Comment 1: Who has a K24 at UCSF? The Clinical & Translational Science Institute offers latest information of UCSF K24 awardees.

Comment 2: The Society of General Internal Medicine has developed a resource list of SGIM members with K24 awards who are willing to make themselves available to members who are interested in learning more about their work and the K24 process. Just search the site for the list!

Comment 3: Sample K24's and K24 renewals. The Career Development Library established by the Clinical & Translational Science Institute (CTSI) offers successful K08, K23 and K24 grants. If you want to access them, contact ctsi@ucsf.edu. The formatting and emphasis has changed over the years, review your institutes guidelines carefully. If you have had a successful K24, please add to the K Career Development Library!

Comment 4: There is general information about Midcareer Investigator Award In Patient-Oriented Research (K24) available. For those of you considering applying for a K24....now is the time! The NHLBI has just changed to a maximum of 25% salary support for 5 years and it is in the rumor mill that other institutes will follow.....if you already have one...you are “grandfathered” or “grandmothered” in.....

Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.

FYI:
NHLBI Specific Information: Beginning with New (Type 1) K24 applications submitted to NHLBI for the application date of February 12, 2011 and beyond, the total maximum length of K24 support will be 5 years. NHLBI will not accept Renewal (Type 2) applications for these K24s (a new mechanism will be announced for Professors).
NHLBI will only accept new K24 applications submitted to NHLBI February 12, 2011 and thereafter that request 3.0 calendar months’ effort (25%). Applications requesting above 25% effort will not be reviewed.

Comment 5: Each institute sets its own rules, so some may allow Ph.D.s that don't see patients and some may allow Professors to apply for the first time. Talk with the program officer for K's at your institute. In general, most institutes are not willing to give these to Professors for the first time.

Comment 6: In my first application, the reviewers seemed not very interested in my mentoring and mostly interested in my research. It took two applications. For my K24 renewal, the mentoring plan was the focus. The project officer said the instructions for reviewers had changed and there was more of a focus on the mentoring. The review committee was very impressed with the MTP activities I was involved in.

Comment 7A: Know your study section—a colleague and I both submitted to the NIA and due to our different areas of research were sent to two different study sections... with very different flavors of what they wanted.

Comment 7B: I learned a valuable lesson this week. I was not aware that the K-awards go to an NIH-institute specific study section.

For my K24, I wrote a grant focused on my last R01. However, because my last R01 was funded by the XXXX institute and my K24 went to an XXXX study section. In short, my K24 grant went to the wrong study section and the wrong NIH institute and although scored, it did not do well.

Comment 7C: With only 2 submissions now, it is really important it goes to the correct group...lots of contact with the correct project officer and NIH institute prior is essential....and some institutes have more than one K award review group....so making sure it goes to the correct one is essential. Your work is not over once you submit the K24: Follow your K24 on eRA Commons- it can easily get sent to the wrong institute and or study section.

Comment 8: A colleague was told they could not receive a K24 because they were a professor, while another colleague received pre-approval from their institute, and this colleague was a Ph.D. that did not see patients but also received pre-approval by the project officer to apply. Later, they were told the institute would not give any K24's to Professors even though they had given pre-approval.

Comment 9: I applied for a K24 to the National Cancer Institute; the project officer told me I needed to apply for a K05 because I did database analyses, so they just made it a K05.

Comment 10: Randall F. Holcombe discusses in his article Reengineering the Clinical Research Enterprise: Will the New Vision for Translational and Clinical Science Be Successful without More Support for Mentors? why mentoring for clinical and translational researchers is crucial, and he reveals several gaps in the award system, for instance that "clinically or patient-oriented awards that require mentors rarely support mentoring activity and do not allow direct funding of a mentor’s salary."

Abstract: Dr. Zerhouni, director of the National Institutes of Health (NIH), recently unveiled his vision for the restructuring of clinical and translational research.1 In this plan, academic centers would function as homes that combine basic science, clinical research, and training under an infrastructure supported by Clinical and Translational Science Awards (CTSAs; RFA-RM-06-002).2 A major component of the CTSA involves the training of a new generation of clinical and translational researchers. Such training requires infrastructural support and a core of experienced mentors. I and many of my colleagues are concerned that insufficient emphasis is being given to the support of clinical research mentoring. Even with very substantial progress over the last decade and the development of several new NIH programs and awards with an emphasis on clinical or patient-oriented research training, more can be accomplished. Now represents an opportune time to dispense with existing myths and start afresh.

Comment 1: There is lots of information at the NIH Data Book on success of grants, institutes.

Comment 2: It would be very helpful to look all through the NIH RePORT (Research Portfolio Online Reporting Tools).

Comment 3: It will depend on the institute. In general, you have to show you are an independent investigator (current grants), and that you have a history of mentoring. If you are interested in taking on a Mentoring leadership role in the CTSI Comprehensive Mentoring Program: contact Jeanette S. Brown.

Comment 1: In general, the first question is what the grant is needed for: salary support (i. e., Career Development Award) or research support?

Comment 2: I guess my idiosyncratic view is that getting stable funding—even K awards—depends on having deep expertise, creativity, research skill and commitment to an important idea. Playing the game well (with the assistance of all the resources) helps but cannot spin gold from straw. So, as a curmudgeon, I would recommend that the mentors spend less time trying to figure out how to get their mentees funded and more time ensuring the mentee has the desire, expertise and a clear vision of what is important for a research career. If they lack those, I think they shouldn't just play the funding game to 'build a career.'

Comment 3: Remind mentees about the Loan Repayment Programs. The NIH will repay up to $35,000 annually of qualified educational debt for health professionals and also provides coverage for Federal and state tax liabilities. To qualify, applicants must possess a doctoral-level degree, devote an average of 20 hours per week or more to research funded by a qualifying domestic non-profit organization, university, or government entity (NIH grant support is not required).

Comment 4: Grant Writing Workshops—Clinical & Translational Science Institute and Department of Epidemiology/Biostatistics sponsor a Training in Clinical Research Program open to the entire UCSF community free of charge. Previously presented by Tom Mitchell and examples of presentations can be found at: K-Grant-Writing page. Currently, you can sign up for the Advanced F, K, R, Grant Writing workshop. You can also sign up for individual workshops at the Office of Career & Professional Development.

Comment 5: CTSI's Consultation Services (formerly BREAD) program provides services to help investigators at UCSF and affiliated CTSI institutions meet these challenges successfully and produce research of the highest scientific and ethical standards. Initial consultations are free of charge, with subsequent services provided on a recharge basis.

Comment 6: The School of Medicine offers information on current funding opportunities.

Comment 7: UCSF Intramural Grants—The focus here is on new investigator awards although others are available too. In general, it is expected that work supported by these funds will lead the applicant to outside (extramural) funding. As a result, successful applications are usually well focused and present a clear pathway from the applicant's present state to the acquisition of extramural funding.

The Resource Allocation Program, catalyzed by the Clinical & Translational Science Institute brings together grant programs currently administered by many groups. There are many funding opportunities now available for pilot studies, translational technologies and novel methods, planning grants, and career development.

RAP is recruiting a panel of reviewers with appropriate expertise to evaluate proposals in multiple areas of basic, clinical and translational research. These reviewers will be called upon as needed to review proposals in which their expertise is required. If you are interested in participating as a potential reviewer, please send a note to rap@ucsf.edu with your name and areas of expertise for reviewing proposals (up to 10 key words).

Comment 8: The Academic Senate has travel grants.

Comment 9: There is the UCSF Bridge Funding Program for faculty in the ladder rank, in residence, and adjunct series, which will provide temporary (six months to one year) and partial support during continuing efforts to obtain full funding. Support for faculty who are likely to be funded upon submission of amended applications (based on scores and comments in previous round(s) of review). Priority will be given to faculty with experienced research teams threatened with disruption, and to new investigators with two or more rounds of well-scored but unfunded federal agency applications who are within one year of exhausting all available startup funds. Get updated info from: Keith Yamamoto, Ph.D.

Comment 10: There are Mount Zion Health Grants available, maximum: $30,000. It is expected that the request will have value to the Mount Zion Campus, usually for education, patient services, start up programs, but not research. For general information and grant application: Carrie Louie carrie.louie@ucsfmedctr.org Administrative Analyst to Jeffrey Pearl, M.D. The deadlines are rotating and there is a broad range of granting areas. Carrie Louie can answer many administrative questions and Dr. Pearl can provide insights if there are funds for the granting area.

Comment 11: Consider Societies and Foundations in mentee's areas of interest: American Heart Association, American College of Obstetricians & Gynecologists, American Urologic Association etc. The mentee should consult with all of their mentors for possible leads.

Comment 12: The Clinical & Translational Science Institute offers a list of funding opportunities and a Successful Grants Library.

Comment 13: Many pharmaceutical companies offer career development awards and investigator-initiated grants in their areas of interest. Mentees should consult with all of their mentors for possible leads.

Comment 1: The Irene Perstein Award by The School of Medicine for the recruitment of outstanding junior women clinician scientists. Eligible candidates include all women who will be appointed at the assistant professor rank, regardless of series, who will develop high caliber independent research programs in clinical or translational science. Up to $175,000 will be awarded to two candidates per year over the next four years. Nominations must come from the chair and include a one page description of the anticipated research program and a current CV. Applications should be addressed to Donna Ferriero MD, Vice Dean of Academic Affairs, Box 0410.

Comment 2: The Clinical & Translational Science Institute provides an overview about awards for career development of junior faculty at UCSF.

Comment 1: Grant Writing Workshops are useful. Are there departmental resources available like a scientific writer?

Comment 2: CTSI's Consultation Services (formerly BREAD) program provides services to help investigators at UCSF and affiliated institutions with grant applications.

Comment 3: Clinical & Translational Science Institute offers a list of all K grant types pertinent to the junior investigator (UCSF K awards as well) with links to the NIH description, awardees at UCSF including the NIH institute, abstract, and contact information. Contact specific UCSF K Awardees to get insights on your institution & application. CTSI also provides a Successful K Proposal Library with examples of successful K08 and K23 grant applications. This resource, available only for UCSF investigators, was made possible by the generosity of individual successful investigators, to whom we are very grateful.

Comment 4: It is important for the mentee to understand what institute(s), divisions, and staff that pertain to their research. The mentee can be encouraged to surf the NIH web, identify potential project officers and begin the discussion early in their process. Each institute also has an annual report identifying the institute's areas of interest. Also, encourage the mentee to talk to multiple NIH staff for advice. A visit to NIH program staff while in DC for a conference or other reasons is also very worthwhile.

Comment 5: Assist your mentee with establishing a timeline for their grant: written products, team, and ongoing meetings with you and co-mentors.

Comment 6: Find a model proposal.

Comment 7: What is the mentee's funding portfolio, including this grant if received?

Comment 1: Mentored K award applications consist of two key components: a career development plan and a research plan. Many applicants for K awards (and their mentors) focus on developing a strong research plan and do not develop an equally strong career development plan. While the research plan in a K award application is important, many K award applications are not funded because the career development plan is weak. It is not difficult to develop a strong career development plan. Here are three important tips that will help mentees develop a strong career development plan that is likely to be well received by reviewers. For even more details: See K-Grant Writing Web page.

• Tip 1: Understand the intent of the mentored K award, which is to help new investigators achieve independence (i.e., to compete successfully for R01-level funding). Therefore, the training plan and the research plan should provide mentees with both the skills and the preliminary data they will need to write a competitive R01 grant application at the end of the K award. How the training plan and the research plan are designed to achieve this goal needs to be made explicit so reviewers will understand the logic of the career develop plan underlying the K award application.
• Tip 2: Make a compelling argument why the mentee needs a mentored K award. Mentees need to explain how additional training and mentored research experience will enable them to compete successfully for R01 funding. Be specific: Give concrete examples of areas where additional training and/or research experience is needed in order to conduct the research proposed in the K award or areas where the mentee is deficient that are directly related to his/her long-term research career goals.
• Tip 3: Develop a career development plan that is uniquely suited to the mentee and that fully exploits the training opportunities available to them. Given their previous training and research experience, mentees should propose a mix of didactic training and hands-on research experience that makes perfect sense for them. For mentees who are planning to conduct patient-oriented research, degree-granting programs (e.g., M.P.H.) are appropriate for those with little or no previous formal training in clinical research methods; however, even these programs should be "customized" whenever possible. For mentees with substantial previous formal research training (i.e., Ph.D.s), a training plan that emphasizes hands-on research experience is appropriate. For all mentees, however, reviewers expect them to fully exploit the training resources available to them.

The career development plan in a mentored K award is presented in Section 1 (called "The Candidate"). This section has 3 sub-sections: (1) Candidate's Background; (2) Career Goals and Objectives: Scientific Biography; and (3) Career Development Activities during Award Period. Here are some general tips on what to emphasize in each of these subsections.

The Candidate's Background: In this section, we provide evidence that the mentee is an ideal candidate for a mentored K award. Using their NIH biosketch as a guide, mentees should provide a personal narrative of their professional career, explaining why they made key career choices (e.g., pursuing specific training opportunities or research projects). They should give examples of the opportunities they've had to engage in research (basic or clinical), as evidence of their long-standing commitment to research. To convince reviewers that the mentee is an outstanding candidate for a K award, we must include evidence of their creativity, resourcefulness, and productivity (e.g., pursuing a specific research question, analyzing data, presenting results at scientific meetings, and publishing in peer-reviewed journals).

Career Goals and Objectives: Scientific Biography: In this section, we explain how further training and mentored research experience will enable the mentee to achieve independence (i.e., to compete successfully for R01-level funding). The research plan proposed in the K award should include some specific "challenges" for which the mentee needs additional training and/or mentored research experience to accomplish successfully. These "deficits" in their training/research experience then become the focus of their career development training plan.

Career Development Activities during Award Period: In this section, we describe how the mentee will acquire additional training and mentored research experience. List and describe specific areas where the mentee has deficiencies (e.g., primary data collection, longitudinal data analysis) and explain why gaining additional training and mentored research experience in these areas is critical to achieving the mentee's short-term and long-term career development goals. For each area where additional training is required, the mentee should describe the specific training they will pursue to acquire these skills (e.g., specific courses, individualized tutorials with local experts, hands-on experience gained from conducting specific research projects).

Examples of Section 1 from recent K23 award applications that have been reviewed at the NIH. (UCSF only — see Choi K23 Section 1 or Collard K23 Section 1.)

Comment 2: It is very important to explain gaps in a CV; you should avoid assumptions by reviewers...they can come to the wrong conclusion.

Comment 3: Often the K award is being awarded not only to the junior faculty, but also to the primary mentor. Their letter needs to be strong and they need to be an established scientist with resources. The support letter should include many specifics, for example exact role the lead mentor will play, how often you will meet, what resources will be shared.

Comment 4: I serve as a reviewer for K grants: Publications are important. If I see an application with many abstract presentations and no or few publications, I often wonder how successful the applicant will be.

Comment 5: Linking resources to the K awardee: There are CTSI resources, K30 (ATCR). Often it is helpful if the primary mentor has a K24.

Comment 1: There is the Clinical and Translational Science K-scholars(CTSK) Program Infrastructure for Recipients of K23 and other Career Development Awards. It is to provide clinical and translational research training and mentored support to individuals with career development awards at UCSF as a component of the CTSI KL2 Program.

Comment 1: Underrepresented minorities include African Americans, Hispanics, Native Americans, Alaska Natives, Natives of Hawaii and non-Asian Pacific Islanders. The National Institutes of Health (NIH) allow host institutions to define underrepresented minorities. In the past UCSF has included Filipinos as Pacific Islanders who are underrepresented in research.

Individuals from disadvantaged backgrounds are defined as individuals who come from a family with an annual income below established low-income thresholds. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL); Loans for Disadvantaged Student Program; or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

Individuals who come from a social, cultural, and/or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Comment 2: The NIDDK Mentored Clinical Scientist Award to Promote Diversity in Health-Related Research(K08) provides an opportunity for specialized study in NIDDK-relevant research areas for clinician scientists committed to a career in laboratory or clinical research. It is a three year career development award made to clinician scientists from diverse backgrounds including individuals from underrepresented racial and ethnic groups and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.

Comment 3: There are Research Supplements to Promote Diversity in Health-Related Research for Principal Investigators holding specific types of NIH research grants and administrative supplements to improve the diversity of the research workforce by supporting and recruiting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented. You may submit (an) application(s) if you are the Principal Investigator, at a domestic institution, who holds an active R01, R10, R18, R22, R24, R35, R37, R43, R44, R41, R42, P01, P20, P30, P40, P41, P50, P51, P60, U01, U10, U19, U41, U42, U54, or S06 grant. Because policies may vary among awarding components regarding eligibility of Small Grant Awards (R03), Academic Research Enhancement Awards (R15), or Exploratory/Developmental Grants (R21) for supplements under this program, grantees holding those awards must check with the appropriate awarding component before submitting an application for a supplement.

Direct costs for individual administrative supplements vary from less than $5,000 to more than $75,000 depending on the career level of the candidate.

Comment 4: The Mentored Career Development Award to Promote Faculty Diversity/Re-Entry in Biomedical Research (K01) provided by the National Heart, Lung, and Blood Institute solicits applications "to increase the number of highly trained investigators, from diverse backgrounds or who have experienced an interruption in their research careers, whose basic and clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary, hematologic, and sleep disorders in the general and health disparities populations. This FOA is a three-to-five-year award made to faculty members who are currently underrepresented on faculty at academic institutions in health-related research on a national or institutional basis, such as individuals from racial and ethnic minority groups, individuals with disabilities, individuals from disadvantaged backgrounds or individuals who have experienced an interruption in their research careers. This strategy will establish a cadre of biomedical and behavioral researchers from diverse backgrounds that will significantly contribute to reducing and ultimately eliminating health disparities and assist basic and clinical scientists to re-enter active careers in science and academic medicine.

Comment 5: As a minority physician scientist, I have always been discouraged from applying for minority based awards. The reason being is that colleagues often frown on these awards as being "second class." There is an unexpected cost associated with these awards. Personally, I have advised other mentees to compete like everyone else.

Comment 6: The ethnicity breakdown for UCSF faculty indicates fewer than 2000 faculty members self identify as Hispanic. Just as it for the US census, it is important, from an institutional standpoint for faculty members to adequately self identify so that gains in diversity support can be adequately documented. Race/ethnicity is only a data point that reviewers might consider when scoring grants. Ultimately, the score reflects the scientific merit of the application.

Comment 1: Yes, call as the lead mentor. I have called for mentees to find out what the skinny is...when is council...what priorities are there? What are their chances? Should they send supplemental materials? Anything else they can do?

Comment 2: For some background info, the Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH.

Comment 1: Read details here: http://grants.nih.gov/grants/new_investigators/ Definition of Early Stage Investigator: A Program Director/Principal Investigator who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).Talk to your project officer!

Comment 1: It is now important to have a NIH eRA Commons number to track your grant and make sure it goes where it is supposed to go.

Comment 1: In phone calls by other lead mentors to colleagues at the NIH Institute X, it might become clear that the NIH Institute X project officer is well respected. A letter of complaint should not be sent because the mentee might be working to establish a long-term relationship with the institute and project officer.

As for the resubmission of K award, several more phone calls toNIH Institute X, including one all the way up to the Deputy Director could be made to ask for advice and assistance. In this scenario it turned out that the payline changed to 145 and the original K was funded prior to the resubmitted K review. It happens and you should always re-submit because this may not happen.

Comment 1: The Method to Extend Research In Time (MERIT) is awarded by the institute to persons with RO1 funding. An institute may give out 0-15 or so awards each year. It provides salary support and other support for 5 years and can be renewed for 3-5 years. Each NIH Institute has its own MERIT.

MERIT examples:

National Institute of Allergy and Infectious Diseases

National Institute of General Medical Sciences

National Institute of Diabetes & Digestive & Kidney Diseases

Comment 2: MERITs are hard to get, and you are supposed to be invited by the institute. I have mentioned it a few times, but haven't been offered one.

Comment 3: You have to be R01 funded at the time to get a MERIT.

Comment 4: Update: the NHLBI is no longer making new awards using the Method to Extend Research in Time (MERIT) Award (R37) funding mechanism.

Comment 1: The UCSF Center for BioEntrepreneurship educates, enables, and empowers researchers to develop innovative and commercializable technologies through industry partnerships.

Comment 2: The Small Business Innovation Research (SBIR) grant program provides early-stage Research & Development funding directly to small technology companies (or individual entrepreneurs who form a company). NIH and other federal government agencies sponsor grant programs specifically targeting small businesses (SBIR/STTR) and academic-industry collaborations. These grants provide unique opportunities for funding principal investigators to partner with industry.

Comment 3: The Department of Defense (DoD) SBIR/STTR programs fund a billion dollars each year in early-stage R&D projects at small technology companies—projects that serve a DoD need and have commercial applications.

Comment 4: The Defense Advanced Research Projects Agency (DARPA) manages and directs basic and applied R&D projects for the DoD, and pursues research and technology where risk and payoff are both very high and where success may provide dramatic advances for traditional military roles and missions.

Comment 5: University of California Discovery Grants provide matching funds for industry-sponsored cooperative research between California R&D companies and UC academic researchers.

Comment 1: The School of Medicine Travel Award Program supports faculty development by providing one award of up to $2,000 to finance child, elder, or other dependent care expenses while faculty travel to conferences.

Regardless of series, all Assistant, Associate, and Full Professors are eligible for one award. Faculty members who have received a Travel Award are not eligible for a second award. Funding must be requested in advance of travel, and the presentation of research at the conference is required.

The application must include a budget about how funds will be used to support care for child, elder, or dependent care expenses related to attending either at the meeting or at home, a one paragraph explanation about why this funding is important for you, identification of the conference, as well as its location and dates, and an explanation of how your presence at the meeting will help your career advancement.

Application form (updated 02/20/2013)

Comment 1: The CTSI Consultation service at UCSF provides an initial free hour of consultation for any clinical/translational researcher at UCSF regardless of rank. The mentor should ask the mentee to submit a request to CTSI for a free hour of Study Design and another free hour of Biostatistics time to help her design the study. Additional consultation hours are charged at the rate of $150 per hour. The mentor should work with the mentee on the recommendations from these consultants and work with the mentee on taking more formal training in clinical research (ATCR, Master's program at UCSF) in order to have a sustainable career in clinical research.

Comment 1: Some additional details would be useful on this one. If the faculty member is maxed out on their %effort allowed by NIH then it's a UC and federal policy issue and any dept requiring this is at risk (certainly ethically) to 'require' this. First, the most obvious answer is to write (so its documented) an email to the chair (or whoever is 'requiring' this effort) and state that although they understand the importance of the grant, they have previous federal grants that in total require all of his/her effort. To do otherwise will "not only compromise the quality of my current funded research but also of the development of the new proposal. (if they are also NIH % maxed they could add) I am also ethically uncomfortable breaking UC and federal policy on effort reporting and maximum allowable %effort." If there is another PI who will be listed as the lead and they only want them to ghost write the grant (again ethically questionable) then perhaps they could offer to write one section/portion and state that that is all they are able to contribute (put some boundaries to it rather than doing the whole thing). As above, perhaps there is a vice-chair or more senior faculty that could intervene with the chair (if that's who's 'requiring' this effort). Sometimes just writing an email stating what they have probably verbally asked of them. Such as (in email documentation—this may be needed to protect them but may also take care of the unreasonable request because they don't want to document it). For instance, "I am writing to confirm what you are asking of me. To be sure you know my situation; I am currently maxed out on percent effort by NIH regulations and indeed my actual time availability. I am concerned that this will not only compromise the quality/timeliness of my currently funded research but also the development of this new proposal. More importantly, that this puts my appointment at UC and eligibility for future NIH funding at risk by disregarding this policy. Is there a section of the proposal [or whatever you find reasonable] that I might contribute to which I could prepare over the weekend(s) which only compromises my family time temporarily and does require me to compromise my ethics?"

Comment 2: This description is too vague to answer. Do you mean that the faculty member has 100% salary funding from NIH? If so, this is not legal, as all faculty need to have some time (generally interpreted as at least 5%) to write grants—their own grants as well as a center grant. If the faculty member has 5% not federally funded time, then it's legal for them to work on other grants. The statement that the "faculty member has no effort to do this" isn't clear. As I noted above, all faculty need to have some non-federally funded time, or just writing their renewal grants isn’t legal. Do you mean that the faculty member isn't getting paid from the Dept. For time spent writing the grant? If so, this is typical. It sounds as if the bigger problem is that the dept wants the faculty member to work on a center grant and the faculty member doesn't want to do it. In this situation, it's hard to determine if the dept is trying to take advantage of the faculty member, or the faculty member isn't being a good citizen.

Comment 3: Regarding comments A and B. My position is that I have a state grant that pays 10% of my salary so there is no violation of NIH rules. My problem is that I have a good number of NIH grants now and the new position in which I would split my time between two groups puts me in the position where the new site wants me (understandably) to write grants for them, while my primary department and chair at the site where I work wants another center grant done. I took the advice of offering to help/write a part and have already searched the literature for them, given them a protocol idea and have given them a summary of what they need to prepare for the project. The faculty working on this seem quite happy with that effort, the chair still appears to be angry. I'm not sure how this will work out.

Comment 4: Regarding Comment 2, all I can say is as a dept chair, I think the faculty member in question would have every right to inform me that he/she cannot write the center grant. If 100% NIH funding, then it is not possible to take on! Alternatively, also fair for to ask for dept offset of salary (if able to change total effort to less than 100% allowing for addition of the center grant).

Comment 5: This does seem like a moment for negotiation. We often go that extra mile for our department- and want to be a team player. Has the department done the same? This can be said in a straightforward way with reason. Certainly in the current situation, the department has some room in comment 1 to be fair and reasonable. Is there a senior member of the department who can guide you or present the situation for you? Or a mentor/mentoring team that may be able to assist?

Comment 6: All of the comments of this group have been helpful. I do think that there is an effort to be reasonable on both sides; it's just that everyone seems to have things that they want done and don't feel can be further compromised. Clearly, something will have to give at some point, but I will say that I feel that despite the difficulty of this issue, I have been treated respectfully through the process.

Comment 7: A center grant requires "team players" at all levels (with lots of effort and little payoff until the shared resources come in with the funded Center grant. A faculty member is never "fully" funded with the same expiration dates for all the grants, so there is some wiggle room for playing on the team. Does "A dept decides" mean that the Chair decided? If the faculty member doesn't want to be the PI, then the grant won't get done, but this faculty member doesn't have to be/can't be the PI if there is no effort left over to do so.

Comment 8: Yes, the chair decided that they wanted the grant and does not want to accept that I cannot be PI because of my other commitments (I did send my current other support for review as well, but this did not seem to make any impact). I will have one grant ending next year, but I have 4 new ones that have only recently started which will last from 3-5 years.

Comment 1: Reminding your mentee of the researcher's and the institution's requirements for K Award support might help in approaching your department chair with a positive outcome:

What are the general K awards?:

• Mentored Clinical Scientists Development Program Award (K12; awarded to the institution)
• Mentored Patient-Oriented Research Career Development Award (K23)
• Mentored Clinical Scientist Development Award (K08)
• support the career development of investigators committed to patient-oriented research
• 3-5 years of support
• At the time of award, the candidate must have a "full-time" appointment at the applicant's academic institution

In particular, the K Awards have basic requirements for both the mentor and the institution, listed below:

• Mentor(s): must name a primary mentor—[and] with the candidate, is responsible for the program
  • accomplished investigator in the proposed area
  • track record of mentoring success
  • independent support to cover excess costs
• Institution: strong record of career development activities and qualified mentors
• commitment to develop the candidate as a productive investigator
• allow protected time

Once an institution sponsors a candidate, the sponsoring institution is required to make the following commitments to a condidates's research career development:

• Sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Assurances that the candidate will be able to devote > 75% of full-time effort to their research program
• Provide office and laboratory space, equipment, and other resources and facilities
• Provide time and support for mentor(s) and/or other staff

Along with the sponsoring institution's commitments listed above, the following requirements apply to awardees:

• K awardee may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K12, K22, K23, K25), a research project grant (R01), FIRST Awards (R29)
• Ineligible: current and former PI's on NIH R01, comparable individual career development awards, equivalent non-PHS peer-reviewed research grants (>$100,000 direct costs / year), or project leaders on sub-projects of program project (P01) or center (P50)
• Eligible: former PI of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21)

Comment 1: In order to address both the duration of training and to protect the flux of new investigators, the NIH announced a new policy in fiscal year 2009 involving the identification of Early Stage Investigators (ESIs)

Comment 1: This can be included in a personal statment on your biosketch. This modification of the Biographical Sketch will permit Program Directors/Principal Investigators and other senior/key staff to describe personal circumstances that may have reduced productivity. Peer reviewers and others will then have more complete information on which to base their assessment of qualifications and productivity relevant to the proposed role on the project.

Comment 1: See the NIH K award success rates by year, award type and institute (includes all institutes). Check it out!

Comment 1: Yes! The Academic Senate Committee on Research will award $500 Travel Grants yearly on a first come, first served basis. Funds are available to assist new and junior faculty (5 yrs or less) attend meetings of learned societies, organized conferences and meetings to present important results of original research.

Details: Download the Travel Grant Application Form from the Academic Senate website. They can get one per year. (March 11, 2013)

Comment 1: The NIH policy permits a "just in time" approach to IRB approval, under which such approval is required before a grant is funded, not before the application is submitted. Thus, one can wait until receiving the priority score to see if a grant is likely to be funded, and still have a few months before the likely funding date. CHR applications now have a Yes/No checkbox in the upper right hand corner to indicate a Just in Time (JIT) submission. The CHR is committed to reviewing these studies in a timely fashion so the awards can be issued as quickly as possible.

Comment 1: Sometimes investigators use the term "new" when the assay is "experimental" because it has not been approved by the U.S. Food and Drug Administration (FDA). It's important to be clear in the CHR application and consent form about whether or not the assay has been approved by the FDA. The concept of "information risk" needs to be considered in every study. In this case, risk includes false positive BNP, potentially leading to unnecessary further diagnostics or treatment. In addition, how will a subject or their physician interpret the results of the new marker that has not yet been clinically validated? On the other hand, is it ethical to withhold results from the new marker that the researcher thinks may have prognostic significance?

In terms of whether to inform subjects about experimental test results, the investigator should consult guidance on the CHR website. In general, only test results certified by the Clinical Laboratory Improvement Amendments (CLIA) should be shared with subjects and their physicians but there are situations where ethical considerations might make it appropriate to inform subjects and their physicians about the results.

Comment 1: Comment 1: Consult with staff or members of the Institutional Review Board (IRB) before preparing your submission. The level of review required depends on which site is the prime grantee and therefore, ultimately responsible for the study. If the site in Brazil is the prime grantee and the UCSF PI will have only a very limited role, then the CHR only needs to review for the limited role the UCSF investigator will have (e.g. access to coded data for help in analysis), which usually means an "Expedited-No Subject Contact" application.

However, if UCSF is the prime grantee and we are subcontracting the research to the investigators in Brazil, then the CHR would have to review the entire study. In this case it would mean a "Full Committee" application because subject identifiers and sensitive information will be collected.

In addition, there are cultural, linguistic and political issues to consider when collaborating internationally and conducting research in developing countries, as well as the requirement for local IRB approval.

Comment 1: Yes, because a UCSF investigator is involved, local CHR approval is required in addition to that of the "primary" Institutional review Board (RB) at the University X. For research that will be conducted at UCSF, the CHR generally requires consent forms that are in the CHR standard format, which incorporates OHRP and FDA regulations. The goal of the CHR standard format is to create a document that satisfies Federal and institutional consent requirements. However, if the mentee believes there is strong justification for using the boilerplate consent form, s/he should explain the situation in a cover letter and make an explicit request for the CHR to defer to the University X's format. At a minimum, the boilerplate consent form should include the name of and contact information for the UCSF investigator, contact information for the CHR, the standard UCSF treatment and compensation for injury clause, and a reference to providing subjects with the Experimental Subject's Bill of Rights (required by the State of California for biomedical studies).

Comment 1: Take the time to fill out the CHR application de novo, and write concisely and clearly. Other mistakes to avoid: referring to another CHR application or to the sponsor's protocol for information requested in the application. The CHR Web site offers information on CHR Approval.

Comment 1: The first crucial question is: Is it research or just clinical quality control? Or perhaps easier to answer, is there any intention (or possibility) the analysis will be published or shared outside your own clinic or department? If so, then it is human research and Committee on Human Research (CHR) approval is needed. In this case, an "Expedited-No Subject Contact" application should be submitted.

For research involving pre-existing data or specimens in which medical records are not involved, the second question is: Does it involve human subjects or not? If the research does not involve interaction with or observations of living individuals or access to identifiable information, then it does not involve human subjects and CHR review is not required. The data or specimens cannot have been collected specifically for the purposes of the proposed research. Examples are research on coded tissue samples from a CHR-approved tissue bank and secondary analysis of coded data from a colleague's previously approved study, provided there is an agreement in place prohibiting the release of subject identifiers to the researcher under any circumstances. Investigators can fill out the new self-certification form, if the funding agency requires it, but nothing needs to be submitted to the CHR.

The third question is: Does the research qualify as exempt? "Exempt" research involves interaction with or observations of living individuals, or access to pre-existing identifiable information, but is very low risk (no sensitive information or medical records review, and the subjects cannot be patients, children or prisoners), and must fall within one of the exempt categories defined by the Federal regulations. Submission of an Exempt Certification is required, which is good for three years. The exempt application for pre-existing data or specimens is available at: http://www.research.ucsf.edu/CHR/Forms/Exempt_4.doc.

To determine whether research using data or specimens involves human subjects and if so, whether it is exempt vs. expedited, use the decision tree available here. Guidance and more examples are available at: http://www.research.ucsf.edu/chr/Guide/chrExemptApp.asp#Determining. Specific guidance on research involving medical records is available at: http://www.research.ucsf.edu/chr/Guide/chr12F_MedRec.asp#5a.

Comment 1: Most investigators are familiar with the concept of a Data and Safety Monitoring Board (DSMB) for clinical trials. Requirements for an independent board to analyze side effect and efficacy data at pre-specified intervals are intended to allow halting or modifying the trial for the safety of the participants. However, many investigators are less familiar with the concept of an OSMB. For large observational (cohort or case control) studies, such a Board may perform a similar function as in a DSMB to assure scientific rigor and ethical safeguards, including pre-mature termination of a study if important safety or etiological findings are detected. For smaller observational studies unlikely to yield important public health findings, a data and safety monitoring plan may simply state that key investigators will examine the data periodically to assure its quality and to detect unforeseen findings of relevance to subject safety.

The UCSF CHR requires a Data and Safety Monitoring Plan (DSMP), but not necessarily a Board, for all interventional studies involving more than minimal risk. In general, the CHR will expect an independent Data and Safety Monitoring Board (DSMB) for all phase III studies and phase II studies that are multicenter and randomized, or high risk. Specific guidance on when the CHR expects a DSMB to be involved is available at: http://www.research.ucsf.edu/chr/Guide/chrDSMB.asp.

Comment 1: Yes, there is a conflict of interest. First, the previous funding must be disclosed on the California State-mandated conflict of interest form 700-U, which accompanies any grant or subcontract application submitted to the research institution's Contracts and Grants. This form may trigger a more detailed review by the UCSF Conflict of Interest committee. Information on investigator conflicts of interest and Committee on Human Research review is available here.

Comment 2: The CHR application also asks about investigators' financial interests. If there are any, the investigator should submit the Disclosure of Investigators' Financial Interests form with the CHR application. CHR staff will forward a copy to the Conflict of Interest (COI) officer who will follow up with the investigator that has the financial interest and communicate the outcome of the COI review to the CHR. The previous funding will probably need to be disclosed to subjects enrolled in the Phase 1 vaccine trial via mention in the informed consent document.

Comment 1: Even though the host PI has given permission for the study it has not yet been approved by the local or regional IRB of the hospital. Three months leaves little time to complete all the necessary paperwork for both the UCSF and international IRBs. It is imperative to move very quickly in this circumstance and be transparent with the CHR about your tight time frame. They are able to expedite reviews in these circumstances. Also, it is important to communicate directly with the host PI to confirm the availability of necessary resources, to review the status of IRB applications, and to confirm the viability of finishing the study in a short time period, rather than depending on the resident for all communication.