Research Ethics Roundup: The future of the CTSA program, sharing scientific data, and more

by Maeve Luthin, JD, Professional Development Manager

Hopkins, UMD Await Word on Grant Funding Key in Medical Treatment Discoveries: In June, the Institute of Medicine (IOM) released a report detailing recommendations to the National Institutes of Health (NIH) regarding its administration of the Clinical and Translational Science Awards (CTSA) program, including that it should consolidate program leadership, establish clearer evaluation standards for applications, and encourage collaborating among participating institutions. CTSA decisions are expected in September. Now, institutions are waiting to see how the report will affect their funding.

Jerry Brown’s Egg Donor Veto Draws Fire From Measure's Author: California Governor Jerry Brown vetoed a bill that that would have allowed women to sell their eggs for medical research, citing the concern that informed consent for egg harvesting procedures is limited by inadequate knowledge of long-term risks. Supporters of the bill have stated that the veto will stifle fertility research as well as studies on the impact of cancer-fighting drugs on fertility.

How to Share Scientific Data: With government agencies facing an increasing demand for transparency of federally-financed research results, a mechanism for making meaningful data accessible to the public is needed. Some believe that the current system gives private companies an unfair advantage, as they are more likely to be able to synthesize raw data sets. To solve this dilemma new cost sharing models for storing and aggregating digital research data, which emphasize the need for public, private, and academic research communities to share the financial and technical burden of investing in infrastructure, are being explored.

Japan Investigations Allege Misconduct in Large-Scale Clinical Studies: The Japanese Ministry of Health is investigating claims of data manipulation and conflict of interest involving five large-scale, post-marketing clinical studies on valsartan, a hypertension drug produced by Novartis. Six papers based on the study findings, which suggested the drug significantly decreased the chance of stroke and angina, have been retracted. The individual sites involved in the studies have all launched their own investigations as well.

Justice delayed is not always justice denied: The Lacks family and the National Institutes of Health

by Joan Rachlin, JD, MPH, Executive Director

One of my close friends runs the Civil Rights and Restorative Justice Project at Northeastern University School of Law, a project that seeks to achieve justice for civil rights era crimes that went unpunished. Last year, I attended a screening of an extraordinary film about their work, The Trouble I’ve Seen, and was struck by the determination of the students and professors who reopened these cold cases and by the comfort that even small efforts at redress and reconciliation can bring to victims and/or their families.

My reaction to seeing that film came flooding back on August 7 when I read about an agreement that Francis Collins, MD, PhD, director of the National Institutes of Health (NIH) and a highly respected genetics researcher, entered into with the family of Henrietta Lacks, a strong and spirited African American woman who died from cervical cancer in 1951. Cells obtained from Ms. Lacks during a routine biopsy were found to possess unique properties. Her cells grew freely and endlessly in cell culture, which allowed researchers to utilize the cell line for decades of research projects, including, notably, the development of the polio vaccine and the discovery of human telomerase. To this day, Ms. Lacks’ cells remain in use, according to Dr. Collins, in, “almost every molecular biology lab” in existence. More than 75,000 papers have resulted from the almost 65 year history of studying the HeLa cell line, and that research has yielded great financial benefits for many researchers.

The trouble is that Ms. Lacks’ cells were obtained without her knowledge or consent, and, to compound that injustice, her family was not told about the HeLa cell line until one of her daughters read about it more than 25 years after Ms. Lacks’ death and began asking questions.

Recently, in March 2013, German researchers sequenced the genome of the HeLa cell line, and, without telling or consulting the family, posted the data online. In doing so, researchers not only revealed Ms. Lacks’ genome for all to see, but also possibly shed light on the genetic predispositions or traits of surviving members of her family. A firestorm of protest followed, and the researchers reached out to the Lacks family with the help of Rebecca Skloot, author of the best-selling book The Immortal Life of Henrietta Lacks. The publication of Ms. Lacks’ genome reignited the debate that has engulfed the use of the HeLa cell line since Ms. Skloot’s book was first released. Issues surrounding the consent and ownership of tissue, genetic privacy, the permissible and impermissible uses of archival samples, and whether tissue or other data can be truly anonymized, were all moved back to the front burner in the wake of the German publication, which was ultimately removed from the web after the public outcry.

This latest round of debate over the online publication of the HeLa cell genome prompted Dr. Collins and his colleagues to seek a remedy for the Lacks family. His account of the decision can be found in a recent article in Nature, which lays out the case for protecting the dignity, privacy, and well-being of research subjects and, where appropriate, their family members as well. In an interview in the same publication, Dr. Collins reminded readers of the importance of ensuring “respect for persons,” a principle defined in The Belmont Report, and one which is, no doubt, familiar to the PRIM&R community. He added: “The most appropriate way to show respect for persons is to ask. Ask people, ‘Are you comfortable having this specimen used for future genomic research, for a broad range of biomedical applications?’ And if they say no—no means no.”

The principle of respect for persons is one that Dr. Collins has demonstrated throughout his work with the Lacks family. In the interview, he spoke about spending a great deal of time drawing diagrams of DNA and explaining to them the genomics of cancer and what made Ms. Lacks’ cells so unique. The time and care that Dr. Collins spent with the family displayed great respect for them, and he augmented that respect by offering his public praise for their ability to handle a very complex situation.

I would like to second his expression of admiration for the Lacks family, and add my own admiration for Dr. Collins, who proved that there is no statute of limitations on saying “I’m sorry,” “We goofed,” “We want to make it right,” and/or “You deserved better.” And, there’s certainly no statute of limitations on modeling respect for persons, beneficence, and justice, all of which were at the core of Dr. Collins’ actions both in this case and throughout his career.

The agreement provides for the creation of a committee that will be charged with reviewing applications from researchers seeking access to the HeLa cell genome. Two members of the Lacks family will sit on this committee. However late and however limited, this is an important step, and not simply a symbolic one, in rectifying a longstanding wrong.

There’s an iconic saying in many advocacy movements that goes “you can’t talk about us, without us,” a variant of which is “nothing about us without us.” Dr. Collins has finally given life to that mantra by involving Ms. Lacks’ descendants in matters that affect and concern them. Thank you, Henrietta Lacks, for your immortal gift to science and health. Thank you to the Lacks descendants for being determined to seek the respect and justice they were due. And thank you, Dr. Collins, for modeling the ways in which respect for persons and the other Belmont principles can be made concrete.

Onward to redress other past injustices—it’s never too late, after all.

Research Ethics Roundup: New restrictions on the research use of animals in Italy, NIH considers validating key results, and more

by Maeve Luthin, JD, Professional Development Manager

In recent days, much has been happening in the research world, both within the US and abroad. Travel around the world from the comfort of your own desk with this edition of Research Ethics Roundup!

Detachment: How Can Scientists Act Ethically When They Are Studying the Victims of Tragedy, such as the Romanian Orphans? Investigators detail how they constructed the ethical parameters and experimental design of the controversial Bucharest Early Intervention Project, a randomized controlled trial that compares the physical, psychological, and cognitive development of orphaned Romanian children placed in foster care with those placed in institutional care.

Italian Parliament Approves Sweeping Restrictions to Use of Research Animals: The Italian parliament approved legislation that puts extreme restrictions on the use of nonhuman primates, dogs, and cats in research; it also forbids the use of animals in research areas such as xenotransplantation. The European Union (EU) may challenge these measures, as they contradict a 2010 EU directive that covers the protection of animals for scientific purposes.

NIH Mulls Rules for Validating Key Results: Senior National Institutes of Health (NIH) officials are considering adding a reproducibility requirement to certain grant applications for foundational projects that are likely to lead to clinical trials. Such verification may be performed by independent laboratories. Also under consideration is a proposal to bring greater scrutiny to the peer review process.

'Informatics' Helps Doctors Unlock Medical Mysteries in Mounds of Data: Biomedical informatics allows investigators to analyze and organize digital data sets, creating a standardized pool of knowledge that researchers can mine in their efforts to diagnose, understand, and cure diseases. Informatics professionals use traditional quantitative analyses alongside such tools as predictive modeling in their efforts to develop the data in meaningful ways.

Apes Need Vaccines, Too: John VandeBerg, the director of the Southwest National Primate Research Center argues that NIH’s recent decision to retire most chimpanzees from research will effectively halt the development of vaccines that may save wild chimpanzees and gorillas from extinction. High percentages of the wild great ape population die from such diseases as the Ebola virus, chimpanzee AIDS, and human respiratory illnesses.

How to Cure a Bubble Boy: Small clinical trials for new gene therapies have begun in the United States, a decade after research stopped due to the link between the treatment and leukemia. Researchers have developed innovative ways to deliver and install genes without replicating cancer cells, and subjects enrolled in small pilot studies in the US, England, and Italy have so far shown no signs of cancer.

The impact of self-interest in scientific research: Lessons from Cantor’s Dilemma

by Nicholas Spetko, Membership Services Intern

The portrayal of scientific research and research ethics in popular media can offer considerable insight. To reflect on some of the lessons offered, PRIM&R staff have spent the summer reading and watching classic books, movies, and television shows that have generated conversation and debate around issues related to research ethics. Over the next several weeks, they will share their reflections here, so join us as we explore popular representations of the research world. 

In this week’s installment of our summer series looking at depictions of research ethics in popular media, I’ll explore the contemporary significance of Cantor’s Dilemma, a novel written more than 20 years ago by Carl Djerassi. The protagonist of the novel, an established scientist named Isidore Cantore, has developed a revolutionary theory of tumorigenesis and an experimental test to prove it. In his race to win the Nobel Prize, he carefully orchestrates the publication and the results of his young research fellow Dr. Jeremiah Stafford.

Throughout Cantor’s Dilemma, self-interest, rather than scientific inquiry, propels the researchers forward. As articulated by Cantor: “But people don’t take on such time-consuming duties solely out of noblesse oblige—some kind of intellectual philanthropy, you might say. There’s always some element of self-interest.” The manipulation and deceit of the characters is accepted as a norm of scientific practice and the only way to truly succeed.

In the past month alone, we have seen numerous blogs and articles about the consequences of this sort of environment, both in academic and corporate settings. Whether it is the rush to publish new findings which lead to questions of accuracy, or the challenge of fostering transparency across corporate-initiated clinical studies, it is clear that this high-stakes environment puts enormous pressure on all researchers to perform. An urgent interest in either profitability or publication fuels a need to establish scientific ownership of ideas, with the Supreme Court case involving Myriad Genetics being the most recent example. Yet perhaps ultimately, the consequence of this intensely competitive research culture is that it can betray and prevent an ideal of true scientific collaboration and therefore impede scientific progress.  While more than 20 years have passed since its publication, the story chronicled in Cantor’s Dilemma remains a relevant missive for understanding how self-interest can cast a shadow on science.

Meeting the needs of PRIM&R members

by Megan Frame, Membership Coordinator

As PRIM&R’s membership coordinator, one of my priorities is assessing how we can serve and support our membership community. This past May PRIM&R members were asked to complete the 2013 Membership Services Survey to evaluate our services and benefits and let us know what they needed from PRIM&R.

On the whole, members reported they were very glad to be a part of PRIM&R. Eighty-eight percent of respondents said they were very satisfied or satisfied with their memberships, while 96% of respondents said they would refer PRIM&R to a colleague.

The top-ranked benefits were the educational discounts available to members, our monthly Newsletter, complimentary access to PRIM&R conference presentations and webinar archives, and our bimonthly Research Ethics Digest (RED). The Knowledge Center, PRIM&R’s newest member benefit, was the benefit members said they were most likely to use in the future. If you’re a PRIM&R member who has not yet had an opportunity to utilize the Knowledge Center, I would encourage you to view the tutorial  before getting started, which will help you navigate the various sections of content.

We also use this opportunity to learn what we can do better, and here are a few of the suggestions that we are prioritizing this year:

• A Workload and Salary Survey revision—Members requested a more comprehensive Workload and Salary Survey that would explore the connections between education, workload, position, and salary. Over the course of the next year, this survey will be rewritten and reanalyzed to make the results even more useful.


• Increased involvement with PRIM&R—Many members said they were unaware of the volunteer opportunities available, or had not taken advantage of them thus far, but would like to get more involved in PRIM&R. If you have not done so already, I invite you to explore our new volunteer webpage, where volunteer opportunities are organized based on time commitment.


• Featuring additional topics in publications—Devoted readers of the Newsletter and RED requested more coverage on the following topics: audit and monitoring, categorization of research proposals, child advocacy, internet-based research methods, and social media research and recruitment. We will make a concerted effort to highlight scholarly journal articles, news stories, and blog posts on these issues wherever possible, so stay tuned into Ampersand, PRIM&R’s social media channels, and our members-only publications.


• Greater promotion of membership benefits—Some respondents did not realize the range of benefits associated with PRIM&R membership. To better showcase the resources to which members have access, we will feature a different benefit each month in the membership section of our Newsletter. 

We look forward to hearing more from our members over the course of the year and in next year’s survey. We strive to support PRIM&R members in their professional lives, and feedback is crucial to our success.