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It’s being said that if you want a baby born on 11-11-11, you should “get ready to get on it this weekend.” So…

By Allen J. Wilcox

You already know where babies come from – the business about sperm and eggs, and getting them together. You also know something about birth control – after all, people spend most of their reproductive years trying NOT to get pregnant.

But there comes a time for many women when they ready to have a baby. That’s when some interesting questions arise.

- Once you stop using birth control, how long does it take to get pregnant?
- Is there something women should do to increase their chances of getting pregnant?
- What can a woman do to help make sure her baby will be healthy?

Let’s start with the last question first. The most important thing a woman can do before getting pregnant is to start taking daily multivitamins with folic acid. Folic acid helps prevent serious birth defects of the brain and spine (neural tube defects) and probably other defects as well. These defects happen very early in the baby’s development – waiting until you think you are pregnant can be too late.

Another thing you can do, if you are a smoker, is to quit smoking. Smoking puts a damper on women’s fertility (although apparently not on the fertility of men – life is not fair). Smoking also increases the small chance of fetal death later in pregnancy. Do yourself (and your baby) a favor, and give up the cigarettes.

Besides that, what should you do (besides the obvious)?

Nothing.

Really, nothing. You already have a lot going for you. Consider the benefits of your family history – not a single one of your ancestors was infertile. If you are a reasonably healthy person with no history of reproductive problems, and if you are having unprotected sex at least weekly, biology is on your side.

Some useful facts

There is a spectrum of fertility, ranging from very low to very high. You won’t know where you are on that spectrum until you actually try to conceive. On average, your chance of getting pregnant in the first month is 25%. For a few unlucky couples, the chances are zero – they are sterile. Other couples may have a 50% or 75% chance of getting pregnant in their very first month of trying. For couples as a whole, about half will be pregnant after three months. That goes up to two-thirds of couples after six months, and more than 90% after a year. Even if you don’t conceive in the first year, you still have a 50% chance in the next year or so. Only about 5% or so of couples are unable to conceive at all by natural means.

Probably the biggest predictor of fertility is woman’s age. Women are at their reproductive peak during their twenties. As they move through their thirties, their fertility begins to decline. This is relevant because many women (for lots of good reasons) delay their childbearing until they are in their 30s or even older. If a woman is not so fertile to start with, this delay can cause problems. Unfortunately, there is no medical test to tell women in advance how fertile they are.

The fertility window

Let’s get down to the biology. Pregnancy happens when couples have sex during the five days before ovulation and the day of ovulation itself. (In other words, sperm can survive up to five days in the woman’s reproductive tract.) This six-day fertility window gives you a fairly wide span of days in each cycle for intercourse that can produce pregnancy.

But there is a catch. Most women don’t know

Ed Note: Today's Ypulse Youth Advisory Board post comes from psychology student Camilla Nord who takes a closer look at the way teens are seeking out and synthesizing health information online compared to the general population. I highlighted... Read the rest of this post

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By Frederick Grinnell

On August 23, 2010, the United States District Court for the District of Columbia granted a preliminary injunction blocking NIH-funded research on human embryonic stem cells (hESC). According to Judge Lamberth’s ruling, NIH-funded research on hESC violates the Dickey-Wicker Amendment, originally passed by Congress in 1996, which prohibits use of federal funds for research in which human embryos are destroyed. The judge rejected the federal government’s claim that hESC research comes in separate pieces, i.e., human embryo destruction in the private domain on one hand vs. investigation of hESC by NIH-funded investigators on the other. Instead, he cited the holistic language of the Dickey-Wicker Amendment and the Random House Dictionary to conclude that the common definition of research includes development, testing and evaluation. According to Judge Lamberth’s ruling, destruction of human embryos and research on stem cells derived from human embryos are part of the same piece.

Destruction of human embryos occurs in the context of diverse research purposes. Some researchers aim to develop hESC-based therapeutic applications. However, others propose to improve the outcome of in vitro fertilization (IVF) procedures or to learn about early embryo development and disease progression. Currently, funding for research in which destruction of human embryos occurs is provided by non-Federal sources ranging from IVF clinics to biotechnology companies to state-sponsored biotechnology initiatives. Some of the research involving human embryo destruction has resulted in production of hESC lines. Some of the hESC lines that have been produced have been authorized to be used in NIH‑funded research, at least until the recent court order. Therefore, while one cannot deny that NIH-sponsored hESC research would be impossible without destruction of human embryos, destruction of human embryos is a research activity whose scope is much broader than and independent from the NIH‑funded work. From the point of view of research practice, the relationship between embryo destruction and hESC research is indirect.

In response to the judge’s preliminary injunction, the federal government has filed an appeal. The appeal challenges the judge’s understanding of the Dickey-Wicker Amendment regarding what constitutes the meaning of “research.” The appeal also challenges the judge’s conclusion that his decision would not seriously harm hESC researchers. On the contrary, if left in place, the injunction will have a potentially catastrophic effect because of its total disruption of NIH intramural and extramural hESC research.

One implication of Judge Lamberth’s ruling that has not been discussed but is of potential concern is whether the injunction against NIH-funding of hESC research might also apply to the FDA. The Dickey-Wicker Amendment concerns all of HHS not just the NIH. FDA is another major HHS agency that plays a role in hESC research. FDA develops guidelines and provides oversight for human clinical trials, including those involving hESC. As mentioned in the government’s appeal of the preliminary injunction, the FDA recently approved the enrollment of spinal cord injury patients in the first ever U.S. clinical trial of a hESC-based therapy. User fees from industry cover about half the costs of FDA drug review, but the remainder comes from federal f

David S. Wendler is Head, Unit on Vulnerable Populations, in the Department of Bioethics at the NIH Clinical Center. His work focuses on the ethics of research with individuals who cannot give informed consent. In his book, The Ethics of Pediatric Research, he looks at what appears to be an irresolvable dilemma: either we can protect pediatric subjects from exploitation, or we can protect pediatric patients from dangerous medicines, but not both. Wendler offers an original justification for pediatric research based on an in-depth analysis of when it is in our interests to help others. In the excerpt below we learn the history of pediatric research constraints.

The early history of pediatric research includes far too many examples of abusive research. One account maintains that: “The history of pediatric experimentation is largely one of child abuse.” In addition, many of the abuses cited by Henry Beecher in his famous 1966 article listing research abuses at prominent institutions in the United States included children, and a number of these studies focused on children specifically. Pappworth also cites many abusive studies involving children. There is inevitable debate over whether one or another of the cited examples in fact involved abusive research. What options did the children have? How are those options relevant to the appropriateness of the study in question? What impact did the study in fact have on the participating children?

Bracketing these questions, which largely are of historic interest, it is clear that many instances of unethical and abusive studies have occurred in the history of pediatric research. One of the earliest recorded cases of abuse occurred in 1892 when Albert Niesser, a medical professor at Breslau, gave serum taken from syphilis patients to unwitting individuals. Several of the recipients contracted syphilis, leading to public outcry and a government ruling, promulgated in 1900 and codified in the 1931 German guidelines, resulting in perhaps the first systematic regulations governing clinical research. These guidelines explicitly prohibit nonbeneficial research with children, as well as pediatric research that “in any way endangers the child.” It is difficult to imagine a research study that does not pose some risks to participating children. Seemingly innocuous surveys of health behavior, for instance, pose some chance of upsetting children. Even widely accepted pediatric research that offers a compensating potential for clinical benefit poses some chance of harm. In practice, then, these guidelines may prohibit essentially all pediatric research.

The German ruling of 1900 is one instance among many in which research guidelines were developed in response to a specific scandal. Most famously, in response to the horrific experiments perpetrated by the Nazis, the Nuremberg Code stipulates that participants’ consent is “essential” to ethical research. This approach, even more so than the German guidelines of 1931, appears to prohibit essentially all research with children. There is an obvious and very important virtue to this approach. If children are prohibited from being enrolled in clinical research, it will be difficult for investigators to exploit them in that context.

By the 1960s, increasing sentiment indicated that the Nuremberg Code needed to be modified in several important respects, especially to address the fact that it did not include a requirement that clinical research studies should be reviewed and approv

The Complete Writing Guide to NIH Behavioral Science Grants provides simple and clear explanations into the reasons that some grants get funded, and a step-by-step guide to writing those grants. This volume is edited by Lawrence M. Scheier, President of LARS Research Institute, Inc., and an Adjunct Professor of Psychiatry in the School of Medicine at Washington Univeristy, and William L. Dewey, a Professor of Pharmacology and Toxicology in the School of Medicine and former Vice President for Research and Graduate Studies at Virginia Commonwealth University. Below, Scheier was kind enough to answer some questions for us.  Click here for part one.

OUPblog: What is the most common mistake people make in submitting grant applications?

Scheier: Not getting a peer review internally or not collaborating with other scientists who can improve the grant. Too often, young investigators hole themselves up in some remote part of a laboratory and never come out for air. This leads to insulated thinking and this can hurt your chances of getting grants. The reason the investigator holes themselves up is because they feel threatened by colleagues who are competing for the same coveted markers of success, funding and publications. When I worked in one laboratory for an extended period of time, we had reams of longitudinal data sitting around. So one day, I decided to write down every idea I had for a paper and ways to mine this data. I even drew pictures of models that we could test and linked the models to the basic questions addressed by this lab, which dealt with drug prevention. Down the road, the time came for me to move on with my life and I left that book with all those pictures and abstracts and said to my colleagues, these are some really good models to test and that link with the overall themes of the Center and research. Now, many years later, bit by bit, each of these models is making their way into publication or has been made part of a grant to explore how drug prevention works. The point is that collaboration will go much further toward helping your career advance than holing up in an office and trying to write top notch grants solo. So the most common mistake people make, and this is particularly true of young investigators, is not to collaborate.

Related to this point, many young investigators don’t’ get assistance from more senior investigators or collaborators in the field. When I wrote my first grant, a NIDA First (R29) award my score was not in the top 10% and I was not funded. I still thought the grant was a solid piece of writing and while not my best work, still reflective of good science. So I sent the grant to one of my consultants on the grant, a very polished researcher who was heavily published and heavily funded. He wrote back a nice critique and pointed out that many essential “elements” of the grant were missing. Had I included them in my first draft, he felt I might have had a better shot at funding. Then I took all of his important comments and revised the grant, which was funded on the second submission. The point is that I reached out to a more senior colleague and asked for a review of my ideas, the writing style I had used to articulate my ideas and whether the grant contained good science. In all three cases, this consultant made comments that enabled me to make fine improvements without losing the “context” of my own thoughts. This is critical and can be the difference between a successful career where you get really good mentoring and a career that has you languishing trying to figure out how other scientists get funded all the time. You must realize that you are looking for a jumpstart to your grant writing career and usually the best way to get that is to ask a more senior (and successful) grant writer to look at their style, the way they express their ideas, how they shape their grants, and so forth. So asking for supervision, getting an internal review, even by someone who knows nothing about your area, is often the ticket to learning about whether you are expressing yourself in a clear and concise manner.

OUPblog: If you could only tell people one thing about NIH grant writing, what would it be?

Scheier: If your career is invested in soft money or obtaining financial support from agencies like NIH, then you need to study the “Beast” as the saying goes. Put your mind to learning what makes other people successful grant writers. First and foremost learn the trade from the inside, participate in grant reviews, talk up a storm among your colleagues, and listen to the wisdom of the sages. Once you get funded, never stop looking for more funding opportunities and don’t rest on your laurels. You will be remembered for your last grant, your last stage show, not your first.

OUPblog: With an increase in NIH funds coming due to the stimulus, what should researchers know about grant writing?

Scheier: You have to be poised to respond quickly to a Research Funding Announcement or Program Announcement as we witnessed with the Stimulus Funding. For many research groups, there was no more than a month to prepare for this windfall of funds and in many respects this is not enough time to write your best grant. Consider that Center applications take some groups 3-6 months of preparation time and so the Stimulus funding is not looking for well thought out Center applications, but much smaller projects that have a quick turnaround time. In this respect, your team must be well prepared and take the time to read the requirements of the grant. One interesting side bar to the Stimulus funding from the Recovery Act, is the grant format changed stylistically. That is, the sections for Approach, Significance, Background, and Preliminary Studies were no longer emphasized and new areas of concern were outlined that needed to be addressed. Careful preparation and advance scouting by the grant team would have noticed this subtle change and the group is then able to restructure their grant accordingly. This is the sign of a prepared group that prides itself on being a veritable grant machine. It is important to recognize that a well positioned group heavily invested in grant writing does not see the newly formatted grant style for the RC-1 Challenge Grants as an obstacle but rather a “challenge” and they make fast headway to recalibrate and re-orient their writing style.

Good grant writers are always thinking of funding mechanisms and ideas to match the mechanisms. At times, I write down grant ideas and then later, expand them writing a paragraph or two, or even outlining an abstract. Then if the right funding mechanism comes along, I am well poised to take my basic ideas and expand them into more fully fleshed out grants. There are new changes on the horizon at NIH in terms of how many pages grants will be (referring primarily to the core research areas) and there are hints the current 25 page PHS or SF424 application will shrink from 25 pages. Nevertheless, you must be prepared to write rapidly and address the pressing public health issues of our times (or point toward future concerns). You must focus on improving your writing skills as grants become increasingly competitive (more grants awarded and more people looking for extramural funding). You must at all times keep your finger on the pulse of science and have at your fingertips the necessary resources to submit grants. It pays every once in a while to read over the NIH website and keep monitoring any intended changes to the grant process. Don’t let your Contracts and Grants group or Research Support Services have exclusive access to this type of information. Make sure you too are current and have a grasp, however primitive, of what is required to submit grants.

OUPblog: How will the increase in funding affect the NIH? Will anything change?

Scheier: This is really a big question that has to sit and percolate until we see how NIH deems fit to spend the stimulus money. NIH has been seeking ways to grow to meet the health demands of our nation. So it is unquestionable that some funds will be used to support more “infrastructure” growth in various states and these funds are slated to promote “better health care” and foster additional medical research with this windfall. NIH has to grow internally to meet the demands of new scientists and NIH has to find ways to keep an entire cadre of younger early career scientists professionally engaged and funded. It is absolutely clear that we need more scientists down the road to keep pace with new developments in health care and basic medical research. To do this, NIH has to grow in ways never before considered, increasing the size and throughput potential of peer review, perhaps create new institutes and centers, develop new RFAs to keep pace with science and discovery and find new avenues to pursue age old questions regarding the human condition. To keep pace even with these few recommended areas, NIH requires additional monies, monies that have not been allocated in the past. Even though the budget for NIH has been growing steadily over the past decade, this growth has been met with increasing challenges, more costly science and other “economic” factors that mitigate the growth in true dollars spent. In many respects, the budget for NIH is just keeping up with inflation.

Now, with the new mandate by the current administration, we can foresee new funds to push the scientific horizons and promote new medical research in areas that have traditionally not been funded well in the past. This will mean NIH has to draw up a new plan to find ways to develop new treatments, fuel the path to find new medical discoveries that help “improve people’s health and save lives.” This can eventually promote science as an important agenda for our entire country. In the short run, we may see a burst of funding and new “challenge grant” activity. However, in the long run, NIH might become a larger part of government spending, a larger component of our nation’s governance as we put medical research and health care (prevention) front and center in our nation’s public health agenda. If there are any changes that we can anticipate, it would be accounting for expenditures and funds in grants, and perhaps a revision to the computation of Facilities and Administration costs (also called “indirect costs”) at Universities and private research think tanks. There seems to be an “air” of accountability in research that will grow to ensure the public’s monies are well spent and directed toward the intended science.

OUPblog: What’s the biggest thing that separates a successful grant application from an unsuccessful one?

Scheier: This is an easy question to answer and comes down to “clarity of thought.” This is one of the most compelling reasons I chose to utilize a quote from Albert Einstein at the beginning of Chapter 3. At some point in his illustrious career Einstein said, “The whole of science is nothing more than a refinement of everyday thinking.” When you are as deeply immersed in science as many NIH funded investigators are, it is essential that you take the deep thinking, the detailed and technical laboratory procedures, and make them clear as a bright sunny day. If your area is studying family systems and social interaction in drug etiology, you need to spell out to the reviewer why looking at parent-child dyads and communication is the single best method to unravel the causes of teenage drug use. If your area involves synaptic transmission and disruption of signaling events by drug consumption and you use rat models; then you need to spell out why the model is appropriate, what are alternative methods, and why the particular assay method you select is best suited to find answers to the research questions you pose. I say this because the reviewer is looking for ways to critique your methodology, and because of their own expertise, that same reviewer can anticipate your research hypotheses. The reviewer is usually quite familiar with the extant literature. Spending pages upon pages reviewing the existing science sometimes “bores” reviewers because they are part of the science, have published in the same journals on the same ideas. They want to be “excited” by something novel and innovative that helps the science grow. Remember, science is a very conservative process and to borrow from historian Thomas Kuhn, we are all in the midst of making a paradigm shift, we just are caught up in the normal day-to-day science. The process of science is slow moving and any advances, or what we call technical advances, are slow to mature and take hold in the mind’s eye. Knowing this, scientists should be more patient, spell their ideas out more carefully, and go to greater lengths to find ways to embed their ideas in the context of the human condition. So, going back to my earlier point, clarity of thought is essential in the unraveling of “good” science and a successful grant application is one that highlights the novelty while at the same time tethering the science to what is “known.”

The Complete Writing Guide to NIH Behavioral Science Grants provides simple and clear explanations into the reasons that some grants get funded, and a step-by-step guide to writing those grants. This volume is edited by Lawrence M. Scheier, President of LARS Research Institute, Inc., and an Adjunct Professor of Psychiatry in the School of Medicine at Washington Univeristy, and William L. Dewey, a Professor of Pharmacology and Toxicology in the School of Medicine and former Vice President for Research and Graduate Studies at Virginia Commonwealth University. Below, Scheier was kind enough to answer some questions for us.  Be sure to check back next Monday for part two of this interview.

OUPblog: What is the purpose of the National Institute of Health?

Lawrence M. Scheier: The National Institutes of Health, often called the nation’s premiere medical research agency, is part of the U.S. Department of Health and Human Services, the primary Federal agency for servicing and conducting medical research. The NIH is composed of 27 Institutes and Centers, providing leadership and financial support in each of the 50 states. It employs over 18,000 people with headquarters located in Bethesda, Maryland. A nice historical piece that details the origin of the NIH can be found here. The NIH serves as stimulus to medical research and health care to improve the quality of our lives, extend life expectancy, and learn more about how the human body works, including tremendous discoveries in genetics, vaccinations, detection and treatment of diseases, bioterrorism, immune system regulation and function, cancer studies and rapid response to disease outbreaks like Severe Acute Respiratory Syndrome (SARS).

Based on the most current budget information, NIH funded over 28 billion dollars in medical research, supporting 50,000 competitive grants awarded to more than 325,000 scientists encompassing 3,000 universities, medical schools, and other research institutions. The full range of the NIH scientific enterprise is worldwide with international collaborations addressing emerging public health needs that go far beyond the US borders.

OUPblog: Who qualifies for grants?

Scheier: Many grant announcements specifically list what types of business enterprises or research groups qualify to receive federal support through NIH. There is a section in each Program Announcement or Research Funding Announcement titled “Eligible Institutions/Organizations” that lists qualifying institutions. In their most recent announcement for Stimulus funding (Recovery Act Limited Competition: NIH Challenge Grants in Health and Science Research [RC1]), the NIH listed the following in the RFA under Section III Eligibility Information

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status
• Nonprofits without 501(c)(3) IRS Status
• Small businesses
• For-Profit Organizations
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S Territory or Possession
• Indian/Native American Tribal Governments
• Regional Organizations
• Other(s).

In this particular RFA, Foreign Institutions/Organizations were not permitted to apply. Whenever there are special eligibility qualifications, these are listed on the PA or RFA under “Eligibility Information” for institutions and there is also a section that designates eligibility for “individuals.” This latter section refers helps qualify whether the application is intended to stimulate submissions from new investigators or younger “junior” Ph.D.s or M.D.s that are trying for their first application. Some RFAs and PAs are specifically intended to stimulate research collaboratively and detail this by outlining Multiple P.I.s or specialized mechanisms to create collaborative centers. It is always important to read these sections carefully to make you’re your institution is qualified and that you as an individual are qualified.

OUP: What are the elements of a successful NIH grant application?

Scheier: This is a trick or “tricky” question. First the question asks “What are the elements …” where the word “elements” is used in the plural case and refers to more than one element. If you think about this for a minute, we generally use the word element when we agree that something is complex and can be broken down into its constituent parts. If we think of a grant as a complex writing tool (or product), then sure, there are certainly “elements” of a grant. The trick part is that when you look at a grant, it is a single cohesive document (made up of parts, mind you) that expresses a position about science or education. In the book we reinforce the need for a grant to be unified, written in a coherent and practical manner and always striving for synthesis. So the trick part of this question is to find the grant’s “elements” while at the same time preaching “synthesis.”

My initial response to the question then is to look carefully at the review process for the required “elements” of a grant. In this respect, an investigator is always hard pressed to make sure these required “elements” comport with the reviewer’s mindset. So we can turn to the reviewer’s criteria to find the required elements. In addition, an investigator must make sure the grant meets with the requirements of the PA or RFA. If the funding announcement is special, like the recent Challenge Grants, the investigator must be careful to read the requirements and make sure the actual writing and sections of the grant comport with the RFA (or Program Announcement). The RFA or PA will have different “elements” that need to be satisfied. Finally, an investigator has to make sure that no matter how well written, or how superb the science, an application must also directly attend to the mission and goals of the parent Institute or Center. This final “element” is critical and in some cases the sole reason that funding is so hard to get. The investigator must keep their finger on the pulse of science at their respective funding source.

From this brief overview, you can see that the question is tricky because there are so many ways to configure the “elements” of a grant and then say which are critical to a “successful NIH grant application?” If we look at things from the reviewer’s mindset there are a few critical elements they are evaluating as they read a grant. Reviewers receive instructions that help guide them during review. There are generally four basic “required” review criteria (for most grants), and these are: “Significance,” “Approach,” “Investigator,” and “Environment.” Each area is usually spelled out in the RFA and PA in terms of basic criteria so all reviewers are usually on the same page. So for instance, if the discussion during a grant review is about “Approach” reviewers are usually talking about methods, assessment, design, sampling, data collection, administration of a treatment and so forth. When the reviewers are hotly engaged in a discussion about the Environment they are probing whether the applicant’s institution is supportive and can really offer the type of instruction, physical space, mentorship and so forth that may be outlined in the grant. The grant may not contain sufficient funds to fully compensate an individual and the applicant has to find alternative funds to keep their position even if the grant is awarded. Stating this at times and in a positive manner, can convince reviewers the applicant has sufficient “resources.” So in this case, an important “element” of a Fellowship application (F31 or F32) would include reference to alternative support and training mechanisms.

In addition to the four stated review criteria, there is another essential element of a grant that falls under “Additional Review Criteria” and that is “Protections for Human Subjects (and this element also extends to Invertebrate Animals but any grant that uses secondary data analysis or does not involve human subjects review, would not have this requirement). A grant can be the most well written product a review team examines, but if it is missing this critical “element” the heavy gavel can come down and a low score result (the committee would express a “concern” with the application). Many times a young investigator does not pay sufficient attention to human subjects concerns, IRB review or data safety and monitoring plans and even with good science, an application suffers during review. Here again, an important “element” of a grant is to think about the myriad of ways a grant can be “examined” during review and suffer is some aspect of the application is not addressed.

If an investigator covers all these sections adequately, reviewers then have a sound base from which to judge the scientific merit of an application. Then, the elements are all in place and the reviewer takes a step back to see the “whole” or synthesize the science and determine if the grant is one of the better ones he or she has read. In our book we carefully review each of the major review criteria, but there are also other “elements” of a successful grant that we cover. These refer to the writing style, formatting, and overall grammatical structure, the synthesis, presentation and the manner in which an investigator hammers home the core issues of a grant, which we call the “science.” We cover this in the book in several chapters but nowhere more poignantly than Chapter 3 (A brief guide to the essentials of grant writing). Consider if an application is not scored or receives a very low (poor) score and is subsequently revised and resubmitted. We cover this procedure (revision and resubmission) in great detail in Chapter 18 of the book. I point you toward this chapter in particular because it is essential that an investigator consider the most important “element” of a successful revision is whether he/she has addressed the comments of previous reviews. If you submit a revised grant, which is more than likely if you are a new grant writer and you have to produce multiple submissions to get your “First” grant, then you have to consider the content of your revision. It is essential to realize that if a reviewer feels “slighted” and that their comments were not taken to heart, this can spell the death knell for a grant during review. In this case, the most successful “element” of a grant is the detail provided in the Introduction (response to reviewers from previous review). An Introduction can either be three pages or one page, depending on the grant mechanism. Usually an R01 revision is allowed three pages, while an R03 small grant mechanism is allowed one page. Either way, the Introduction is where the applicant shapes the response to the reviewer and provides an overview of how the application has changed. So in this brief example, a Revision has to include several elements, one of which is an overview of how the grant has changed to incorporate the reviewer comments.

If we take a step back and consider this notion of “elements” from a reviewer perspective, then the most significant element is synthesis (we also call this “organization” in the book), whether the grant is written clearly and coherently, and whether the applicant spells things out so the reviewers does not have to dig deeply to find the major points. If we think of “elements” from the funding agency perspective, then the single most important thing is whether the grant fits the overall mission and goals of the Institute or Center and whether the applicant spells out these components. Regardless of how well a grant fares during review, it still must pass muster during the Advisory Council Review. This is where a handful of experts and senior scientists address whether the grant fits with the overall mission of the Institute or Center and specifically whether the grant addresses pressing research and public health concerns at that time.

OUPblog: What is the most misunderstood aspect of NIH grant writing?

Scheier: Perhaps the most misunderstood aspect of NIH grant writing is how easy it can really be, and how fun. Remember, the challenge of grant writing is tied inextricably to your professional aspirations. If you are a clinician who practices and sees patients all day, then you are not honing your grant writing skills regularly. If you jump into grant writing to expand your professional horizons, then sure, getting a low priority score can be disconcerting and even dissuade you from pursuing grant writing activities. On the other hand, if you are a research scientist in some laboratory and you know full well that your survival rests with your success in grant writing, then developing effective grant writing skills is a “sin qua non” of your profession. Even though you may not have acquired the best set of skills in graduate school (where your focus was on your terminal degree), you have at your fingertips the most comprehensive training guides to help you write grants. These come in the form of books, like the one we edited, government assistance accessible through the web, manuals, and work experience. All told, these ingredients and training resources should position you to be more competitive as you write your first grant. So, the message here is to make grant writing not a task, but rather a part of your professional growth. So when you get your first grant, it is rewarding and fulfilling. In the end, you want grant writing to be positive and reinforcing, not depicted as drudgery. Many groups have parties after they write grants (whether the grant is successful down the road during review is not important, just that the group finalized an important task). Other groups build their relationships around collective and collaborative writing and use grants as opportunities to cement their relations. Some grant organizations bring on board consultants that help them shape the grants and these opportunities expand the group’s potential, thus opening new collaborations and pushing scientific horizons. If we look at grant writing with a stronger professional flair, then we see it can be fun, rewarding and challenging in the same context.

OUPblog: What is the biggest secret to grant writing you’ve discovered?

Scheier: In a nutshell, “Preparation.” Once I bumped into a colleague that had an illustrious career, very successful grant writer, heavily published, and a really smart guy, with vision backed by hard work. He said to me, “You know people want to get Center grants and funded for multiple years, but they spend so little time on the one thing that will help them get funded, the grants they write.” I took this to heart and decided to spend much more time on each grant, making sure they were polished and accurate, both historically and from a scientific point of view. I would submit each and every grant thinking it was my best piece of work and not take it personal if the grant was not received well by reviewers, but rather take to heart the comments made by reviewers. In fact, I would use their critiques as a means to improve my own thinking and writing. Then grants became a challenge rather than an obstacle and I grew as a person, submitting better grants and helping others to write better grants. My funding percentage increased and I found myself more helpful to other groups that used my grant writing skills to improve their lot as well. So the secret you will learn from any grant writer is preparation and using your time to make the grant a really solid work. In many cases, ideas developed for grants mature into themes used for chapters or even an entire prospectus for books. So you have to see the “work” that goes into a grant as part of your overall scientific development.