Month: March 2013

You Talkin’ to Me?

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by Suzanne M. Rivera, Ph.D.

The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects.  Equitable in this context means that the risks and benefits of the study are distributed fairly.  Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and 2) avoiding the unjustified exclusion of any population ( whether out of bigotry, laziness or convenience).  

Recruitment strategies invariably shape the selection of research subjects and the extent to which a pool of participants really represents a cross-section of society.  Institutional Review Boards (IRBs) are charged with evaluating whether study recruitment plans and materials used to obtain informed consent are easily understood and free of misleading information.  This is relatively straightforward when researchers, IRB members, and study subjects all speak the same language.  But when studies are done in geographical areas that include numerous cultural and language communities, it can be quite tricky.

One of the barriers that prevents people from enrolling in (or even knowing about) studies is a lack of awareness and planning by researchers to address language differences.  The human research protection regulations at 45 CFR Part 46.116 require that informed consent information must be provided to research participants (or their representatives) in language understandable to them.  IRBs are supposed to be vigilant about this and require investigators to obtain translated Informed Consent Documents (ICDs) for use with non-English speaking research subjects.  But researchers commonly balk at this expectation, saying it’s unreasonable.   (A disproportionate number of objections have been raised to me thusly, “And what am I supposed to do if someone shows up speaking only Swahili?!”) Read More

Job Posting: EPA’s Office of the Science Advisor (OSA), Office of Research and Development (ORD) seeks Human Subjects Research Review Official

The Petrie-Flom Center Staff Leave a comment

EPA’s Office of the Science Advisor (OSA), Office of Research and Development (ORD) is seeking a senior executive and scientific leader for the position of Human Subjects Research Review Official (HSRRO) in Washington, DC, who is the Agency’s focal point for providing guidance and leadership, and who serves as the expert technical resource to EPA in matters related to human research ethics and human subjects protection. The HSRRO provides strategic vision and leadership for a scientific program whose results serve as a basis for informing Agency decisions in areas related to human subjects research.

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Time Magazine on Solving Health Care’s #1 Problem: “All the Prices Are Too Damn High”

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By Patrick O’Leary

The cover story of the March 4, 2013 issue of Time Magazine is a piece by Steven Brill titled Bitter Pill: Why Medical Bills Are Killing Us. The article has apparently made a pretty big splash: in an interview (Part 2, Part 3) with Brill last week, Jon Stewart of Comedy Central’s The Daily Show told his audience that the article was so good that it “should be required reading for . . . not only every individual in this country, but lawmaker in this country.”

What most seems to fascinate Stewart, and what Brill emphasizes, is an insight that is old hat to health law types: the market for health care is just plain screwy. Brill explains that health care consumers “have no choice in what you’re buying, you have no idea what you’re buying, you have no idea what the price is, even when you get the bill you have no idea what it says.” The starting point for the article was Brill’s observation that in all the debate over the last few years about health care, “we seem to jump right to the issue of who should pay the bills, blowing right past what should be the first question: Why exactly are the bills so high?” Read More

Petrie-Flom Interns’ Weekly Round-Up: 2/23-3/01

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

  • As the federal government clambers to meet deadlines and broker deals ahead of the sequestration, Medicare remains, again, one of the more contentious issues. While Medicare spending has slowed, Democrats are resisting any further spending cuts to such entitlement programs beyond the $300 billion reduction agreed upon last year.
  • The healthcare sector has been suffering from a lack of consensus and resources, both financial and in human capital. Adding to these burdens is the federal panel on the health care work force that, two and a half years after its creation, has never met because they were never appropriated any funding. The commission was created to debate over crucial details of the health care law.
  • Despite the hullabaloo in Europe over the contamination of beef products with horse meat, the U.S.D.A. is on the verge of approving a horse-slaughter plant in New Mexico for the human consumption of equine meat.
  • Lower-income consumers have been waiting for the release of knockoff versions of highly expensive biotech drugs, but it seems that they will have to wait some more. Pharmaceutical company projects to create such “biosimilar” drugs have faltered and policy has not been clearly established as to how to proceed.

Worth Reading This Week

Nicolas P. Terry Leave a comment

By Nicolas Terry

Peter Orszag on Former Petrie-Flom Center Fellow (now Prof.) Michael Frakes’ Work on Med-Mal, Sequestration, and the Budget

I. Glenn Cohen Leave a comment

In Bloomberg News earlier in the week, Peter Orszag praises a paper that Cornell Law Professor Michael Frakes wrote when he was a fellow at the Petrie-Flom Center.  As Orszag writes

“Most of the costs in the U.S. health-care system are incurred in a small number of expensive cases. The top 25 percent of Medicare beneficiaries ranked by cost, for example, account for 85 percent of total spending. And the expenses in those cases are driven significantly by the recommendations that doctors make to pursue one treatment path and not another.

In making these choices, doctors are influenced by various things, including medical-school training, traditions among their peers, financial incentives (which are distorted by fee- for-service payments) and, yes, the medical-malpractice system. Improving the criteria for what constitutes appropriate care could significantly change doctors’ behavior and also save money, recent research by Michael Frakes of Cornell Law School suggests.”

The paper “The Impact of Medical Liability Standards on Regional Variations in Physician Behavior: Evidence from the Adoption of National-Standard Rules” in the American Economic Review can be found here.