Research Committee — FAQs

• How do I find a funding agency? (Excerpted from Research News vol. 1)

• First, you can do an on-line search. Go to www.kumc.edu, click on Research, and then Research Administration and go to COS/SPIN. COS and SPIN are two international web sites that our university subscribes to that are updated daily and allow you to search for grants in your specific area. On the COS web site, simply click on Find Funding and COS Funding Opportunities. I find that the Main Search option is best as it allows you to define exactly what type of grant you hope to find. On the SPIN web site, just type in a search word on their main page to do a simple search, or click on Advanced Search (just below the simple search) to be more specific to your search.
• Another option is to contact Vicky Eaton, the Director of Pre-Award at the KUMC Research Administration (588-1239). Vicky and her staff are very helpful and have several tools available to help you in your search. One of the tools they have available is an individual “Funding Opportunities & Notices” Folder that can be inserted right into your GroupWise e-mail system. This service has Vicky and her staff do all of the searching for you. When you have a free moment, you simply sift through the emails they send to this folder to see if any of the grant opportunities are right for you (the emails do not come to your regular GroupWise account to clog up your mailbox).
• Finally, as you may know, the Department of Pediatrics has its very own Research Committee. This committee is available for your assistance should you want to write a grant, but need assistance. We are available for everything from brainstorming to proofreading. Dr. Michael Rapoff is chair of this committee; please contact him if you would like to come to one of our meetings to discuss your ideas with our team to see how we can help (588-6323 or mrapoff@kumc.edu).
• How do I submit a project to the Human Subjects Committee? (from Research News vol. 2)

• The Human Subjects Committee reviews all proposed research projects conducted by or at KUMC that involve Human Subjects. There are 4 items that must be submitted with every protocol:
1. Form HSC 1-83 – This form can be found on the KUMC Research Administration web site at http://www2.kumc.edu/researchadmin/humansubjects.htm. The form is a cover sheet that requires the signature of the responsible investigator and all sub- or co-investigators along with the department chairman.
2. The Protocol Summary – According to the KUMC Research Administration web site the protocol summary “should describe the project's long-term objectives and specific aims, and describe concisely the research design and methods for achieving the goals. It should serve as a succinct and accurate description of the proposed work. It should, however, be in sufficiently 'lay' language so as to be understandable by all HSC members, and not just those with expertise in the particular field. It should rarely be longer than about 2/3 of a page and should never exceed one (1) page (absent getting the prior consent of the Committee to such a length).”
3. The HSC Consent Form – This is probably the most important part of the HSC application. The consent form must follow certain sub-sections and must have specific signature lines. For a sample consent form, see the web site listed in #1(above).
4. Proof of Completing the Human Subjects Tutorial – This certificate must be included for all personnel on the research project, including the responsible investigator and all sub- or co-investigators. Also, all project coordinators, nurses, research assistants and other project staff must complete the tutorial and get proof of such to the HSC before they begin working on a research project.
• It is also possible that your project may qualify for “exempt” status. This status is for projects that: 1) study commonly accepted educational or classroom techniques; 2) research involving educational tests; 3) research involving the collection of existing data; 4) taste and food quality evaluation and consumer acceptance studies. When in doubt, always call Sharon Grable at the HSC at 588-5712 to see if your study is exempt. Or, you can just go ahead and submit the full protocol and have the HSC decide whether or not your study is truly exempt. The important thing to remember is that all research involving human subjects, especially children, should go through the HSC, even if it is simply a chart review of your own patients. Also, keep in mind that more and more journals are requiring proof of HSC approval before they will publish studies that involve human participants.
• How does HIPAA affect my research? (from Research News vol.3)

• As you know, HIPAA was designed to protect patient information and to make patients aware of how their information is being used. To be compliant with HIPAA, a HIPAA review will now take place on all applications submitted to the Human Subjects Committee (HSC). As part of the HSC review process, all applications will be reviewed to ensure they also meet HIPAA guidelines. What this means for researchers is that for new applications we now need to submit an extra copy of your proposal when you submit your HSC application. Also, a new template titled “HIPAA Requirements for Informed Consent” should be added to all HSC applications to ensure they are HIPAA compliant. This template can be found at http://www.kumc.edu/hipaa/research/ under the “Research Documents” section. However, if you have a project that is currently underway, you will need to contact the HIPAA office to determine how to get your project HIPAA compliant.
• Another issue that has come up as a result of the new HIPAA guidelines is subject recruitment. It is no longer acceptable for researchers to contact subjects through medical care clinics, unless the researcher is a part of the clinical care team. Rather, a member of the medical care team who has contact with the patient in a clinical role must make the initial contact and solicit participation. Then, if patients indicate they are interested in participating in the research project, the medical care team can release information to researchers who can contact the subjects for recruitment. It is still acceptable for patients to self-refer from flyers and adds in the community and in publications.
• As there is also clinical research going on in our department that is completed as a part of clinical care, it is important to note changes in this area. If patient information is being collected with the intent of using the information for publications or for other research purposes, consent must be sought from patients. As the HIPAA web site states “creation of a research repository requires HSC approval… and patient authorization.” Therefore, if the project is ongoing, contact the HIPAA office for suggestions (588-0952). If the project is new, prepare and submit an application to the HSC with the new HIPAA template mentioned above.
• For any additional HIPAA questions, contact Karen Blackwell, the Director of HIPAA Compliance, at 588- 0942 or Rachel Dalthrop, the Assistant Director at 588-0940.
  http://www.kumc.edu/hipaa/
• How do I gather pilot data? (from Research News vol. 5)
  Most grants are better received if they present pilot data. How does one go about actually getting pilot data?

• The simplest method of gathering pilot data is to conduct a chart review. Choose a topic of interest and sit down to develop a data form. What data would you need to extract from your patients’ charts in order to answer your question? Weight? Height? Lab values? Then, create the blank data form and use this to empirically review the charts. This will give you some idea as to whether your clinical hunches are actually supported by the data. And, this type of pilot information can be extremely valuable to a grant application. It may be necessary for you to review the charts of other physicians here at KUMC or even to try to partner up with other providers in the Kansas City area in order to gather the data. Be sure when you gather these data that you comply with all the new HIPAA guidelines (see above).
• Another method of gathering pilot data is to apply for a small grant in order to test out your treatment on a small number of subjects, or to demonstrate project feasibility. There are many sources of small grants, some of which are internal (from KUMC) and some of which are external (Kaufman Foundation, NIH, Sunflower Foundation, etc.). To learn more about these sources, talk to any member of the Pediatric Research Committee or the Research Institute at KUMC, or see Volume 1 of Research News on “Research Tips: Searching for a Grant.”
• How do I resubmit a grant? (from Research News vol. 5)

• When you receive the information that your grant was not funded, it is often difficult to refrain from being resentful and hopeless. So, put it aside for a day or so, and then jump right back in. Call the granting agency, tell them you’d like to resubmit, and get the details on how to do so (deadlines, forms, etc.). Look at the reviewer comments, which we hope are detailed and specific. Choose the most easily addressable suggestions and start there. When making changes to your grant document, be sure to track the changes (either typing them in bold or by using the track changes function) as your reviewers will want to see exactly what you have changed. Also, keep track of each reviewer suggestion, and how you addressed the suggestion in a typewritten document. If there are changes you can’t make, be sure to address this. And, if you choose not to make any recommended changes, be sure you can defend this decision as well. Then, after you have finished your editing, and all the changes are marked, you will need to write a cover letter to the granting agency stating that you wish to resubmit the grant. In your letter be sure to report that the reviewer feedback was extremely helpful and that you feel it has greatly improved your project. Then, go through each reviewer suggestion in detail and state exactly how you addressed the suggestion (this is where the typewritten document mentioned earlier comes in handy – you can just cut and paste). It is often helpful to do this in list or table format.
• What are the pitfalls of collaborative research? (from Research News vol. 6)

1. There can be lack of agreement between investigators on who does what and when. It is important to have written protocols for implementing all aspects of a study, including recruitment, data collection, treatments or conditions, and data analysis. All research staff needs to be trained using the same protocols and there needs to be a monitoring system in place to ensure that protocols are followed by all staff. There also needs to be a designated site and person who has overall responsibility for data integration and analysis. Finally, there needs to be advanced written agreements about who will write up results for publication and the order of authorship.
2. Lack of flexibility and receptivity to new ideas may be a particular pitfall for established investigators who are accustomed to conducting research in a certain way. “Thinking out of the box” is one of the main benefits of collaborative research.
3. Being too concerned about who gets the credit can be a problem (Clint Eastwood, playing the character Dirty Harry, referred to this as “being a legend in your own mind”). The group should get credit for a group effort, if everyone contributes equally or in important ways.
4. Human subjects’ approval across sites can be a major problem. Research compliance personnel and human subjects committee chairs must communicate to address the issues of which parental consent and child assent forms should be used and their format and data and safety monitoring issues. With the new HIPAA regulations, it is vital that data shared between investigators is properly handled when protected health information is accessed and coded.
5. To maintain effective collaboration, figure out what reinforcers are preferred by collaborating investigators and provide them. Most often these would be reimbursement for a portion of their salary, presentations at professional meetings, and publications.

These seem to be the major pitfalls to successful collaboration, but they are manageable and need to be addressed from the outset of any joint research project.

• When should I speak with a statistician? (from Research News vol. 7)

  There are excellent reasons for paying a call on your friendly statistician before undertaking to write a grant application or to begin a research project.

  • Granting agencies draw comfort from seeing a statistician listed on the research team, especially when the agency requires you to provide a formal "sample-size determination" (also sometimes called a "power analysis"). And whether it's a grant application or the study itself, statisticians will perk right up if you ask them to sit in on planning conferences, early enough to comment on the data collection plan, including such things as the number and types of measures that might be taken per subject, the construction of experimental groups, randomization schedules for assignment of subjects to treatments, and data-entry formats. The formats are very important because, if you expect the statistician to analyze the data, you will need to supply them in a format that is friendly to the chosen statistical program.
  • The number of different measures (variables) that are taken per subject has many implications, statistical and non-statistical. More measures mean more time, more expense, and...more subjects. How's that? Yes, generally speaking, you will probably find yourself paying for at least 10 to 15 subjects for each additional measure that you intend to analyze together. It is not uncommon to run multivariate analyses including demographics like age, birthweight, mother's age; and clinical values like temperature, WBC, length-of-stay. Count them up, that's six variables right there, and you might hardly have begun listing what you think should be measured. Yet, if you intend to use those six variables for predicting an outcome, you're probably already talking a minimum of 60 subjects.
  • The other big influence on the number of subjects is the sample-size determination. The granting agencies (and more and more journals) are asking investigators to justify the number of subjects included in the proposal or in the finished study. The agency wants to know that it is paying for enough but not too many subjects; and the agency and the journal want to know that there are enough subjects in the study to allow it to obtain results that are not only statistically significant but also clinically or theoretically important. The statistician will work you pretty hard to obtain the estimates needed to do the sample-size determination, but it'll be worth it when the reviews come back praising the project's attention to statistical details.