Archive for the ‘ethics’ Category

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (2014)

April 11, 2014 Comments off

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (2014)
Source: National Research Council

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences examines how to update human subjects protections regulations so that they effectively respond to current research contexts and methods. With a specific focus on social and behavioral sciences, this consensus report aims to address the dramatic alterations in the research landscapes that institutional review boards (IRBs) have come to inhabit during the past 40 years. The report aims to balance respect for the individual persons whose consent to participate makes research possible and respect for the social benefits that productive research communities make possible.

The ethics of human subjects research has captured scientific and regulatory attention for half a century. To keep abreast of the universe of changes that factor into the ethical conduct of research today, the Department of Health and Human Services published an Advance Notice of Proposed Rulemaking (ANPRM) in July 2011. Recognizing that widespread technological and societal transformations have occurred in the contexts for and conduct of human research since the passage of the National Research Act of 1974, the ANPRM revisits the regulations mandated by the Act in a correspondingly comprehensive manner. Its proposals aim to modernize the Common Rule and to improve the efficiency of the work conducted under its auspices. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences identifies issues raised in the ANPRM that are critical and feasible for the federal government to address for the protection of participants and for the advancement of the social and behavioral sciences. For each identified issue, this report provides guidance for IRBs on techniques to address it, with specific examples and best practice models to illustrate how the techniques would be applied to different behavioral and social sciences research procedures.

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HHS OIG — Questionable Billing for Medicare Electrodiagnostic Tests

April 8, 2014 Comments off

Questionable Billing for Medicare Electrodiagnostic Tests
Source: U.S. Department of Health and Human Services, Office of Inspector General

In 2011, Medicare paid approximately $486 million to 21,700 physicians who billed for electrodiagnostic tests for 877,000 beneficiaries. Electrodiagnostic tests are used to evaluate patients who may have nerve damage. Recent investigations have found that electrodiagnostic testing is an area vulnerable to fraud, waste, and abuse. For example, in 2011, following work by the Medicare Fraud Strike Force, a group of physicians was charged with fraudulently billing Medicare $113 million for false claims, including claims for electrodiagnostic tests. CMS issues comparative billing reports to providers for a variety of services, including electrodiagnostic testing. Such reports are intended to proactively educate providers and to help them identify and correct errors in their billing.

We developed seven measures of questionable billing on the basis of past OIG work and input from CMS staff. We analyzed Medicare 2011 electrodiagnostic test claims to identify physicians who had unusually high billing for at least one of these measures. We also determined whether physicians with questionable billing for electrodiagnostic tests received comparative billing reports in 2011 for such tests. Finally, we identified the geographical areas with the highest amounts of questionable billing.

In 2011, 4,901 physicians had questionable billing for Medicare electrodiagnostic tests totaling $139 million. Additionally, we found that approximately 20 percent of these physicians received comparative billing reports in 2011 on the basis of their 2010 billing for electrodiagnostic tests. Finally, physicians in the New York, Los Angeles, and Houston areas had the highest total questionable billing for Medicare electrodiagnostic tests in 2011.

We recommend that CMS (1) increase its monitoring of billing for electrodiagnostic tests, (2) provide additional guidance and education to physicians regarding electrodiagnostic tests, and (3) take appropriate action regarding physicians whom we identified as having inappropriate or questionable billing. CMS partially concurred with two of our recommendations and concurred with the third recommendation.

EPA OIG — Improvements to EPA Policies and Guidance Could Enhance Protection of Human Study Subjects

April 3, 2014 Comments off

Improvements to EPA Policies and Guidance Could Enhance Protection of Human Study Subjects (PDF)
Source: U.S. Environmental Protection Agency, Office of Inspector General

The EPA obtained approval to conduct the five human research studies, including approval from a biomedical Institutional Review Board (IRB) and the EPA Human Studies Research Review Official (H SRRO). However, t he EPA’s policies and guidance do not address when HSRRO approv al is needed for significant study modifications. Developing guidance for when HSRRO must approve significant modifications would ensure their independent review.

The EPA obtained informed consent from the 81 human study subjects before exposing them to pollutants. While the consent forms met the requirements of 40 CFR Part 26, we found that exposure risks were not always consistently represented. Further, the EPA did not in clude information on long-term cancer risks in its diesel exhaust studies’ co nsent forms. An EPA manager considered these long-term risks minimal for short-term study exposures. We believe presenting consistent information about risks further ensures that study subjects can make the most informed choice about participating in a study.

The EPA addressed six adverse events during its studies, reported them to the IRB, and provided clinical follow-up after t he events. While the clinical follow-up appeared to be reasonable, the EPA’s polic ies, guidance and cons ent forms do not establish the EPA’s clinical follow-up re sponsibilities. Acco rding to EPA managers, the agency uses the latest University of North Carolina at Chapel Hill (UNC) IRB’s adverse event definitions and reporting ti meframes to respond to adverse events. However, the agency’s guidance provides different definitions and reporting timeframes and does not state that t he EPA has adopted the UNC-IRB definitions and timeframes. Using EPA’s guidance, the EPA reported two of the six adverse events later than required and did not report two other events to IRB.

Subcommittee exposes Caterpillar offshore profit shifting

April 2, 2014 Comments off

Subcommittee exposes Caterpillar offshore profit shifting
Source: U.S. Senate Permanent Subcommittee on Investigations

Caterpillar Inc., an American manufacturing icon, used a wholly owned Swiss affiliate to shift $8 billion in profits from the United States to Switzerland to take advantage of a special 4 to 6 percent corporate tax rate it negotiated with the Swiss government and defer or avoid paying $2.4 billion in U.S. taxes to date, a new report from Sen. Carl Levin, the chairman of the U.S. Senate Permanent Subcommittee on Investigations shows.

“Caterpillar is an American success story that produces phenomenal industrial machines, but it is also a member of the corporate profit-shifting club that has shifted billions of dollars in profits offshore to avoid paying U.S. taxes,” Levin said. “Caterpillar paid over $55 million for a Swiss tax strategy that has so far enabled it to avoid paying $2.4 billion in U.S. taxes. That tax strategy depends on the company making the case that its parts business is run out of Switzerland instead of the U.S. so it can justify sending 85 percent or more of the parts profits to Geneva. Well, I’m not buying that story.”

Congressional Officials Grant Access Due To Campaign Contributions: A Randomized Field Experiment

March 28, 2014 Comments off

Congressional Officials Grant Access Due To Campaign Contributions: A Randomized Field Experiment (PDF)
Source: University of California-Berkeley

Concern that lawmakers grant preferential treatment to individuals because they have contributed to political campaigns has long occupied jurists, scholars, and the public. However, the effects of campaign contributions on legislators’ behavior have proven notoriously difficult to assess. We report the first randomized field experiment on the topic. In the experiment, a political organization attempted to schedule meetings between 191 Members of Congress and their constituents who had contributed to political campaigns. However, the organization randomly assigned whether it informed legislators’ offices that individuals who would attend the meetings were contributors. Congressional offices made considerably more senior officials available for meetings when offices were informed the attendees were donors, with senior officials attending such meetings more than three times as often (p < 0.01). Influential policymakers thus appear to make themselves much more accessible to individuals because they have contributed to campaigns, even in the absence of quid pro quo arrangements. These findings have significant implications for ongoing legal and legislative debates. The hypothesis that individuals can command greater attention from influential policymakers by contributing to campaigns has been among the most contested explanations for how financial resources translate into political power. The simple but revealing experiment presented here elevates this hypothesis from extensively contested to scientifically supported.

Clergy as Mandatory Reporters of Child Abuse and Neglect

March 20, 2014 Comments off

Clergy as Mandatory Reporters of Child Abuse and Neglect
Source: Child Welfare Information Gateway

This factsheet discusses laws that require members of the clergy to report cases of suspected child abuse and neglect. The issue of whether a member of the clergy can claim privileged communications as a reason for not reporting also is discussed. Full-text excerpts of laws for all States and U.S. territories are included.

New From the GAO

March 19, 2014 Comments off

New GAO Report
Source: Government Accountability Office

Whistleblower Protection Program: Opportunities Exist for OSHA and DOT to Strengthen Collaborative Mechanisms. GAO-14-286, March 19.
Highlights -

Physicians as Fundraisers: Medical Philanthropy and the Doctor-Patient Relationship

March 17, 2014 Comments off

Physicians as Fundraisers: Medical Philanthropy and the Doctor-Patient Relationship
Source: PLoS Medicine


+ American medical institutions commonly have “grateful patient” programs that solicit donations from wealthy individuals who receive care. Physicians are often encouraged to assist in these programs.

+ Development efforts have intensified in recent years, and the increasing reliance on physician fundraisers risks blurring the lines between clinical care and fundraising. New changes to the US Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule continue that trend by allowing development officials to access certain types of clinical information without patient consent.

+ The practice of physicians fundraising from their own patients raises three main concerns: (1) undue pressure on patients to contribute, (2) possible expectations of preferential treatment from donors, and (3) concerns about patient confidentiality and trust.

+ We propose that institutions voluntarily adopt development policies that mitigate these risks. Specifically, we recommend that patient consent be secured before development staff access patient information or physicians refer patients to the development office. We also recommend that physicians not directly solicit donations from their own patients.

The concerns discussed here in the context of American grateful patient programs are relevant to similar patient fundraising efforts in other nations.

Hundreds of Justice Department Attorneys Violated Professional Rules, Laws, or Ethical Standards

March 16, 2014 Comments off

Hundreds of Justice Department Attorneys Violated Professional Rules, Laws, or Ethical Standards
Source: Project on Government Oversight

An internal affairs office at the Justice Department has found that, over the last decade, hundreds of federal prosecutors and other Justice employees violated rules, laws, or ethical standards governing their work.

The violations include instances in which attorneys who have a duty to uphold justice have, according to the internal affairs office, misled courts, withheld evidence that could have helped defendants, abused prosecutorial and investigative power, and violated constitutional rights.

From fiscal year 2002 through fiscal year 2013, the Justice Department’s Office of Professional Responsibility (OPR) documented more than 650 infractions, according to a Project On Government Oversight review of data obtained through the Freedom of Information Act and from OPR reports.

In the majority of the matters—more than 400—OPR categorized the violations as being at the more severe end of the scale: recklessness or intentional misconduct, as distinct from error or poor judgment.

The information the Justice Department has disclosed is only part of the story. No less significant is what as a matter of policy it keeps from the public.

Handling ethical problems in counterterrorism: An inventory of methods to support ethical decisionmaking

February 21, 2014 Comments off

Handling ethical problems in counterterrorism: An inventory of methods to support ethical decisionmaking
Source: RAND Corporation

This document presents the findings of a study into methods that may help counterterrorism professionals make decisions about ethical problems. The study was commissioned by the Research and Documentation Centre (Wetenschappelijk Onderzoek- en Documentatiecentrum, WODC) of the Dutch Ministry of Security and Justice (Ministerie van Veiligheid en Justitie), on behalf of the National Coordinator for Counterterrorism and Security (Nationaal Coördinator Terrorismebestrijding en Veiligheid, NCTV). The study provides an inventory of methods to support ethical decision-making in counterterrorism, drawing on the experience of other public sectors — healthcare, social work, policing and intelligence — and multiple countries, primarily the Netherlands and United Kingdom.

The report introduces the field of applied ethics; identifies key characteristics of ethical decision-making in counterterrorism; and describes methods that may help counterterrorism professionals make decisions in these situations. Finally, it explores how methods used in other sectors may be applied to ethical decision-making in counterterrorism. It also describes the level of effectiveness that can be expected from the various methods. The report is based on a structured literature search and interviews with professionals and academics with expertise in applied ethics.

This report will be of interest to counterterrorism professionals who are responsible for strengthening ethical decision-making in their organisation. It may also provide insights for counterterrorism professionals who seek new methods to help them make ethical decisions. The findings may additionally be relevant for professionals in other sectors, if complemented with a review of decision-making characteristics in their sector of specialism.

CRS — Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

February 19, 2014 Comments off

Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients (PDF)
Source: Congressional Research Service (via MSPB Watch)

Food fraud, or the act of defrauding buyers of food or ingredients for economic gain—whether they be consumers or food manufacturers, retailers, and importers—has vexed the food industry throughout history. Some of the earliest reported cases of food fraud, dating back thousands of years, involved olive oil, tea, wine, and spices. These products continue to be associated with fraud, along with some other foods. Although the vast majority of fraud incidents do not pose a public health risk, some cases have resulted in actual or potential public health risks. Perhaps the most high-profile case has involved the addition of melamine to high-protein feed and milk-based products to artificially inflate protein values in products that may have been diluted. In 2007, pet food adulterated with melamine reportedly killed a large number of dogs and cats in the United States, followed by reports that melamine-contaminated baby formula had sickened thousands of Chinese children. Fraud was also a motive behind Peanut Corporation of America’s actions in connection with the Salmonella outbreak in 2009, which killed 9 people and sickened 700. Reports also indicate that fish and seafood fraud is widespread, consisting mostly of a lowervalued species, which may be associated with some types of food poisoning or allergens, mislabeled as a higher-value species. Other types of foods associated with fraud include honey, meat and grain-based foods, fruit juices, organic foods, coffee, and some highly processed foods.

Views of internists towards uses of preimplantation genetic diagnosis

February 5, 2014 Comments off

Views of internists towards uses of PGD
Source: Reproductive BioMedicine Online

Preimplantation genetic diagnosis (PGD) is increasingly available, but how physicians view it is unclear. Internists are gatekeepers and sources of information, often treating disorders for which PGD is possible. This quantitative study surveyed 220 US internists, who were found to be divided. Many would recommend PGD for cystic fibrosis (CF; 33.7%), breast cancer (BRCA; 23.4%), familial adenomatous polyposis (FAP; 20.6%) and familial hypertrophic cardiomyopathy (19.9%), but few for social sex selection (5.2%); however, in each case, >50% were unsure. Of those surveyed, 4.9% have suggested PGD to patients. Only 7.1% felt qualified to answer patient questions about it. Internists who would refer for PGD had completed medical training less recently and, for CF, were more likely to have privately insured patients (P < 0.033) and patients who reported genetic discrimination (P < 0.013). Physicians more likely to refer for BRCA and FAP were less likely to have patients ask about genetic testing. This study suggests that internists often feel they have insufficient knowledge about it and may refer for it based on limited understanding. They view possible uses of PGD differently, partly reflecting varying ages of onset and disease treatability. These data have critical implications for training, research and practice.

Leaked Records Reveal Offshore Holdings of China’s Elite

January 22, 2014 Comments off

Leaked Records Reveal Offshore Holdings of China’s Elite
Source: Center for Public Integrity (International Consortium of Investigative Journalists)

Close relatives of China’s top leaders have held secretive offshore companies in tax havens that helped shroud the Communist elite’s wealth, a leaked cache of documents reveals.

The confidential files include details of a real estate company co-owned by current President Xi Jinping’s brother-in-law and British Virgin Islands companies set up by former Premier Wen Jiabao’s son and also by his son-in-law.

Nearly 22,000 offshore clients with addresses in mainland China and Hong Kong appear in the files obtained by the International Consortium of Investigative Journalists. Among them are some of China’s most powerful men and women — including at least 15 of China’s richest, members of the National People’s Congress and executives from state-owned companies entangled in corruption scandals.

PricewaterhouseCoopers, UBS and other Western banks and accounting firms play a key role as middlemen in helping Chinese clients set up trusts and companies in the British Virgin Islands, Samoa and other offshore centers usually associated with hidden wealth, the records show. For instance, Swiss financial giant Credit Suisse helped Wen Jiabao’s son create his BVI company while his father was leading the country.

By the numbers: a 2013 money-in-politics index

December 28, 2013 Comments off

By the numbers: a 2013 money-in-politics index
Source: Center for Public Integrity

Number of bills passed by Congress this year that have been signed into law: 58

Number of bills passed in 1948, the year President Harry Truman* assailed the “Do-Nothing Congress”: 511

Number of minutes Sen. Ted Cruz, R-Texas, spent reading Dr. Seuss’s “Green Eggs and Ham” during a 21-hour talk-a-thon in September: 5 ½

Number of hours per day the Democratic Congressional Campaign Committee recommends embattled freshmen spend fundraising: 4

Amount of campaign cash all members of Congress have reported raising so far in 2013: $403,952,012

Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute

December 26, 2013 Comments off

Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute (PDF)
Source: U.S. Department of Health and Human Services, Office of Inspector General

In this final rule, the Office of Inspector General (OIG) amends the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). Amendments include updating the provision under which electronic health records software is deemed interoperable; removing the electronic prescribing capability requirement; extending the sunset provision until December 31, 2021; limiting the scope of protected donors to exclude laboratory companies; and clarifying the condition that prohibits a donor from taking any action to limit or restrict the use, compatibility, or interoperability of the donated items or services.

Adequacy of U.S. Secret Service Efforts to Identify, Mitigate, and Address Instances of Misconduct and Inappropriate Behavior (Redacted)

December 23, 2013 Comments off

Adequacy of USSS Efforts to Identify, Mitigate, and Address Instances of Misconduct and Inappropriate Behavior (Redacted) (PDF)
Source: U.S. Department of Homeland Security, Office of Inspector General

Although individual employees have engaged in misconduct or inappropriate behavior, we did not find evidence that misconduct is widespread in USSS. Furthermore, we did not find any evidence that USSS leadership has fostered an environment that tolerates inappropriate behavior. Of the 2,575 employees who responded to our electronic survey, 2,144 (83 percent) indicated they were not aware of USSS employees engaging in any of six behaviors that were displayed in Cartagena. Additionally, 61 percent of survey respondents believed management does not tolerate misconduct.

Political advertisers and TV stations ignore disclosure rules

December 20, 2013 Comments off

Political advertisers and TV stations ignore disclosure rules
Source: Sunlight Foundation

In a 2003 Supreme Court opinion on the biggest campaign reforms in a generation, Justice Stephen Breyer reflected on a little-known provision that required outside groups to disclose additional details about their political ad spending at local TV stations. “Recordkeeping can help both the regulatory agencies and the public evaluate broadcasting fairness,” Breyer wrote, “and determine the amount of money that individuals or groups, supporters or opponents, intend to spend to help elect a particular candidate.”

But a decade after the Supreme Court ruling, an extensive review of these documents by the Sunlight Foundation reveals that TV stations often fail to report even the most basic information about the political ads that outside groups buy on their airwaves. As a result, the records that Breyer said would facilitate public watchdogging are spotty or don’t exist. There’s no way to total reliably how much is being spent for or against a candidate, or, in some cases, who is doing the spending. A systematic review of 200 randomly-selected ad buys made by outside groups found that fewer than 1 in 6 ads targeting federal candidates disclosed the name of the candidate or election mentioned.

Such omissions deprive the voting public of important information. TV ad files have become an increasingly important tool for tracking otherwise undisclosed political spending by groups that run the gamut from well-known trade associations and unions to lesser-known operations whose anodyne names offer little information about the financial or political interests behind them: “Americans for Job Security,” for instance, or “Checks and Balances for Economic Growth.” In the wake of court decisions making it easier to route big money through outside groups, broadcast political TV ads jumped to an estimated $5.6 billion in 2012 — up 30% from 2008. Yet in spite of this massive payday, stations still find it hard to fill out paperwork about their benefactors.

More Settlements Reached in Foreign Bribery Cases, but Only 3% of Penalties Goes Back to Affected Countries

December 3, 2013 Comments off

More Settlements Reached in Foreign Bribery Cases, but Only 3% of Penalties Goes Back to Affected Countries
Source: World Bank and United Nations Office on Drugs and Crime

A new report by the Stolen Asset Recovery Initiative (StAR) highlights the increase in enforcement actions to counter foreign bribery and the growing prevalence of settlements – that is, any resolution short of a full-scale trial – to conclude such cases and impose monetary sanctions.

The study, “Left out of the Bargain,” looks into the scope and value of settlements in 395 foreign bribery cases that took place between 1999 and mid-2012. StAR’s research examined cases in which the country where the legal settlements took place was different from the country where the bribery occurred.

The study illustrates how little money has been returned or ordered returned to the countries whose officials were alleged to have been bribed. According to the report, only 3 percent (US $197 million out of US $5.8 billion) was returned to those countries.

Robust action to counter foreign bribery is a key factor in the global fight against corruption. The return of stolen assets to their legitimate owners and the compensation to affected parties are vital components of that effort.

Please Deposit All of Your Money: Kickbacks, Rates, and Hidden Fees in the Jail Phone Industry

November 27, 2013 Comments off

Please Deposit All of Your Money: Kickbacks, Rates, and Hidden Fees in the Jail Phone Industry (PDF)
Source: Prison Policy Initiative

At a time when the cost of a phone call is approaching zero, one population is forced to pay astronomical sums to stay in touch: the families of incarcerated people. For a child to speak with her incarcerated parent, a family member or friend is forced to pay almost $1 per minute, plus a long list of other fees that easily double the total cost of the call. Faced with phone bills that can total hundreds of dollars, many families have to choose between paying for calls and paying for basic living expenses.

This report finds that fees have an enormous impact on prison phone bills, making up 38% of the $1 billion annual price of calling home. This report details the fees that prison phone companies charge for “services” such as:
• accepting customers’ money (deposit fees of up to $10/deposit)
• holding on to customers’ money (monthly account fees as high as $12)
• closing customers’ accounts (refund fees of up to $10)

See also: Return to Sender: Postcard-only Mail Policies in Jail (PDF)

Business, Corruption and Crime in Bosnia and Herzegovina: The impact of bribery and other crime on private enterprise

November 26, 2013 Comments off

Business, Corruption and Crime in Bosnia and Herzegovina: The impact of bribery and other crime on private enterprise (PDF)
Source: United Nations Office on Drugs and Crime

This survey of private businesses in Bosnia and Herzegovina reveals that corruption and other forms of crime are a great hindrance to private enterprise and have a negative effect on private investment. A significant percentage of businesses pay bribes to public officials repeatedly over the course of the year. Businesses in the Building and Construction sector are those most affected by bribery, followed by businesses in the Transportation and Storage sector. The public officials with the highest risk of bribery in interactions with businesses are health authorities, police officers, customs officers and judges/prosecutors.


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