University of California, San Francisco s3

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO INFORMATION SHEET ON PARTICIPATION IN A RESEARCH STUDY

Study Title: Impact of Extensive Consultation on Career Development Grant Outcomes

This is a research study about whether extensive (up to 15 hours) multidisciplinary consultation in biostatistics, study design, data management, ethics, and writing improves peer reviewed scores of career development grants. The study administrators working for Clay Johnston, M.D. on the Clinical and Translational Science Institute (CTSI) Biostatistics, Research Ethics, and Design (BREAD) will explain this study to you. Research studies include only people who choose to take part. Please take your time to make your decision about participating, and discuss your decision with your family or friends if you wish. If you have any questions, you may ask the researchers.

Why is this study being done? The purpose of this study is to collect data on the effectiveness of extensive (up to 15 hours) multidisciplinary consultation in biostatistics, study design, data management, ethics, and writing by comparing outcomes: peer reviewed scores and funding career development grants between those who have received extensive consultation services and those who have received the usual levels of consultation services.

This study is part of CTSI BREAD, which is funded by the National Institutes of Health (NIH) grant, 1 UL1 RR024131-01.

How many people will take part in this study?

About 150 researchers will take part in this study, 75 assigned to each arm. We plan to recruit 150 participants who are not enrolled in other mentoring programs for the primary analysis. Resources permitting, we also plan to recruit and randomize participants who ARE enrolled in other mentoring programs for secondary analyses.

What will happen if I take part in this research study?

After receiving an initial free hour of BREAD consultation, you will be contacted by the BREAD administration and asked if you would like to participate in this study. If you agree, you will be randomized to either:  Receive an extensive multidisciplinary consultation that may include up to 15 hours of free service from expertise represented in the CTSI BREAD program, including biostatics, study design, data management, ethics, and scientific writing. You will then be assigned to a research design consultant, who will act as a primary study contact and will assist in the development of a timeline and consultation plan.  OR receive the usual levels of BREAD support, with up to 3 additional hours of free consultation (up to 1 hour in each of four units: biostatistics, ethics, research design, and data management) and the availability of additional consultation at standard recharge rates.

Following receipt of your scores for your proposal, BREAD administration will contact you for the scores and the review of your proposal.

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How long will I be in the study?

You will receive consultation services for up to three months prior to the submission of your career development award. You will be contacted by the CTSI BREAD administration following the receipt of the scores for your grant proposal.

Can I stop being in the study?

Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you wish to stop being in the study.

What side effects or risks can I expect from being in the study?

The proposed trial is associated with minimal risk to subjects due to loss of privacy and confidentiality. There is a risk of loss of privacy and confidentiality since the study will collect, analyze, and report results of the reviews of grant proposals.

Are there benefits to taking part in the study?

Yes, for those selected to receive extensive free service they will have an uncommon opportunity to work with highly experienced consultants. No services normally available are being denied subjects.

What other choices do I have if I do not take part in this study?

You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. You will still receive up to four hours of BREAD consultation services at no charge to you. You may still obtain additional hours of consultation services at the standard recharge rates.

Will information about me be kept private?

We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

What are the costs of taking part in this study?

You will not be charged for any of the study treatments or procedures.

Will I be paid for taking part in this study?

You will not be paid for taking part in this study.

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What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. You will not lose any of your regular benefits.

Who can answer my questions about the study?

You can talk to the researcher(s) about any questions or concerns you have about this study. Contact the researcher(s)_Mark Pletcher, MD, MPH__ at _415-514-8008_.

If you have any questions, comments, or concerns about taking part in this study, first talk to the researcher (above). If for any reason you do not wish to do this, or you still have concerns after doing so, you may contact the office of the Committee on Human Research, UCSF's Institutional Review Board (a group of people who review the research to protect your rights).

You can reach the CHR office at 415-476-1814, 8 am to 5 pm, Monday through Friday. Or you may write to: Committee on Human Research, Box 0962, University of California, San Francisco (UCSF), San Francisco, CA 94143.

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