Thursday, May 6, 2010

Busted by the IRB!!

My identity as the mad submitter has been discovered! This is my own fault, since I should have known better than to list the rationale for a late (legitimate) report as "Time Travel." I vowed that this would not stop me, and the following status report is calculated to FREEZE THE VERY MARROW OF THEIR BONES. 

For definitions, see Page 5.  For instructions on how to complete this form, see Page 6.
For HSD Office Use Only
Date Received:

[  ]     Master Copy

[  ]     Approved

[  ]     IRB Working Copy

[  ]     Conditional Approval

[  ]     Researcher Copy

[  ]     Approval in Principle

[  ]     Full IRB Review Required  

[  ]    Denied

[  ]     Expedited Review
[  ]     Withdrawn


Approval period from:

Date of IRB action:
Printed name:

IRB Chair or Designee Signature:


Research Study Information

Submission Reason

[  ] RENEW IRB application

[  ] CLOSE IRB application

Expiration date of IRB approval

IRB Application #
IRB Committee
IRB Application Title
Lead Researcher Name
Contact Name
Le Gandeau
Position and/or
academic appointment
Position and/or
academic appointment
Phone #
Phone #
Fax #
Fax #
Box #
Box #
Street address, if applicable
Street address, if applicable
NOTE: Signature must be in ink.

Lead Researcher Signature:

Lead Researcher Printed Name:         

Date Signed:       

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
[  ] Other, explain:       

2.     CLOSE IRB application because:
[  ] Enrollment closed, research completed, & data analysis described in initial application completed
[X] Research never begun
[  ] Other, explain:       

B.    Summaries

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). 
A remarkable sight met their eyes upon first entering the room – There lay in heaps the torn fragments of hundreds of books and papers, the bindings ripped violently away and piled madly in tremulous and outrageous heaps. The marks of savage fingers rent the walls, a wild path across the barred windows showed the marks of frenzied teeth. The rain beat through the broken glass with a grim ruthlessness, and the water had seeped into the pages of the books, steeping the floor in rivulets of soggy pulp. But wait! Was this not a shadow touching these puddles, turning them dark? What does this mean, that the shadows in this room are so red? These most unnatural and heavy shadows, with a metallic pungency?

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.
The echoes of his ragged breath filled the passageway as he gazed upon the trunks of treasure. The door swung shut with a crash that truncated his reverie. His nerveless fingers groped behind him for the latch – Gone, by God! Cut away and the door locked securely behind him! The corridor shook from without by the force of the storm, but no lightning illuminated this tomb, the walls crumbling atop the mouldering trunks and casks. He searched frantically among the caskets, desperate for any tool to free himself from this claustrophobic room, but the rotting trunks yielded only the gold he had searched for so mercilessly, each glittering piece a mockery.
      The tower swayed crazily, as he beat at the door, its planks alone a solid testament to his imprisonment. Behind him in the corner, a section of the wall gave way, and behind those dusty stones, a skull grinned madly from its heap of offal! In a confusion of horror he fell backwards, and the feeble light emitted by his dark lantern sputtered and went out. The thunder shook the foundations of the structure, and as it fell, the skull came sliding towards him across the filthy floor, borne upon a wave of gold. Before the building collapsed upon its ruined base, he had been suffocated by its hoarded bounty.

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.”
How loud the clock was! It must be a giant clock, to tick so loudly as to fill the room! Now it was more than one clock, now a thousand clocks! And one clock a mere half second behind the rest, throwing the rhythm into chaos, and slowly driving the prisoner mad.

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.
But even the dogs would not come near him after this, and when he finally abandoned the struggle and collapsed, it was long before even the beasts would worry his bones.

C.    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 :  74,859

Number of adverse events that were related to research procedures and expected, but more severe or occurred at a greater frequency than expected : 100,000,000

List the adverse events that were related, non-serious, but unexpected in the table below:

Event type/description
Number of events
Number of subjects affected
EXAMPLE:  Nausea
But the imprisonment had driven her mad! Never again did her graceful step or dancing eyes affix and enslave her admirers! Alone and despised, she bared her teeth to her caretakers, and raved and chaffed until she wasted away to a corpse.
It was by the full moon they found the body, encased in the barrel and drenched in the salt water that had drowned him, and the blood from the hands he had rendered fleshless in his last frantic attempts to escape his doom.
In the wan light of the dying fire, she faced the corpses, and rent her garments to shreds. The fire died away and in the suffocating darkness she fell, and, unable to stand, lay helpless, and shrieked, and shrieked.
He started up. Had his reflection moved? His nerves were all to pieces in this grim manor. He rang the bell again. Where had R________ gone?  What tragedy had rendered the butler deaf and mute?

Does the occurrence of any of the adverse events listed above suggest that the risk(s) to subjects are greater than described in your initial IRB application? [X] Yes   [  ]  No     [  ]  Not applicable
·         If yes, provide an explanation: Inside the cask, upon a yellowed silken pillow, was a severed hand.

Number of other problems (unanticipated problems, protocol violations, protocol deviations)      
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: 1
Describe each complaint, and explain how you handled each one. 
She tried many times to appease me, but I would not be calmed. I knew the flight was madness, that we would be caught, she would be taken from me, I would be locked away, tried, convicted and then - . But no; they would not take her from me so easily. Her pleas were nothing to me, her lips formed entreaties for mercy but I was deaf to her appeals. Now she would make this supplication, now, when the years that she wore so lightly had impressed themselves so bitterly across my own countenance! It was then that I began to hear the voice whispering. I heard it in the wind, the squeaking of the door hinges, the scrape and rustle of the rats and vermin in the lees! When she begged for her release I heard only the voice, sibilant, insistent: “POISON!”

Number of subject withdrawals: 0.5
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.
There they had scrawled the judgment, his diagnosis, in letters that appeared to writhe and glow in the anemic light of the train compartment. “Nervous Exhaustion; Prostration.” He clung to the paper as a lifeline, a link to his old life, a proof that this banishment from the gay and lively whirl of New York was a temporary measure, necessitated by a transitory and common evil, a brief inconvenience. As the gloom that had threatened the first class carriage slid slowly overall, a dim submergence, he slept.

When he awoke, it was to find the shadow of a man’s back stretching across the compartment. The man’s back was to him as he faced the leaded window,  staring out at the moving landscape in nerveless abstraction. His sleep had been such that he had not noticed the train stopping to board, and had not heard the porter unlock his door.  He was momentarily annoyed; he had requested the first class cabin remain empty apart from himself. The prospect of conversing lightly had chilled him, causing a rise in those distracted terrors that portended so darkly. Nothing must disturb him in this fragile state, nothing must agitate him. Now, however, he felt a surge of gratitude close upon the fleeting heels of his irritation – perhaps a companion through the long hours would lighten the journey, provide him a welcome diversion from the horrors of his own consciousness.

The man’s back was an upright one, clothed in a well-fitted suit of dark tweed. The final sanguine rays of the sunset radiated around the form, making a discernment of color impossible. The man’s back was black against the window, and the only indication of the coming night the shrinking beams of red surrounding the dark silhouette.

He studied the man’s back in the waning light. It was strong, a stubborn back. The relentless rhythm of the train shuddered him to and fro, to and fro. But the man’s back remained motionless, impervious to the rocking of the cars and the intermittent howl of the dismal horn.  From his couch he watched, fascinated, as the light dimmed, and faded, and broke, once more, in a blinding flash as they passed a break in the hills! And fell, again, more, to almost nothing.

The man’s back darkened with the sky, now was it charcoal grey, the suit, or was it a murky brown? Now was it a mottled crimson? No, it was gone. The man’s back remained, staunch, outlined by the wasted day.

He stirred, allowing his cushions to rustle softly. He anticipated the turn, the smile, the inevitable apology for the intrusion. A moment passed, the man’s back rigid against a muted dusk. He cleared his throat softly, knowing that this would prompt the civility of a greeting, an explanation. The man’s back stood stationary against the blur of the landscape outside, formless shapes rushing past even as they faded out, casting flickers across the top of the cabin.

He made up his mind to speak, the momentary relief overcome by annoyance at the responsibility of his position, an unwilling host to an uninvited imposition.  But somehow he could not loosen his tongue to speak. A query as to the time, an observation on the terrain (obliterated, by and large, by the man’s back); these stuck in his throat, and he swallowed them.

Now the man’s back was illuminated harshly at regular intervals as the railway lamps were lit outside. Moving at a great speed, the lamps sparked briefly, and the light flashed across the man’s back thusly. The outline was sharp, the boundaries precise. Not an inch could be seen past the man’s back; what color of shirt, what nature of face? The agitation of the proximity of a strange and silent adjutant was becoming overwhelming, and he bethought himself desirous of knowing his companion, and acknowledged  the difficulty of judging the quality of the face by the man’s back. If only the man’s back would turn! Then would the face be revealed, the face of the man’s back in a black coat – was it a red coat? Perhaps a grey coat. Would the face be changeable as the color of the suit? Would the face be handsome, amenable? Was it possible the face was averted from shame; a mutilation, a dread disease? Oh, Horror – what if, supposing the light were lit within the cabin, and the man’s back were to turn – what if upon that mysterious countenance were to exist NOTHING AT ALL? These thoughts were choking, dangerous – it was best to stuff them away, to relax as the doctors had commanded. They had advised against excitement, against disturbance. But what if the man’s back were all in all – a blank front, a creature of only two dimensions – a grotesquerie, a fiend? What if the man’s back should turn and in turning reveal that which was hidden?

The lamps were coming more quickly now, the iron monster accelerated in the night, and the rapid blinks of the railway lights jumped abruptly on the man’s back. What if the man’s back should turn? He felt a cough rising and struggled to suppress it, thrusting his head into a cushion. Even the slightest noise might cause a confrontation. The lights sped past, throwing the man’s back into a relief of hideous sharpness, casting a perverted facsimile on the wall opposite; the wall above his head! Oh God, the shadow stretched nearly to his feet, growing larger as the track turned sharply and the lights blinked in from above.

The shadow was growing! The man’s back, immovable – but did it tremble? His breath was ragged and his heart pounded deafeningly in his ears. He must remain perfectly still, he must not move or make a sound. He must concentrate now, anticipate a turning, prepare himself to flee, to fall away from whatever would be presented, if only the man’s back should move! There! And there again! The lurching of the train, the eerie shriek as the train signal disappeared into the blemished night, and came back again, and wound about them, and increased, rising in its tone, to an unbearable height and pitch! Did the man’s back move? Would it turn?

A piercing scream split the night, rising above the rattle of the wheels, mounting even into the corridors where the porters slept, shaking the hellish glow of the coal fires.

In Attica a medical attendant boarded and was seen to come out again, white faced, and shake his head. The porters who went to bring him out covered him first with a sheet, and again with a sheet, and were loath to touch or turn him, repelled by the sight. The first rays of a grey dawn slipped inside the car, illuminating the faces of the watchers, and irradiating the couch upon which  death had stolen upon an abandoned man, leaving him deserted in the isolated night, accompanied by his own unbearable face.

D.    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:  

And then I woke, alarmed and rigid, through the stifling darkness frigid,
There I heard the rasping of a desperate voice of dread
Thence I felt a creeping feeling, a frozen form of blood congealing,
Whispering malevolence, malevolently said
“By the ink that you have bled, Black as blackest midnight dead,
    Do not sign your forms in red!”


  1. Any IRB would do well to post your final verse in plain view of all principal investigators and their minions. Perhaps in red, though I haven't decided for sure.

  2. I think that the researchers will be prostrate with nervous exhaustion after reading this. They may hear strange tickings and things bubbling in the walls. Their floorboards may twitch. All their darkest deeds will be unearthed in the most hallucinatory manner. In fact, I predict that they will be too scabbed, sweaty and wild-eyed to challenge your methods. Good work!