NIH Issues Draft Policy That Would Require A Single IRB For Multi-Site Clinical Trials

For years, grantees have been encouraged to use a shared IRB in multi-site clinical trials as part of shared research networks at NCI, and it appears to increase efficiency without compromising protection. In early December 2014, NIH released a draft policy proposing that multi-site trials in the U.S. be required to use a single IRB. NCI has already conducted an analysis demonstrating that a single IRB decreases time and costs when compared to having individual IRB at each participating clinical site. To read and comment on the draft policy, click here. NIH is eliciting input until January 29, 2015. A commonly used model of joint IRB review is IRBshare, which according to its website “facilitates the sharing of full board approved documents between IRBs, accelerates the initial review process by enabling a temporary reliance between IRBs, and minimizes the need for all sites to conduct a full board review.” See the IRBshare website for details.

Patient-Centered Clinical Research Network (PCOR-net)

As we all know, comparative effectiveness research is smokin’ hot right now. We are all anxious to see what PCORI funding produces in the upcoming years. In December they unveiled PCOR-net, a highly innovative, clinical data sharing network. In a recent blog post, Dr. Francis Collins (who sits on PCORI Board of Governors) stated, “This initiative will provide an unprecedented opportunity to streamline clinical trials, empower patients, and build a solid foundation for personalized medicine.” He goes on:

“PCORnet will be made up of two types of data networks: Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs). CDRNs include academic health centers, community hospitals, health plans, inpatient and outpatient hospitals and providers, Veterans’ Administration clinics, pediatric hospitals and providers, private electronic health record companies, and many other health care groups. Utilizing electronic medical records, all of these organizations will build patient databases and a clinical trial infrastructure that can be accessed by researchers from many different organizations (including NIH), while protecting patient privacy and confidentiality.

“As the name suggests, PPRNs are patient-oriented groups united by a certain disease or condition. The successful groups receive support from PCORnet, and are charged with outreach, expanding networks of patients, and collecting standard patient data—all of which are critical for researchers looking to recruit volunteers for a clinical trial.”

In December, PCORI distributed $93.5 million to 11 CDRNs and 18 PPRNs who will conduct pilot studies on data models over the next 18 months.

If successful, this single, overarching network has the potential to include over 100 million people across the US of all ages, ethnicities, and SES who have agreed to participate in clinical research.

Read the complete blog post here.

HHS Prepares For A Government Shutdown

I remember not-so-fondly the government shutdown in 1995. I had just started my post-doc at NINDS — after four years in grad school I was flat broke, and horrified to learn I would be without a paycheck for a while. Today, with the midnight deadline looming and no FY11 budget on the horizon, government agencies prepare for another shutdown of the federal government. What does that mean for the Department of Health and Human Services? The only programs that will remain in operation are those that are necessary for the safety of life and the protection of property, or those funded through other sources.

The NIH operates a world-class Clinical Center where every patient is enrolled in a research protocol. While the 1443 studies currently running will remain in effect, no new patients will be enrolled. Of those studies, 60 are clinical trials for children with cancer. Reduced hospital staff will focus only on caring for patients already in the Clinical Center. No new studies will begin during a shutdown. NIH has eight studies ready to commence next week—four of them involve children, and two of those involve children with cancer. None of them will be initiated during a shutdown. For further information, read on:


Contingency Plan One Page Summary

I. Services and programs that will remain operational.

Please list major services that will continue at the agency and identify the reason each is able to continue – either “other funding source” or “necessary for the safety of life and the protection of property”.

Health care reform implementation (CCIIO) Affordable Care Act funding
IHS direct clinical services Safety of life
TANF, foster care grants, child support enforcement grants Mandatory funding
Suicide prevention hotline Safety of life
NIH direct clinical services & research protocols for current patients Safety of life
FDA import monitoring Safety of life
Medicare provider payments Mandatory funding[i]
Medicaid payments to states, CHIP Mandatory funding


II. Services and programs that will be closed.

  • New grants and ongoing technical assistance to Head Start centers will cease
  • NIH Clinical Center will not take on additional patients nor begin new clinical trials.
  • Technical support to local behavioral health services will cease
  • No new service grants (e.g. Ryan White HIV/AIDS grantees)
  • FDA review of new pharmaceuticals and medical devices

III. Key citizen services that will be impacted.

  • Food & drug safety reporting – monitoring of negative drug interactions and some food safety inspections suspended
  • Medicare services – services for beneficiaries, such as 1-800 Medicare, the Medicare and You handbook, and website updates could be limited, with longer hold and wait times.
  • Medical research – NIH Clinical Center clinical trial recruitment shut down

IV. Employees.

  • Total Agency Employees: 76,348
  • Total Employees Furloughed: 47,693