BioethicsWatch

Do We Have a Problem Here? Federal oversight agencies regularly complain about objectionable conduct in human research. These are some favorite extracts from warning letters issued by the US Food and Drug Administration.

Scientific Misconduct:

There were no source documents regarding drug disposition for subject 1156 [redacted]. In addition, it is obvious that any drug accountability records for the four subjects who were fabricated are false.

The signed consent forms for subjects 1157 [redacted] 1159 [redacted] and 1337 [redacted] were not the latest version approved by the IRB. It is obvious that valid informed consent to participate could not have been obtained from subjects 1014 [redacted] 1101 [redacted] 1154 [redacted] and 1158 [redacted] whose signatures were forged on informed consent documents.

Read more FDA warning letters issued to clinical investigators …

Imbecility:

The practice of recording data for study subjects prior to their actual study visits is unacceptable.

Browse the collection of documents from human subject research released under FOIA …

Indifference:

During the inspection, records for the study [redacted] were examined. This study had been ongoing for 24 years, having been approved in 1974 and closed in 1999. There was no evidence that the COMIRB ever re-evaluated this study to ensure consideration of current technology or changes in the COMIRB procedures for approval or review.

Indifference and Ineptitude:

During the inspection conducted in 1997, the continuing review of studies was found to be severely inadequate with approximately 758 studies overdue for continuing review …

Employees have not been fully trained in the use of the database. Employees were not able to sort or print certain databases and did not know what all the database fields were even though they were responsible for entering data into those fields. It was necessary to utilize a former employee to obtain printouts of open and closed studies.

Read more FDA warning letters issued to Institutional Review Boards …

About This Web Site

BioethicsWatch is currently run by Elizabeth Woeckner, board member of Citizens For Responsible Care and Research – CIRCARE. BioethicsWatch will be the public beta site for a database that will function as a repository of public documents from research on human beings. The first phase of testing will make the FDA Clinical Investigator Inspection List available online to the public for free. This exercise should allow me to locate any glitches and see what it does to our bandwidth; once this smaller database is functioning properly, scanned documents (protocols, informed consents, medical board actions, etc.,) will be added. The ultimate goal is to afford full-text search capability to scholars, industry members, and the general public. This site is not affiliated with CIRCARE, although the organization links to a number of documents on this web site.

Thanks and acknowledgment for web design resources go to the following:

Documents Released Under the Freedom of Information Act
or Otherwise Publicly Available
Alphabet Soup (US Federal Agencies):
CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of HHS); HHS: Health and Human Services; OHRP: Office For Human Research Protections (part of HHS); ORI: Office of Research Integrity (part of HHS); OIG: Office of the Inspector General

US Food & Drug Administration [FDA]
What follows are FDA warning letters organized (as indicated) and alphabetized for sanity; FDA sources are indicated at the bottom of each web page. These letters are redacted as per FDA FOIA policies unless otherwise noted. We update our indices weekly. Annual indices of CDER warning letters to pharmaceutical manufacturers, CBER warning letters, Cyber Letters (dietary supplements-not), NIDPOE (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain), NOOH (Notice of Opportunity for Hearing) lists, current warning letters, debarment and restricted lists, etc., are available on our FDA Information Index

FDA Warning Letters Issued to Institutional Review Boards
FDA Warning Letters Issued to Clinical Investigators [A – L]
FDA Warning Letters Issued to Clinical Investigators [M – Z]
FDA Warning Letters Issued to Sponsors and Contract Research Organizations
FDA Form 483s, Notices of Inspection
Documents From Notorious Cases
Great Lakes College of Clinical Medicine Index of Documents – Research Conducted and Approved the the IRB
Malariotherapy for HIV (Henry Heimlich M.D. and the Heimlich Institute Foundation Inc.)
Malariotherapy for Lyme Disease (Henry Heimlich M.D. and the Heimlich Institute Foundation Inc.)
Miscellaneous Document Holding Page
Coming soon

Litigation and Other Regulatory Actions
Physician-Researchers (state medical board actions, depositions, and more)
Institutions and Organizations
Institutional Review Boards
Sponsors of Drug and Device Studies
Documents By Topic
Informed Consents
Protocols

LOI PINEL : APPRENDRE À CALCULER LE BON MONTANT DU LOYER

Investir en loi Pinel impose de respecter certaines règles avant de fixer votre futur loyer. Pour son calcul, vous devez notamment tenir compte de la localisation du bien, du plafond des loyers et de sa surface

PLAFONDS DES LOYERS PINEL
Fixés par les pouvoirs publics, les plafonds de loyers mensuels d’un investissement en loi Pinel sont révisés tous les ans. Ils servent de référence pour les baux conclus en métropole dans l’année en cours.
Ces plafonds mensuels de loyers (hors charges) diffèrent selon la zone géographique où se situe votre logement.

En 2021, ils s’établissent à :
17,17 €/m2 en zone A bis*
12,75 €/m2 en zone A*
10,28 €/m2 en zone B1*

COEFFICIENT MULTIPLICATEUR

Le plafond de loyer mentionné ci-dessus doit par la suite être ajusté à la taille de votre logement. Car un studio ne se loue pas au même prix du mètre carré qu’un 3 pièces. La valeur locative rapportée au mètre carré diminue au fur et à mesure que la surface s’agrandit.
Pour déterminer le « vrai » loyer de référence, il convient d’appliquer un « coefficient multiplicateur » dont la formule est : 0,7 + 19/Surface.
Le résultat obtenu doit être arrondi à la 2eme décimale la plus proche, sans excéder 1,2.
Exemple : pour un 2-pièces de 50 m2 loué en zone B1, le plafond de loyer plafond Pinel 2018 s’élèvera à 10,96 €/m2/mois, hors charges (soit (10,15 x (0,7 + 19/50)).

LOYERS DE MARCHÉ

Si les loyers plafonds fixés chaque année par les pouvoirs publics représentent une référence à ne pas dépasser, les prix observés sur le marché locatif local constituent également un paramètre à prendre en compte au moment de fixer le montant de votre loyer.
Si ce dernier se situe largement au-dessus des seuils du Pinel, comme c’est le cas sur Paris, le manque à gagner réduit l’intérêt d’une telle opération. En revanche, lorsque l’écart reste limité à 20 % ou moins cela peut valoir le coup.

INVESTING IN THE PINEL LAW: FOCUS ON ELIGIBILITY CONDITIONS

The criteria to be met in order to invest in the Pinel law are strict. Better to know them before you decide. The checklist so you don't forget anything.

The tax advantage of the Pinel law , in force until December 31, 2021, allows you to reduce the amount of your income tax thanks to a tax reduction in return for respecting a certain number of commitments.

INVESTORS CONCERNED

To benefit from this regime, you must have the status of taxpayer and be domiciled for tax purposes in France at the time of investment. For investments made on or after 1 st January 2019, taxpayers who made a qualifying purchase tax reduction when it was domiciled in France for tax may retain the benefit of the tax benefit for the years during which its tax residence will no longer be located in France (the tax reduction will be deducted from the tax due in respect of its income - land in particular - remaining taxable in France).

Any taxpayer, regardless of his tax bracket, is able to make this investment with a tax reduction of between 6 and 12 years in the event of an extension request.

However, to take advantage of this scheme, it is estimated that you must pay at least 2,500 euros in income tax per year. In addition, you must not have already taken full advantage of tax benefits, the Pinel reduction entering into the calculation of the annual cap on tax loopholes of 10,000 euros per year.

DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONDISTRICT ADOH, $ANO PHONE NUMBER1941 Certral parkvayCincingati, OH 45207513-694-3507CANAVARANNLTMNAME OF INDIVIDUAL TO WHOM REPORT 13SVED PERIOD OXINXECTION c. F, NUMERTO; L., Terry Chapsel 1.MD10/7412/21/94TITLE OR INDIVIDUALTyrt 68TAOLISHMENT INOTECTEDSecretaryTRBFINN NAMENAME OF FIRM, DAANCH OR UNIT INSPECTADGreat Lakes A of clinical Medicine-IR_ ameSTREET ADDRESSSTREET ADDRESS OF EMIEUS INTACTOL 22 Thurman StreetCITY AND STATE Z Code)CITY AND STAT# {Zip Coda)luffton, OH 45817.+wyDURINO AN INSPECTION OF YOUR IAMDOSERVO1. The original protocolThe Amarantam(974/93) forthe entertainment, open tomore otherperson. Pour unebecomea studia w who iswellknow thatwere the themeprip,was approved at the 9/18/93 meeting pending sugg 'stionsfor revisions. The main suggestion was having the entry criteria moreclearly defined.A revised protocol was submitted on 11/24/93. in that protocol themaximum daily dose was defined to becs. the initial protocol wasco daily. There !$ 10 indication the IRB approved this chance. Thefrequency of progress reports was not listed in the 10/?3/93 letterto the investigator or in the minutes of the Septemher 18, 1993 meetin.A 9/13/9 letter from the Investigator states the FDA put the stud.on hold on 1/5/94, and as of July 1994, the study wit still on 10ld.There is no indication whether subjects had ever been enrolled in thestudy..2. There is no progress report available for mewas originally approved on 3/15/93,mwhich3. Numerical counts of tre vot!nis not recorded in the minutes,yWWW.MEou to 16162727O Drut on theoth1wwwusersTrorLOY RID) SIGNATVAEEMPLOYEESTNAME AND TITLE /Print orLATE ISSUEDSEE REVERSEOF THIS PAGEwirra$Gibert . Heidenriut. INY,+Z/21/9ONE MAOEDFOAM FDA 4(6PREVIOUS DITION MAY BE USED. INSPECTIONAL OBSERVATIONS PAGE