emergencies could also help ensure that NIH has timely and complete data to assist recipients’ recovery efforts and report accurate information to stakeholders (e.g., Congress, the public).