Scientists Raise Concerns About Revisions to Human Research Regulations; The Scientist, February 19, 2019

Katarina Zimmer, The Scientist; Scientists Raise Concerns About Revisions to Human Research Regulations

"When Henrietta Lacks visited the Johns Hopkins Medical Center in the 1950s to be treated for cervical cancer, she had no idea that some of her cancer cells would be used to create one of the most scientifically valuable and financially profitable cell lines that is used in labs today. Nor was she asked for permission.

Lacks’s experience has become nationally acknowledged as a shameful episode in the history of biomedical research in the US—particularly after the publication of a popular book about Lacks and her family—and forced the scientific community to consider how to conduct ethical research with human samples. The case was one of the reasons for a heated debate during a recent, six-year-long process of revising the Common Rule, a package of regulations adopted in the 1990s intended to ensure that all federally funded research conducted on human subjects is done ethically.

The revisions, enacted last month, are an attempt to strike a better balance between patients’ need for privacy and the benefits of using their tissue for research. In a paper published January 31 in JAMA Oncology, a group of clinicians and ethicists from the University of Michigan and the University of Pennsylvania argue that the revisions could have unintended consequences for research with various types of biospecimens, and propose that regulators should consider them differently when creating research protections."

Worse Than Tuskegee; Slate, February 26, 2017

Sushma Subramanian, Slate; 

Worse Than Tuskegee

"“Most people think we don’t conduct trials this way,” Annas said. “We always act shocked by research scandals and see them as historical anomalies that cannot be repeated. But so far, we’ve always been wrong.”

In 2011, the presidential commission for the same bioethics commission that completed the Guatemala syphilis report also published a report on international research. It recommended that the country develop a compensation system perhaps akin to the U.S. National Vaccine Injury Compensation Program—which covers people harmed by certain vaccines—for people who are injured as test subjects in research. The site hosting that report, bioethics.gov, is no longer in service: A note on the archived site says that it will stop being updated as of Jan. 15, 2017, likely in anticipation of the presidential transition.

In addition to providing compensation to victims, the advisers on the Archdiocese of Guatemala’s petition are also advocating for sharpening the teeth of laws that protect research subjects internationally. They suggest amendments to the Common Rule, the set of guidelines used by institutional review boards overseeing research involving human subjects in biomedical and behavioral research in the United States and internationally." 

Scientists Needn't Get A Patient's Consent To Study Blood Or DNA; NPR, 1/18/17

Rob Stein, NPR; 

Scientists Needn't Get A Patient's Consent To Study Blood Or DNA

"The Obama administration has dropped a controversial proposal that would have required all federally funded scientists to get permission from patients before using their cells, blood, tissue or DNA for research.

The proposal was eliminated from the final revision of the Common Rule, which was published in the Federal Register Wednesday. The rule is a complex set of regulations designed to make sure federally funded research on human subjects is conducted ethically. The revision to the regulations, set to go into effect in 2018, marks the first time the rule has been updated in 26 years.

The initial proposal that researchers be required to get permission before using a patient's tissue sample for research came out of the desire to avoid repeating what happened to Henrietta Lacks, an American who died of cervical cancer in 1951. Some of the cells from Lacks' cancer were kept alive for decades, used in research and for commercial purposes without her consent or her family's knowledge.

But scientists have argued that the mandate for consent in the initial Obama proposal was unnecessary and would hinder crucial research...

The final decision was welcomed by scientists and universities."