From Rhetoric to Reality: QRCG's Counterproposal for Strengthening HRPPs

Published April 9, 2025

Full Op-Ed: A Grounded Counterproposal to PRIM&R’s Call on OHRP

Introduction: Bridging the Gap Between Promise and Practice

A recent statement by leading organizations in the research ethics and compliance space called for bolstering OHRP leadership and funding is a welcome spotlight on human research protections. As professionals dedicated to research ethics, we share the aspiration behind that call – who wouldn’t want a well-resourced federal champion safeguarding participants? However, after years on the frontlines of research compliance, we also share a healthy dose of realism. We’ve watched federal leaders pledge commitment to ethical research, only to see those words fizzle out in practice. The rhetoric from the top doesn’t always match the reality on the ground.

Consider the current state of OHRP: for over a decade, its enforcement actions dwindled to near invisibility – dropping from dozens of findings a year to virtually zero​ (jdsupra.com). Funding has flatlined around a mere $6 million, with over half of staff positions sitting vacant due to “resource constraints”​ (jdsupra.com).

Until late 2024, the agency even lacked a permanent Director, operating under interim leadership for nearly two years. These facts paint a sobering picture. While 2024’s 50th anniversary of the National Research Act was commemorated with speeches about public trust and ethical oversight​ (hhs.gov), the truth is that OHRP has been stretched to its limits – a tiny office asked to oversee the entirety of U.S. human subjects research with too few people, too little money, and inconsistent political support.

In this context, simply urging “more leadership and resources” at OHRP, as these organization have collaboratively has, may not be enough. Yes, we need strong leadership – but we need the right kind of leadership, coupled with systemic change. And yes, more resources are critical – but waiting on Congress or top officials to act has left us waiting for years. It’s time to confront the systemic constraints head-on: bureaucratic inertia, competing federal priorities, and an increasingly complex research landscape that outpaces our 20th-century regulatory framework.

This counterproposal offers a forward-thinking yet pragmatic plan to strengthen human research protections. It is rooted in authentic observations from the compliance frontlines – where good intentions meet real-world hurdles – and it prioritizes action over idealism. Rather than relying solely on top-down fixes, we envision an ecosystem-wide effort driven by collaboration, innovation, and the wisdom of those who do this work every day. Here’s what it will actually take to protect participants, rebuild public trust, and enforce integrity in 2025 and beyond:

1. Interagency Coordination: A Unified Front for Oversight

One office alone cannot shoulder the burden of safeguarding millions of research participants. OHRP’s mandate overlaps with numerous other agencies – from the Food and Drug Administration (FDA) (which oversees clinical trial conduct for drug and device approvals) to the National Institutes of Health (NIH) (which sets policies for its funded research) and even the Office for Civil Rights (which enforces privacy laws like HIPAA in research contexts). A realistic strategy is to coordinate these efforts rather than silo them.

What would this look like? It starts with OHRP exercising convening power – an interagency task force on human research protections. Imagine OHRP, FDA, NIH, the Office of Research Integrity (which handles research misconduct), and others at one table, aligning policies and enforcement strategies. This could mean joint guidance documents (as OHRP and FDA have done in the past on consent and IRB policies), sharing of intelligence about noncompliance, and even collaborative enforcement when egregious violations occur. Coordination can also reduce contradictory instructions to research institutions. For example, if the FDA and OHRP harmonize their requirements and inspection priorities, IRBs won’t be caught between two rulebooks.

Crucially, interagency collaboration can amplify limited resources. While OHRP has a small budget, agencies like FDA have field inspectors and NIH has grant oversight levers. A unified approach could deploy these strengths in a complementary way. Perhaps FDA auditors could be trained to flag Common Rule (OHRP) issues during trial site inspections, referring serious findings to OHRP for action. NIH, for its part, could incorporate OHRP compliance data into grantmaking decisions – sending a message that ethical lapses jeopardize funding. Such cross-agency support would expand OHRP’s reach without solely depending on a bigger budget. It’s a way of “working smarter” within current constraints.

Finally, a united front presents a powerful message to the research community: that participant protection is a government-wide priority, not a niche concern. It shows leadership through collective action. We would no longer have the excuse of “the left hand doesn’t know what the right is doing” in federal oversight. For institutions and researchers, this clarity and consistency can streamline compliance and ensure that important issues don’t fall through the cracks between agencies.

2. Modernizing Guidance for the Digital Age of Consent

In today’s research ecosystem, obtaining “informed consent” is not confined to paper forms in a clinic. Participants enroll in clinical trials via smartphone apps; health data is gathered from wearables and social media; genomic and biobank studies seek broad consent for future, unforeseen research. Yet, the core guidance on informed consent hasn’t fully caught up to these realities. The last major revision of the Common Rule (in 2018) introduced the idea of presenting “key information” up front, but researchers and IRBs are still navigating how to effectively inform participants in novel contexts. We need to update our ethical playbook for the digital age.

Modernizing consent guidance should be a top priority for OHRP’s new leadership – and it’s an area where interagency and stakeholder collaboration will be key. For instance, clear, practical guidelines on electronic consent (e-consent) could be developed jointly by OHRP and the FDA, building on their previous efforts. Such guidelines must address questions we hear every day on the frontlines: How do we ensure a participant really understands a 30-page online consent form on their phone? What privacy assurances should we give for data collected by fitness trackers in a study? How do we handle “dynamic” consent models where participants can choose what sub-studies to opt into over time?

Equally important is guidance on return of results and ongoing communication in long-term digital studies. In the era of patient-centered research, participants often expect to stay informed about the research they contribute to – including receiving study findings or alerts if something concerning is uncovered. Ethical oversight should redefine “participant protection” to include these information rights, especially when research is pervasive in someone’s digital life. The ability to implement methods to decrease admin burden will need to be innovated in electronic platforms.

By convening experts in technology, ethics, and patient advocacy to refresh consent standards, OHRP can help demystify compliance for digital research. Many IRBs and investigators are currently improvising solutions in isolation. Central leadership in the form of up-to-date guidance would not only protect participants better but also reduce the compliance confusion that can slow down valuable research. Modern consent is not about longer forms – it’s about smarter consent processes that respect the participant’s capacity to understand and choose, even amid complex data flows.

We propose concrete action: OHRP (in partnership with FDA and NIH) should issue a modernized guidance or “playbook” on digital consent and data use within the next year, with community input. This document could cover best practices for multimedia consent delivery, guidelines for re-consenting participants as studies evolve, and standards for safeguarding digital data to uphold trust. It should also emphasize the principle of respect for persons in the digital realm – meaning participants deserve clear information and ongoing agency regarding their data. By taking the lead on this, the research oversight community shows that we’re not stuck in a paper-and-pen era, but are proactively evolving with science and society.

3. Scalable Pilot Programs: Innovating From the Ground Up

If there’s one thing those of us in research compliance have learned, it’s that innovation isn’t just the domain of laboratories – it’s needed in oversight, too. Waiting for sweeping regulatory reforms can feel like waiting for Godot; meanwhile, clever solutions are often bubbling up at individual institutions. We should encourage and systematize this ground-up innovation through scalable pilot programs.

Imagine if OHRP (or a consortium of oversight bodies and funders) launched a “Research Ethics Innovation Challenge” – inviting institutions, IRBs, and community organizations to pilot new ideas for protecting participants and enhancing integrity. Importantly, these pilots must be evaluated and, if successful, scaled or shared widely. Here are a few examples of what we mean:

• Community-Engaged Oversight Pilots: One pilot might test deeper community involvement in research oversight for studies impacting specific populations. For example, a university partners with a local patient advocacy group to create a participant advisory panel that works alongside the IRB for a gene therapy trial. Does this improve trust and communication? Does it catch concerns the formal process misses? If yes, how can we replicate this model elsewhere?

• Technology-Enabled Monitoring: Another pilot could explore using technology to aid compliance oversight. Perhaps an IRB could use an automated tool to scan consent forms for overly complex language or to ensure required elements are present, thereby streamlining ethics review. Or consider a secure mobile app for study participants to report adverse events or consent issues in real-time, which triggers alerts to investigators and oversight bodies. Testing these tools on a small scale will show what actually helps participants and researchers in practice.

• IRB Reliance and Collaboration Models: With the Common Rule’s single IRB mandate for multi-site studies, there is still trial-and-error happening in how institutions share oversight. Pilot programs that develop consortia IRBs or regional IRB partnerships (perhaps across academic and community hospitals) could yield blueprints for efficient yet thorough review processes. The goal is to maintain rigor while avoiding redundant bureaucracy – a win-win for ethics and research speed. Successful pilots here could relieve burden on both researchers and OHRP staff, by reducing oversight gaps that occur when multi-site studies slip through the administrative cracks.
  
  

What’s crucial is that these pilots be rigorously assessed and reported out. Not every idea will work – and that’s fine. In a forward-thinking ecosystem, even “failed” pilots teach us valuable lessons. OHRP and thought leaders like PRIM&R can facilitate forums to share these results (perhaps at conferences or in published case studies). When something does work – for example, a particular way of integrating community members into the IRB process that measurably increases participant satisfaction – then we push for broader adoption of that practice, turning a grassroots innovation into a new standard.

By fostering pilot programs, we also send a message that ethical oversight need not be stagnant. We can be just as innovative in protecting humans as scientists are in inventing new therapies. This approach is realistic because it doesn’t assume a monolithic change overnight; it harnesses the diverse creativity of the research community and builds momentum for change piece by piece. It’s the opposite of a one-size-fits-all mandate. Instead, it’s evolutionary: test, learn, improve, expand.

4. Redefining Ethical Leadership and Participant Protection

Ultimately, rules and structures can only go so far. What will truly renew public trust in research is a redefinition of ethical leadership – a culture change that permeates from federal agencies to universities to industry sponsors. We must re-examine what it means to be a “leader” in research ethics and what genuine “participant protection” entails in 2025.

Firstly, ethical leadership must be modeled at the top and the grassroots. It’s encouraging that OHRP now has a permanent director in Dr. Molly Klote, but leadership is not just one person’s job. We should expect agency heads, university presidents, principal investigators, and IRB chairs alike to champion integrity. This means leaders who don’t just pay lip service to “compliance” but actively resource and empower their teams to do the right thing. For example, a university leader demonstrates ethical leadership by investing in their Human Research Protection Program – hiring sufficient IRB staff, rewarding researchers who prioritize ethics, and making it clear that shortcuts at the expense of participants are unacceptable. On the federal side, ethical leadership could mean OHRP’s director pushing for transparency in the agency’s actions (publishing metrics, reporting outcomes of investigations promptly) and being a visible advocate for participants’ interests in policy discussions.

Secondly, participant protection in today’s landscape must be about more than ticking regulatory boxes. We should redefine success as earning the trust of the public. Are participants telling us they feel respected and informed? Do communities believe that researchers have their best interests at heart? Achieving affirmative answers to those questions is as important as adhering to subpart this-or-that of the regulations. Protection includes ensuring diversity and equity in research – so that ethical burdens and benefits are justly distributed. It includes safeguarding data as an extension of safeguarding the person. It also includes giving voice to participants: a truly protected participant is one who can speak up without fear if something isn’t right, and who knows that their feedback can improve how research is done.

One practical step to embody this redefined protection is to build feedback loops from participants into the system. Institutions might implement post-study surveys asking participants about their experience: Were they satisfied with the consent process? Did they feel their welfare was a priority? Regulators and accreditors could then use these data as part of oversight – an organization consistently getting poor marks from its research participants should not be viewed as meeting its ethical obligations, no matter how flawless its paperwork. In contrast, a culture of listening to participants and acting on their concerns will drive trust like nothing else.

Finally, we need to highlight and celebrate examples of ethical leadership to set the tone. When an agency official goes above and beyond to enforce protections in a tough situation, or when a company halts a trial because early signals raise questions about participant welfare (even at great expense), those stories should be elevated. They become part of the narrative that integrity in research is alive and valued. The more we talk about positive models – not just scandals – the more we inspire current and future leaders to follow suit.

Conclusion: Collaborative Action for a Trusted Future

Reforming human research protections is a complex challenge, but the path forward is clear: it lies in collective, sustained action rather than one-dimensional solutions. PRIM&R’s call for stronger OHRP leadership and resources has opened the conversation. Now, as practitioners, we’re reframing it: what will it actually take, in practice, to uphold ethics and rebuild public trust?

Our answer, in summary, is to work together across agencies and institutions, modernize our approaches, innovate boldly but pragmatically, and live the values we profess. This is a future-facing vision grounded in the reality we know. It’s not about waiting for a savior from on high; it’s about leveraging the insight and will of real practitioners and communities to drive change from the ground up – with support from the top when available.

Every stakeholder has a role. Federal agencies must break out of silos and coordinate. Regulators should update the rulebook for the digital era. Institutions and IRBs can be testbeds for new ideas, sharing what works (and what doesn’t). And leaders at all levels must foster a culture where protecting participants is everyone’s mission, not just the compliance office’s job.

Rebuilding public trust and ensuring research integrity will not happen overnight. But with concrete, actionable steps and a united mindset, we can make tangible progress. The public is watching – and recent decades have given them reasons to be wary, from scandals of misconduct to lapses in oversight. It is on us to demonstrate that those were wake-up calls, not just fleeting headlines.

As we implement this counterproposal, let’s keep the dialogue open. We invite thought leaders, compliance professionals, researchers, participants, and institutional officials to join this conversation. What ideas have you seen succeed on the ground? Where are the barriers that we haven’t addressed? By crowd-sourcing our collective wisdom, we refine and strengthen the roadmap toward a more trustworthy research enterprise.

In the spirit of collaboration, consider this an open call. Connect with us – whether through comments, professional forums, or upcoming roundtables – to share your perspectives and commitments. Together, QRCG and its peers in the research compliance community are ready to move from talk to action, from rhetoric to reality. Let’s build a system of human research protections that is worthy of the public’s trust and the noble research it enables.

Let’s lead – collaboratively, authentically, and effectively – to protect those who make research possible. The future of ethical research depends on nothing less.

Sources:

• Defino, Theresa. OHRP FY 25 Budget Request Lacks Prior Plea For Funding, Staff Increases; Plans Are Modest. Report on Research Compliance 20, no. 4 (April 2023): citing OHRP’s flat funding and unfilled positions​
  jdsupra.com,jdsupra.com, and noting the decline in compliance enforcement letters​ jdsupra.com
  
  

• HHS Office for Human Research Protections. Commemorating the 50th Anniversary of the National Research Act – Program. (July 12, 2024) – emphasizing the importance of public trust in research during commemorative remarks​
  hhs.gov.
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