About the K Trial - Help us assess the impact of Consultation Services

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 on the Clinical and Translational Science Institute (CTSI) Consultation Services program 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.

You are being asked to take part in this study because you have applied for CTSI Consultation Services to assist you with preparation of your career development grant.

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 Consultation Services, which is funded by the National Institutes of Health (NIH) grant, 1 UL1 RR024131-01.

Who is eligible to participate in this study?

The trial is open to all residents, fellows, or junior faculty members at UCSF and CTSI-affiliated institutions (see list below), applying for a K series grant, with at least three months lead time before anticipated submission and a recognized potential benefit from additional consultation.

Eligible CTSI affiliates are:

  • Kaiser Foundation Research Institute (Kaiser)
  • Children's Hospital Research of Oakland Research Center (CHORI)
  • San Francisco Veterans Affairs Medical Center (SFVAMC)
  • J. David Gladstone Institute
  • Blood Systems Research Institute (BSRI)
  • Jewish Home of San Francisco (JHSF)

How many people will take part in this study?

About 200 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 (see Statistical Analysis Plan).

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

After receiving an initial free hour of consultation, you will be contacted by the Consultation Services 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 Consultation Services 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 CTSI Consultation Services 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, administration will contact you for the scores and the review of your proposal.

What kind of assistance does Consultation Services offer?

CTSI's Consultation Services offers expert faculty consultations in Study Design, Data Management, Biostatistics, Ethics, and Health Policy. Our services are primarily focused on supporting and improving the methodological aspects of your grant. For more details on what we offer, please see our services.

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 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 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.

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 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.

Accelerate is managed by the UCSF Clinical and Translational Science Institute (CTSI), part of the Clinical and Translational Science Award program funded by the National Center for Advancing Translational Sciences (Grant Number UL1 TR000004) at the National Institutes of Health (NIH).

Cite CTSI NIH Funding Acknowledgment: Important — All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH Funding Acknowledgment and must comply with NIH Public Access Policy.