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Zika and Human Subjects Research

Concerns related to Zika virus disease (Zika) continue to arise daily and the World Health Organization (WHO 2016) recently declared it a Public Health Emergency of International Concern (PHEIC). In response, the U.S. government has taken several steps towards accelerating and increasing Zika research efforts.

  • President Obama initially called for the acceleration of Zika research efforts. The National Institutes of Health’s (NIH) Director, Dr. Francis Collins, echoed this call to action, "It is now critically important to confirm, through careful epidemiological and animal studies, whether or not a causal link exists between Zika virus infections in pregnant women and microcephaly in their newborn babies" (Collins 2016).
  • President Obama then submitted a proposal to Congress requesting $1.8 billion in funding for research into Zika, with monies designated for research and development of vaccines, therapies, and improved diagnostics (Pope 2016).

Zika Virus and Human Subjects Research - 2016 OHRP Research Community Forum Miami RCF - CITI Program

What May This Mean for Human Subjects Research?

It is important to first note that the research world is better prepared to respond to threats, such as those from Zika, following the response to last year’s Ebola epidemic. WHO now has an accelerated assessment process for the use of experimental products during an epidemic (Kieny 2016).

With the rise in the number of Zika infections, Institutional Review Boards (IRBs) may begin to see more Zika-related research protocols, such as:

  • Social and behavioral quality-of-life surveys for Zika-infected persons
  • New vaccine testing to prevent Zika infections
  • Diagnostics to identify Zika
  • Public health research for mosquito control efforts

During the review of such studies, IRBs should be aware of possible issues for vulnerable populations. The CITI Program has specific modules that researchers and IRBs may utilize to review relevant issues that should be considered when designing and reviewing studies involving vulnerable populations:

  • Populations in Research Requiring Additional Considerations and/or Protections
  • Vulnerable Subjects – Research Involving Pregnant Women, Human Fetuses, and Neonates
  • International Studies/International Research – SBE

Reports have also surfaced from Brazil regarding the use of social media applications and technology, where individuals can share information about Zika, their own experiences, and ways to seek treatment (Worth and Osborn 2016). IRBs should consider the potential issues associated with social media in research and communicating with subjects. The CITI Program is currently developing the following modules to address such issues:

  • Research with Apps and Mobile Devices in Human Subjects Research
  • Principal Investigator Responsibilities in Disaster and Conflict Research
  • Examples, Best Practices, and Recommendations for Research in Areas of Conflict and Disasters

Upcoming 2016 OHRP Research Community Forum (RCF)

On April 7, the Office for Human Research Protections (OHRP) is co-sponsoring a Research Community Forum (RCF) in Miami, Florida with the CITI Program at the University of Miami, Baptist Health South Florida, Miami Children’s Research Institute, Nova Southeastern University, University of Miami Human Subject Research Office, and the University of South Florida.

2016 OHRP Research Community Forum Miami RCF

Individuals interested in learning more about current trends in research, including those related to vulnerable populations and disease-related challenges, would benefit greatly from this event. Presentation highlights in these areas include:

  • “Research During Humanitarian Disasters – Changing Priorities and Challenges” by Dr. Susan Briggs
  • “Ebola and Other Emerging Pathogens – A New Challenge in Research” by Dr. Bruce Gordon

About the Author

Margaret Rankovic is the Associate Director for Educational Initiatives for Human Subjects Research and Good Clinical Practice at CITI Program.


References

Collins, Francis. 2016. “Zika Virus: An Emerging Health Threat.” NIH Director’s Blog, January 26. http://directorsblog.nih.gov/2016/01/26/zika-virus-an-emerging-health-threat/.

Kieny, Marie-Paule. 2016. “WHO research and development on Zika.” Accessed February 29. http://www.who.int/mediacentre/commentaries/zika-research-development/en/.

Pope, Amy. 2016. “The Zika Virus: What You Need to Know.” The White House Blog, February 23. https://www.whitehouse.gov/blog/2016/01/27/zika-virus-what-you-need-know.

World Health Organization (WHO). 2016. “WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations.” Accessed February 29. http://www.who.int/mediacentre/news/statements/2016/1st-emergency-committee-zika/en/.

Worth, Katie, and Catherine Osborn. 2016. “How Brazil's favorite app is helping doctors and parents cope with microcephaly.” Accessed February 29. http://kosu.org/post/how-brazils-favorite-app-helping-doctors-and-parents-cope-microcephaly#stream/0.


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Last Updated: 12-Mar-2017 9:16 p.m. EDT

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