As much as we hate to admit it, many of us have been there…that moment when we suddenly realize “Oh no. I need to fill an HRPP position YESTERDAY. Help!”

Maybe a colleague has gone on short-term leave to address an illness, or someone has decided to take their much-deserved retirement. Maybe fiscal restrictions have led to hiring delays, or your team is experiencing staffing shortages due to the COVID-19 pandemic or your institution is waiting to backfill positions until the institution gets a better sense of how the revised Common Rule will affect IRB staff resourcing going forward. No matter how much advance notice you are given regarding a staff vacancy, time inevitably flies by, protocols and amendments keep coming for review, and things become overwhelming and chaotic before you know it.

Coupled with this sense of drowning, you may also be receiving pushback from your boss and the finance team that your organization can not afford to bring in the interim staffing support that you desperately need. They ask why you can’t just work with the resources that you currently have. They likely have good reasons for pushing back like this—leadership may be under pressure to tighten the budget and streamline operations, do more with less.

Risks of an Understaffed HRPP

You could certainly work with the limited resources that you currently have, but doing so means introducing potentially significant delays and compliance risks. With fewer people working in the human research protection program (HRPP), there will be delays in getting studies approved given the limited resources dedicated to processing, reviewing, and ultimately approving research. Such delays lead to unhappy investigators and irritated sponsors, which could lead to fewer future research opportunities for your institution.

There may also inevitably be more errors as current staff members work to do as much as they can in the time they have available. Items may get overlooked when a limited number of staff members, working through a large (and growing) backlog, are asked to process studies expeditiously. Some errors may be simply a data entry mistake—but some could have major bearing on subject safety and data integrity, like a study being approved without the necessary risk/benefit review.

Last, but not least, all this extra effort can easily lead to employee burnout and low morale. Left unchecked, these issues could result in losing additional staff, thereby only making the situation worse.

How Interim Staffing Support Can Help—No Matter the Situation

While hiring the three or four full-time employees you really need may be out of the question right now, bringing in interim support could help get your HRPP through the current backlog while maintaining a compliant, high-quality program.

It does cost money to bring in interim support, but the institutional cost of noncompliance and a hobbled research program can be far greater. Interim HRPP staff are typically already experts in the space—they may only need basic training on your institutional processes before they’re able to jump in and start helping out.

You may also want interim support to address projects that are important, but for which no one else has time. Documenting all of the contingency measures and emergency changes implemented during the COVID-19 pandemic is critical and necessary according to the FDA. Skipping this important step may lead to audit findings down the road. An interim HRPP staff member could focus on getting your documentation in order while the permanent staff focus on keeping the day-to-day HRPP activities moving.

Interim support can also be provided remotely, even if your institution uses paper-based workflows. Working remotely is the norm right now anyway, and a virtual interim support person may help to reduce the overall cost of the engagement.

Interim HRPP support staff can help with a variety of roles—not just entry-level administrative support. For example:

  • IRB members to augment existing expertise in unique or complicated study designs (e.g., virtual trials, new indications)
  • Regulatory attorneys to help the institution navigate new regulations or complicated regulatory situations like COVID-19
  • Senior analysts to make sure submissions are complete and appropriate, IRB members are sufficiently prepared, and IRB meetings are properly conducted
  • Consent form editors to ensure that participants receive useful information about the risks and benefits of participation that meets institutional and regulatory requirements
  • HRPP educators to train investigators and staff on the latest regulations and best practices

Help is available, for as short or as long as you need it. Talk to institutional leadership about why interim support is essential and explain that flexible options are available. It’s not just about figuring out how to do more with less. Bringing in interim support can help ensure your research program maintains compliance and remains an important, sustainable part of the institution and its community.

With over a century of collective HRPP experience, Advarra can help your organization weather a staffing shortfall and maintain compliance. Or solve your HRPP staffing challenges for good with Advarra’s GPS™ service, which combines all your IRB office staffing and IRB review together for a turnkey solution. Find out how our experts can keep your research moving forward.

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