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						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		[  ]     Expedited Review		[  ]     Withdrawn			DORA CRR #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 #	William Faulkner		IRB Committee
IRB Application Title	OLD DOVER CHARLIE
Lead Researcher Name	Graft Spalding	Contact Name			Kent Travis James
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:  Still gators

2.     CLOSE IRB application because:

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

[  ] Research never begun

[  ] Other, explain:       

C.    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). 

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:

Event type/description	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.	3	2

     

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