DELAWARE HEALTH AND SOCIAL SERVICES

RESEARCH ABSTRACT

FOR APPLICATION TO 
THE HUMAN SUBJECTS REVIEW BOARD  (HSRB)
(Revised September 2008)

The form below is to be completed for all projects 
involving research and human subjects within the 
Department of Health and Social Services, in compliance 
with DHSS Policy Memo 55 and Policy Memo 60.  

In addition to completion of the form provided here, the 
researcher will need to submit any proposal prepared for 
the funding agency to the HSRB.

The researcher also needs to sign and submit an 
Investigator’s Agreement, which is available from the 
HSRB chairperson, and a Certificate of Completion of 
Training on Human Subjects Protection. 

Item 19 below relates to review of the project by the 
Attorney General's Office.  This submission is to be 
handled by the  Division Director and should be done 
prior to submitting the material to the Human Subjects 
Review Board so that any comments from that Office can 
be used by the Board in its deliberations.  The need for 
this is to be handled on a case-by-case basis.  

Once the form below is completed and signed by the 
Researcher and the Division Director, one hard copy 
original of all signed materials, including the 
Investigator’s Agreement, and the Training Certificate, 
should be sent to:  Linda Barnett, Ph.D., Chairperson, 
Human Subjects Review Board, Division of Management 
Services, DHSS, Main Building, Herman Holloway Sr. 
Campus, 1901 N. DuPont Highway, New Castle, DE  
19720.  In addition, all project materials should be sent 
electronically to Dr. Barnett 
(linda.d.barnett@state.de.us).  

If there are any documents not available electronically 
and for those project documents which are extremely 
lengthy, then fifteen paper copies will need to be 
supplied.  For clarification of these instructions, Dr. 
Barnett can be reached at 302-255-9133.





Project Descriptions; check all that apply:

?	Must be HIPAA-compliant; involves protected 
health information maintained by a ‘covered 
entity’  

?	Meets the criteria for exemption from HIPAA 
compliance allowed under 45 CFR Sec 164.512 
(b)(i): involves protected health information 
to be used by a public health authority for a 
public health purpose  

?	Access to protected health information included 
in this project will require tracking on the 
part of _______________________ in order to be 
able to comply with the HIPAA provision that 
individuals, upon request, must be given an 
accounting of certain disclosures of their 
protected health information  

?  No protected health information is involved; 
does not require HIPAA compliance  


1.Title of project


2.Name, address, agency, e-mail address, and phone number of 
principal investigator(s) or project manager(s)


3.Division whose clients/consumers will serve as research 
subjects


4.Name and phone number of Division contact person for the 
project


5.Role of Divisional staff in the project  


6.Purpose of project; hypotheses; or research questions (including 
information to substantiate the scientific merit of the project)  


7.Subjects or Population to be Studied

	a.  Age, gender(s) and approximate number


	b.  Inclusion/exclusion criteria


8.Method(s) of Recruitment, including plan for determining and 
recording reasons for refusal to participate  


9.Compensation/Inducements to Participate:	


10.Method(s) for ensuring participant understanding of the project 
and obtaining prior informed consent and HIPAA authorization – if 
applicable [include copy of form(s) to be used].   


Provide the following information, to document method(s) used to 
maximize participant understanding.  Please elaborate on/explain 
all responses in column two.

Form(s) have been edited to reduce use of 
technical terms/jargon
yes/no
Form(s) have been pre-tested by 
individuals comparable to potential 
participants
yes/no
Form(s) use subheadings
yes/no
Conceptual density has been minimized
yes/no
Active voice is used as much as possible, 
instead of passive
yes/no





 Assistance is planned to ascertain 
participant understanding – such as:
?	having participant read form 
aloud to researcher with the 
option of asking for clarification 
as the reading progresses;
?	having participant rephrase key 
aspects of the information in the 
form, as prompted by the 
researcher; 
?	having participant respond to 
questions designed to elicit 
understanding after going through 
the form independently first;
?	putting a highlighted statement – 
right before the signature line – 
urging the individual to be sure to 
ask the researcher if he/she has 
any questions at all about the 
meaning of anything in the 
consent or authorization form 
(and in the case of materials that 
are mailed to potential 
participants, such a statement 
could remind the individual of  the 
phone number to call to reach the 
researcher)    
Yes/no.  
Readability score of form(s) / scale or 
methodology used






11.Method for dealing with research subjects who choose to 
withdraw from the project and/or revoke their authorization, to 
include procedures for ensuring that participants understand 
these are or can be two separate steps.




12.Description of any protected health information that is being 
requested from DHSS files (or the files of its contractor agencies) 
for this research project, along with the justification for needing 
such information (in order to comply with the “minimum 
necessary” rule in the HIPAA regulations)


13.Methodology and/or description of project approach, including 
description of plans for data collection and methods that will be 
used to analyze data, if applicable (include copies of proposed 
data collection instruments)


14.Methods for ensuring privacy and confidentiality of data 
collected [include copy(ies) of the Notice of Privacy Practices for 
the Covered Entity(ies) which maintain(s) the protected health 
information to be accessed, if applicable] .

	
15.Costs/Funding 

	a.  Cost of project to DHSS


	b.  Funding source(s) 


	c.  Source of funding after research or pilot phase, if 
applicable


16.Timeframe

	a.  Target start date

	b.  Completion date
 

17. Are subjects/clients at risk for any negative impact (often 
referred to as “adverse event”) or consequences on their physical, 
psychological, economic or social well being as a result of 
participation in this project?

If yes, delineate the type of risk(s), the probability of occurrence, 
the anticipated level of severity, and steps to be taken to minimize 
such consequences.


18.Anticipated benefit(s) to subjects or society


19.Review by Attorney General's Office, if applicable 

	a.  Date sent for review

	b.  Feedback received



Submitted by:								   
			Signature of Researcher/Title/Date
My signature attests to my agreement to carry out this 
project in accordance with the principles of the Common Rule 
and the Privacy Rule.
	

Approved by:					                             
             	Division Director/Date
My signature attests to my understanding of and agreement to 
any HIPAA-related obligations imposed by this project, 
including any necessary recordkeeping to be able to account 
for disclosures as mandated by HIPAA regulations.   



Approved by:						
                Chairperson, DHSS HSRB/Date
My signature attests to the fact that this project was 
reviewed and approved by the DHSS Human Subjects Review Board 
/ Privacy Board.


Approved by:								                              
			Secretary/Date	 


DHSS RESEARCH ABSTRACT
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