Attach 3_Example of Past Submission #3

Attachment 3: Pre-Test for Advocates, CARRA Peer Review Workshop

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ID #

MB # 0925-0046-17

Public reporting burden for this collection of information is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0046-08). Do not return the completed form to this address.

Expiry Date: 10/31/2006

CARRA Pre-Training Assessment Form

Please answer the questions below to the best of your knowledge. Your identity will remain anonymous. The ID number in the upper right-hand corner will only be used to match your pre- and post-assessment forms.

1. Please check whether you strongly agree, agree, disagree, or strongly disagree with each of the eight statements listed below.

Statement	Strongly Agree	Agree	Disagree	Strongly Disagree
a. I can explain the process NCI uses to select CARRA members to participate in the peer review process.	□	□	□	□
b. I can explain NCI’s expectations of CARRA members for commenting on scientific research applications during the peer review process.	□	□	□	□
c. I know how to efficiently prioritize the preparation materials I will receive prior to a peer review activity/meeting in which I will participate.	□	□	□	□
d. I feel confident that I can participate in the peer review scoring system for grant applications.	□	□	□	□
e. I am capable of writing a useful critique of a grant application assigned to me.	□	□	□	□
f. I can explain the difference between 1) my role as a CARRA member participating in an NCI peer review, and 2) my role as an advocate for a specific research agenda.	□	□	□	□
g. I would feel confident participating in a peer review meeting.	□	□	□	□

Over →

2. Please read each statement and check if it is true or false.

	True	False
1. NCI’s CARRA staff is responsible for making the final decisions regarding which CARRA members participate in specific peer review activities.	□	□
2. A CARRA member is a full participating member of the review panel and has voting status equal to that of all other voting panel members.	□	□
3. The role of CARRA members on a peer review panel is to share their personal cancer experience, as well as represent people with, and at risk for, cancer.	□	□
4. CARRA members may not participate in any lobbying activities from the time the peer review panel is convened to the time it is officially adjourned.	□	□
5. If you think you may have a conflict of interest regarding the review of an application, immediately contact the nearest NCI Cancer Center to determine whether a conflict exists.	□	□
6. The appearance of a conflict of interest is permitted in NCI peer review if no actual conflict of interest exists.	□	□
7. Because advocates focus primarily on human subjects issues during a peer review, CARRA members are not permitted to use the same review criteria as other review panel members.	□	□
8. CARRA members are responsible for reviewing plans for the inclusion of women, minorities, and children in grant applications and determining if the plans are acceptable, unacceptable, or absent.	□	□
9. Applications are scored on a scale of 1 to 5, with a “1” being the least acceptable and a “5” being outstanding.	□	□
10 The difference between Phase I and Phase II clinical trials is that Phase I trials are done to test a new intervention with a small group of people for the first time to evaluate safety, and Phase II trials are done to test an intervention in a larger group of people to determine efficacy and to further evaluate its safety.	□	□
11. It is important to keep the details of a grant application confidential before and during the review meeting, but it is acceptable to discuss the application with others after the peer review meeting.	□	□
12. A summary statement is prepared after the peer review meeting by the SRA and is based on the individual critiques submitted by each reviewer.	□	□
13. If informed consent documents are not included in a grant application, human subjects will never be involved in the application’s proposed research.	□	□
14. The members of the review panel who score applications include the Scientific Review Administrator (SRA), the chairperson, scientists, consumer(s), and fiscal consultants.	□	□
15. An application’s plan to protect human subjects should address the following criteria: risks to the subjects, adequacy of protections against risks, potential benefits of the proposed research to subjects and others, and the importance of knowledge to be gained.	□	□
16. A plan for monitoring data and safety is not required in applications for Phase I or Phase II clinical trials.	□	□
17. For research purposes, the NIH defines a child as an individual under 18 years of age.	□	□
18. CARRA members should include comments in their written critiques about the research design of an application, which directly or indirectly relate to patient recruitment and retention.	□	□
19. When reviewing grant applications, CARRA members should compare each application to the review criteria, but should not compare grant applications to each other.	□	□
20. Peer review is generally not time consuming, and should on average take about 24 hours spread over two weeks.	□	□ Over→

3. In the past year, have you participated in a grant/contract peer review panel?

□ Yes. If yes, please check all that apply.

□ The National Cancer Institute

□ The Department of Defense (DOD) Congressionally Directed Medical Research Program (CDMRP)

□ Other (please specify agency or organization) ___________________________

________________________________________________________________

□ No

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