Significant Events from 2016 and How They May Shape the Year Ahead

January 30th, 2017 by Sharon L Nelson, MSN, RN, CNS, CIP, Executive Director, Consulting and Compliance Services

As 2016 fades in the rear-view mirror, we will remember it as an eventful year for health and human subject research. At Schulman IRB, we read, we learned, we taught, we published. To all our contributors and consumers – thank you for your time, your efforts and your feedback.

In this month’s edition, we look at some highlights from 2016 and contemplate how these events might influence activities in 2017.

Cancer MoonShot

The Cancer Moonshot, launched by the Obama White House in early 2016, is a $1 billion effort to accelerate cancer research. The Cancer Moonshot Task Force, established within the Office of the Vice-President, “will focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care.” In March 2016, Schulman IRB was named the national IRB for the Cancer Breakthroughs 2020 program, a national coalition of leaders from pharma, biotech, major academic cancer center, community oncologists and a pediatric consortium.

These Cancer MoonShot initiatives seek to make dramatic improvements to the way we prevent and treat cancer. We’ve already seen some impressive results from these programs, like GPS Cancer™, which integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics to provide a more complete picture of each patient’s cancer and can help clinicians understand why certain therapies do or do not work.

By bringing together so many oncology experts in these concerted efforts, it’s likely we’re in for some real (and some really incredible) advances in the fight against cancer in the coming years.

Bial and BioTrial

A Phase I trial went wrong, leaving one participant brain dead and five others with neurological symptoms. The tragic events of the BioTrial study, hauntingly reminiscent of the 2006 TeGenero Phase I trial, led to regulatory agencies, research ethics committees and other research organizations carefully reexamining their processes and guidelines for first-in-human clinical trials.

The ripple effects from this tragedy will endure, as we continue to learn from the event and seek ever better means to protect the rights, safety and welfare of research participants. For those conducting Phase I research, it may be helpful to consult with your IRB on appropriate safety measures for participants. In this Schulman IRB webinar, learn what the IRB looks for in reviewing an adaptive Phase I study as well as best practices for developing informed consent forms for Phase I trials.

Data Sharing

Might big data support enhanced clinical decisions, patient outcomes, and medical research? How might patient health information help us realize advances in oncology research and treatment? How do the current methods for engaging patients in data sharing and for managing data stack up?

These questions and others dominated conversations in 2016, and we will likely continue to discuss big data’s role in research in the year ahead. It’s probable we’ll also start seeing regulatory guidances on big data in the near future as more and more clinical trials collect and use large amounts of health data.

For more on this hot topic, our August 2016 News Round-Up features several articles on data sharing, including a summary of an NIH survey of U.S. adults on contributing health data; an opinion piece about encouraging patients to share their health data; and an overview of four Perspectives published in the August issue of NEJM addressing data-sharing – from support to a clarion call for caution.

NIH Policy – Single Institutional Review Board

Effective September 25, 2017, a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. The policy, published first in 2014 as a draft and finalized in 2016, is intended “…to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.”

As you might expect, the 167 stakeholders responding to the call for public comment included both supporters and critics. According to the NIH, “most of the comments… were supportive of NIH’s goal…. Commenters, especially individual researchers, scientific and professional societies, and patient advocacy organizations, generally agreed that the use of a single IRB for multi-site studies involving the same protocol would help streamline IRB review and would not undermine and might even enhance protections for research participants.” Considering the comments, the final policy modified several implementation provisions, among them:

  • The final policy is intended to apply only to studies where the same research protocol is being conducted at more than one site.
  • Applicants/offerors will be expected to submit a plan identifying the sIRB that will serve as the IRB of record for all study sites.
  • It will be the responsibility of the applicant/offeror to assure that the sIRB is qualified to serve.
  • Exceptions to the policy will be granted, if the use of an sIRB is prohibited by federal, state, or tribal laws or regulations; where the federal, state, or tribal prohibition on the use of an sIRB is established by policy, and possibly where a request is made and a compelling justification provided for why an exception is needed.

The new NIH policy represents a significant shift in the research landscape, though we’ve seen it coming. In 2017 we will look for guidance in effectively and efficiently implementing the new policy. We’ll also be following a brand new development in the single IRB space: the final rule to update the human subject protection regulations known as the Common Rule. For now, consider the difference in nomenclature – single IRB and central IRB – in this recent blog post.

Thank you, readers and learners, for your interest and for sharing with us. We look forward to growing our circle of learning in 2017.