Antagonizing the IRB
As an individual concerned with the ethics of developing research and research protocol, it is imperative that I maintain a highly professional relationship with those persons responsible for reviewing and approving our project submissions. That being said, there are certain challenges that no honorable gentleman can ignore, such as the invidious calumny that there is no room for creativity in Human Subject Division forms. Below is the first installment of my response, mailed anonymously to the front desk of the IRB.
For definitions, see Page 5. For instructions on how to complete this form, see Page 6.
For HSD Office Use Only
[ ] Master Copy
[ ] Approved
[ ] IRB Working Copy
[ ] Conditional Approval
[ ] Researcher Copy
[ ] Approval in Principle
[ ] Full IRB Review Required
[ ] Denied
[ ] Expedited Review
[ ] Withdrawn
DORA CRR #
Approval period from:
Date of IRB action:
IRB Chair or Designee Signature:
Research Study Information
[ ] RENEW IRB application
[ ] CLOSE IRB application
Expiration date of IRB approval
IRB Application #
IRB Application Title
OLD DOVER CHARLIE
Lead Researcher Name
Kent Travis James
Street address, if applicable
Street address, if applicable
NOTE: Signature must be in ink.
Lead Researcher Signature:
Lead Researcher Printed Name:
A. Research Activity Status
1. RENEW IRB application because:
[ ] New subject enrollment still in progress
[ ] Enrollment closed but subjects are still undergoing research procedures
[ ] Enrollment closed, subjects have completed research procedures, but are still in follow-up
[ ] Subject involvement completed, need approval for data analysis only
[ ] Enrollment not yet begun
[X] Other, explain: Still gators
2. CLOSE IRB application because:
[ ] Enrollment closed, research completed, & data analysis described in initial application completed
[ ] Research never begun
[ ] Other, explain:
1. Provide an abstract of the research using lay-language. Provide the following:
· A summary of the purpose of this research activity,
· A summary of the procedures subjects will undergo, and
· A description of the subject population(s).
When we go by the broken fence near them old houses the shadows longer and longer til nobody else can see deep in the crowded grass. Then they go off farther and I stay. Jonah say and Gracie say and also Tessa say nobody live in those houses no more, all falling down with the dusty rattlers and the long brown hoppers. Those roofs fall in like a struck heap, Tessa says nobody play there don’t y’all play there. I go there before she tell me to look up and up through the no more roof. When mama makes that bread the steam rise up and up til nobody can see no more where it went.
2. Provide a summary of the research progress to date.
· Do NOT cut and paste from last year’s status report.
· If you have not yet enrolled subjects, please explain why.
· Send one copy of each manuscript based on the data from this research, written since the last approval.
· If you are closing your IRB application, explain what you will do with identifiable data and/or the link to the subjects’ identities.
We hid lots of things can’t nobody find, not for looking and looking all day. All seven of us play hide and seek, look and look and look behind the barrel and on the porch swing. Jonah say he hid the best but you can tell where they all went.
3. List all modifications you have made during the last period of approval by IRB approval date. Include a summary of each modification. If you have pending modifications, please list them as “pending.”
Jonah need new shoes and Gracie need new shoes, Dellie from down near the graveyard getting big. I see my feet don’t change, I watch and watch to see them grow but no time at all pass before I forget and run and run and run and run
4. Describe the changes in the risks and/or benefits to subjects over the last period of approval. If there are no changes in the risks or benefits, provide an explanation of why not.
Water don’t close too good over the trunk we threw in the water. All them branches overhanging making light thicker than mama’s grits. I poke that trunk with a stick, all them bubbles float out popping in the air where that man’s eyes used to look so mean. He ain’t comin back again, even if he float for long.
D. Adverse Events and Other Problems:
· Provide this information about adverse events and/or other problems for the approval period since your last status report by answering the questions below.
· If there were no adverse events or other problems, write “None.”
· If you are reporting events in questions #1 and #2, and you have not submitted a Serious Adverse Event Report Form to HSD, complete the SAE Report form and submit it under separate cover.
· Use the definitions at the end of this form for guidance.
- NOTE: If you have an outside monitoring body (DSMB/DSMC), you are responsible for reporting the events to that body.
Number of adverse events that were related to research procedures, serious, and unexpected : Gracie she still get sick every time she smell the chitlins cook
List the adverse events that were related, non-serious, but unexpected in the table below:
Number of events
Number of subjects affected
Mama stone fret for Dellie who got pregnant. I’d be pregnant too if I et that many hush puppies, get whupped too. Tessa say don’t be greedy y’all enough to get you fed good. Sometimes I stay hungry after all the smells put away too.
Number of other problems (unanticipated problems, protocol violations, protocol deviations) Picnic get canceled y’all don’t shape up say Tessa How we supposed to shape different if God made us say Jonah but he make Mama cry can’t nobody say what he did
If you answered 1 or more to the above question and have not already submitted the Modification Form with accompanying Supplemental Form: Report of Other Problems to report an Unanticipated Problem, complete both forms and submit separately from this status report.
Number of complaints:
Describe each complaint, and explain how you handled each one.
Dellie she need to put up her feet again, can’t walk farther than a three legged bent mule. Jonah stay back by us sometimes but he keep run ahead, farther and farther til he look tall and black with the small sun behind.
Number of subject withdrawals:
For each withdrawal, explain:
· why the subject chose to withdraw, or
· why you withdrew the subject from the research, and/or
· how the withdrawal affects your subject enrollment numbers for the past year as well as your overall enrollment totals.
When the foal dropped last June there was no ruckus but today there is a ruckus and no pancakes on Sunday Then they all say quiet quiet and nobody notices if I go down by the fences to see the houses that belong to nobody with their eyes hollowed and their roof that goes up forever and ever.
H. Attachments (check all that apply):
[ ] Abstracts/manuscripts (please do not submit more than one copy of each abstract/manuscript with your submission)
[ ] Conflict of Interest Management letter
[ ] Current consent materials with IRB approval stamp
[ ] Current HIPAA Authorization Form
The HIPAA Authorization Form template was significantly revised as of 11/1/09. If you are still enrolling subjects, you must use the revised HIPAA Authorization Form with new subjects. If you have not yet submitted a revised HIPAA form for IRB review, use the revised HIPAA Authorization template to change your form and send it to HSD with a completed Modification form as soon as possible.
[ ] Radiation Safety Application and/or approval
[X] Other, explain: Gracie said Jonas gone for good now but I did not hear the train come and I would have heard the train
What kind of asshole made this puzzle anyway? I am still waiting for answers.
To whom it may concern:
I am writing to inform you of my extreme discontent regarding your appalling puzzle, “VEGAS COMMA BABY FACTORIAL.” I have had the pleasure of assembling myriad puzzles, and, though not afflicted by any condition on the autism spectrum, usually enjoy them very much. It is not with unnecessary rodomontade that I interpose the remark that I am generally considered, within my small congress, to be remarkably competent at their assemblage. I am forced, however, to concede that your particular monstrosity consumed me for several months with its infernal futility.
It is senseless to comment on the vapidity of the subject matter, the paucity of talent inherent in the photograph, or the arresting deficiency of the craftsmanship. I do, however, feel it incumbent upon myself to indicate the fabulous iniquity native to the ploy in which you devise pieces that fit together that shouldn’t. This device is an outrage of infamy. The depths of moral turpitude in which your corporation must wallow are both alarming and repellent.
The abomination which you have perpetuated upon an innocent public is without a doubt among the utmost in profligacy. The enormity of this offense is approximated only by the tremendous chouse effected by the The Anglo-Bengalee Disinterested Loan and Life Insurance Company.
This depravity could be compounded by one thing only, and unsurprisingly, the lubricity of your imposture was augmented by the conspicuous fact that not only was your ostensible “thick premium board” “snap[ping] into place” with erroneous sundry chunks of your fine quality paper, your alleged 2000 piece “ever-changing fantasy land” was nothing more than a hollow chicanery, a barbarous speciousness, and insufferable swindle. The acarpus results of my labors produced an abortion of jigsaw malfeasance, a structure demanding a full complement of the arguably inadequate 2000 yet comprising, a mere 1997 pieces.
If it is possible to justify this miscarriage of manufacture, I invite you to vindicate yourselves. Spurious claims citing my own carelessness will be repudiated with calumny, as will any efforts on the part of your subsidiaries to insinuate that the consumer is in any way culpable for your base hypocrisy.
Guarantee both this puzzle and my satisfaction a big headed ghost. You people are barbarians and charlatans.
I really enjoy corresponding with Nigerian scammers. This guy was a disgrace. Here I tell him his bidness.
On Thu, 24 Sep 2009, Ubanga wrote:
My name is Mr John Ubanga the only son of late Mr Frederick Ubanga,I am the only child of late Mr Frederick Ubanga. My father was a very wealthy cocoa merchant based in Abidjan, the economic capital of Ivory Coast. He was poisoned to death by his business associates on one of their outing to discuss on a business trip. Before the death of my late father he made a deposit of(USD$10,500.000)with a security company here in abidjan Cote D' Ivoire,where I am contacting you from. Now I have decided to move this fund out of this country to your country for investment purpose. I want you to assist me and receive this fund in your country.If acpected to assist me then reply me back so that we can proceed.Anticipating to hearing from you.
> Mr John Ubanga.
Jesus Christ it's like you're not even TRYING. Like, could you at least kiss my ass? Could you tell me that my name was recommended to you out of millions of Americans because of my outstanding personal attractions and qualifications? Has anyone EVER sent you money? Listen, Jackass, if you want to get ahead in the jingle business, you are really going to need to step it up. Try sucking up to people, say nice things to them, compliment them on their email address or their shoes. It's obscene the way you scammers just expect money for nothing! I mean, you're not even attempting to pretend that this is anything other than a rip off. Where's the back story? The drama? I suggest that while you're inventing a fake father and some fake chocolate, you also throw in a fake grotesquely crippled sister, a drunk grandmother, a brother in jail for political protesting, and a legless dog. What on earth do you expect my motivation for helping you out would be? Because I am bored? You had damn well better come up with a better reason. You don't even sound GRATEFUL! Why do you need to transfer this money? Is your evil step mother trying to disinherit or murder you? is the government seizing your assets to punish you because you saved 100 orphans from burning to death when the poorhouse caught fire? Do you want to save American Puppies?
If you find that you are unable to accommodate these perfidies, if you lack the creative imagination necessary to infuse some of what we call "Human Interest" into your approach, I suggest you start offering people cash for gold, shares in salt mines, Van Eyck paintings, or miraculously discovered Stradivarius violins.
All these are good ideas which you may or may not implement in the future. Regardless of whether you adopt my suggestions, or invent your own obviously mendacious piteous tarradiddle, I hope that you will endeavor to improve. It is absolutely scandalous what the scam business is coming to these days. This was profoundly pathetic. Think over your business plan, and when you come up with a more compelling sentimentalism, feel free to write me again.
On Fri, 2 Oct 2009, Ubanga wrote:
So coherent of you. Honestly l kept wondering why your Americans believe
that you had it all, whereby 99% of the problems in World was ochestreated
by you Americans. From Africa to Europe, Asia and other part of the world.
Anyway let me just give you abreak for now, perhaps if you write back and
wish to help me out, than we will talk more. Have a nice day.
DEaR MR JHON JOHN UBANGE MR UBANGE MR JOHN
We are REgRET to TeLL tO you MR UBENGE that EMME BANE MR EMME BAIN Is only
this week haVE SUICIDED from guilt THAT CAUsinG yoU to Be pO00r. MR BENE
HaVE REquEST all of her ASSETS AND HOLDINGS AND INHERITANCE tO Be SHIP To
yOU in overNIght FEDEX SHiPpinG for YOU to RECievE in oRder to D0 th1s we
have necessaRY your Bank AcOUNT and ROUTING NUMBERS can yoU UrGent MR UBINGY
BINGY BINGY WHEEEE To SEnDING to US Quickly witHOUT DelAy so We ARe quicker
in PrOCESSing your CLAim to THis InHeriTancE CaN you SeNdInG to us @Us
DoLLars of 250 (250) US DOllarS (US $$$$$$$$) For IMMEDIATE SHIPPING MR JOHN
OOOBINGA MR JON
MR. PaRent SPAVINs
LAWYER ESTATE LAWYER WILLS AND ESTATES
Yup, tears o' mirth, just as desired.ReplyDelete
Very well-played, miss.ReplyDelete