Sketch of the letters X, Y, and Z

Using SciENcv to create compliant biosketches

SciENcv biosketches will be required for NSF proposals with submission deadlines on and after October 5, 2020. With that date coming up quickly, we want to give all of the faculty at Miami a heads-up about creating their biosketches on SciENcv. Please follow the directions below.

  • Click the NSF login button to connect SciENcv with your profile on
  • You will be redirected to’s sign-in page. Enter your login information and click the Sign In button.
  • After you log in, you will be redirected back to the NCBI website, where you will now be logged in. Click the Create New Document link.
  • Once on the “Create a New Document” page you will need to name your bio-sketch. We highly recommend naming it with a date so you know when updates will be needed in the future. In the format section, select NSF Biosketch.
    • Select an option in the “Choose data source” section.

      • If you select National Science Foundation from the “External source” drop-down menu and you have nothing in your NSF profile, you will see a message warning you that some SciENcv fields will be left blank.
      • If you select Start with a blank document and then click Create, you will be taken to a page where you can input your professional preparation, appointments, products, and synergistic activities.
        • Under “C. PRODUCTS,” clicking the Select citations link will allow you either to connect your ORCID account or to visit “My Bibliography,” where you can select citations to add to your ScieENcv.


        • If you do not have existing citations uploaded to NSF or ORCID, you will need to add them in SciENcv individually, but you will only need to do this once because the system will save the information and auto-populate it in future bio-sketches. Clicking the add citations link in the “Products” section allows you to access PubMed citations.
  • Once you have completed your bio-sketch, click Download: PDF in the bottom right of the page, below “Synergistic Activities.” Select PDF download your biosketch in the format shown below.

If you need more help creating a biosketch in SciENcv, please contact me ( or the proposal consultant assigned to your department!

Public domain image from Max Pixel.

Large stack of paper

NIH to transition to Forms-F grant application forms and instructions

The National Institutes of Health (NIH) will require applicants to use a new set of forms and instructions for proposals due on or after May 25, 2020. The changes appear to be very minor. The most substantive change, in PHS Human Subjects and Clinical Trials Information, involves the separation of the current “Inclusion of Women, Minorities, and Children” attachment into two attachments: “Inclusion of Individuals Across the Lifespan” and “Inclusion of Women and Minorities.” Miami’s interface, Cayuse 424, will automatically update to the new forms for applications with due dates after May 25, 2020. While we expect that many applicants won’t even notice the changes, Research & Sponsored Programs staff will be available to answer any questions that arise.

Written by Amy Hurley Cooper, Assistant Director of Proposal Development, Research & Sponsored Programs, Miami University.

Paper stack image by Egle_pe via “Coming soon” image by Mian Shahzad Raza via Pixabay. Both used under Creative Commons license.

A collection of chicken eggs, each stamped with an identifier

ORCID identifiers help researchers distinguish themselves

Screen shot of ORCID homepage. Text: ORCID. Connecting Research and Researchers. (Tabs:) For Researchers, For Organizations, About, Help, Sign In. (Main text:) Distinguish yourself in three easy steps. ORCID provides persistent digital identifier that distinguishes you from every other researcher and, through integration in key research workflows such as manuscript and grant submission, supports automated linkages between you and your professional activities ensuring that your work is recognized. Find out more. 1. Register. Get your unique ORCID identifier Register now! Registration takes 30 seconds. 2. Add your info. Enhance your ORCID record with your professional information and link to your other identifiers (such as Scopus or ResearcherID or LinkedIn). 3. Use your ORCID ID. Include your ORCID identifier on your Webpage, when you submit publications, apply for grants, and in any research workflow to ensure you get credit for your work. Members make ORCID Possible! ORCID is a non-profit organization supported by a global community of organizational members, including research organizations, publishers, funders, professional associations, and other stakeholders in the research ecosystem. Curious about who our members are? See our complete list of member organizations. (Sidebar:) Latest News. Fri, 2016-09-23 Peer Review Week - The Video! Thu, 2016-09-22. #RecognitionReview with ORCID. Tue, 2016-0-20 Recognition for Review: Who's Doing What? Mon, 2016-09-12. Meet the Lens: Integrating ORCID IDs into patents. Mon, 2016-08-29. PIDapalooza - What, Why, When, Who? More news.
ORCID is an organization that assigns researchers unique identifiers.

You may recall a 2015 paper on the Higgs boson published in Physical Review Letters that boasted a record-breaking 5,154 authors. Twenty-three of those authors had the last name Wang, two each with the first initials C, F, H, and Q, and four with the first initial J.

What this example of “hyperauthorship” make clear is that there can be multiple researchers with similar, if not identical, names in the same field. That can make things difficult for researchers, funders, and publishers alike.

To help resolve this issue, a number of organizations have begun issuing unique identifiers researchers can use to distinguish themselves from others with the same or similar names, thereby protecting their scholarly identities.

One of the most popular of these organizations is ORCID. ORCID is a non-profit organization supported by research organizations, publishers, funders, and professional associations. Its iD is  “a persistent digital identifier that distinguishes you from every other researcher and, through integration in key research workflows such as manuscript and grant submission, supports automated linkages between you and your professional activities ensuring that your work is recognized.”

Specifically related to grant submission, ORCID integrates with SciENcv to make creating NIH and NSF biosketches easier. In addition, NIH will soon begin requiring ORCID iDs for anyone supported by NIH research training, fellowship, research education, and career development awards.

Signing up for you own ORCID identifier is easy — registration takes 30 seconds. Once you’re registered you can add professional information to your ORCID record.

Written by Heather Beattey Johnston, Associate Director of Research Communications, Office for the Advancement of Research and Scholarship, Miami University.

Egg identification Image by Mabel Amber, still incognito via Pixabay.

Professor Jay Smart and a student look at a screen during testing related to psychology research.

NIH offers a new resource for behavioral and social scientists

A student places EEG machine equipment on a subject's head. Posters depicting the anatomy of the brain are in the background.

In response to recently expanded clinical trial requirements for behavior and social interventions, National Institutes of Health (NIH) has released a new resource for behavioral and social science researchers. The Clinical e-Protocol Writing Tool includes a template that leads the writer through the process of preparing a research protocol involving human subjects.

The Writing Tool requires the user to set up a new log in. Once in the system, the user can find a link to instructions for each subsection of a protocol. Newer investigators may find the examples linked to the subsections to be particularly helpful, although examples are not currently provided for all subsections.

According to William Riley, Director of the NIH Office of Behavioral and Social Sciences Research, the Writing Tool “allows users to seamlessly send and edit protocol information directly to” It can also help with developing IRB applications.

Written by Amy Hurley Cooper, Assistant Director of Proposal Development, Office for the Advancement of Research and Scholarship, Miami University.

Photos by Miami University Photo Services.


Samples from a lab experiment sit on a lab bench.

NIH revamps their Rigor and Reproducibility webpage

NIH has added new resources to their Rigor and Reproducibility webpage. According to NIH Deputy Director for Extramural Research Mike Lauer, “the webpage now reflects policy updates and explores new resources, all in a simple and easy to read manner. And, better yet, these changes do not reflect any additional requirements or forms!”

Lauer shared news of the redesign in a December 13 Open Mike blog post. The main focus of the redesigned page is clarifying what is meant by “scientific premise” of grant applications. Lauer points out that the original NIH definition of the term referred to the rigor of the prior research used to support the proposal, rather than just referring to the hypothesis or rationale for the proposed study.

The Rigor and Reproducibility page links to four subpages, including relevant guidance, application preparation resources, training materials, and links to notices, blogs, and other resources. The application preparation resources may be of most interest to Miami faculty, as they include examples of the rigor of some funded proposals, tools for enhancing or clarifying the rigor of your application, and examples of plans for authenticating chemicals, plasmid DNA, antibodies, and cell lines.

Written by Amy Hurley Cooper, Assistant Director of Proposal Development, Office for the Advancement of Research and Scholarship, Miami University.

Photos by Miami University Photo Services.

Guest post: Recent changes to NIH R15 mechanism mean Miami faculty are more competitive than ever

Students presenters discuss their poster with an Undergraduate Research Forum attendee.
Highlighting their students’ participation in the Undergraduate Research Forum is one way PIs can demonstrate the excellence of the research environment for undergraduate students at Miami University.

The following guest post was written by Dr. Gary Lorigan, a professor in Miami University’s Department of Chemistry and Biochemistry. Since 2010, he has served on 18 NIH study panels. During that time he was a member of the Biochemistry and Biophysics of Membranes (BBM) NIH Study Section and served on several NIH and NSF instrumentation panels. Below, Lorigan shares insights about changes to the NIH R15 mechanism, suggests some tips for writing NIH  grant applications — especially R15s — and offers encouragement for Miami researchers based on his experience.

The major goals of the NIH R15 Academic Research Enhancement Award (AREA) program are to support meritorious research at predominantly undergraduate institutions, strengthen the overall research environment, and provide valuable research experience for undergraduate students. The R15 application is a 3-year award with a maximum of $300,000 in direct costs for the entire project. The R15 guidelines have changed significantly, as described in a new Funding Opportunity Announcement (FOA), PAR-18-714: Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed).

Additional changes to the R15 program, including the addition of the REAP program, are coming next year as well.

This fall I was on an NIH study panel that reviewed both R01 and R15 applications. I wanted to share with you some of my experiences from that panel, offer some helpful hints, and encourage more researchers at Miami to apply for R15 funding. First of all, NIH has placed a much greater emphasis on training undergraduate students for R15 applications. This change should have a major impact at Miami University. Researchers at Miami should have a significant advantage with the R15 proposals, since we strongly emphasize and encourage undergraduate research.

The FOA Research Strategy states the following:

Research Strategy: Describe how the proposed plan can achieve the specific aims using a research team composed primarily of undergraduate students. Describe how undergraduate students will be exposed to and supervised in conducting hands-on, rigorous research. Describe how undergraduate students will participate in research activities such as planning, execution and/or analysis of research. Formal training plans (e.g., non-research activities, didactic training, seminars) should not be provided, although a brief description of activities related to enhancing students’ research capabilities and progress (e.g., the use of individual development plans, etc.)  is permitted.

Here are some tips to make your proposal stronger:

  • Make sure that you discuss everything that is listed in the FOA Research Strategy in your proposal. The reviewers of the application are asked to comment on these issues directly.
  • The research team described in your application must be primarily composed of undergraduate students. I would include in your budget salary for undergraduate students during the school year and the summer, as well as salary for a graduate student to train and work with the undergraduate students.
  • In your biosketch and in the proposal, make it crystal clear that you work with undergraduate students in your lab. Dedicate at least half a page in the application to showing that you are training undergraduate students in your lab. In your proposal, I would include the following: “I have been at Miami University for ZZ years and I have mentored XX undergraduate students. These students have published XX papers as co-authors and YY as first authors. I currently have XX undergraduate students working in my lab.”  In the application, you need to explain how students are trained.  Briefly discuss papers that undergraduates have co-authored in your lab and mention what graduate or professional schools your students have attended. This will provide clear evidence to the reviewers that you have a proven track record in training undergraduate students and helping them pursue careers in biomedical sciences.
  • In your biosketch, underline the names of the undergraduate co-authors. Make it easy for the reviewers to clearly see that you are dedicated to conducting research with undergraduate students and that you have plenty of experience in that area.
  • Describe innovative approaches that you are using to engage undergraduate students in your lab. Describe how you will stimulate the interests of the students. Discuss how you will recruit a diverse and inclusive group of undergraduate students to the lab.
  • Make sure you mention that Miami University has a dedicated Office of Research for Undergraduates that provides valuable resources for students interested in research. Discuss all of the outstanding programs that Miami offers undergraduate students who are interested in conducting research, including Undergraduate Research Awards (URA), Undergraduate Summer Scholars (USS), First Year Research Experience (FYRE), and Doctoral Undergraduate Opportunity Scholarships (DUOS). Mention that workshops that discuss all aspects of scientific research are available to students. Finally, have your students present a poster at Miami’s annual Undergraduate Research Forum, held in April. These components of the proposal really emphasize the strength of Miami University and enhance your application.

One of your overall goals in writing the R15 proposal should be for the reviewer to want their son or daughter to conduct research in your lab as an undergraduate student. This is very important. You want the quality of the research work and the training experience to be outstanding in the application.

In addition, here are a few general tips for NIH proposals that are not specific to the new R15:

  • The proposal needs to be strong scientifically; it is not just about undergraduate training. Try to have good preliminary data for each specific aim in the proposal. This will clearly show that you can conduct the experiments proposed in the application.
  • At the very end of each specific aim, discuss outcomes, potential problems, and alternative strategies.
  • Make sure you include a resource sharing plan in the application. Several applications forget to include this.

I strongly encourage faculty at Miami to apply for NIH R15 grants. If any researchers have any questions about this program or other grant applications, please do not hesitate to contact me.

Finally, although NIH funding is still highly competitive, I think it is getting a bit better for researchers. Good luck with your submissions!

Written by Gary Lorigan, John W. Steube Professor, Department of Chemistry and Biochemistry, Miami University.

Photos by Scott Kissell, Miami University Photo Services.


A background pattern consisting of different colored equilateral triangles.

NIH issues notice of changes to AREA/R15 program

Gary Lorigan works with a piece of equipment in his lab.
Changes to the AREA/R15 program recently announced by NIH will have very few practical implications for Miami University researchers, including past AREA recipient Gary Lorigan a professor in the Department of Chemistry and Biochemistry.

NIH issued a long-anticipated notice about changes to its Academic Research Enhancement Award (AREA)/R15 program last week. The changes are being made to “focus AREA support on grants to undergraduate-focused institutions that do not receive substantial funding from NIH, rather than all institutions with less than $6 million of NIH support.” Since Miami University meets both these criteria — it is undergraduate-focused and receives relatively little NIH funding — the impact of these changes on our researchers will be fairly limited, as described below.

CHANGE: The current AREA Parent Announcement will expire after January 7, 2019
EFFECT: Miami PIs will need to look for (and apply under) new FOAs, to be issued soon.

CHANGE: Eligibility requirements are as follows: 1) Applicant institution must be accredited and grant baccalaureate degrees in biomedical sciences. 2) Applicant institution may not have received $6 million or more per year in total NIH awards (direct and indirect costs combined) in 4 of the last 7 years. 3) The qualifying academic component (school, college, center, or institute) within an institution has an undergraduate student enrollment greater than its graduate student enrollment.
EFFECT: 1) Not a change; Miami meets this requirement with accreditation by the Higher Learning Commission. 2) Not a change; Miami meets this requirement, having received no more than $3.9 million (in FY2011) in annual funding from NIH in the last 7 years. 3) A significant change for some institutions, but not for Miami; none of our divisions enrolls more graduate students than undergraduate students.

CHANGE: NIH will no longer maintain a list of R15-ineligible institutions and all applications due on or after February 25, 2019 will need to include a letter verifying institutional eligibility.
EFFECT: OARS will provide the required letter to be included in applications. Anne Schauer, Director of Research and Sponsored Programs, is authorized to sign such letters on behalf of the university, and PIs should not request them from the president or the provost.

CHANGE: NIH will issue separate FOAs for R15 opportunities to support health professional schools and graduate schools.
EFFECT: Anticipated to be minimal.

A description of the R15 Activity Code, which reflects the changes, is available on the NIH website.

Written by Heather Beattey Johnston, Associate Director of Research Communications, Office for the Advancement of Research and Scholarship, Miami University.

Triangle image by DavidRockDesign via Pixabay, public domain/Creative Commons CC0 license. Photo of Gary Lorigan by Scott Kissell, Miami University Photo Services.

Metamorphosis Cocoon Close Up

Changes to NIH R15 mechanism are coming

Mike Lauer addresses an audience as part of a panel discussion.
NIH Deputy Director for Extramural Research, Mike Lauer (right), says changes are coming to the R15 program, but reaffirms NIH’s commitment to the funding mechanism.

With their focus on engaging students in meaningful research experiences, National Institutes of Health’s Academic Research Enhancement Awards (AREA, R15) are a popular mechanism for Miami University principal investigators. These grants are designed for institutions receiving less than $6 million per year in NIH support (currently the case at Miami) and emphasize enhancing the research environment at eligible schools.

I attended an NIH Regional Seminar in mid-October. Held semi-annually, these seminars clarify federal regulations and policies and highlight current areas of special interest or concern. The R15 grant mechanism was highlighted in the plenary session presented by Mike Lauer, the NIH Deputy Director for Extramural Research. Lauer hinted at upcoming changes to the R15 program, but emphasized that the NIH commitment to the R15 program will remain the same.

One change that Lauer made clear is that the current practice of the NIH maintaining a list of institutions ineligible for AREA grants will be discontinued. It will become an institution’s responsibility to affirm eligibility based on the level of NIH funding over the last 7 years. OARS will be developing a template letter to cover this requirement.

In spring 2018, the NIH National Institute of General Medical Sciences (NIGMS) issued a specific call (PAR-18-714) for R15 proposals with an emphasis on providing biomedical research experiences primarily for undergraduate students. While graduate students shouldn’t be excluded, they are not the focus of this call.

In a seminar breakout session on R15 grants, the presenter, Tracy Waldeck, Director of the Office of Extramural Policy and Review (OPER) for the National Institute on Drug Abuse, stated that other NIH institutes and centers will be signing on to participate in this call. The current call lists all the institutes and centers that have signed on to participate, some as recently as October 31. Waldeck also alluded to an upcoming announcement about changes to the AREA grant program. OARS is monitoring the situation and will share news as it becomes available.

Written by Amy Hurley Cooper, Assistant Director of Proposal Development, Office for the Advancement of Research and Scholarship, Miami University.

Cocoon photo via Max Pixel, used under Creative Commons license. Photo of Mike Lauer by Ernie Branson and Rich McManus for the NIH, public domain.

Rick Page working with senior Matt Morris, a 2018 Beckman Scholar

In a first at Miami, two biochemists awarded MIRA grants

Gary Lorigan and Dan Drew work with an EPR spectrometer.
Gary Lorigan, left, with doctoral student Dan Drew.

A new type of grant from the National Institutes of Health (NIH) is designed to allow proven and promising researchers to be more ambitious and creative in their research.

The NIH has recognized Miami University biochemists Gary Lorigan and Rick Page: They were each awarded about $1.8 million over five years, as part of the Maximizing Investigator’s Research Award, or MIRA.

The MIRA grants, part of the National Institute of General Medical Sciences (NIGMS), are highly competitive and essentially set the researcher for a career in NIH funding, said Mike Crowder, chair and professor of chemistry and biochemistry.

“It would be rare for a school like Miami to have two MIRAs; it is very unlikely for one department to have two,” he said.

After the first five years of funding, the MIRA program is set up to provide another funding cycle to the researchers, as long as the group was productive, Crowder said. The current system requires researchers to apply repeatedly for a grant.

“Given their success rate on NIH grant proposals using the ‘old’ system, Gary and Rick are positioned for consistent funding for many years. I could not be happier for them or for their students,” Crowder said.

Describing the new grant program, now in its second year, NIGMS director Jon Lorsch said, “We hope that by creating the stability for investigators, we can really empower them to be more ambitious and more creative in their research. We also hope to increase the flexibility for investigators to follow new ideas and new research directions as they arise during the course of their work. If they discover something very interesting, they’ll be able to follow that.”

Freedom to let the science guide the research

Lorigan, professor, and Page, assistant professor of chemistry and biochemistry, will each receive around $360,000 per year for five years. Page received the MIRA for Early Stage Investigators (MIRA ESI).

The funding supports their research programs, rather than individual projects.

Portrait of Gary Lorigan
Gary Lorigan

Lorigan’s research program: Membrane protein structure; heart disease

The MIRA grant gives his research group a lot of flexibility and the ability to explore new scientific directions, Lorigan said.

His research program focuses on membrane protein channels that are directly related to heart disease.

Internationally recognized as a leader in the field of membrane protein structure, he and his research group have pioneered strategies to characterize membrane proteins by using magnetic resonance techniques, such as electron paramagnetic resonance (EPR) and nuclear magnetic resonance (NMR) spectroscopies.

His expertise has attracted several significant collaborators with important biological problems.

His goal:

  • To develop transformative biophysical techniques to study the structural and dynamic properties of membrane proteins.
  • These state-of-the-art pulsed EPR spectroscopic techniques will move the field forward by dramatically increasing sensitivity and accuracy of distance measurements for all membrane protein systems.

Lorigan is currently adviser to a postdoctoral researcher and four graduate students and is mentor to nine undergraduate researchers.

Portrait of Rick Page
Rick Page

Page’s research program: Protein quality control; antibiotic resistance

The award “provides my laboratory with the freedom to let the science guide us,” Page said. It will advance both the protein quality control and the antibiotic resistance projects in his lab.

The three-dimensional structures of proteins determine the roles and functions proteins play within cells, Page said. Exposure to chemical or mechanical stresses can cause proteins to misfold, resulting in large changes in three-dimensional structure and loss of protein function.

To survive, cells have developed quality control systems that guide misfolded proteins towards pathways that lead to them either being repaired or discarded.

Defects in protein quality control pathways can contribute to diseases including neurodegenerative disorders and cancers.

His goal:

  • To enhance our fundamental knowledge of protein quality control pathways and identify avenues that may be exploited for future therapeutic targeting.

He has multiple research collaborations with colleagues in chemistry and biochemistry and in bioengineering on his research project on clinical inhibitors of metallo-beta-lactamases (MBLs), which render bacteria resistant to antibiotics.

Page is currently adviser to six graduate students and mentor to 12 undergraduate researchers.

Proven and Promising
Lorigan (2003) and Page (2016) have each been named a Miami University Junior Faculty Scholar. Lorigan was named a Distinguished Faculty Scholar in 2014.

They each received a National Science Foundation CAREER grant – one of the organization’s most prestigious awards in support of junior faulty. Lorigan was the first scientist at Miami to receive one, in 2003. Page is the eighth to receive one, in 2016. (Dominik Konkolewicz, asssitant professor of chemistry and biochemistry, recently received the ninth NSF CAREER grant at Miami).

Last month Lorigan received a $450,000 grant from the National Science Foundation for his research on membrane proteins.

Research at Miami is competitive at the highest level

“We are incredibly proud to have received a MIRA ESI,” Page said. “That there are now two MIRAs in the department is continued evidence that research at Miami is competitive at the highest levels,” he said.

There are 231 established MIRA grantees and 192 ESI MIRA grantees nationally, awarded over the first two years of the program, according to the NIGMS.

Written by Susan Meikle, University News Writer/Editor, University Communications and Marketing, Miami University. Originally appeared as a “Top Story” on Miami University’s News and Events website.

Photos by Scott Kissell and Jeff Sabo, Miami University Photo Services.


HeLa cells grown in culture and stained with antibody to tubulin (green), antibody to Ki-67 (red) and the blue DNA binding dye DAPI. The tubulin antibody shows the distribution of microtubules and the Ki-67 antibody is expressed in cells about to divide.

Guest post: Ancillary criteria can make or break a borderline NIH proposal

A lab mouse sits on the gloved hand of a researcher.
Consideration for the gender of animal or human research subjects is one of several ancillary criteria PIs should address in NIH proposals to maximize their scores.

The following guest post was written by Dr. Carl Batt. Batt is Liberty Hyde Bailey Professor in Cornell University’s Department of Food Science. In his 30-year career, he has served on a number of NIH study sections. Below, Batt shares his experience with ancillary criteria that may affect how NIH proposals are scored in the review process.

Sitting on a study section (review panel) at NIH helps researchers understand (as much as possible) the nuances of how panels work and what the collective wisdom of the panel might be. For those of you not familiar, the standard practice is to have three or more preliminary reviewers whose scores form the basis for the selection of proposals that will (or will not) be discussed at the review panel. There, the lead reviewer presents the case, followed by the secondary and tertiary reviewers. If the proposal is not scored at the review panel, there is no reporting of these preliminary scores.

The following comments address a number of ancillary criteria that reviewers are asked to comment on and may (or may not) impact the preliminary scoring. Should the proposal move forward to the panel, these criteria are sometimes not discussed until after the reviewers have offered their final scoring. Each and every member of the panel (aside from those who have a conflict of interest) provide a score, which could be impacted by the discussion about these criteria.

There is no doubt that the research plan is the most important element judged by the reviewers, beyond the importance of the topic itself. There is no saving a bad idea, especially if it is deemed not to be innovative. Over the past few years a number of additional criteria have been introduced as the NIH (and other agencies) attempt to address a number of issues, some of which are external, and others internal. The following are things to keep in mind. While they will not sink a great proposal, they could potentially tank a borderline proposal. They are not scored but reviewers are asked to note compliance and challenges. What that translates into is reviewer concerns that could — if they get noticed and bother the reviewer — creep into the preliminary scoring (for the initial reviewers) and the overall impact score if your proposal gets scored.

Ancillary criterion 1: Rigor

Significant attention is being directed toward the reproducibility of research and this has crept into all science, not just that which involves qualitative, seemingly-subject experimental methods. Rigor is defined by the inclusion of controls, replicates, and other matters that are typically thought of as just “good science,” but that you might not include in an explicit manner. The Center for Scientific Review (CSR) manager (and sometimes the academic panel manager) will often remind the reviewers to comment on “rigor” and for the most part the answer is “affirmative,” meaning either there is an explicit mention of “rigor” in the experimental plan or the reviewers simply didn’t notice it. On rare occasions, the reviewer might comment about the lack of rigor and, as with everything else related to review, you are not in the room to defend your proposal. It is important that you explicitly mention controls and replicates to ensure that the matter of rigor is covered. In the past it might have been mentioned as part of a reviewer’s commentary but now it is an explicit part of the review process.

Ancillary criterion 2: Gender of animal or human subjects

If you propose to use animals or human subjects be aware there is a specific question asked: “Has the applicant considered ‘sex’ as a potential variable in their animal studies?” At a minimum you should state the gender of the animal or human subjects you will be using. It’s appropriate to state that you will use both male and female subjects,  but you should follow that statement with an additional statement that you will consider gender as a variable in your experimental plan.

Ancillary criterion 3: Milestones

Along with other agencies, the NIH has moved toward a more rigorous set of expected outcomes. Some funding opportunity announcements (FOAs) have explicit language requiring milestones, and it isn’t a bad idea to include them even in proposals for FOAs that don’t require them. The following is the language found in one NIH FOA.

Milestones. This sub-section is required for all applications. All applicants must describe here a set of discrete benchmarks that will allow unequivocal determination of the progress made towards the goals of the project. Milestones should be scientifically justified and well defined for each year of the project and be based on the proposed specific aims. Whenever feasible, milestones should provide quantitative benchmarks for comprehensively assessing the annual progress of the project. Milestones must not be simply a restatement of the specific aims. The specific aims describe the research goals of the project. Rather, the milestones should provide the means for assessing the progress made towards each aim and offer a timeline and a “pathway” for the testing of a discovery concept or development of a technology. The completion of these milestones will be used to judge the success of the proposed research on an individual-project basis.

Examples of Milestones:

  • Verify that the designed composite nanoparticles are able to reproducibly release an activated component at tumor/cancer cell sites in vivo.
  • Ascertain that a new targeted nanoparticle can specifically deliver a therapeutic agent to the tumor by demonstrating that agent concentration in tumor exceeds at least “x” times its blood concentration.
  • Demonstrate the ability of a nanoparticle diagnostic construct to detect at least “x” specific proteins in blood (out of “y” specific proteins proposed) at a femtomolar level.
  • Demonstrate the ability of the proposed nanotechnology to achieve 95% rate of capture for circulating tumor cells in blood.

Reviewers have various opinions about milestones and most don’t understand exactly what they mean. But some do, and the simple advice is to have milestones that include quantitative outcomes that can be measured and promised with some degree of temporal specificity. In other words instead of “I will build you a house,” think “I will complete your 3 bedroom, 2 bath, 2000 square foot home by April 1, 2019 for $100,000.”

Ancillary criterion 4: Resource availability

This request has to do with how you will make available some of the outputs of your research, including data, but also including physical resources such as strains, plasmids, or other things. The simplest answer is to offer everything to everyone, but the practical reality might be different. The goal is to make sure there are no doubts about the availability of resources. The section should consider what and when you might make things available and under what conditions. It is certainly acceptable to include the prerequisite that a material transfer agreement (MTA) be in place.

Ancillary criterion 5: Resource validation/concern for authenticity

This section addresses how you will know that the reagents (animals, cell lines, chemicals) you are working with are what you think they are. This stems from reports that cell lines for example are frequently not what people say (or believe) they are. “I will buy stuff from established vendors,” is an answer, but sometimes reviewers have objections to that statement and will make note of it (and sometimes that might impact their initial scoring). Even established chemical vendors (e.g., Sigma) are the subject of some derision. There is little to be done, as nobody can afford to send every chemical out for independent analysis. Certainly a statement about the certificate of identity might be worth noting. In the case of cell lines, having some markers that you state will be assayed (especially where there are specific mutations or knock-outs) is a way to address this section.

Written by Carl Batt, Liberty Hyde Bailey Professor in Cornell University’s Department of Food Science.

HeLa cell image by EnCor Biotechnology via Wikimedia Commons. Mouse photo by Rama via Wikimedia Commons. Both used under Creative Commons license.