Thursday, May 31, 2012

Jewish Ethical Themes That Should Inform the National Healthcare Discussion

J Relig Health. 2012 May 30. [Epub ahead of print]

Jewish Ethical Themes That Should Inform the National Healthcare Discussion: A Prolegomenon.


Institute for Studies of Religion, Baylor University, One Bear Place #97236, Waco, TX, 76798, USA,


Despite the passage of H.R. 3590 in the 111th Congress, the national healthcare debate in the United States continues, with repeal or modification of the Patient Protection and Affordable Care Act under ongoing consideration. Reference is often made to morality or ethics, but typically in general terms only. This paper elucidates themes from one system of moral theology, namely Jewish healthcare ethics, that would valuably inform this debate. Themes include "covenant," "holiness," "justice," "mercy," "for the sake of peace," "to save a life," "peoplehood," "repair of the world," "repentance," and "jubilee." Policy-related, economic, political, and moral challenges to acting on these principles are discussed.

"Okay, you're hit, Darnold," Kocher concedes. "We're gonna fix it. Keep driving."

"For a moment, Kocker's power of suggestion works so well, Darnold not only keeps driving, he continues simultaneously firing his M-4 rifle out the side of the Humvee.
Then Darnold wavers. "I am hit!" he insists.
"Okay, you're hit, Darnold," Kocher concedes.  "We're gonna fix it. Keep driving."

Generation Kill 

by Evan Wright (Jul 1, 2008)

"I was helping with burial detail now; I couldn't get out of it as there weren't enough healthy men left."

Abandoned on Bataan: One Man's Story of Survival by Oliver Craig Allen and Mildred Faye Allen (Oct 2002)

"Rescue? Do I look like I need rescuing?"

"Who the hell are you?" [Private First Class Dick Bonelli] said.
"Baker Company.  Here to rescue you."
"Rescue?  Do I look like I need rescuing?"

The Last Stand of Fox Company: A True Story of U.S. Marines in Combat

Bob Drury (Author), Tom Clavin

Bariatric surgery in the Caribbean

Minim Invasive Surg. 2012;2012:427803. Epub 2012 May 8.

Bariatric surgery in the Caribbean: is it safe in a low-volume, third world setting?


Department of Clinical Surgical Sciences, The University of the West Indies, St. Augustine, Trinidad and Tobago.


Bariatric surgery is a well-recognized modality of management of obesity. In addition to obesity, it effectively controls diabetes mellitus, and hypertension. It has been recommended that bariatric surgery should be done in "designated centers" of excellence where there is a high volume of case turnover. Caribbean nations are not spared from the global spread of theobesity epidemic; however, not many patients get the benefits of bariatric surgery. This study aimed to establish that bariatric surgery could be safely and efficiently undertaken in a low-volume center outside the "designated centers" with comparable patient outcomes even in a third world setting. Though "patient numbers" generally imply better outcome, in an environment where these numbers cannot be achieved, patients should not be denied the access to surgery once good outcomes are achieved.

From NewStatesman: Why American writers are obsessed with apocalypse

Living in the end times

Why American writers are obsessed with apocalypse.


"Nothing of the 9/11 attacks even remotely suggested an apocalypse but they certainly helped expose the troubling fiction of our immortality. Which might mean that fictions of our end times are now, through bad luck or comeuppance, however you wish to view it, among the truest and most realistic stories that we can tell."

"college today faces not only a fiscal, not just an ethical, but even an existential challenge."

The university: still dead
Andrew Delbanco’s insightful new book on the history and future of the American college exposes an institution that has no idea what it should be.

"College presidents and faculty can rightly point out that they have always had to find a way of negotiating teaching the best of the past with the demands of the present, not to mention the need to balance the books. That was the very real debate played out between McCosh and Eliot. Yet, today, Eliotism has taken hold to such an extent that even he would recoil from what has happened in his name rather than pretending that all is well in the academy. Delbanco quite rightly stresses that college today faces not only a fiscal, not just an ethical, but even an existential challenge."

From Emory U: How federalism shapes public health financing, policy, and program options

J Public Health Manag Pract. 2012 Jul;18(4):317-22.

How federalism shapes public health financing, policy, and program options.


Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, Georgia. Dr Ogden is now with the Office ofHealth Reform Strategy, Policy, and Coordination, Centers for Disease Control and Prevention, Atlanta, Georgia.


In the United States, fiscal and functional federalism strongly shape public health policy and programs. Federalism has implications for public health practice: it molds financing and disbursement options, including funding formulas, which affect allocations and program goals, and shapes how funding decisions are operationalized in a political context. This article explores how American federalism, both fiscal and functional, structures public health funding, policy, and program options, investigating the effects of intergovernmental transfers on public health finance and programs.

From MD Anderson: Molecular Imaging of Mesothelioma with (99m)Tc-ECG and (68)Ga-ECG

J Biomed Biotechnol. 2012;2012:232863. Epub 2012 May 8.

Molecular Imaging of Mesothelioma with (99m)Tc-ECG and (68)Ga-ECG.


Department of Experimental Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, P.O. Box 59, 1515 Holcombe Boulevard, Houston, TX 77030, USA.


We have developed ethylenedicysteine-glucosamine (ECG) as an alternative to (18)F-fluoro-2-deoxy-D-glucose ((18)F-FDG) for cancer imaging. ECG localizes in the nuclear components of cells via the hexosamine biosynthetic pathway. This study was to evaluate the feasibility of imaging mesothelioma with (99m)Tc-ECG and (68)Ga-ECG. ECG was synthesized from thiazolidine-4-carboxylic acid and 1,3,4,6-tetra-O-acetyl-2-amino-D-glucopyranose, followed by reduction in sodium and liquid ammonia to yield ECG (52%). ECG was chelated with (99m)Tc/tin (II) and (68)Ga/(69)Ga chloride for in vitro and in vivo studies in mesothelioma. The highest tumor uptake of (99m)Tc-ECG is 0.47 at 30 min post injection, and declined to 0.08 at 240 min post injection. Tumor uptake (%ID/g), tumor/lung, tumor/blood, and tumor/muscle count density ratios for (99m)Tc-ECG (30-240 min) were 0.47 ± 0.06 to 0.08 ± 0.01; 0.71 ± 0.07 to 0.85 ± 0.04; 0.47 ± 0.03 to 0.51 ± 0.01, and 3.49 ± 0.24 to 5.06 ± 0.25; for (68)Ga-ECG (15-60 min) were 0.70 ± 0.06 to 0.92 ± 0.08; 0.64 ± 0.05 to 1.15 ± 0.08; 0.42 ± 0.03 to 0.67 ± 0.07, and 3.84 ± 0.52 to 7.00 ± 1.42; for (18)F-FDG (30-180 min) were 1.86 ± 0.22 to 1.38 ± 0.35; 3.18 ± 0.44 to 2.92 ± 0.34, 4.19 ± 0.44 to 19.41 ± 2.05 and 5.75 ± 2.55 to 3.33 ± 0.65, respectively. Tumor could be clearly visualized with (99m)Tc-ECG and (68)Ga-ECG in mesothelioma-bearing rats. (99m)Tc-ECG and (68)Ga-ECG showed increased uptake in mesothelioma, suggesting they may be useful in diagnosing mesothelioma and also monitoring therapeutic response.

From Adam B at Daily Kos: DOMA found unconstitutional

THU MAY 31, 2012 AT 08:11 AM PDT

Analysis: Defense of Marriage Act found unconstitutional

"This Court, however, will not have the last word. As the panel notes,
This case is difficult because it couples issues of equal protection and federalism with the need to assess the rationale for a congressional statute passed with minimal hearings and lacking in formal findings. In addition, Supreme Court precedent offers some help to each side, but the rationale in several cases is open to interpretation.We have done our best to discern the direction of these precedents, but only the Supreme Court can finally decide this unique case."

The First Circuit's DOMA decision (HT: MB)

Saturday, May 26, 2012

U Chicago Law School's Todd Henderson on the Facebook IPO 

From Francoise Galateau-Salle and colleagues: Pulmonary botryomycosis

Gen Thorac Cardiovasc Surg. 2012 May 25. [Epub ahead of print]

Pulmonary botryomycosis on a lung cavity: a rare pulmonary infection mimickingcancer.


Department of Thoracic Surgery, University Hospital Center of Caen, 14000, Caen, France,


Lung botryomycosis is a rare disease. We report what is to our knowledge the first case occurring on a lung cavity. In a 42-year-old man suffering asthenia and cough, a chest radiograph revealed a right upper lobe opacity. Computed tomography scan showed a necrotic mass which was also spiculated. Repeated research for Mycobacterium tuberculosis was negative. The patient underwent a lobectomy. Histological and bacteriological examinations made the diagnosis of botryomycosis, because the cavity presented numerous colonies of pyogenic Fusobacterium nucleatum bacteria. Botryomycosis is a difficult diagnosis that clinically mimics actinomycosis, tuberculosis or cancer. In most cases, surgery is necessary to assess diagnosis and treatment.

Texas Tech and U. of Houston Qualify for Tier-One Prize Money (HT:DF)

Tech and U. of Houston Qualify for Tier-One Prize Money

After completing its review, the state auditor confirmed that, indeed, both Texas Tech University and the University of Houston have met the state's requirements to gain access to the National Research University Fund."

“There’s only one way you can learn how to work — you’ve got to work”

Number of high-school students with jobs hits 20-year low

"In the long run, the trend could produce more and more young adults who lack the basic skills, such as how to interact with a customer, gained while working early in life. The longer a young person goes without a job,Mr. Sum said, the less attractive he or she looks to employers.
“There’s only one way you can learn how to work — you’ve got to work,” he said."

Catsmeat Potter-Pirbright: Very arguably Wodehouse's best name

The Escapist

P. G. Wodehouse’s comic gift was built on his brilliant capacity for repressing unpleasantness.


" ...Pongo Twistleton, Boko Fittleworth, Catsmeat Potter-Pirbright, Stilton Cheesewright, J. Chichester Clam, Cyril Bassington-Bassington. "

Medical malpractice in Taiwan

Acad Emerg Med. 2012 May;19(5):598-600. doi: 10.1111/j.1553-2712.2012.01360.x.

Medical malpractice in taiwan: injury types, compensation, and specialty risk.


From the School of Public Health (KYC, HYC, WTC), Graduate Institute of Injury Prevention and Control (KYC, SHT, MRL, WTC), Taipei MedicalUniversity. Taipei, Taiwan; the Department of Neurosurgery, Taipei Municipal Wan Fang Hospital (WTC), Taipei, Taiwan; and Shuang Ho Hospital (CMY), Taipei, Taiwan.


The authors analyzed all medical malpractice claims from 2000 to 2008 using cases from the national database of the judicial system of Taiwan. The objective was to describe the factors associated with malpractice claims in Taiwan, a non-Western country that does not have a common law heritage. Emergency physicians (EPs) were the most likely to be sued and made the highest median payments. Most lawsuits involved death or permanent injury. Eighty-two percent of the cases were settled in the physician's favor.

From Michigan State: Legal implications of pushing the endovascular envelope (or any medical envelope, for that matter)

J Vasc Surg. 2012 May 23. [Epub ahead of print]

Legal implications of pushing the endovascular envelope.


OU/WB School of Medicine, Division of Vascular Surgery, William Beaumont Hospital, Royal Oak, Mich and Michigan State University College of Law, Royal Oak, Mich.


Endovascular technology continues to improve for the treatment of vascular disease. However, application of these technologies without first obtaining proper informed consent may result in medical malpractice litigation. Similarly, use of these technologies without proper government and/or hospital approval may result in both criminal and/or civil liability. Care must be taken when pushing the envelope of endovascular interventions.

Cancer screening: Its all about epidemiology

Ann Epidemiol. 2012 Jun;22(6):439-45.

Cancer screening: the journey from epidemiology to policy.


Department of Thoracic Surgery, Vanderbilt University, Nashville, TN.



Cancer screening procedures have brought great benefit to the public's health. However, the science of cancer screening and the evidence arising from research in this field as it is applied to policy is complex and has been difficult to communicate, especially on the national stage. We explore how epidemiologists have contributed to this evidence base and to its translation into policy.


Our essay focuses on breast and lung cancer screening to identify commonalities of experience by epidemiologists across two different cancer sites and describe how epidemiologists interact with evolving scientific and policy environments.


We describe the roles and challenges that epidemiologists encounter according to the maturity of the data, stakeholders, and the related political context. We also explore the unique position of cancer screening as influenced by the legislative landscape where, due to recent healthcare reform, cancer screening research plays directly into national policy.


In the complex landscape for cancer screening policy, epidemiologists can increase their impact by learning from past experiences, being well prepared and communicating effectively.

The ACA, dialysis, and the Medicare ESRD program

Clin J Am Soc Nephrol. 2012 May 24. [Epub ahead of print]

Comparing Mandated Health Care Reforms: The Affordable Care Act, Accountable Care Organizations, and the Medicare ESRD Program.


Oregon Health & Science University, Portland, Oregon;, †Tufts Medical Center, Boston, Massachusetts;, ‡American Society of Nephrology, Washington, DC;, §University of Texas Southwestern, Dallas, Texas;, ‖Indiana University, Indianapolis, Indiana;, ¶Harbor-UCLA Medical Center, Torrance, California, *David Geffen School of Medicine, University of California, Los Angeles, California.


In addition to extending health insurance coverage, the Affordable Care Act of 2010 aims to improve quality of care and contain costs. To this end, the act allowed introduction of bundled payments for a range of services, proposed the creation of accountable care organizations (ACOs), and established the Centers for Medicare and Medicaid Innovation to test new care delivery and payment models. The ACO program began April 1, 2012, along with demonstration projects for bundled payments for episodes of care in Medicaid. Yet even before many components of the Affordable Care Act are fully in place, the Medicare ESRD Program has instituted legislatively mandated changes for dialysis services that resemble many of these care delivery reform proposals. The ESRD program now operates under a fully bundled, case-mix adjusted prospective payment system and has implemented Medicare's first-ever mandatory pay-for-performance program: the ESRD Quality Incentive Program. As ACOs are developed, they may benefit from the nephrology community's experience with these relatively novel models of health care payment and delivery reform. Nephrologists are in a position to assure that the ACO development will benefit from the ESRD experience. This article reviews the new ESRD payment system and the Quality Incentive Program, comparing and contrasting them with ACOs. Better understanding of similarities and differences between the ESRD program and the ACO program will allow the nephrology community to have a more influential voice in shaping the future of health care delivery in the United States.

"The Court's decision will thus mark the beginning, not the end, of health reform." More like the opening of Act III, actually.

Hastings Cent Rep. 2012 May-Jun;42(3):14-5. doi: 10.1002/hast.45.

Whither the affordable care act?


The U.S. Supreme Court has likely already decided how much, if any, of President Obama's signature Affordable Care Act it is going to strike down as unconstitutional; its holding will be published this summer. No matter what the Court decides, though, it will send state and federal legislators scrambling-either to implement the law or to deal with the consequences of its alteration. There are various decisions the Court might make, but it is still most apt either to leave the ACA standing, or to selectively invalidate some of its mandate-related provisions. In either case, there will be exchanges to design and manage, subsidies to allocate, transparency standards to design and enforce. The Court's decision will thus mark the beginning, not the end, of health reform.

Friday, May 25, 2012

From CDC/Johns Hopkins/U South Carolina: Stability of diagnosis of autism

J Dev Behav Pediatr. 2012 May 10. [Epub ahead of print]

Retention of Autism Spectrum Diagnoses by Community Professionals: Findings From the Autism and Developmental Disabilities Monitoring Network, 2000 and 2006.


From the *National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA; †Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; ‡Department of Medicine, Medical University of South Carolina, Charleston, SC.



Past research is inconsistent in the stability of autism spectrum disorder (ASD) diagnoses. The authors therefore sought to examine the proportion of children identified from a population-based surveillance system that had a change in classification from ASD to non-ASD and factors associated with such changes.


Children with a documented age of first ASD diagnosis noted in surveillance records by a community professional (n = 1392) were identified from the Autism and Developmental Disabilities Monitoring Network. Children were considered to have a change in classification if an ASD was excluded after the age of first recorded ASD diagnosis. Child and surveillance factors were entered into a multivariable regression model to determine factors associated with diagnostic change.


Only 4% of our sample had a change in classification from ASD to non-ASD noted in evaluation records. Factors associated with change in classification from ASD to non-ASD were timing of first ASD diagnosis at 30 months or younger, onset other than developmental regression, presence of specific developmental delays, and participation in a special needs classroom other than autism at 8 years of age.


Our results found that children with ASDs are likely to retain an ASD diagnosis, which underscores the need for continued services. Children diagnosed at 30 months or younger are more likely to experience a change in classification from ASD to non-ASD than children diagnosed at 31 months or older, suggesting earlier identification of ASD symptoms may be associated with response to intervention efforts or increased likelihood for overdiagnosis.

From U Pennsylvania: Imaging in the diagnosis and management of pulmonary hypertension

AJR Am J Roentgenol. 2012 Jun;198(6):1320-31.

Current role of imaging in the diagnosis and management of pulmonary hypertension.


Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, Philadelphia, PA 19104.


OBJECTIVE: The purpose of this review is to describe classification schemes and imaging findings in the diagnosis and management of pulmonary hypertension

CONCLUSION: Pulmonary hypertension is a complex pathophysiologic condition in which several clinical entities increase pressure in the pulmonary circulation, progressively impairing cardiopulmonary function and, if untreated, causing right ventricular failure. Current classification schemes emphasize the necessity of an early, accurate etiologic diagnosis for a tailored therapeutic approach. Imaging plays an increasingly important role in the diagnosis and management of suspected pulmonary hypertension.

More on Transfusion-related Acute Lung Injury

Curr Pharm Des. 2012 May 22. [Epub ahead of print]

Prevention of Non-immune Mediated Transfusion-related Acute Lung Injury; from Blood Bank to Patient.


Sanquin Research, Dept. of Blood Cell Research, Plesmanlaan 125, 1066 CX Amsterdam, The Netherlands.


Transfusion-related acute lung injury (TRALI) is a severe form of pulmonary insufficiency induced by transfusion. TRALI is the leading cause of transfusion-related death, and is caused by the infusion of either anti-leukocyte antibodies in plasma containing blood products or neutrophil priming substances that accumulate during storage of cellular blood products. Among these neutrophil priming substances are bioactive lipids, such as lysophosphatidylcholines (lysoPCs) and arachidonic acid, soluble CD40L (sCD40L) and possibly other, as yet unidentified substances. The accumulation of these substances during cellular blood product storage and their role in the induction of "non-immune mediated" TRALI pathogenesis are highly relevant for the current debate of the use of longer vs. shorter stored blood products. In this review, the accumulation of these different substances during storage, as well as their mode of action in inducing TRALI are discussed. In addition, different improvements in current blood banking procedures to prevent TRALI due to these non-immune mediators will be proposed.

Well, my parents told me it was nothin' but noise...

"The most benefit on health in intensive care medicine patients is visible in classical (Bach, Mozart or Italian composers) music and meditation music, whereas heavy metal music or techno are not only ineffective but possibly dangerous and can lead to stress and/or life-threatening arrhythmias, particularly in intensive care medicine patients."

Int J Crit Illn Inj Sci. 2012 Jan;2(1):27-31.

Role of music in intensive care medicine.


Department of Cardiology and Angiology, University of Bochum, Germany.


The role of music in intensive care medicine is still unclear. However, it is well known that music may not only improve quality of life but also effect changes in heart rate (HR) and heart rate variability (HRV). Reactions to music are considered subjective, but studies suggest that cardio/cerebrovascular variables are influenced under different circumstances. It has been shown that cerebral flow was significantly lower when listening to "Va pensioero" from Verdi's "Nabucco" (70.4+3.3 cm/s) compared to "Libiam nei lieti calici" from Verdi's "La Traviata" (70.2+3.1 cm/s) (P<0,02) or Bach's Cantata No. 169 "Gott soll allein mein Herze haben" (70.9+2.9 cm/s) (P<0,02). There was no significant influence on cerebral flow in Beethoven's Ninth Symphony during rest (67.6+3.3 cm/s) or music (69.4+3.1 cm/s). It was reported that relaxing musicplays an important role in intensive care medicine. Music significantly decreases the level of anxiety for patients in a preoperative setting (STAI-X-1 score 34) to a greater extent even than orally administered midazolam (STAI-X-1 score 36) (P<0.001). In addition, the score was better after surgery in the music group (STAI-X-1 score 30) compared to midazolam (STAI-X-1 score 34) (P<0.001). Higher effectiveness and absence of apparent adverse effects make relaxing, preoperativemusic a useful alternative to midazolam. In addition, there is sufficient practical evidence of stress reduction suggesting that a proposed regimen of listening to music while resting in bed after open-heart surgery is important in clinical use. After 30 min of bed rest, there was a significant difference in cortisol levels between the music (484.4 mmol/l) and the non-musicgroup (618.8 mmol/l) (P<0.02). Vocal and orchestral music produces significantly better correlations between cardiovascular and respiratory signals in contrast to uniform emphasis (P<0.05). The most benefit on health in intensive care medicine patients is visible in classical (Bach, Mozart or Italian composers) music and meditation music, whereas heavy metal musicor techno are not only ineffective but possibly dangerous and can lead to stress and/or life-threatening arrhythmias, particularly in intensive care medicine patients.

From UC Irvine: Neural Strategies for Selective Attention Distinguish Fast-Action Video Game Players

Brain Topogr. 2012 May 22. [Epub ahead of print]

Neural Strategies for Selective Attention Distinguish Fast-Action Video Game Players.


Department of Cognitive Sciences, University of California, Irvine, CA, 92617, USA.


We investigated the psychophysical and neurophysiological differences between fast-action video game players (specifically first person shooter players, FPS) and non-action players (role-playing game players, RPG) in a visual search task. We measured both successful detections (hit rates) and steady-state visually evoked EEG potentials (SSVEPs). Search difficulty was varied along two dimensions: number of adjacent attended and ignored regions (1, 2 and 4), and presentation rate of novel search arrays (3, 8.6 and 20 Hz). Hit rates decreased with increasing presentation rates and number of regions, with the FPS players performing on average better than the RPG players. The largest differences in hit rate, between groups, occurred when four regions were simultaneously attended. We computed signal-to-noise ratio (SNR) of SSVEPs and used partial least squares regression to model hit rates, SNRs and their relationship at 3 Hz and 8.6 Hz. The following are the most significant results: RPG players' parietal responses to the attended 8.6 Hz flicker were predictive of hit rate and were positively correlated with it, indicating attentional signal enhancement. FPS players' parietal responses to the ignored 3 Hz flicker were predictive of hit rate and were positively correlated with it, indicating distractor suppression. Consistent with these parietal responses, RPG players' frontal responses to the attended 8.6 Hz flicker, increased as task difficulty increased with number of regions; FPS players' frontal responses to the ignored 3 Hz flicker increased with number of regions. Thus the FPS players appear to employ an active suppression mechanism to deploy selective attention simultaneously to multiple interleaved regions, while RPG primarily use signal enhancement. These results suggest that fast-action gaming can affect neural strategies and the corresponding networks underlying attention, presumably by training mechanisms of distractor suppression.

"...essential elements of human subjects protection are not implemented uniformly across IRBs"

Acad Med. 2012 May 22. [Epub ahead of print]

How Closely Do Institutional Review Boards Follow the Common Rule?


Dr. Lidz is professor, Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts. Dr. Appelbaum is professor, Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York. Dr. Arnold is professor, Department of Medicine, Division of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Dr. Candilis is associate professor, Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts. Dr. Gardner is professor, Department of Pediatrics, Ohio State University College of Medicine, Columbus, Ohio, and professor, Department of Obstetrics and Gynecology, Dalhousie University Faculty of Medicine, Halifax, Nova Scotia. Ms. Myers is research project director, Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts. Ms. Simon is data analyst, Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts.



To determine how closely institutional review board (IRB) discussions reflect the ethical criteria specified in the Common Rule federal regulations.


Between November 2006 and July 2009, the authors observed, audio-recorded, transcribed, and coded protocol reviews from 20 IRB meetings at 10 leading academic medical centers. They also reviewed each of the applications discussed to identify the Common Rule criteria-(1) risk minimization, (2) risk/benefit comparison, (3) equitable subject selection, (4) informed consent, (5) data monitoring to ensure safety, (6) privacy protection and confidentiality, and (7) protection of vulnerable subjects-that were both relevant to the study and not adequately addressed in the application. They then determined if the IRB addressed each of the relevant and not-discussed Common Rule criteria in their discussions.


IRBs made no mention of many of the Common Rule criteria that required their discussion-In 17/82 (21%) reviews, they failed to address risk minimization; in 52/91 (57%), risk/benefit comparison; in 31/52 (60%), equitable subject selection; in 32/59 (54%), data monitoring; in 13/52 (25%), privacy and confidentiality; and in 7/55 (13%), protection of vulnerable populations. However, they discussed informed consent in 102/104 (98%) reviews and raised questions about, or requested changes about, informed consent for 92/104 (88%) protocols.


These findings suggest that essential elements of human subjects protection are not implemented uniformly across IRBs. Although not directly addressing this issue, the current proposed changes to the Common Rule offer an opportunity to improve, in general, the effectiveness of IRBs to protect human subjects.