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Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. There are too many cost variables to account for.This post covers the key cost drivers for medical device clinical trials. If you are a researcher or financial analyst working in clinical trial space or simply curious about clinical trial costs, this post will serve you well.So let’s get started.1. PATIENT GRANTPatient grant costs are broken down into screening, baseline and follow-up visits and medical imaging costs.A. SCREEN FAILURESClinical trial protocols have inclusion and exclusion criteria to qualify patients. Strict inclusions and exclusion criteria reduce the available patient pool for trial enrollment. Clinical sites spend physician and site coordinator time to screen for potential patients.During the budgeting process, map out the complete patient screening workflow. Speak with a few clinical sites to understand how many patients they would have to see in order to find one qualified patient. For example, a site may need to screen four patients to find one qualified patient. Understand how many hours the site is spending on screening activities and reimburse accordingly. It is not unusual to reimburse sites anywhere between $50 to $250+ per screen failure.B. BASELINE/INDEX PROCEDURE AND FOLLOW-UP VISITSDepending on the clinical trial design, data is collected at baseline/index procedures and follow-up visits. The site coordinator is generally responsible for entering the data in the case report form. Sites are reimbursed for the time spent to collect clinical trial data.Based on number and type data fields you are collecting, you’ll want to estimate the site coordinator time needed to collect and input trial data. Multiply the estimated coordinator time by the hourly bill rate to obtain the fair market value for each patient visit.In some cases, sponsors may choose to reimburse patients. Reimbursement for patients can include paying for their participation, reimbursement for travel, meals or overnight hotel stays.C. NON-STANDARD OF CARE TESTSMedical device trials may require non-standard of care tests such as medical imaging scans. These costs are generally not reimbursed by insurance companies or medical care agencies and should be budgeted as part of the clinical trial cost.D. PROCEDURE COSTSIf the clinical trial procedure is reimbursed, you don’t need to budget for the procedure cost. Insurance or medical care agencies will pay for the procedure. In case a brand new procedure where no reimbursement available, budget for the procedure costs.2. SITE COSTSA. START-UP FEESClinical sites spend significant time to initiate a new clinical trial. Sites are responsible for site specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. It is typical for sponsor to pay anywhere between $2000 – $5000+ in site start-up fees.B. EC/IRB FEESEC/IRB fees are in addition to site start-up fees. These fees cover the time spent to by EC/IRBs to plan and conduct review of the clinical trial protocol and other associated materials. Many EC/IRBs update and publish their rates annually.C. CLOSE-OUT FEESClose-out fees include time spent by site staff to reconcile clinical trial data, finances and regulatory documents during study closure. Not all sites require this payment but has started to become a more common practice in recent years.D. STORAGE FEESGovernment regulations require that clinical trial data be stored after study close-out. The duration for storage can range from 2-years to permanent storage. It is not uncommon for sites to have boxes of regulatory paperwork that needs to be stored once a clinical trial ends. The storage fees vary by country and site.Some sponsors make arrangements for site to send trial documents to an offsite storage location. Due to country specific regulations, a site might be unable to move documents outside their country.E. ADMINISTRATIVE OVERHEADClinical sites may require as much as 30% administrative overhead in addition to per patient grant amount. This cost covers management and legal resources needed to provide clinical research oversight and legal review of clinical contracts respectively.F. SITE MANAGEMENT ORGANIZATION (SMO)In certain countries such as Japan, data entry and collection tasks are outsourced to SMOs. For post approval studies, sites do not research coordinator support. Sponsors are expected to hire SMOs to support the site or pay the sites to hire their preferred SMOs.3. NON-PATIENT COSTSA. CLINICAL EVALUATION COMMITTEE (CEC)Adverse event and endpoint data is adjudicated by a non-biased, independent CEC. CEC is generally composed 3 or more physicians. CEC members review adverse events and trial endpoints in a team setting or independently.A sponsor can hire physicians to serve as the CEC and reimburse them at fair market value rates. It is more cost effective for sponsor to contract with physicians directly. However the sponsor has to assign its own resources to manage the CEC.The other option is for the sponsor to outsource management and conduct of CEC activities. This option is more expensive because you are hiring professionals to manage the CEC.CEC is a very important component of medical device clinical trial. Adjudicated adverse event data is highly regarded by regulatory agencies and the physician community. In many cases, it is a requirement to have adjudicated adverse event data in order to get the product on market.B. DATA SAFETY MONITORING BOARD (DSMB)DSMB is also known as the Data Monitoring Committee (DMC). According to IMARC research, the purpose of the DMC is to advise the sponsor on continuing safety of the trial subjects and those yet to be recruited and provide continuing validity and scientific merit of the study.For budgeting purposes, it is important to know that DSMB is required during trial enrollment phase and in some cases till all patients have reached their primary endpoint. The decision of whether or not to conduct DSMB meetings after the primary endpoint is reached, is up to the sponsor.C. PHYSICIAN CONSULTINGPhysicians are consulted during all phases of a clinical trial. Physician guidance is needed to develop clinical trial strategy, enrollment plan, final data analysis and publication plans.Depending on the physician’s medical expertise and geographical location, consulting costs can be anywhere between $150 – $600+ per hour. If a clinical trial is interesting to the physician, he or she may be willing to provide consulting services at no cost.D. INDEPENDENT CORELAB ANALYSISMany medical device trials collect imaging data such as angiograms, CT scans and X-Rays. Since this data comes from multiple sites, variability is expected. An independent corelab standardizes the collection and analysis of imaging data.Corelab costs can add up quickly. Costs depend upon the number of images analyzed per patient, the time it takes for the corelab to analyze the data, and the duration of the trial.Corelabs usually hire analysts to collect and calibrate data from different sites. The final analysis is usually done by a physician. Given the complexity of imaging data collection and analysis combined with the importance of corelab data to regulatory agencies, it is important that adequate and accurate budget is allocated for independent corelab analysis.E. MEDICAL DEVICE COSTOnce you are ready to enroll patients in the clinical trial, you’ll need to ship medical devices to the sites. Most sites will expect to receive these devices for free. The only exception is when conducting post approval trials for commercially available devices.Medical device manufacturers conduct trials for indication expansion. For example, a stent company may conduct a trial to get their heart stent approved for use in a different anatomy. For such expansion trials, sponsors may need to provide commercially available devices to sites at no cost.Whether or not you want to provide devices at no cost is a business decision. When investigational medical devices are provided at no cost, sites enroll faster and have a much stronger, collaborative relationship with the sponsor.4. LABOR COSTSIn order to conduct a clinical trial, you need to hire people that have expertise in clinical research and clinical trial management. Depending on the size of the trial and the number of trials conducted, resource allocations vary. Therefore amount of labor needed to run a study also varies.A. CLINICAL RESEARCH ASSISTANTS OR ASSOCIATES (CRAS)CRAs are primarily responsible for monitoring clinical trial data that is collected during the course of the study. They visit clinical research sites to ensure data is collected in a compliant manner.B. PROJECT MANAGER (ALSO KNOWN AS CLINICAL TRIAL MANAGER OR STUDY MANAGER)A project manager’s responsibilities can vary from one organization to another. Project managers are like “general contractors.” A project manager is responsible for managing the clinical trial budget, resources and timelines. The core function of a project manager is to resolve or escalate issues that come up during the course of a clinical study.C. DATA MANAGERA data manager’s job is to address data discrepancy issues by generating queries to sites. Data managers may also be responsible for implementing electronic data capture system or paper case report forms needed to collect trial data.D. SCIENTISTThe scientist is primarily responsible for developing the clinical strategy for a trial. Individuals with Ph.D. or M.D. degrees are usually the right fit for this role. In some organizations, the project manager also play the role of the scientist.E. BIOSTATISTICIANA biostatistician is responsible for developing a statistical analysis plan (SAP). The SAP documents on the data will be analyzed during the course of the study. A statistician or statistical programmer is also responsible for programming data tables that are incorporated in the final clinical study reports.F. QUALITYClinical research is a regulated industry. Quality plays an important role in ensuring sponsors, CROs, and clinical sites are conducting the trial in a compliant manner. A quality associate or manager helps an organization create and implement standard operating procedures (SOPs).Salaries for these roles can vary by geography and experience. The above list is not comprehensive. However it should give you an idea of the core resources needed to conduct a medical device clinical trial.5. SITE MANAGEMENTA. PRE-STUDY VISITSPrior to inviting any site to participate in a clinical trial, you want to conduct pre-study visit, also know as the site assessment visit. This visit becomes even more important if you don’t have any prior experience working with the site in a clinical or commercial setting.Although sites don’t charge for this visit, the sponsor will need to pay for travel and CRA labor costs.B. SITE INITIATION VISITS (SIV)Once the site has received Institutional Review Board (IRB) approval and the trial contract has been signed, it’s time to activate the site for patient enrollment.A SIV is conducted once you are ready to activate the site. SIV involves training the site on the clinical protocol and any other study-specific requirements.Similar to the a pre-study visit, the sponsor will need to pay for travel and CRA labor costs.C. MONITORINGOnce patients are enrolled in the study, you want to ensure data is collected in a compliance with regulations and the clinical study protocol. This is when monitoring comes into play.A CRA, sometimes known as the site monitor, visits clinical sites at regular intervals to ensure compliance.In recent years, due to push for reduction in clinical trial costs, several sponsors have started to monitor remotely rather than conducting an in-person monitoring trip.D. CLOSE-OUTOnce all patients at a site have completed their follow-up visits, it’s time to conduct a close-out visit. Any open items related to study conduct are addressed during the close-out visit.Although it’s always nice to have in-person close-out visits, it’s acceptable to close trials via remote close-out calls.6. MISCELLANEOUSA. INVESTIGATOR MEETINGSInvestigator Meetings usually serve to kick-off a new clinical trial. Investigators and research coordinators participating in the study are invited to participate in a 1-2 day meeting. The purpose of these meetings is to educate site personnel on the clinical trial protocol and any other specific trial requirements.These meetings can be quite expensive as airfare, hotel and meals are usually provided by the sponsor.B. TRAVELPlan and budget for adhoc travel. Since clinical trials are heavily regulated, you may need to visit a site to address a compliance issue or help them prepare for an audit. In other cases, you may want to visit a site to motivate them to enroll patients. Whatever the case may be, it’s always good to have some money set aside for travel.C. DOCUMENT TRANSLATIONSDocument translations costs can increase significantly depending on the countries in which the clinical trial is conducted. Sites where English is not the primary language, you may receive request for translation of key documents such as the protocol and site specific informed consent in the local language.Also if the adverse event source documents from non-English speaking sites are in their native language, additional costs will incur to translate documents into English for event adjudication purposes.D. TECHNOLOGY SOLUTIONSClinical Trial Management System (CTMS), Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), Interactive Voice/Web Response System are a few common technology solutions implemented when conducting a clinical study. These systems are needed to manage site contact information, collect clinical data and maintain clinical trial records. There is a monthly or annual license fee associated with these systems. Additionally staff is needed to manage and maintain these systems.E. REGULATORY FILING FEESRegulatory filing fees should not be overlooked as these can run into thousands of dollars. Depending on the class of medical device, different applications need to be filed with regulatory agencies, competent authorities and notified bodies.7. OTHER FACTORS:A. PROTOCOL AMENDMENTSDue to unforeseen circumstances, a clinical protocol amendment may be necessary. A protocol amendment has many downstream effects that can increase the cost of a clinical trial.A protocol amendment usually leads to additional IRB/EC fees, site costs, regulatory re-submissions and more.B. INFLATION, VALUE ADDED TAX (VAT) AND FOREIGN EXCHANGEInflation should be factored in for multi-year clinical trials. In the US, a minimum 3% inflation is expected.Sites in countries such as Australia and Europe, add VAT for the research services. VAT can be upwards of 12% on all research services.For trials conducted in multiple countries, paying attention to foreign exchange rates. At a minimum, annual review of exchange rates is advised. Clinical trial cost projections should be adjusted based on exchange rates.C. TRIAL ENROLLMENT DELAYSEnrolling in trials is tricky business. It takes longer to complete enrollment and initial projections are overly optimistic. Account for these delays when you develop your clinical trial budget.[1]To summarize, you should now have a solid understanding of these factors that impact clinical trial costs:Patient grant amount such as screen failure costs, data entry costs and travel reimbursementSite costs such as site start-up fees, EC/IRB fees, close-out and storage feesNon-patient costs such as core labatory fees, clinical events committee and data safety monitoring boardLabor costs – clinical research employee salaries or contractor paymentsSite management costs such as pre-study, site initiation, monitoring and close-out visitsMiscellaneous costs such as travel, technology solutions and regulatory filing costsOther factors such as value added tax, inflation, protocol amendment and delays in enrollmentFootnotes[1] Ultimate Guide to Clinical Trial Costs - Clinical Trial Podcast

They have been hiding shit for hundreds of years. Lol Get a clue lolChurch Committee on US INTELLIGENCE AGENCIES SPYING ON AMERICANS lolSenate Select Committee to Study Governmental Operations with Respect to Intelligence ActivitiesVIEW ARCHIVED FLOOR PROCEEDINGSSenate Select Committee to Study Governmental Operations with Respect to Intelligence Activities(The Church Committee)Resolution passed: Jan 27, 1975Final report issued: Apr 29, 1976Chairman: Senator Frank Church (D-ID)Vice Chairman: Senator John Tower (R-TX)Committee members:Senator Howard Baker (R-TN)Senator Barry Goldwater (R-AZ)Senator Gary Hart (D-CO)Senator Philip Hart (D-MI)Senator Walter Huddleston (D-KY)Senator Charles Mathias (R-MD)Senator Walter Mondale (D-MN)Senator Robert Morgan (D-NC)Senator Richard Schweiker (R-PA)Chapter 1: OriginsChapter 2: ProcessChapter 3: Public RelationsChapter 4: InvestigationChapter 5: OutcomeOriginsIn 1973 the Senate Watergate Committee investigation revealed that the executive branch had directed national intelligence agencies to carry out constitutionally questionable domestic security operations. In 1974 Pulitzer Prize–winning journalist Seymour Hersh published a front-page New York Times article claiming that the CIA had been spying on anti-war activists for more than a decade, violating the agency’s charter. Former CIA officials and some lawmakers, including Senators William Proxmire and Stuart Symington, called for a congressional inquiry.ProcessOn January 21, 1975, Senator John Pastore introduced a resolution to establish a select committee to investigate federal intelligence operations and determine “the extent, if any, to which illegal, improper, or unethical activities were engaged in by any agency of the Federal Government.” The Senate approved the resolution, 82-4.Majority Leader Mike Mansfield cautioned the Senate "against letting the affair become a ‘television extravaganza.’” He and Republican Leader Hugh Scott carefully selected committee members, balancing experienced lawmakers with junior members and ensuring that members represented a variety of political viewpoints. When Philip Hart declined to lead the committee for health-related reasons, Mansfield selected Democrat Frank Church of Idaho to serve as chairman. A 16-year member of the Committee on Foreign Relations, Church had co-chaired a special committee to critically examine the executive branch’s consolidation of power in the Cold War era. Church recognized the strategic value of the nation’s top intelligence agencies and was also mindful of the need for American institutions to function within the confines of U.S. constitutional law. He had aggressively lobbied to lead the investigation. Republican John Tower of Texas, a member of the Armed Services Committee, was selected as the committee’s vice-chairman.Public RelationsThe committee decided that most of its hearings would be held in closed, executive session, in order to protect intelligence sources and methods. The committee held a series of public hearings in September and October of 1975 to educate the American public about the “unlawful or improper conduct” of the intelligence community, highlighting a few carefully selected cases of misconduct. These hearings examined a CIA biological agents program, a White House domestic surveillance program, IRS intelligence activities, and the FBI’s program to disrupt the civil rights and anti-Vietnam War movements. These nationally televised events offered the American public an opportunity to learn about the secret operations conducted for decades by U.S. intelligence agencies.Though the committee’s work garnered much national attention, it was not without its critics, some of whom dismissed the inquiry as a vehicle for Senator Church’s 1976 presidential bid. (Church declared his candidacy in March 1976.) Others argued that congressional inquiries (the House conducted its own separate investigation) undermined the security and credibility of U.S. intelligence agencies. The assassination of Richard Welch, CIA station chief in Greece, outside his home in Athens on Christmas Day, 1975, diverted the public’s attention from the committee’s focus on intelligence abuses. Church remained resolute in his belief of “the right of the public to know what the instrumentalities of their Government have done.”InvestigationThe committee faced a formidable task: to conduct a wide-ranging investigation of the nation’s most secret agencies and programs, and based on those findings, write a detailed report including legislative recommendations. All of this work was to be completed within one year (later extended to 16 months). After a meeting with President Gerald Ford and his top national security advisors, Church and Vice-Chairman Tower secured from the president a pledge that the White House would cooperate with Senate investigators. Staff identified potential programs for study and began requesting documents from intelligence agencies. Though staff did not always receive documents in a timely fashion, they enjoyed unprecedented access to materials that had never before been made public. Perhaps the most well-known of these internal reports, the CIA’s so-called “Family Jewels,” outlined the agency’s misdeeds dating back to President Dwight Eisenhower’s administration. This report, as well as those found in other agencies, provided road maps that staff investigators used to piece together complicated histories of domestic, foreign, and military intelligence programs during the Cold War era. Even with a peak staff of 150, however, organizing and analyzing these materials proved to be an arduous task.Despite these numerous challenges, the Church Committee investigated and identified a wide range of intelligence abuses by federal agencies, including the CIA, FBI, Internal Revenue Service, and National Security Agency. In the course of their work, investigators identified programs that had never before been known to the American public, including NSA’s Projects SHAMROCK and MINARET, programs which monitored wire communications to and from the United States and shared some of that data with other intelligence agencies. Committee staff researched the FBI’s long-running program of “covert action designed to disrupt and discredit the activities of groups and individuals deemed a threat to the social order,” known as COINTELPRO. The FBI included among the program’s many targets organizations such as the Southern Christian Leadership Conference, the anti-Vietnam War movement, and individuals such as Martin Luther King, Jr., as well as local, state, and federal elected officials.OutcomeAfter holding 126 full committee meetings, 40 subcommittee hearings, interviewing some 800 witnesses in public and closed sessions, and combing through 110,000 documents, the committee published its final report on April 29, 1976. Investigators determined that, beginning with President Franklin Roosevelt’s administration and continuing through the early 1970s, “intelligence excesses, at home and abroad,” were not the “product of any single party, administration, or man,” but had developed as America rose to a become a superpower during a global Cold War.“Intelligence agencies have undermined the constitutional rights of citizens,” the final report concluded, “primarily because checks and balances designed by the framers of the Constitution to assure accountability have not been applied.” In a separate appended view, Senator Tower acknowledged “intelligence excesses” and the “need for expanded legislative, executive, and judicial involvement in intelligence policy and practices.” He cautioned, however, that Congress should not “unnecessarily” restrain the president from exercising discretion in the realm of national security.The final report included 96 recommendations, legislative and regulatory, designed “to place intelligence activities within the constitutional scheme for controlling government power.” The committee observed that “there is no inherent constitutional authority for the President or any intelligence agency to violate the law,” and recommended strengthening oversight of intelligence activities. The Church Committee’s thoughtful and careful investigative work, which earned it the respect of many members of the Senate, ultimately led to reform efforts throughout the intelligence community.Congress approved legislation to provide for greater checks and balances of the intelligence community. In 1976 the Senate approved Senate Resolution 400, establishing the Senate Select Committee on Intelligence, to provide “vigilant legislative oversight over the intelligence activities of the United States to assure that such activities are in conformity with the Constitution and laws of the United States.” In 1978 Congress approved and President Jimmy Carter signed into law the Foreign Intelligence Surveillance Act (FISA), requiring the executive branch to request warrants for wiretapping and surveillance purposes from a newly formed FISA Court.Some agencies pursued internal reform, in part because the Church Committee’s inquiry revealed the extent to which agencies had encouraged, or permitted abuses, by individuals. One example includes new guidelines established by Attorney General Edward Levi. The executive branch issued Executive Order 12036 in 1978, which provided new guidelines related to intelligence activities (revoked in 1981).Today, the Church Committee reports and hearings are frequently used by scholars who continue to examine U.S. intelligence activities during the Cold War era.Print Version with FootnotesFurther ReadingSenate Historical OfficeInformation provided by the Senate Historical Office.Questions about Senate History?Email a Senate historian.The Church CommitteeMembers of the CommitteeContact | Content Responsibility | Usage Policy | PDF Help | Privacy Policy | www.senate.gov

Here is a fairly long list of reasons that came across my Facebook feed a few days ago, posted by Andrew Aulenback (who I don't know). The original post is here and appears to be public. I have reformatted slightly.I have been asked recently by some of my Conservative-Party-Loyal friends why I would ever support someone other than Stephen Harper as Prime Minister. "What has he done that every other politician hasn't?" I am asked. Well, in the interest of keeping my promise, here is a short list. I apologize for the obviously partisan [well, not party-loyal to any party, but the focused on what Stephen Harper has done to dissuade me from his consideration] nature of the post:Stephen Harper Found in Contempt of ParliamentFor refusing to disclose information on the costing of programs to Parliament, which Parliament was entitled to receive, the Harper government became the first in Canadian history to be found in contempt of Parliament. This alone is a big deal. Even the Speaker of the House found it indefensible.Against Court Order, Refusal to Share Budget InfoEven though it lost a court case and was ordered to comply, the Harper government nevertheless still refused to share 170 times reasons and impacts for cuts with Canada's independent budget watchdog, mocking Parliament's right to control the public purse.Conservative Cabinet Staffers Granted Immunity from TestimonyA PMO edict absolved, or claimed to absolve, political staffers from ever having to testify before parliamentary committees.Conservatives Falsify Reports and DocumentsAmong documents deliberately altered in the writing or the quoting by the government: CIDA document by Bev Oda's office on Kairos; the Senate Committee Report on the Duffy affair; a report by former auditor general Sheila Fraser on financial management.Repeated Duplicity in Afghan Detainees ControversyAmong the abuses: Parliament was misled and denied documents. An inquiry was shut down. CPC MPs attempted to discredit diplomat Richard Colvin whose testimony diverted from the government's line of denial.Repeated Duplicity on Costing of F-35 Fighter JetsAn auditor general's report revealed serial deceptive practices used by the Conservatives in misleading both the public and especially Parliament on the projected cost of the fighter jets. Additionally, after the government agreed to review the purchase, perhaps even open it up to competitive bidding, the committee chosen by the Harper Government reported (18 months later) that the review will recommend buying the same plane, on the same terms — without competition.CPC Minister Lies, Blames Statistics Canada for Killing Long Form CensusUnder fire for Conservatives killing the long form census, Industry Minister Tony Clement falsely stated that StatsCan backed the idea and assured the voluntary substitute would yield valid statistical data. Neither was true, outraged StatsCan sources confirmed, such that the head of StatsCan publicly refuted the lies about his statements and support, stepping down in protest as well.Conservative MP Lies to Parliament, Later Admits He Lied to ParliamentAs opposition members claimed the Harper government was out to rig election rules in its favour, Conservative MP Brad Butt rose in the House of Commons to say why the bill was needed -- all the voter fraud he had personally witnessed in Nova Scotia. Weeks later he rose again to say his statements had been entirely false. Delivering his strained apology, he failed to explain why he lied in the first place.Conservative House Leader Admits to Mockery of Question PeriodCriticized far and wide for farcical answers in question period, Paul Calandra, parliamentary secretary to Harper, made a tearful apology for abuse of the democratic process, in this case for having pretended to repeatedly hear "Iraq" as "Israel." He continued to fail to answer questions by instead giving spurious and "comedic" answers, however, as time went on.Harper Maligns the Supreme Court Chief JusticeThe Prime Minister took the unprecedented step of alleging inappropriate conduct by Chief Justice Beverley McLachlin. Facts undermined the credibility of the PM's position.Conservatives Engage in Abuse of Process with Omnibus BillsHarper's party pushed legislation through Parliament via omnibus bills, the scale of which Parliament had never seen. Such bills are widely condemned as an abuse of the democratic process, because they blend and bury so many controversial laws within one dense package. Harper himself once railed against them, and his born again love for them made his own MPs queasy. Referencing such bills, former auditor general Sheila Fraser said that "Parliament has become so undermined that it is almost unable to do the job that people expect of it."Harperites Deliberately Sabotage, Stymie Committee SystemConservatives used tactics such as barring witnesses, closure, time limitations, and in camera sessions to an extent rarely, if ever, witnessed in Canada. In their early days in power, top Conservatives prepared a handbook instructing committee chairpersons how to obstruct proceedings.Harper's Own CPC MPs Protest MuzzlingIn a caucus known for his tight discipline, in 2014 some members finally rose up to contest being censored at question period by the Prime Minister's Office. Former Conservative backbencher Brent Rathgeber turned independent and published a book, Irresponsible Government, decrying anti-democratic practices.Conservative Bill Back-Dates Bill To Before Bill Was Enacted to Protect Mounties from Potential Criminal Charges Against Access To Information ViolationTo protect the RCMP's acceding to demands from the PMO to illegally destroy records early, the government made an old bill come retroactively into force before it had actually been passed by Parliament.Harper Minister Caught in Advertising Scam with Public FundsThe Globe and Mail revealed that Harper's chosen Minister for Democratic Reform Pierre Poilievre commissioned a team of public servants for overtime work on a Sunday to film him glad-handing constituents. The vanity video on the taxpayer dime was to promote the government's benefits for families.Access to Information System ImpededMany new roadblocks have been put up by the Harper Conservatives. Former Information Commissioner Robert Marleau concluded that having obtained absolute power, the prime minister "has absolutely abused that power to the maximum."The Silencing of the Public ServiceThe PMO took an unprecedented step in instituting a system wherein the bureaucracy has all its communications vetted by the political nerve centre. The policy contribution role of the public service is significantly reduced. Complaints from insiders allege that the Privy Council office has become increasingly politicized. In particular, science and scientists have been controlled and impeded in their communications, especially but not exclusively in preventing information on climate change.Loyalty Oaths Imposed on Public ServantsArchivists and librarians were made to swear strict oaths of allegiance and were hit with restrictions on freedom of speech that editorialists of the right and left described as chilling, as they are not being applied to the crown or the nation, but to the party and politicians in power, and are expected to apply 24 hours a day, seven days a week.Harper Government Sued by Justice Department WhistleblowerTime and again the Harper government propose bills that end up being shot down by the courts, prompting critics to say such legislation is more about making political statements than lasting policy. The wasted efforts bothered senior justice department lawyer Edgar Schmidt so much he finally sued the government for breaking the law by inadequately evaluating whether proposed bills violate the Charter of Rights and Freedoms. He was promptly suspended without pay.Conservatives Block Accreditation for Opposition MPsIn another example of partisanship taken to new heights, the PMO blocked opposition members from being accredited for international environment conferences and from visiting military bases.Clampdown on Freedom of Speech of Diplomatic CorpsOttawa's diplomats must get all communications approved from Conservative political operatives. Under Harper, the country's ambassadors are hardly heard from any more. In a recent speech, former United Nations ambassador Stephen Lewis said our political culture under the Conservatives has descended into "a nadir of indignity."Marine Science Libraries DecimatedThe Harper government's downsizing of federal libraries included sudden closing of seven world famous Department of Fisheries and Oceans archives. A leaked memo revealed the destruction and consolidation would save less than half a million dollars. Scientist patrons of the libraries, who witnessed chaotic chucking of rare literature, called it a "book burning" with no logical purpose other than to restrict environmental information. The Harper government claimed vital works would be digitally preserved, but never provided a plan or cost for doing so, nor any proof it had happened. No scientists interviewed by The Tyee believed digitizing would or could replace what was lost.Harper Government Denies Khadr Basic RightsDefying court rulings, the Conservative government refused to accord Omar Khadr basic rights such as access to media. Editorialists of right and left persuasion described the move as unbefitting a democratic government.Illegitimate Prorogation of Parliament, TwiceProrogations are a legitimate procedure that can be abused depending on motivations. The Harper government provoked 60 protests across Canada and beyond its borders in 2010 after shutting the legislature's doors to escape condemnation on the Afghan detainees' file. It was the second prorogation in a year's period.Undue Interference with Independent AgenciesCommand and control system was extended to meddling in bodies like National Energy Board and CRTC whose arms-length autonomy is significantly reduced. A special target was the Parliamentary Budget Office, which was hit with condemnations and budget cuts for its critical reports.Billions Borrowed without Parliament's PermissionThe auditor general sounded alarms about the "prodigious" growth and size of federal borrowing. Those billions in "non-budgetary" spending used to get Parliament's oversight, but no more. The finance minister can borrow what he wants without Parliament's permission. Why? A loophole buried in a 2007 Harper omnibus bill.Lapdogs Appointed as WatchdogsThe most controversial was the case of former Integrity Commissioner Christiane Ouimet. Her office reviewed more than 200 whistleblowing cases. Disciplinary action followed on none of them. Ouimet's own angry staffers blew the whistle on their boss. The auditor general foundOuimet intimidated her employees, took "retaliatory action" against them and may have breached their privacy, all part of the Harper appointee's "gross mismanagement." Ouimet was paid more than $500,000 to leave her post.The 'Harper Government' Labelling DeceptionPublic servants were told to use "Harper Government" instead of "Government of Canada" in publicity releases. The Conservatives denied it was happening -- until internal memos revealed by the Canadian Press revealed the denial to be without basis.Conservatives Place Party Logos on Government of Canada ChequesOnce "caught red-handed," they backed off. The federal ethics commissioner, adopting the exasperated tone of an adult lecturing a child, noted: "Public spending announcements are government activities, not partisan political activities, and it is not appropriate to brand them with partisan or personal identifiers."Record Amounts of Partisan Political Advertising, on the Public PurseSeveral media reports told how the Conservatives used taxpayer money for partisan political advertising in record quantity, costing the public treasury $750 million since Harper became PM. In one instance, the Tories spent lavishly on ads for the promotion of a jobs grant program that had yet to be made public or presented to parliament or the provinces. Even more nakedly partisan, a mailed blast, charged to the taxpayers, targeting Justin Trudeau.Government Muzzles Science CommunityTop scientists came under such heavy monitoring by the Conservatives that they staged "Death of Evidence" protests for being denied freedom of speech. The Conservatives sent out chaperones or "media minders" to track Environment Canada scientists and report on them. Continued and repeated silencing of scientists and scientific dialogue continues.Like Never Before, Limits Placed on Media AccessJournalists have been hard-pressed to recall another time when controls put on them were so tight. At the Conservatives' 2013 Calgary convention, reporters wrote of being harassed and penned in at every turn by the PMO's command and control system. In his book Killing The Messenger, journalist Mark Bourrie charts the many examples of new limits on freedom of speech introduced in the Harper era.Harper's Team Tries to Ban Journalist for Asking QuestionVeteran TV cameraman Dave Ellis covered a Harper speech about oil to a business audience. Though media had been instructed no questions allowed, Ellis posed one about charges laid against a Conservative MP. The PMO tried to punish Ellis and his network by kicking him off covering Harper's trip to Malaysia. After media hue and cry, Harper backed down and Ellis went.Suppression of ResearchIn the gun registration debate, incriminating research and documents such as a Firearms Report were deliberately withheld from the public. While ramping up their prison building, Conservatives suppressed related research and studies contradicting their political priorities.Protesters Put under Blanket SurveillanceAccording to a leaked memo, as part of its command and control approach, the Conservatives have approved a system wherein all advocates, protesters and demonstrations can be monitored by authorities. The Government Operations Centre has requested federal departments to assist it in compiling a comprehensive inventory of protesters. Security specialists have called it a breach of Canadians' Charter of Rights. Conservatives have moved to give CSIS even more powers than the spy agency wants.Rights and Democracy, Other Groups, DismantledIn a show of brute force, the Montreal-based group Rights and Democracy was pole-axed for its alleged political leanings and eventually disbanded. Organizations like the church group Kairoswere de-budgeted or dismantled for political leanings. Nuclear Safety Commission head Linda Keen was dumped. Among the complaints cited by the PM was that in her distant past, she had some Liberal ties.Harper Government Spied on Aboriginal Critic, 'Retaliated'Aboriginal child welfare advocate Cindy Blackstock was spied on by the Harper government, and when she arrived for a meeting with other First Nations leaders at the Ministry of Aboriginal Affairs only she was barred entry. Finding Blackstock had been "retaliated" against by a ministry official, the Canadian Human Rights Tribunal awarded her $20,000 for pain and suffering.Revenue Canada Targeted to Attack CharitiesNot all charities, just the ones that don't seem adequately aligned with the Harper brand. Enough to include many environmental, aid, human rights and free speech charities that banded together to push back against what looks like a politically motivated witch hunt. When an investigation into whether there was PMO coercion became possible, Revenue Canada instructed all staff to destroy all text message records, against standard procedures.Conservatives Use Unheard of Tactic to Force through Anti-Union BillConservative senators went to the unprecedented extent of overruling their own Speaker. What could be so important to break Senate rules? A bill pushed by Harper that is almost certainly unconstitutional for its privacy invading measures forced onto unions, unlike other groups. Latest in a steady stream of Conservative attacks on organized labour in Canada.Harper Smears Liberal Sikh MP, Insinuating Tie to TerrorismWhen Liberals opposed a 2007 Conservative plan to extend anti-terror legislation, Stephen Harper singled out Grit MP Navdeep Bains, seeming to suggest that Bains' party was motivated by a desire to protect Bains' father-in-law, Darshan Singh Saini. A recent news story had claimed Singh Saini was on a list of witnesses sought by the RCMP for its Air India investigation, but provided no proof he was involved. In the House, Liberals erupted with outrage and Bains asked, in vain, that Harper apologize.Veterans' Advocates SmearedMedical files of Sean Bruyea, a strong advocate for veterans' rights, were leaked in a case that privacy commissioner Jennifer Stoddart described as "alarming." Veterans Affairs Canada ombudsman Pat Stogran was dumped after criticizing the government.Conservative Convicted on Robocalls ScamTory operative Michael Sona was given jail time for his role in the robocalls scam. The judge indicated more than one person was likely involved. In another court judgment in a case brought by the Council of Canadians, the ruling said the robocalls operation was widespread, not just limited to the Guelph riding. Donald Segretti who did dirty tricks for the Nixon White House told a Canadian reporter his skullduggery didn't go so low as to run schemes sending voters to the wrong polling stations.Harper's Ex-Parliamentary Secretary Jailed for Breaking Election LawDean Del Maestro was one of Harper's favourites. As his parliamentary secretary, the PM frequently used him as an attack dog to allege misdeeds by opposition members. Del Maestro was given a jail sentence in June for his own election spending violations, which is to say, cheating.'Reprehensible' Dirty Tricks Campaign against Irwin CotlerConservative Commons Speaker Andrew Scheer ruled his party's own tactics in running a surreptitious misinformation campaign in the riding of the highly respected MP were "reprehensible."Election Violations Prompt Resignation of Cabinet MemberPeter Penashue, another Harper Conservative was compelled to step down over election spending violations.Harper's Office Deploys Interns for Dirty TricksIn one instance that brought on allegations of Nixonian tactics, junior PMO staffers in the guise of normal citizens were sent out to disrupt a Justin Trudeau speech.Citizens Ejected from Conservative RalliesTory operatives hauled out citizens from a Harper rally in the 2011 campaign because they had marginal ties to other parties. A spokesperson for the PM was compelled to apologize. Problem fixed this time around: Only fully vetted Harper supporters will be allowed, by invite only, to attend the PM's campaign stops. If they have a ticket.Conservatives Make Campaign Event Attendees Sign Gag OrderNot only have Harper's campaign handlers made his campaign events by invite only, they are forcing anyone let in to sign an agreement not to transmit any description of the event or any images from it.Conservatives Unfix Their Own Fixed Date Election LawIn 2008, Harper pulled the plug on his own government, violating his own new law, which stipulated elections every four years.Guilty Plea on In and Out AffairThe Conservative Party and its fundraising arm pled guilty to some Elections Act charges stemming from their exceeding spending limits in the 2006 campaign. The investigation cost taxpayers over $2 million.CPC Elections Bill Strips Power from Elections CanadaThe Fair Elections Act also makes it harder for Canadians to vote as more ID is required. Nationwide protests in which more than 400 academics took part forced Pierre Poilievre to withdraw some measures in the bill because of their alleged anti-democratic bent.Harper Minister Smears Head of Elections CanadaIn a bid to impugn his integrity, Democratic Reform Minister Pierre Poilievre accused the Elections Canada CEO Marc Mayrand of being a power monger and wearing a team jersey.Copyright Grab for Attack AdsCTV News found out Conservatives aimed to rewrite copyright law to let political parties grab any media content and use it for free in their ads. The impact, warned CTV's Don Martin, "will be to cast a chill on every broadcast appearance" by MPs, commentators and reporters, who "must now be aware their views could end up featured in a political attack ad." By asserting "unlimited access to the airwaves for propaganda purposes," Martin said, the Harper government "could be seen as flirting with fascism."Conservatives Use Terrorists' Propaganda in Attack Ad Immediately After Making That IllegalHarper's party created a political ad incorporating music and horrifying images of doomed captives pulled straight from the Islamic State's own promotional video. The target: Justin Trudeau, whose views on the risks and rewards of bombing ISIS differ from Harper's. This immediately after making it illegal to spread terrorists' propaganda even incidentally or accidentally.Canada Is The Only UN Member To Reject Landmark Indigenous Rights DocumentCPC aboriginal affairs deputy minister Colleen Swords represented Ottawa at the United Nations assembly in New York, where Canada was the only nation to object to a non-legally binding UN outcome document which promotes indigenous peoples' legal and political standing and participation in their various home countries. This after UN Special Rapporteur on the Rights of Indigenous Peoples found in the UN's 2014 report that Canada's relationship as a nation with its indigenous peoples continues to be an antagonistic rather than cooperative one.Prime Minister's Office Charged in Court By Information CommissionerCanadian Press submitted Access to Information request identified 28 pages of documents available, according to the Privy Council Office, but the PMO refused to allow access to 27 of the 28 pages, despite being legally obliged. The case has gone to federal court.Conservative Party's Lawyers Declare No Responsibility Between Government And Combat VeteransIn response to a lawsuit by Canadian combat veterans over the new Veterns Charter, wherein the veterans stated "The social covenant is this promise that our country, Canada, has promised service people they will be protected when they get maimed and their families will be looked after if they are killed," the federal government responded that "At no time in Canada's history has any alleged 'social contract' or 'social covenant' having the attributes pleaded by the plaintiffs been given effect in any statute, regulation or as a constitutional principle written or unwritten." That the government has no obligation to care for wounded combat veterans. The lawsuit has been put on pause during the election, and will resume afterward.Department of Foreign Affairs Instructed To Meet Quota Of TerrorThe Prime Minister's Office instructed the Department of Foreign Affairs in April of 2015, with an election looming, to ensure a minimum of three Terrorism Warning media releases each week. The bureaucrats of the Department declined to meet the "odd" demand for a quota.--These are a number of things which help Stephen Harper and, through the "Harper" brand, the Conservative Party of Canada, stand out from other politicians and other parties current and historic.David Beers has a more extensive listing of this list and more, over at The Tyee. His version of this list breaks 70 items. I am evidently more conservative than that, and consider mis-spending and pork-barrel scandals to be similar enough to previous governments to not be worth listing.Andrew refers to David Beers' list at The Tyee: Harper, Serial Abuser of Power: The Evidence CompiledWhile "worst" is subjective and difficult to define, this is certainly a terrifying list of examples of Harper and the Conservatives' contempt for democracy. Only time will tell how history will view them, though.