Planning for the unknown is impossible, however planning for the loss of essentials is plausible. All institutions that conduct research should have an established emergency process and procedures that incorporate a routine self-evaluation and an assessment of potential environmental concerns. The National Institutes of Health Office of Laboratory Animal Welfare has specific requirements for assured institutions to have an emergency plan. The United States Department of Agriculture just last month issued new guidance that will require registered institutions to have emergency plans. As stated in the article by APHIS Acting Administrator Kevin Shea, “Over the years we learned that many registered facilities do not have adequate contingency plans for natural disasters and other emergencies…This rule will give USDA licensees and registrants a greater awareness and understanding of their responsibilities to safeguard their animals and APHIS will provide guidance as needed while giving regulated entities the flexibility to develop a plan that works best for them.”
Currently neither the Office of Human Research Protections or the Food and Drug Administration have similar requirements for research with human subjects, however it is considered best practice to have an emergency plan in place. According to Roxanne Johnson, director of Tulane’s Human Research Protection Office, “In New Orleans we experience threats of hurricanes from June through November each year. Hurricane Katrina taught us to be more proactive in developing evacuation plans that ensure proper protection and monitoring of human participants in research studies at Tulane University.”
When conducting research with human subjects, it is essential that communication is maintained and retention of study data is not compromised in any way. All institutions at the very least should conduct a risk assessment that covers all areas of research that are conducted at the institution and any essential business functions. The bare minimal core areas for this risk assessment should include but are not limited to: geographic predisposition for natural disasters, backup power, emergency cash, insurance, payroll, alternate suppliers, secure virtual working environments, alternate communication (phone tree/social media/walkie-talkies), computer backup system(s), relocation of subjects/animals, secure storage of toxic chemicals/biohazards/select agents, recovery plan, and strategy for reporting to federal agencies. Also institutions should consider using an evacuation card similar to that of Tulane University, who adopted this system after hurricane Katrina. The Tulane evacuation card lists the investigator’s name, a 24-hour phone number, email address, study number, participant number, and the IRB office contact information. This card could also include any other information deemed necessary in an emergency situation.
Although there is no such thing as a perfect plan, being aware of your risks and preparing for what you can is consistent with best practice. Moreover, it is the right thing to do for the welfare of research participants and those responsible for their well being as stewards of research ethics.
Please contact us for more information about how HRP Consulting Group can help organizations develop a contingency plan.