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Compliance In Focus


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Posted by Victoria Sawczak on Mon, Nov 06, 2017

The Real Costs of Clinical Research

In 1996 The University of Rochester was offering $150 to volunteers for what was designed to be a minimal-risk research study. To 19-year-old Nicole ( Hoiyan ) Wan, a hundred and fifty dollars meant being able to afford a trip home to see her parents in Queens, New York. Nicole, like many college students, found the money offered on a campus flier for participation in the clinical research study to be extremely enticing. Back in Queens, New York, Mr. and Mrs. Wan were unaware of their daughter’s intention to enroll in any study.

Topics: New York Times, Clinical Research, Nicole Wan

Posted by Brandy Chittester on Wed, Mar 04, 2015

Protocol Development - Is this Medical Test Really Necessary?

Regardless if you are reading this from a sponsor, site, monitor or IRB perspective, we have all worked on a protocol with a medical test that really seems unnecessary or obsolete, not to mention, difficult to obtain with in the time window specified by the protocol.

Topics: Medical Test, New York Times, Protocol Development

Posted by John Lehmann on Wed, Mar 04, 2015

Small Victory for the Family of Henrietta Lacks

There is a new development in the story of Henrietta Lacks, the woman whose cancerous cells were obtained without her consent and developed into the immortal HeLa cell line.  You may recall that Henrietta presented to John Hopkins in Baltimore Maryland in 1951 and was treated for cervical cancer.  During her treatment, her doctors obtained a sample of healthy cervical cells along with a sample of the cancerous ones for testing.  Unexpectedly, Dr. George Otto Gey was able to keep the cells alive in a culture and they have been used without Henrietta’s permission in numerous research studies ever since.  In fact, you can still obtain a sample of HeLa cells today.  Unfortunately, Henrietta was never even informed of this and it wasn’t discovered until over 20 years later when Johns Hopkins contacted her children to see if they would be willing to give blood samples in order to better understand the immortal cells.  Not only has the Lacks family had no say in how Henrietta’s cells could be used, but they themselves have struggled to receive adequate medical care because the family has never been compensated in any way for their mother’s contribution to science.

Topics: NIH, Henrietta Lacks, New York Times, Clinical Research

Posted by John Lehmann on Wed, Mar 04, 2015

Clinical Research - Does the Evidence Make Sense?

The New York Times published an article that poses an important question to researchers- Do new medical procedures, products, and drugs work better than the old practices that they commonly replace?  It is a similar question that consumers are faced with every time a new version of their favorite cell phone is released- it is new, but is it necessarily better?

Topics: New England Journal of Medicine, New York Times, Clinical Research

Posted by Stephani Hulec on Wed, Mar 04, 2015

New Symptom in Clinical Studies: The Nocebo Effect

Most people are familiar with the term placebo effect, in which patients experience beneficial symptoms associated with a specific treatment, even when they are given an ineffectual treatment, or “placebo”.  Recently, this New York Times article discussed the opposite medical phenomena known as the nocebo effect.  The nocebo effect is defined as:

Topics: Clinical Studies, The Nocebo Effect, New York Times, New Symptom

Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.