Antagonizing the IRB II

 This one is my favorite so far since I used it as a vehicle to satirize and deride my favorite author. Also my boss told me I was welcome to do this as long as SHE wasn't going to get sued, so I'm pretty sure that means I can use department funds. (If you're new to this saga, start here.)

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		[  ]     Expedited Review		[  ]     Withdrawn			DORA CRR #
	Approval period from:				To:
	Date of IRB action:				Printed name:
	IRB Chair or Designee Signature:
	Notes:

Research Study Information
Submission Reason	[  ] RENEW IRB application		[  ] CLOSE IRB application
Expiration date of IRB approval
IRB Application #			IRB Committee
IRB Application Title	Dickens
Lead Researcher Name	Drover Godshack	Contact Name			Vincent Whifflesnout
Position and/or academic appointment		Position and/or academic appointment
Department/Division		Department/Division
Phone #		Phone #
Fax #		Fax #
Box #		Box #
Street address, if applicable		Street address, if applicable
Email		Email
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

[X] Other, explain:  The relict of the late, celebrated Captain Skimmer was to all appearances one of the treasured elite of the congregation at Whimpering Penitence; her fair hand dispensed that parsimonious brand of Christian charity so aptly named the “handout,” insomuch as with her own fair hand she provided for the wants and needs of those less fortunate in the very manner as to make them most desirous of the concluding syllable, and with respect to the former’s capacity for holding but a very, very little (Mrs. Captain Skimmer being of the slightest corporeal manifestation), it was with no great skepticism that her many admirers were wont to overhear her frequent proclamations that Mrs. Captain Skimmer did “quite as much as she could for the poor;” although there may have been some possessed of the blasphemous notion that it would have required a very great power indeed to render the yield of those merciful exertions any less.

2.     CLOSE IRB application because:

[  ] Enrollment closed, research completed, & data analysis described in initial application completed

[  ] 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). 

There never was such a restful place as the Newgate! There one could linger countless hours without the shrill disturbance of birds, muffin boys, or carriages; never in this haven might a stray and piercing ray of sunlight penetrate into the darkness of one’s thoughts; Here, mind you, was the penultimate respite from the weary and strenuous world (the ultimate respite being of a more permanent and metaphysical nature, and not, perhaps, suitable for those wishing to cogitate deeply upon the diverse philosophies and imaginations associated with this mortal coil, it being requisite to these interesting pastimes that the author of such be marginally cognizant), here, I say, was a richness! Here was luxury! Here were the innumerable benefits of a life of idol impoverishment, the opulence of indolence, the enforced (unnecessarily, naturally!) sumptuousness of compulsory meditation! What a lavish illustration of happiness; never to have to seek for one’s diversions, or employments, safe in the comfort of being denied any at all, save those so noisome and insalubrious as to render the participant insensible of any need for diversion at all! Here was a place so seductive in its diverse charms, so compelling in its attractions, as to never once be under the necessity of advertising its vacancies, as the moment one became available it was instantly and seamlessly filled with an occupant indistinguishable from the previous; moreover, here were masses of applicants, thronging its gates and waving their credentials of poverty, misery, neglect and starvation! Here, Gentlemen, is a paragon! Here, my lords and ladies, is a haven indeed.

2.     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.”

And contorting his face into a countless array of gruesome grimaces, and comporting his worsted clad legs in a most singularly menacing hornpipe, he swarmed up the pillar to the thatched roof and composing himself comfortably by way of entwining his feet upon the nether sides of the roof beam, faced the company in this outrageous position and gibbered hideously.

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 :  12,556

Number of adverse events that were related to research procedures and expected, but more severe or occurred at a greater frequency than expected : 10,000

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	3	2
Here upon this chaise was Ms. Whisping relegated, the excitement of the previous evening having prostrated her utterly, and here around her couch were scattered the various proofs of this indisposition, namely a bottle of smelling salts, several lace handkerchiefs, and two or three abandoned novels by the Countess De l’Angier. “Ah, me,” sighed the fatigued sylph. “If only the aristocracy were not quite so insistent upon my presence as the ambrosia of the evening! If only one could be a charmless peasant, how heavenly that would be.”	13, 245	0
Years of dissipation and dissolution had produced in him a complexion so grotesque, so hideously mottled, that it proclaimed itself a very map of immoderation and excess - his very nose seemed but a terrestrial carbuncle on a topography of licentious indulgence.	4500	1
“Get away with you, you brute!” Mrs. Crammge shrieked, wielding the mop savagely in a series of unsteady feints and jabs alarmingly near the waistcoat buttons of Mr. Foggs. “To apply these most perwerse and insidlyous libels to a poor wulnerable gennlewoman as has never taken a drink in life saving those considered as necessary restoratives by them as are medical professionals!” And Mrs. Crammage collapsed in a heap, exuding as she did a veritable gust of gin scented musty air, and proceeded to sob and choke to the effect that she had never heard such a thing, and wished she were struck dead, and buried too, this instant if she ever had.	245	2

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? [  ] Yes   [  ]  No     [  ]  Not applicable

·         If yes, provide an explanation: having lisped breathlessly to the completion of the Lord’s prayer, and entreating, in that same whispered prayer, that He would bless the poor, and the ill, and old drunk Jemmy’s dog Plug, little Jonny turned up his face to heaven, and affectingly expired of an ambiguous pestilence directly attributable to the evils of neglect and insensibility by the upper middle class and parish wardens. “May them’s that are at fault learn a lesson from that brave, dear angel!” Sobbed Ancient Sally. “And I don’t know but that I’ll forgive my estranged son on account of that blessed, blessed example little dead Jonny!”

Number of complaints: 2

Describe each complaint, and explain how you handled each one. 

And so it would seem, in the manner of all hotels and boarding houses, that there was never enough muffins to toast, and never enough butter to go around, and if there was, never enough fire to toast them properly, and there was either too much cold meat and not enough milk punch, which caused a general uproar and demand for various refreshments at the expense of the establishment and the integrity of the establishments furniture, or conversely, too much milk punch and not enough cold meat, the consequence of which was that the eyes of the party grew heavier and their movements somnolent and clumsy, and they retired too early and slept far too late, resulting in their taking more usage out of a single bedstead than had been allowanced by the nightly rate.

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:  Behold, Gentlemen, the fruits of your labor! Feast your eyes upon the vast expanse of the poor, the wretched, the insolvent, the hungry! Marvel at the work that produced these blisters, these rashes, these welts and weals of want and degradation! Behold the products of your indifference, your greed! These are not the works of the Devil, these boils, these scars, these miles of humble, parched graves filled with the earthly shells of innocents and victims! Behold your work, My lords, my nobles, my water rate collectors and dance instructors! View this, your legacy, your opus, you teaching assistants, you dog trainers! See this, your creation, you chop vendors, you Swedish milkmaids!

Do not avert your eyes in fear or disgust! The sanguine rays of the setting sun may bathe it all in crimson light, but from this single sunset will the absolving blindness of dark never come – and here for all eternity may you view the callous product of your wasted lives, illuminated in all its terrible glory!