DELAWARE HEALTH AND SOCIAL SERVICES
HSRB PROJECT REPORT
Revised January 2007

INTERIM REPORT 0	FINAL REPORT 0





Original Review Date: _______________________

Date of Previous Review: __________		_


1.	Title of Project:	
	
	
	
2.	Principal Investigator (name, mailing address, phone #, e-mail address):	
	
	
	
3.	Co-Investigators (name, mailing address, phone #, e-mail address):



4.  Has the study been initiated? 	 Yes             No		

5.  Please provide a brief (no more than 2 sentences, if possible) description of this project. 



 


6.  How many potential subjects were approached to enter into the project?   	  __________
      	        						 		 			
				     	 			 (must equal GRAND TOTAL below)

a.	Subject status:
1.	Active …………							__________(a1)
2.	Completed 						………..	 ____   ___(a2)
3.	Lost to follow-up 							__________(a3)
		(Attach explanations)
		Total (sum of a1, a2, a3)						………..	__________ (a)

	b.  Subjects dropped from study, categorized by reason:
	1.   Voluntarily									__________(b1)
	(Attach explanations)
		2.   By investigator								__________(b2)
		(Attach explanations for dropping each subject) 
		3.   Due to Adverse Events(both ‘anticipated’ and ‘unanticipated’)			__________(b3)
(Attach explanation for each subject  dropped  due to an adverse event and include 
a description of steps taken to ameliorate the adverse impact) 
		4.    Due to project-related death during active phase of study			__________(b4)
		(Attach explanations of deaths.)
		5.    Due to non-project-related death during active phase of study			__________(b5)

			Total Subjects Dropped (sum of b1, b2, b3, b4, & b5)…__________ (b)

	c.  Potential subjects who declined to participate:  			…_________(c)
	 (Attach summary/tabulation/analysis of reasons subjects gave for declining)
	 d. GRAND TOTAL (sum of a, b & c)						__________ (d)



7.  What is the status of this project?

	a.  Open	__________			
	b.  Closed to subject accrual		Date                         				   
	c.  Closed  				Date			                         
		If closed:  reason					
	  d.  On hold             			Date ___________				
		If on hold: reason ________________________________                
	e.  Cancelled				Date			
		If cancelled: reason					

8. Describe any additional adverse events  not covered in item 6b that occurred over the reporting 
period.  Specify the steps taken to ameliorate the adverse impact.  (This item covers events that were 
foreseeable in the project’s design/methodology, the type of events that were described/anticipated 
when the project was reviewed initially by the Board.)   



9.  Summarize any  unanticipated problems resulting in harm or potential harm to subjects, 
including the number of subjects involved (attach relevant reports or documents).  Include a 
description of intervention(s) used for subjects adversely affected.  [Note:   This section should be a 
summary of information that has already been provided to the Board, as it is mandatory that such 
reports be submitted  IMMEDIATELY upon the occurrence of any such unanticipated problems.]


10.  For projects utilizing questionnaires, please respond to all of the following:

a)	Delineate any specific question(s) that one or more subjects did not answer.  The actual 
question(s) should be listed – with the number of persons who did not answer. 
b)	 If respondent(s) displayed significant stress when a ‘refused’ question was posed, identify 
that question and describe how the stress was ameliorated. 
c)	For those questions with a significant number of non-responses, please discuss the 
ramifications (for instance, should changes of any kind be made to the study’s design – if 
the study is still in progress?  If the project is over, are there changes that, in retrospect, you 
would have made – now that this information is known?).  


11.  Did any of the subjects experience decreased capacity after the study began, such that they were 
no longer able to give informed consent or voluntarily withdraw from participation?  If so, how was 
that issue addressed in each instance?  Were surrogate decision makers consulted?  Did such 
individuals in fact continue in the study?  

12.  Have you received any complaints about the research over the past year?  If yes, please 
summarize and describe steps taken to resolve the concerns expressed.	

13.  Please describe any additional or new information that has become available on this study or 
related studies which:  (a) subjects need to know, particularly information that might affect their 
willingness to continue to participate, and/or (b) the Board needs to know ~~ in particular, anything 
that could affect the level of risk attributable to the project.  If there is such information, how has it 
been or how will it be used to modify the project?  If such information should be shared with 
participants no longer involved with the project, how will the information be provided to them?      




For INTERIM REPORTs, attach a Narrative describing the Project’s status and detailing any 
preliminary Project findings.  Also attach a copy of the current consent form.


For FINAL REPORTs, attach Executive Summary with Project findings.

____________________________________							
								_________________
INVESTIGATOR'S SIGNATURE				REPORT DATE
DEPARTMENT OF HEALTH AND SOCIAL SERVICES
STATE OF DELAWARE
HSRB PROJECT REPORT
Revised January 2007
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