#10_Justif Memo Attach A B_Camp_3-7-2011

Date: March 2, 2011

To: Office of Management and Budget (OMB)

Through: Seleda Perryman, DHHS Report Clearance Officer

Mikia Currie, Program Analyst, NIH Project Clearance Branch, OPERA

Vivian Horovitch-Kelley, NCI OMB Project Clearance Liaison, OMAA

From: Anne Menkens, Ph.D., Program Director

Cancer Imaging Program, Division of Cancer Treatment and Diagnosis (DCTD)

Nina Goodman, Project Officer

Office of Communications and Education (OCE), National Cancer Institute/NIH

Subject: Bundled Generic Sub-studies “NCI Cancer Research Imaging Camp” under “Formative Research, Pretesting, and Customer Satisfaction of NCI’s Office of Communications and Education,”

OMB No. 0925-0046-10, Expiry Date 02/28/2013

Background, Need and Use of Information

The National Cancer Institute supports an annual educational opportunity entitled “NCI Cancer Research Imaging Camp”. The goal of this 6-day, intensive training course is to educate early career-level cancer scientists in the specifics of in vivo imaging modalities. Through lectures and hands-on laboratory sessions, participants gain experience with a wide range of imaging modalities, including advanced optical imaging, MRI, PET, SPECT, CT, and ultrasound. After the completion of this course, participants should be able to select and apply the appropriate in vivo imaging techniques necessary to investigate a biological hypothesis and to interpret the resulting imaging data.

The Cancer Imaging Program, part of the Division of Cancer Treatment and Diagnosis (DCTD), in collaboration with the NCI Division of Cancer Biology, offers a NCI Cancer Research Imaging Camp. This camp was first offered in 2007 and has been offered each year since. Approximately 25 students attend this course each year. To ensure that the Camp is successfully meeting its goals, we are requesting approval to contact the students who have completed the course and ask them to answer a few questions pertinent to their abilities to integrate in vivo imaging into their current research.

The goal of the NCI Cancer Research Imaging Camp is to provide young scientists with the knowledge to efficiently and effectively integrate in vivo imaging into their research. It is important to know whether the Camp curriculum and format are actually accomplishing that goal. The responses by students who have been trained through Camp will provide that critical information and practical utility; this project will determine whether the NCI should continue the effort in its previous format, change the format, or terminate the program. To date, no other evaluation has been performed.

Participants, Research Instrument and Methodology

The participants will be former and new students who have completed the NCI Research Imaging Camp. To date, 86 students have completed the camp. These students will be located through the contact information they provided when they attended the camp. These 86 students will be surveyed in FY11 and FY13. An additional 25 new students will participate in both FY12 and FY13 for a total of 50 new students. Those 50 students will be surveyed in FY13 .

An invite letter with the link to the web-based survey will be sent to the student’s last known email address (Attachment 10A). Additionally, the invitation letter will include a consent form which can be read and confirmed on-line prior to the survey (Attachment 10B and 10C).

The students will be asked to answer 5 questions:

• Did the knowledge that you gained at the Camp Research Imaging Camp directly impact your research? If so, how?

• Did your experience at the Cancer Research Imaging Camp directly impact your ability to form and sustain productive scientific interactions with imaging scientists (collaborations, mentoring, improved interactions with imaging scientists, etc.)? If so, how?

• Were there unexpected benefits or outcomes following your completion of the Cancer Research Imaging Camp? If so, what were they?

• Do you have any other comments or suggestions regarding the Cancer Research Imaging Camp content or format?

• Would you like an NCI staff member to contact you and follow-up on your comments/suggestions? If so, please provide contact information below.

Surveys will be analyzed using qualitative analysis methods to determine themes and concepts. We will summarize and categorize key themes to determine the depth and quality of the training experience. This information will be used to possibly modify the format and content of subsequent Camp training sessions, but will not change the content of the questionaire. Names or identiers will not be associated with the data.

The survey does not ask for any personally identifiable information (PII) unless they specifically ask to be contacted). The student’s responses will not be linked to their contact information. Respondents will not be provided payment or gifts/trinkets. We would like to collect data 2 times over the next three years, prior to the expiry of this generic.

Other Considerations

An application for exemption has been submitted to the Office of Human Subjects Research (OHSR) and is pending. The information collected from this survey will be reviewed by NCI Staff and the faculty of the Camp. The information collected with be used solely to modify the curriculum and format of the Camp if necessary. No publications are planned.

Burden

The survey should take participants less than 10 minutes to complete. A response rate is anticipated to be 85% and with some flexibility it is expected that the maximum number of students expected to complete the survey will be 110. The total respondent burden for this effort is estimated to be 17 hours. This effort will account for less than 1 percent of the total burden hours granted in the full generic OMB clearance package. To date, a total of 1691 burden hours have been used of the 7050 hours that were requested.

Estimates of Total Burden Hours
Types of Respondents	Number of Respondents	Frequency of Response	Average Time Per Response (Minutes/Hours)	Total Hour Burden
Former Students	70	1	10 (0.167)	12
New Students	30	1	10 (0.167)	5
Totals	110			17

List of Attachments (attached below)

10A: Invitation Email letter

10B. Consent Form

List of Attachments (in a separate file)

10C. NCI Cancer Research Imaging Camp Survey

Attachment 10A: Invitation Email Letter

Dear NCI Cancer Research Imaging Camp Attendee,

On behalf of the National Cancer Institute, NIH, we would like to thank you again for attending the NCI Cancer Research Imaging Camp.

In order to understand how the knowledge gained during the Camp may have impacted your research career, we invite you to provide feedback to the NCI. Your responses will be very important as we assess the utility of the Camp for future students. This survey will take less than 10 minutes of your time. Attached is the consent form that provides more information.

You can access the survey by going to: http://www….

Thank you for taking the time to respond, and please contact me directly if you have additional questions.

Anne

_______________________
Anne E. Menkens, Ph.D.
Program Director
Cancer Imaging Program
National Cancer Institute
National Institutes of Health
EPN 6068
6130 Executive Boulevard
Rockville, MD   20892 (20852 for express mail)
Tele#:  301-496-9531
Fax#:  301-480-3507
e-mail:  am187k@nih.gov

Attachment 10B: Consent Form

Informed Consent Form

Identification of Project	NCI Cancer Research Imaging Camp
Purpose	The National Cancer Institute (NCI) proposes conducting a questionnaire to students that have completed the 6-day Cancer Research Imaging Camp.
Procedures	NCI proposes a Web-based survey which will be sent to new and former students to complete once.
Confidentiality	All information collected in this study will be kept secure to the extent permitted by law. I understand that the data I provide will be grouped with data others provide for the purpose of reporting and presentation and that my name will not be used
Risks	I understand that the risks of my participation are expected to be minimal in nature.
Benefits, Freedom to Withdraw, & Ability to Ask Questions	I understand that this study is not designed to help me personally but that the investigators aim to use the data to improve the curriculum and format of the NCI Cancer Research Imaging Camp if necessary. I am free to ask questions or withdraw from participation at any time and without penalty.
Contact Information of Investigators	Name: Anne Menkens, Ph.D. Position: Program Director Telephone: 301-496-9531 Email: am187k@nih.gov

Printed Name of Research Participant _____________________________

Signature of Research Participant ________________________________

Date______________________

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