Developing an Emergency Preparedness Plan for your HRPP

The COVID-19 pandemic highlighted the need for organizations conducting research to have certain protocols in place, including robust emergency preparedness plans. Designed to guide communications and operations throughout an ongoing public health emergency, it’s important an organization has an emergency preparedness plan in place.

Identifying Potential Risks to Your Organization

There are many factors to consider when developing a Human Research Protection Program (HRPP)-focused emergency preparedness plan. Developing an HRPP-focused plan should begin by assessing potential emergencies affecting an organization’s HRPP and their impact on the HRPP’s operations.

When identifying potential emergencies, it’s helpful to understand risks involved. Types of risks may range from public health emergencies like the COVID-19 pandemic, to weather-related events (e.g., hurricanes, tornados). A risk is also anything likely to affect HRPP staff and research participants, such as cybersecurity incidents (e.g., data breaches) impacting electronic regulatory systems critical for conducting day-to-day operations.

Once potential risks are identified, organizational leadership should collaborate with HRPP leadership and staff. Together, they will consider any research operation modifications during an emergency to mitigate or manage risk based on the type of emergency. An HRPP’s emergency preparedness plan should clearly specify the actions an organization and its HRPP may take in response to an emergency, including what types of research may be suspended.

For example, during the COVID-19 pandemic, many HRPPs have shifted from working in an office-based setting to working remotely in order to mitigate the risk of staff spreading the virus to one another. Similarly, research teams have moved from conducting study visits in person to conducting them remotely when feasible in order to minimize risk to research participants.

Another risk management strategy institutions may want to consider is temporarily suspending non-interventional research – or research presenting no benefit to participants – during an emergency. Other examples of items to include in an emergency preparedness plan may include:

• How research participants will receive a study drug/investigational product
• How study teams will obtain informed consent from newly enrolled participants
• How current participants will learn significant new information, possibly affecting their willingness to participate
• How an IRB would respond if it no longer had access to records
• Whether the organization might cede review of ongoing or newly proposed research if their IRB couldn’t operate due to an emergency
• How the site will modify operational processes if it no longer has access to participants’ electronic records

Involving the Right Staff

Another critical component of an organization’s emergency preparedness plan is designating who is responsible for implementing the plan when an emergency arises and evaluating the plan on an ongoing basis. Organizations should consider designating an alternate or backup to assume responsibility, in case the individual primarily responsible is unavailable.

Once an organization has developed its HRPP’s emergency preparedness plan, educating its research community – including researchers, IRB members, HRPP staff and leadership – about the plan is critical to ensuring successful implementation.

Incorporating AAHRPP’s Element I.1.H

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) recognizes the importance of having and executing an emergency preparedness plan to protect human research subjects during emergencies in its newest accreditation element: Element I.1.H.

AAHRPP’s Element I.1.H requires accredited organizations to have and follow “written policies and procedures specifically designed to protect the rights and welfare of research participants during an emergency.” [i] The Element includes four essential requirements:

1. The HRPP has an emergency preparedness plan, appropriate to the size and complexity of the HRPP
2. The plan is periodically evaluated and, when necessary, adjusted to ensure continuity of operations
3. Organizations provide education about their emergency response plan for IRB members, staff, researchers, and other members of the HRPP
4. Persons in the HRPP are knowledgeable about the organization’s expectations during emergencies [ii]

It’s important to recognize Element I.1.H is included in Domain I of AAHRPP’s Accreditation Standards, [iii] underscoring the responsibility of having an emergency preparedness plan to protect research participants rests with an organization, not just with its HRPP or institutional review board (IRB) office. AAHRPP’s guidance on Element I.1.H specifies emergency preparedness plans should be risk-based and tailored to the size and complexity of the organization’s HRPP—there is no one-size-fits-all emergency preparedness plan. [iv]

Organizations submitting initial applications for AAHRPP accreditation after January 1, 2022 must include an emergency preparedness plan in their written materials. Beginning in March 2022, AAHRPP-accredited organizations seeking reaccreditation must include plans for emergency preparedness in their reaccreditation applications. [v] Accredited and non-accredited HRPPs alike can benefit from having an emergency preparedness plan in place to guide human subjects research operations during an emergency and protect the rights, safety, and welfare of research participants.

[i] https://admin.aahrpp.org/Website%20Documents/Element%20I.1.H.%20(published)(2021-10-03).pdf

[ii] https://admin.aahrpp.org/Website%20Documents/Element%20I.1.H.%20(published)(2021-10-03).pdf

[iii] https://www.aahrpp.org/apply/process-overview/standards

[iv] https://www.aahrpp.org/apply/resources/procedures-and-standards, last accessed December 16, 2021.

[v] Id.

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