NIH Review, 10
Major Points Learned on Grant Mechanisms and Review
Assignment 2
Amie Lefort
NIH Grand Writing Strategies, Politics and Format
HIS 4075
Lynn Freeman, Ph.D.
5 June 2005
In the following pages I will review the five most interesting points from about funding from the NIH grant mechanisms and the review process for grant award video as found on the NIH website. I will additionally review the five most interesting points I have learned from reviewing the grant funding mechanisms as described on the NIH website (http://grants1.nih.gov/grants/funding/funding_program.htm).
In reviewing both I have found it helpful as I evaluate the material to think of NIH as a venture capitalist corporation. While there is money available for research, it is not dispersed due to duty but rather due to a belief in the research program. The many corporate scandals that make the nightly news provide an inspiration for what not to do when writing a grant. Just like there is corporate financial accountability there is clearly financial accountability when managing a grant.
In writing a grant a researcher takes on the roll of both scientist and salesman. Without sufficient research and documentation the proposed research or intervention can be a tough sell. I consider the corporate analogy a helpful notion because after spending a considerable time on the NIH website I view this agency to be more like a savvy venture capitalist than a charitable benefactor.
Peer Review Video
Point One- Innovation
The first most interesting points I have developed an awareness of is that NIH likes to review and potential fund grants that are novel and push the limits of what is currently being done. It seems like novelty sparks the interest of the committee, but is clearly not the sole issue that makes an application successful. The review committee will not seriously look at a proposal that is not supported by some empirical evidence. There is clearly a balance between supporting innovation and not having a thoroughly developed research proposal.
When submitting an application it is undoubtedly beneficial to employ novel concepts or approaches to the research questions being addressed. The mock committee was also interested or methods that are novel so the research can both generate the intended data and potentially develop a new methodology. Generating methodological data and descriptive data increases the value of the proposal. Developing new methodologies is clearly the hallmark of an innovative proposal. An application will do better in the committee if it challenges existing knowledge or paradigms.
With ideas that are too innovative to be supported by existing empirical evidence it is a good idea to first attempt to be funded by a feasibility or pilot study. The idea of first applying for a pilot study grant seems like the perfect way to get an “in” with NIH funding. Since the funding for feasibility studies is very small or limited it would be easer for NIH to fund the concept when there are missing pieces of information. Perhaps funding with a pilot study would be the easiest for a beginning researcher to obtain. One problem with going after a pilot study is that some of the institutes do not fund this type of grant, the R03. Currently, the National Cancer Institute, the one institute I am most interested in, does not accept applications for this form of grant. This is interesting because it raises a few questions about the wishes of this agency. I would expect that using an R03 grant would be a good way to get in with the agency, prove research skills, and financial accountability. If they do not utilized this option for preliminary investigations I am unsure of how younger researchers will be able to get into the agency.
Overall, knowing that NIH likes innovation contributes to me becoming a better grant writer because without this knowledge I would have been extremely cautious. I would have made the mistake of writing a very safe grant proposal, that would not necessarily catch the attention of the peer review committee.
Point two- Strong Researcher or Research Group
One of the most thoroughly discussed points of each application on the peer review video was the quality of researcher or of the research group. The peer review committee seemed very interested in not only reviewing the academic credentials, but also the publication history of the applicants.
When evaluating a solo researcher the committee was very concerned about the experience level of the applicant. The applicant clearly needs to be well versed and likely experienced with the exact topic they would like to investigate. NIH is clearly not the funding source one would want to consider applying for if you have not worked on your topic of interest before. An individual researcher must show a relative level of expertise and a proven record of academic success in order to be considered for NIH funding either as a sponsored researcher or as the principal investigator for a grant.
As mentioned in the video meeting, ideally an individual researcher should have support from the chairman of their department if they are in an academic institution. This approval seems to indicate an institutional accountability for the researcher. A letter from the head of the department could also indicate institutional support for the research goals that are stated in the grant. If the head of the department has reviewed the application they have likely advised the researcher on ways to avoid problems with research approval and institutional review boards. The head of a department would not write a letter of support for a researcher they did not believe in. In addition to a letter from the department chair an individual researcher should also have a mentor. The presence of a mentor that is well versed in the intended area of study will give NIH confidence that a beginning researcher will have the guidance necessary to ensure the validity of the study. Overall, an Individual researcher needs a good training environment that supports them in achieving their research goals.
When evaluating a research team that is applying for NIH funds there are many questions that must be answered. If the researchers have not worked together in the past then they should ideally be from the same location or be exceptionally experienced researchers. The peer review committee seemed hesitant to trust a multi-institutional study when the researchers had not worked together in the past. The quality control questions for researchers who have not worked together in the past are many. Coordinating a study that involves several locations and different researchers can be a daunting task filled with the potential for fiscal mismanagement and not adhering to study protocols. Generally, funding from NIH requires an appropriately trained researcher with a staff that is capable of doing the necessary jobs.
Point 3-Checks and Balances
One of the most commonly discussed items in the video was ensuring multiple levels of control or checks and balances in order to have the best research application. The researchers in the video meeting never once noted overly detailed documentation of the checks and balances for a research proposal. Rather, the researchers expressed concern at several points when, the believed the applicant did not have an understanding of the protocols that need to be developed in order to properly run a large study or grant.
One of the ways to keep non-medical interventions within a system of checks and balances is to consider even psychological interventions to be doses. This is analogous to the study of medicine. When an intervention is given in a dosage, then it is easy to control for the effects. Often psychological research takes on a more qualitative approach. The lack of quantifiable data that is often produced from mixed method or qualitative research does not seem to work for the purposes of an NIH grant. An example of a dosage in psychological research could be a breaking the intervention into time intervals with specific amounts of time constituting as a dosage. Participants and control subjects could then be given an equal dosage.
The committee was very interested in detailed documentation of exactly what the workings of the study will consist of. They clearly wanted applicants to think ahead to potential problems with the research and be prepared with an alternative plan.
Point 4- Approaches of Project
One of the paramount questions behind the approach of a research project is; what scientific advances will be made if the project is successful? This is a key question to address in the application as it connects the method selected to the end result. The peer review committee is clearly very interested in the approach of the project. The approach of the project includes the conceptual methods, the analyses, and the aims of the project.
In the approach of the project the number of patients desired must be justified. The number of patients used must be justified showing that the number will yield results that are generalizeable to a large population. The number of patients should not be too large. The numbers must not be too small unless the study is just to test the feasibility of the idea. One of the ways to justify the number of patients used would be to conduct a literature review and find a study that is similar to the one you hope to use. If the sample study is well respected, cited often and published in a reputable journal then this could be a justification for the number of patients. Along with the number of patients used the researcher will have to outline the roll of control subjects. The control subject must be used to show the success or failure of the intervention. Control subjects are used in psychological interventions the way placebos are used in medical treatments.
The application must also show the researcher’s proof of how they will be able to recruit patients. The peer review committee must believe the researcher will be able to collect patients or any amount of funding will be useless. There should be a clear definition of what constitutes compliance or full participation in the study. The research proposal should include a calculation of an anticipated drop out rate which should be determined based on the population used. For patients who do drop out, it should be documented if any of the data will be used from their time as a participant.
The approach of the project must include the justification for how long the intervention will be. There is a critical point between the intervention being too short and too long.
Overall, the approach of the project must have a scientific rational in order to appeal to the peer review committee. There should be a storing literature review to justify the methods selected. The literature review should show the scientific evidence for how the results will be analyzed
Point 5- Statistical Integrity
The importance of statistical thinking and integrity was clearly a priority for the peer review committee. The member of the committee who was the statistical representative was very vocal, her opinion seemed key and well regarded. Attention to the many details of statistics is clearly an essential component of a successful application. I would imagine this is a problem for many researchers because often department statisticians are relied upon for final analysis so lead researchers may not have a full understanding of what exactly goes on to produce the final statistical analysis. To prevent this problem a researcher should have their application reviewed by a respected statistician. One of the ways to work towards ensuring that all statistics will be accurate is to have an established policy regarding exactly how certain variations on the protocol will be quantified. Controlling for such variations is a good way to show an understanding of the many complex issues that arise in research.
Overall, a researcher must demonstrate a clear understanding of how statistical thinking will apply to their work. In order to do this the presentation of the models that will be used must be done clearly. Another way to show an understanding of the importance of the statistics and data is establishing a data safety oversight committee to ensure that potential problems do not go unnoticed. Attention to the important details of statistics can make or break an application.
Point five- Organize application.
Overall, the peer review panel seemed as if they were critical, but willing to be sold in the idea of a project, especially a well organized project. It seemed that having a great idea with good organization could result in a successful application. Even the best idea would not stand a chance of being funded without a clearly organized application. Organizing an application for a grant means considering the many questions the committee would have and addressing them in an orderly fashion.
When organizing an application it is key to not overstate the goals of the project. While overstated goals may look like an impressive idea when isolated on paper, the reality of such an inaccuracy will not get the peer review committee to approve of the application.
Review of Points from Grant Funding Webpage
Point One- Commitment to human subjects
The office of extramural research has a funding solicitation for research on ethical issues in human studies. This separate call for research indicates NIH’s commitment to ethical integrity when using human subjects in studies. While there has not been an overwhelming amount of grants in this area, the existence of this separately funded research area shows the agency’s desire to not only uphold a high level of academic ethics, but to be a leader in producing the research in the area of ethics.