Attachment 9 IRB Approval

Salazar, Silvia (NIH/NCI) [E]
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Eiserman, Julie (NIH/OD) [C]
Friday, May 29, 2015 12:07 PM
Ousley, Anita (NIH/NCI) [E]
Bridge, Heather (NIH/OD) [E]; Salazar, Silvia (NIH/NCI) [E]
RE: Follow-up on Call about IRB determination

Thanks for contacting us Anita.  Based on our conversation and my review of the description below, I agree that your 
planned activity is solely a quality assessment or quality improvement activity, and  does not  falls within the scope of 
the definition of research under DHHS regulations (45 CFR 46).  As you implied in your email, the definition of ‘research’ 
under the regulations, is the following: “a systematic investigation , including research development, testing and 
evaluation, designed to develop or contribute to generalizable knowledge”. Investigations designed to develop or 
contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize 
findings beyond a single individual or internal product, service or program. Accordingly, there is no need for you to 
submit a request for a determination to our office. 
Feel free to contact us again whenever you have questions. 

Julie M. Eiserman, MA, CCRP [C] 
Health Science Policy Analyst 
Office of Human Subjects Research Protections 
Office of Intramural Research, Office of the Director 
National Institutes of Health 
10 Center Drive, Bldg. 10, Suite 2C146 
Bethesda, MD  20892‐1154 
Direct Phone: 301‐402‐8665 
Fax: 301‐402‐3443 
Email: julie.eiserman@nih.gov 
OHSRP website: https://federation.nih.gov/ohsr/nih/index.php (NIH login required) 
Public site: http://ohsr.od.nih.gov/  

From: Ousley, Anita (NIH/NCI) [E]  
Sent: Thursday, May 28, 2015 4:02 PM 
To: Eiserman, Julie (NIH/OD) [C] 
Cc: Bridge, Heather (NIH/OD) [E]; Salazar, Silvia (NIH/NCI) [E] 
Subject: Follow‐up on Call about IRB determination 

Julie, 

Thank you, and thank you Heather, for talking with Silvia and I today about IRB determination for our usability testing 
program. It was very useful.  As I mentioned on the call, we are preparing the OBM clearance package for submission 
and one of the items it requests is the IRB approval.  Below is a description of the program. 

NCI AARB plans to schedule bimonthly Open Call website usability testing sessions starting in FY 2015 to inform revisions and improvements to the
NCI website. These regularly scheduled usability testing sessions will provide an opportunity for NCI web portal managers, designers, content
managers, application designers, and communications practitioners, to better understand if the website information meets the needs of the users.
With a regular schedule of sessions, usability testing can be easily and quickly included for testing the Cancer.gov and Cancer.gov/espanol, without
creating a special project or schedule. This will also lead to a greater understanding of appropriate and effective content, structure, navigation and
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presentation of information on cancer.gov pages. This is a quality assessment and improvement program and the data collected is strictly about the
product/service of interest. The results will be used for improving NCI communication products and will not be generalizable.

Would you please let us know if this project needs to be submitted to your office for IRB determination? 

Thank you, 
Anita 

Anita Ousley, PhD 
Acting Branch Chief 
Analytics and Audience Research Branch 
Office of Communications and Public Liaison 
National Cancer Institute  
9609 Medical Center Drive, Room 2E‐302 
Rockville, MD  20850 
Phone:  240‐276‐6629  

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