From Cells to Communities - From Training Grants to Center Grants...What's Next?
Next In 2018 Was A Banner Year For BBMC
The title of the last summary of goings-on at BBMC was "From Cells to Communities - from Training Grants to Center Grants...What's Next?" Little did I know in 2017 when I wrote the last report that I would be repeating myself in the lead sentence of my 2018 report..."It has been a very long time since I last reported on the activities at Braveman BioMed." Nor did I anticipate having to say again in the 2018 report that the reason wasn't because of laziness or that there was nothing for me to report. As I sit down to write this report 2018 is almost over...and it's been more than a year and a half since my last report! So what's up with that?
The simple and short answer is that the What's Next , 2018, was busier, almost doubling the volume, of any of the preceding nine years of BBMC! And from the looks of what's on my calendar for 2019, the 10th anniversary year, it could continue. While most of my work during 2018 involved providing help in preparing grant applications, I spent approximately 6 months of the year supporting a major evaluation study for one of the NIH institutes. At the same time I added several new clients using my services to help prepare grant applications. Still a large percentage of our work was with returning clients, some of whom have used my services since the start of BBMC. Some of my clients had taken new positions at new universities and these moves, in and of themselves, resulted in the addition of new clients and with them the addition of new areas of science for BBMC...and, of course, new opportunities for conducting grant writing seminars and intensive one-week grant writing sessions.
The applications that I worked on in 2018 covered a full range of research project grants supported by NIH and NSF. The scientific topics were diverse, the ideas very creative, and the scientists very bright and devoted to their work. Taken together it made my work very interesting and me appreciate even more the opportunities I've been given to work with very talented people in helping them seek support for their research. The topics of the applications that I worked on included epigenetic effects of health practices as well as risk behaviors, an area that continues to be popular indicating that previous research was successful and continues to be of interest to funding agencies. I also continued to work with groups proposing research addressing health and disease issues of interest to Native Americans including preventing suicide in adolescents as well as research by other groups studying dementias, including Alzheimer's disease, in these populations. Not surprising, another area of interest to several of my clients has been in the area of the opioid crisis in the US, particularly in preventing and treating opioid addiction in all US populations. Other research areas included studies of multisensory processing, signaling pathways in metabolic diseases, prevention of exercise-induced injury, prevention and treatment of head trauma, seasonal changes in sleep patterns, and microbial adherence to various surfaces. As I indicated, the range of science projects has been both diverse and very interesting, and I've been very busy.
Don't get me wrong...this doesn't mean that I'm not taking on any new clients in 2019. In fact, I've already heard from people planning to apply for grants. Some are using my services for the first time, some are returning for the first or second time, and some have been with BBMC since it's inception. Further, being busy doesn't mean that each client will get less of my attention...particulalry since their plans include submitting applications at various times during the year. But let me assure you that the 'tag line' for BBMC, working with you for excellence in research, is still the foundation for my consulting work and, judging from the feedback that I've received from clients it is greatly appreciated. However, it does mean that I need to be very careful in planning my schedule so that I can give each client as much attention as necessary in helping prepare what we both hope will be a competitive application. So the sooner you can let me in on your timeline the better for both of us.
Not only has the workload at BBMC changed in 2018, there have been some important changes in application requirements at NIH. The changes take effect starting in 2019, and I'm sharing the jist of them with you in case you haven't already heard of them. Among the most recent and perhaps far reaching changes is a revision of the policy and guidelines on the Inclusion of Children (NOT-OD-18-116/grants.nih.gov/grants/guide/ notice-files/NOT-OD-18-116.html). The policy is effective for both grant applications and contract proposals due on or after January 25, 2019. The new policy shifts the focus on inclusion of children to inclusion of individuals across the entire lifespan in all research involving human participants supported by NIH unless there are scientific or ethical reasons for not including them. Applications and proposals must not only include a description of plans for selecting the specific age range justified in the context of the scientific question proposed. An acceptable justification must be provided if individuals are excluded from the proposed research based on age. Acceptable reasons may include: "(1) the disease does not occur in or the disease is not relevant to the excluded group(s); (2) the knowledge being sought in the research is already avaialable for the excluded group or will be obtained from an ongoing study and/or additional study; (3) an age-specific study in the excluded group is warrented or preferred; (4) the study will collect or analyze data on pre-enrolled study participants (e.g., longitudinal follow-up studies that did not include data on children, or analsysis of an existing data set) and data inclusive of individuals across the lifespan are not available to address the scientific question; (5) there are laws or regulations barring the inclusion of individuals in a specific age group in research; or (6) the study poses an unaccpetable risk to the excluded group, such that their inclusion would not be considered ethical by the local IRB, peer review group or NIH staff." Review groups are charged with the responsibility of assessing each application as being "acceptable" or "unacceptable" with regard to the age-appropriate inclusion or exclusion of individuals. In addition, grant and contract recipients "must submit data on participant age at enrollment in progress reports. "Individual-level participants information information about sex/gender, race, ethnicity, and age at enrollment should be de-identified and applicants should ensure that informed consent allow submission to NIH of the de-identified individual-llevel information. I encourage you to contact your program official well in advance of preparing an application if you have any questions about your individual study with regard to this new policy.
A second topic that seems to getting additional attention is what is meant by a clinical trial. You may already be aware of the fact that all applications involving clinical trials are submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. Some of my clients have expressed uncertainty about the NIH definition of a clinical trial. NIH has now provided a very useful information page about clinical trials that addresses many of the questions that have been posed to me, particularly NIH's definition of a clinical trial (grants.nih.gov./policy/clinical-trials/definition.htm). It seems to boil down to if any of the following questions can be answered by 'NO', the study is NOT considered by NIH to be a clinical trial: (1) Does the study involve human participant research? (2) Are participants prospectively assigned to an intervention? (3) Is the study designed to evaluate the effect of the intervention on the participants? (4) Is the effect being evaluated a health-related biomedcial or behavioral outcome? As one of my clients has indicated, there's room for interpretation of some of these questions. For example, what constitutes an intervention? Suppose you're studying the genetic pathways involved in production of endorphins that lead to positive mood changes resulting from exercise. Does the exercise regimen used in your study constitute an intervention? If you prospectively assign participants on a random basis to one of several exercise regimes or a control, does that qualify your experiment as a clinical trial? These are important but not easily answered questions and can impact whether or not your application would even be accepted for review if there wasn't an FOA requesting a clinical trial in this area of research.
A third topic that seems to be getting additional attention by review groups as well as by NIH staff involves the use of the terms scientific premise and scientific rigor. You may recall that about three years ago NIH indicated that applications needed to show evidence of 'rigor and reproducibility.' Since the introduction of these terms there has been a sharpening of what they mean as far as preparing a research grant application is concerned. Recently NIH has issued an announcement that beginning with applications due on January 25, 20019 the applicationinstructions and review criteria will be clarified to replace the term 'scientific rigor' with the term 'rigor of the previous research.' Applicants will also be instructed to describe plans to address any weaknesses in the rigor of the prior research within the Research Strategy section of the application. The stated aim of this change is to encourage applicants to not only provide evidence of the feasibility of the proposed experimental approach as a type of proof of concept but also to evaluate the strengths and weaknesses of the previous published work on which the proposed research is based. In other words, the significance of the proposed research is not only based on a review of the published literature but also on the qualirty of the studies comprising the literature review and forms the Scientific Premiseof the proposed research. Issues reducing the quality of the research need to be addressed in the review and, from my perspective,, should form the basis of or at least be addressed in the design of the proposed studies, referred to as the Scientific Rigor. The following table is taken from a document provided to the peer reviewers summarizing the intended meaning of Scientific Premise and Scientific Rigor. Not only does it indicate what reviewers will be looking for but also where in the application the information should appear.
Review Criterion - Research Grants
Review Criterion - Mentored Research Grants
Additional details of instructions to reviewers can be found at grants.nih.gov/grants/peer/guidelines_general/Reviewer_Guidance_on_Rigor_and Transparency.pdf. I encourage you to read these details as it is critically important that your application provides the information that reviewers are instructed to look for.
These modifications and changes in NIH grant policy point to the importance of continuing to monitor NIH so that you can stay up to date on changes. I have been able to keep track of them and forward them to my clients as I find them. However, you too should be tracking this kind of information so I suggest that, if you haven't already, you subscribe to NIH Nexus (nexus.od.nih.gov) and to any internal alert system that your local Office of Sponsored Programs (or similar office) operates.
A third source of important information is the NIH Program Official, the person in an institute thatt has administrative responsibility for your grant or is likely to have administrative responsibility for a future grant that you submit. They can be very helpful in sorting out issues about whether an application is responsive to new or modified policies. In addition to providing information about changes in grant policies, Program Officials can provide feedback about whether a planned application is of interest to their institued. My suggestion is to develop what I term a concept paper. This is a 3-4 page paperthat includes the following information:
Study Goals and Aims..."I am looking for support from your institute to study...(the specific focus of your research).
Scientific Premise...The specific issue that you're propose to study, why it needs to be studied and specifically the problem that keeps your field from moving forward that it will address, and how your study will do that.
Specific Aims and hypotheses that each aim will address
Scientific Rigor...How your study will improve on or address problems that you've identified with already published research.
Team...The key participants and collaborators, their individual expertise, and how it will be used to a carry out the research.
I suggest that you email the concept paper to the Program Official and request a telephone conversation at his/her convenience to discuss the planned research. During the conversation you can also raise quetions you may have about whether your study is compliant with changes in NIH grant policy or what you need to do to ensure that it is.
Finally, to those of you who are not familiar with my services and might be interested or are just curious about what I do, how I do it, and why I do it that way, I encourage you to contact me either by email, phone, or by using the form on this site. As people who have used my services to help them prepare a grant application or have attended one of my grant writing seminars already know, I am a firm believer that there are many different approaches to grant writing and any or all of them can lead to funding. From my perspective, the single thing that stands out in applications that receive funding is the 'idea' or what some call the basis for the research you are proposing...whether it answers an important question in your field. It is also critically important that the 'idea' be presented in a way that makes it easy for the reviewers (and NIH program officials) to understand what you plan to do, why you plan to do it, how you plan to do it, and the specirfic way(s) in which it will move your scientific field forward. Or in the words of a former NIH colleague of mine, Dr. Bill Raub...
"No amount of grantsmanship will turn a bad idea into a fundable one...there are many outstanding ideas that are camouflaged by poor grantsmanship and never receive funding."