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Apr2019

Twenty years ago in 1999 I attended my first annual PRIM&R conference. I did so in the aftermath of then OPRR (now OHRP)’s shutdown of human subjects research that year of three federally funded institutions: University of Illinois at Chicago, Duke University, and the Los Angeles Veterans Administration Hospital. At the time, there was a feeling of “there go I but for the grace of god;” if it could happen at these institutions, it could happen anywhere. I distinctly remember chatting in the lobby of the Boston Sheraton with the old guard from PRIM&R and ARENA, who were both welcoming to the newbies in their quickly expanding ranks and also sort of shell-shocked.

In some ways the problems identified in these shutdowns were confusing; not everyone agreed there was a problem, and if they did, there was still the question of how could it be fixed? What did a strong and robust Human Subject Protection Program look like? How long would it take to get there? Even the folks I would later consider mentors were not sure of where things were going, that chilly day in Boston. But they encouraged me to stay on board, saying that it would certainly make for an interesting ride—and indeed, it has.  

The last 20 years have seen explosive growth and change in the field of human subjects protections, heralded, in particular, by those shutdowns. And here we are in 2019, and there are once again scandals grabbing the research compliance headlines. This time it involves scientific misconduct and questions of research integrity.

On March 25, 2019 the Justice Department announced that Duke had agreed to pay $112.5 million to the federal government to settle allegations that research applications and reports were submitted containing falsified data to win more than two dozen grants; the allegations were originally brought by a whistleblower and covered studies from 2006-2018. And it’s not only Duke that is back in the news; there have been other well-publicized research integrity violations at other institutions, including the University of Illinois, Dartmouth College, and Cornell University. Most of these cases involve a single researcher going rogue, but all highlight failures of some part of the research integrity oversight system. I cannot help but step back 20 years to that pivotal moment for IRBs and human subjects protections programs across the United States and ask again, what does a strong and robust Research Integrity program look like?

The juxtaposition of these research integrity issues against the backdrop of the resurgence of measles in the United States cannot be overlooked. It was in 1998 that Andrew Wakefield published his fraudulent paper in BMJ linking the MMR vaccine to autism. Twenty-one years later we are continuing to live with the significant damage to society, public health, and individuals that was caused by his falsified and fabricated data. Not to mention the damage to trust in science, medical providers, universities, and higher education. We can and we must do better.

To that end, the Office of Research Integrity at DHHS has published two funding announcements with upcoming deadlines and I encourage everyone who cares about the integrity of the research process to apply:

2019 Funding Opportunity: Conference Grants on Research Integrity
Application due: April 26, 2019
Amount: $50,000

2019 Funding Opportunity: Research on Research Integrity Grants
Application due May 8, 2019
Amount: $150,000

I do also applaud the efforts being made at Duke in addition to the training and education already in progress:

  • The appointment of a new Advisory Panel on Research Integrity and Excellence aimed at improving the structure and function of research administration, with a focus on promoting research integrity
  • The establishment of a new, integrated leadership structure for research to provide clear and consistent policy guidance
  • A new initiative to promote values and a culture of excellence and accountability

As their President and Executive Oversight Committee stated in an open letter to the Duke community:

“We expect everyone at Duke to adhere to the highest standards of ethical behavior. This includes the responsibility to act with integrity and to report conduct that does not meet these standards. In this case and others, we have seen first-hand that the actions of those who do not can harm the entire institution.

To be clear: fraudulent and unethical behavior violates the fundamental values of our academic community and must be addressed. However, we know that it does not reflect the vast majority of our students, faculty, staff, and trainees. We are very proud of the work you do every day and the contributions you make to Duke’s enduring and essential mission of excellence in teaching, learning, discovery, service and healing.”

Just like 20 years ago during the high-profile human subjects research shutdowns, many in the research community could swap Duke out for their own organizations. Ask yourself: Do you know what a robust research integrity program looks like? What are you doing to ensure the integrity of your research programs? Because the reality is it could happen anywhere.

Cynthia "Cyndi" Hahn is an expert in human research protections programs and research operations, with extensive experience in executive leadership at research organizations. She currently serves as the President of Integrated Research Strategy, LLC. She has served as the Managing Director Human Research Protection Programs for a consulting firm and the Institutional Official for an independent IRB. In addition she spent over 20 years in various research roles at academic institutions include roles as a Research Compliance Officer, sequestering official for Research Integrity and Chief Operating Officer. She is a published author on multiple publications related to research administration and human subjects protections and is an active member of PRIM&R and SRAInternational among other organizations.

Guest contributors to PRIM&R's blog are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

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