IRB, Office of Research Development COOK COUNTY BUREAU OF HEALTH SERVICES
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COOK COUNTY BUREAU OF HEALTH SERVICES

GRANTS NEWSLETTER



Volume 7, Number 10 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~October, 1999
Back Issues

Published by
OFFICE OF RESEARCH DEVELOPMENT
Hektoen Building
627 South Wood Street
Chicago, IL 60612
FAX: 312-738-3102

Karen M. Smith, PhD, Director
312-633-4940
email: kmsmith@wwa.com
Bennetta Anderson, Administrative Assistant
312-633-4941
Lillian Hampton, IRB Administrator
312-633-7792
email:  lhampton@hektoen.org
Funeka Sihlali, RN, Scientific Quality Coordinator
312-572-3506
email:  fsihlali@hektoen.org

COOK COUNTY BOARD OF
COMMISSIONERS
John H. Stroger, Jr., President
  Jerry Butler 
  Allan C. Carr
  Earlean Collins
  John P. Daley
  Gregg Goslin 
  Carl R. Hansen
  Ted Lechowicz 
  Roberto Maldonado
 William R. Moran
 Joseph Mario Moreno 
 Mike Quigley
 Herbert T. Schumann, Jr.
 Peter N. Silvestri 
 Deborah Sims
 Bobbie L. Steele 
 Calvin R. Sutker
COOK COUNTY BUREAU OF HEALTH
SERVICES 
Ruth M. Rothstein, Chief
Affiliates
Ambulatory & Community Health Network 
of Cook County
Cermak Health Services of Cook County
Cook County Department of Public Health
Cook County Hospital 
Oak Forest Hospital of Cook County 
Provident Hospital of Cook County

NIH GRANT APPLICATIONS GO MODULAR 
 

What if you could cut down on the number of forms you have to submit to get National Institutes of Health funding? What if you didn't have to justify how much you plan to spend on pencils? Well, your wish has been granted NIH has rolled out "modular" grant applications for most of its funding programs. 

As of the June 1, 1999 application due date, most grant applications to the National Institutes of Health (NIH) will take a modular format if they request $250,000 or less in direct costs per year. This change is intended to make both the preparation and the review of grant applications less time consuming. Under the modular system, you won't submit a detailed budget, but rather will request funding in $25,000 increments, up to $250,000. Rather than poring over budget details, reviewers will use their expertise and experience to judge if the requested funding total fits the proposed activities. 

Along with the elimination of detailed budgets, budget justifications are abbreviated and the "other support" form will not have to be filed unless and until the application is seriously considered for funding. To give reviewers a better understanding of the key personnel's ongoing research, the biosketch will be expanded to include this information. 
 

These changes will eliminate at least three pages of forms from the standard NIH application, and will shorten the budget justification considerably. This is undoubtedly good news for applicants who are stretched for time to fill out all those forms at the last minute. 

With all this good news, however, there is a catch you will still have to prepare a budget, even if you don't put it on a form and send it to NIH. The reason: You don't know if you can do the project with the funds you're requesting unless you have outlined all your major costs. This is particularly important when a project will depend crucially on hiring new personnel. You must, at the least, assure yourself that you will be able to hire staff at the salaries you think are appropriate with the full costs of their fringe benefits included. If you don't carry out this step, you will be in serious danger of under-budgeting your project. 

In practical terms, these are the major changes in application procedures you will see with modular grants: 

o Applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year for all unsolicited new, revised, and competing continuation R01, R03, R15, R21, R41, and R43 grants and competing supplements, as well as applications responding to RFAs for these mechanisms. Specific grant mechanisms, e.g., R03, R15, R21, and Institute/Center programs may define a particular number or range of modules allowed. 

o A typical modular grant application will request the same number of modules in each year. 

o Application budgets will be simplified. Detailed categorical budget information will not be submitted with the application; budget form pages of the application kits will not be used. Instead, total direct costs requested for each year will be presented. Information, in narrative form, will be provided only for Personnel and, when applicable, for Consortium/ Contractual Costs. 

o Additional narrative budget justification will be required only if there is a variation in the number of modules requested. 

o There will be no routine escalation for future years. In determining the total for each budget year, applicants should first consider the direct cost of the entire project period. Well-justified modular increments or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested. For example, purchase of major equipment in the first year may justify a higher overall budget in the first, but not in succeeding years. 

o Scientific Review Groups (SRG) will evaluate the budget on the basis of a general, expert estimate of the total effort and resources required to carry out the proposed research, rather than on the basis of detailed categorical costs. Recommendations for change in the budget will be made in modules. Reviewers also may comment on the requested budget without making specific recommendations, suggesting issues to be handled by NIH staff. 

o Other Support pages of the PHS 398 will not be submitted with the application. 

o Information on other research activities of the principal investigator and key personnel will be provided as part of the "Biographical Sketch." This information will include the goals of any active research and of research conducted during the previous three years, and will be used by reviewers in the assessment of investigators' qualifications to carry out the proposed project. 

o Following peer review, information about Other Research Support will be requested by NIH from the applicant for applications being considered for award. 

o Additional budget information will be requested only under special circumstances. 

o Every attempt will be made to fund these grants at a level at or close to the recommended total direct costs. In unusual situations, individual Institutes and Centers may make some reductions to accommodate portfolio management policies. 

o Submission, review, and award of competitive supplements will follow modular procedures. 

o Modular grant awards are eligible for administrative supplements, in accordance with current policy. 
 
 

If you would like more information on modular grants, or look at samples of modular forms pages, go to http://grants.nih.gov/grants/funding/modular/modular.htm



 

SPEAKING OF FRINGE BENEFITS...

The soaring medical insurance costs that caused so much concern in the early 90's are flying again. You may not be aware that medical insurance costs, which by and large drive the fringe benefit rate, have begun to grow rapidly. This has an impact on grant-funded projects because a reasonably accurate estimate of fringe benefit costs must be included in the grant budget. If you underestimate those costs, you will have to cut expenses someplace else to cover them. Remember, these are genuine costs of hiring staff with grants. 

If you plan to have the Hektoen Institute handle your grant, you are requested to consult with Hektoen personnel when preparing your budget to insure that fringe benefit costs are estimated correctly. If you plan to have a Cook County affiliate manage your grant, make sure to call your Finance Office to check on the current rate to be used for Cook County employees. 

Here are some other points to keep in mind when you ask the Hektoen Institute to handle your grant: 
 

The joint Hektoen Institute, LLC-Cook County federal indirect cost rate (also known as F&A, for facilities & administration) is 38.7% on a "Salary & Wages" cost base. That is, for federal grants, F&A is calculated as 38.7% of the total for salaries & wages, excluding fringe benefits. This rate is predetermined for the period 9/1/98 through 8/31/00. 

The Hektoen Institute charges actual Payroll Tax and Fringe Benefit amounts for grant-funded employees. This means there is no "standard" Hektoen fringe benefit rate. A fringe benefit rate will be custom calculated for each grant application. Consult John Prochaska (312-633-7131) for details. 

Grant applications should indicate the applicant institution as "The Hektoen Institute for Medical Research, LLC on behalf of Cook County Hospital". The federal employer identification number (EIN #) is 1362244897A1, or for W-9 tax forms (FEIN): 36-2244897. 
 
 


MEDICAL JARGON AND LAY LANGUAGE

When you say participants understand your consent form how much are you really taking for granted? 

According to William C. Waggoner, Ph.D. FAACT, some words found in consent forms that medical researchers use all the time, and expect a layperson reading the consent form to understand, are in fact confusing. For instance, one interviewee thought that a placebo was a small animal like an amoeba. Another thought that "occult blood" was blood drawn by witches. Nine out of ten interviewees did not know the meaning of a "topical preparation," a term commonly used in dermatology research, consent forms and advertising. 

Advanced thought should be given to the use of terms. It would be beneficial to give a consent form (without identifying the sponsor or drug) or advertising to an individual not associated with a medical institution to see whether or not that person fully understands the terminology. The form can then be rewritten on the basis of the person's response. 

Lillian Hampton, CIM 
Certified IRB Manager 
Scientific Committee (IRB) 
Cook County Hospital/ 
Bureau of Health Services 
 

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SEMINARS, CONFERENCES, WORKSHOPS, ETC 

[A long-term calendar showing most of the major academic medical society meetings can be found on the web at: http://www.aamc.org/meetings/mjmtgcal.htm

Clinical Investigations: Changing Expectations and Regulatory Requirements, will be held November 1 and 
The Changing Regulatory Environment for IRB's, on November 2, both in Washington, DC, sponsored by The Food and Drug Law Institute. For information, call 800-956-6293. 

Fetal Alcohol Syndrome, a satellite presentation by the Illinois Department of Public Health, Division of Community Health and Prevention, will be held November ( at 10:00. For more information, call 217-753-4066. 

Health Care Systems: Ethical and Economic Considerations, will be held in Sacramento, CA on January 13-14 by the Medical alumni Association of the University of California, Davis. Call 916-734-2177 for more information. 

Advocacy 101: The Why, What & How of State and National Policy Advocacy, is a training workshop offered by the Donors Forum of Chicago. It will take place November 4. For more information call 312-578-0090. 
 
 

Office of Research Development Workshops 

These workshops are open to any County-affiliated investigator or grant-seeker. Enrollment for some sessions is limited, so please register only for those you will be able to attend. 

Grant Writing Seminar:

Gives an overview of the entire process of developing a project and applying for funding. Includes information on approaching both governmental and private funders, describes an approach to developing grant budgets, discusses stylistic and content issues that are frequent stumbling blocks in writing grant applications.


Constructing a Grant Budget:

Covers many of the technical aspects of developing an accurate time line and budget for a grant proposal.


What Are All These Forms? Interacting With the Scientific Committee

Gives an orientation to procedures -- and the associated forms -- used by the Scientific Committee to 
ensure that patients are protected from undue risks in research. The Bureau forms will be discussed, and new policies and changes in federal regulations will be covered.


To register for any of these, call Bennetta Anderson at 312-633-4941. If you would like to schedule one or more of these workshops in your Department or at another site, please call Karen Smith at 633-4940. 
 
 
 
 

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FUNDING OPPORTUNITIES

National Institutes of Health:
All NIH announcements from the past several years, including full text versions of RFA's and PA's, can be reached on the web at:  http://grants.nih.gov/grants/guide/index.html

To have the NIH Guide sent automatically to your e-mail address every week, click on the LISTSERV link on this page and follow the instructions.

To ask specific questions about NIH grant programs, send e-mail to: grantsinfo@nih.gov 
 



NIH RFA'S AND RFP'S: 

These are one time only opportunities. Call 312-633-4940 to check for due dates or to get copies of full announcements

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CENTERS FOR RESEARCH TO REDUCE ORAL HEALTH DISPARITIES (RFA-DE-99-003) National Institute of Dental and Craniofacial Research, Health Resources and Services Administration, National Institute of Child Health and Human Development, National Institute of Nursing Research, Centers for Diseases Control and Prevention, Office of Research on Minority Health, Office of Behavioral and Social Science Research, Office of Research on Women's Health 

NEW STRATEGIES FOR THE TREATMENT OF TYPE 1 DIABETES (RFA-DK-00-001) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development 

SPECIALIZED CENTERS OF RESEARCH --PATHOBIOLOGY OF FIBROTIC LUNG DISEASE PATHOBIOLOGY OF LUNG DEVELOPMENT CELLULAR AND MOLECULAR MECHANISMS OF ASTHMA (RFA-HL-00-001) National Heart, Lung, and Blood Institute 

PREPAREDNESS AGAINST ILLEGITIMATE USE OF BACTERIAL PATHOGENS (RFA-AI-00-004) National Institute of Allergy and Infectious Diseases 

PROTEASE INHIBITOR RELATED ATHEROSCLEROSIS IN HIV INFECTION 
(RFA-HL-00-007) National Heart, Lung and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases 

CONSORTIUM ON DEEP BRAIN STIMULATION FOR THE TREATMENT OF PARKINSON'S DISEASE AND OTHER NEUROLOGICAL DISORDERS (RFA-NS-99-006) National Institute of Neurological Disorders and Stroke, National Institute on Aging 

INTERNEURONAL CIRCUITS UNDERLYING VOLUNTARY MOVEMENTS IN NORMAL AND INJURED SPINAL CORD (RFA-NS-99-008) National Institute of Neurological Disorders and Stroke 

DEVELOPMENTAL MECHANISMS OF HUMAN MALFORMATIONS (RFA-HD-99-008) National Institute of Child Health and Human Development, National Institute of Environmental Health Sciences 

CLINICAL TRIALS PLANNING GRANT 
(RFA-AR-99-007) National Institute of Arthritis and Musculoskeletal and Skin Diseases 

NIDDK BIOTECHNOLOGY CENTERS 
(RFA-DK-00-002) National Institute of Diabetes and Digestive and Kidney Diseases 

THE ROLE OF THE ENVIRONMENT IN PARKINSON'S DISEASE (RFA-ES-00-002) National Institute of Environmental Health Sciences, National Institute of Neurological Disorders and Stroke 

THE ROLE OF THE ENVIRONMENT IN PARKINSON'S DISEASE: CAREER DEVELOPMENT PROGRAMS FOR PHYSICIAN-SCIENTISTS (RFA-ES-00-003) National Institute of Environmental Health Sciences, National Institute of Neurological Disorders and Stroke 

SPECIALIZED NEUROSCIENCE RESEARCH PROGRAMS AT MINORITY INSTITUTIONS 
(RFA-NS-00-001),National Institute of Neurological Disorders and Stroke, National Center for Research Resources 

POSITIONAL CANDIDATE GENE APPROACHES IN ASTHMA GENE DISCOVERY (RFA-HL-00-005) National Heart, Lung, and Blood Institute 
 

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NIH PROGRAM ANNOUNCEMENTS 
(PA'S): These are ongoing funding priorities, with due dates usually October 1, February 1 and June 1 of each year. Note that HIV-related applications are due January 2, May 1 and September. Past PA's, many of which are still open, can be searched at the NIH Guide web site.
 

NEI SMALL RESEARCH GRANTS FOR DATA ANALYSIS (R03) (PAR-99-170) 
National Eye Institute 

BIOENGINEERING RESEARCH PARTNERSHIPS (PAS-00-006) National Cancer Institute, National Center for Research Resources, National Eye Institute, National Human Genome Research Institute, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute on Deafness and Other Communication Disorders, National Institute of Dental Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences, National Institute of General Medical Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute of Nursing Research, National Library of Medicine 

SCIENTIST DEVELOPMENT AWARD FOR NEW MINORITY FACULTY (PAR-99-169) National Institute of Mental HealthAGING WOMEN AND BREAST CANCER 
(PA-00-001) National Institute on Aging, National Cancer Institute, National Institute of Nursing Research 

DRUG ABUSE PREVENTION INTERVENTION RESEARCH (PA-00-002) National Institute on Drug Abuse 
MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD (K08) 
(PA-00-003) All Institutes 

MENTORED PATIENT-ORIENTED RESEARCH CAREER DEVELOPMENT AWARD (K23) (PA-00-004) All Institutes 

RESEARCH ON THE ORIGINS AND PATHWAYS TO DRUG ABUSE (PAR-99-168) 
National Institute on Drug Abuse 

SPECIALIZED PROGRAM OF RESEARCH EXCELLENCE IN HUMAN CANCER 
(PAR-99-167) National Cancer Institute 




POP QUIZ: CLINICAL RESEARCH TERMINOLOGY 
by Funeka Sihlali, RN 
Scientific Quality Coordinator 

How well do you know your research terms? On the left are scrambled acronyms and terms commonly used in clinical trials. See if you can unscramble them and match them to the definitions on the right. 
 

A)     CEI 
B)     FAD 
C)     RROP 
D)     FEENNEEBIC 
E)     SIDE 
F)     BMSD 
G)     HIC 
H)    CRAP 
I)      MADE 
J)      FCR 
K)     NID 
L)     AND 
1. Investigational New Drug 
2. International Conference on Harmonization 
3. Association of Clinical Research Professionals 
4. Code of Federal Regulations 
5. Office of Protection from Research Risks 
6. Absorption, distribution, metabolism and excretion 
7. Independent Ethics Committee 
8. Drug Efficacy Study Implementation 
9. New Drug Application 
10. Food and Drug Administration 
11. Data and Safety Monitoring Board 
2. One of the three basic ethical principles from the Belmont Report



 
 
 



OTHER OPPORTUNITIES
December 9 
GERIATRIC TRAINING: PHYSICIANS AND DENTISTS, Health Resources and Services Administration, (301-443-6887 or http://www.hrsa.gov

December 17 
NURSING WORKFORCE DIVERSITY, Health Resources and Services Administration, (301-443-5763 or http://www.hrsa.gov

January 17 
POSITIVE HEALTH BEHAVIORS FOR WOMEN, Health Resources and Services Administration, (301-443-9534 or http://www.hrsa.gov

December 15 (letter of intent) 
NATIONAL CENTER FOR SCHOOL HEALTHCARE, Health Resources and Services Administration, (301-443-4026 or http://www.hrsa.gov

January 14 
JOB CREATION FOR LOW INCOME FAMILIES, Administration for Children and Families (202-401-5282 or http://www.acf.dhhs.gov/program/ocs/kits1.htm

January 18 
INVESTIGATOR-INITIATED JUSTICE RESEARCH, National Institute of Justice (800-851-3420 or http://www.ncjrs.org/fedgrant.htm#nij

December 1 
HARVARD FACULTY FELLOWSHIP IN ETHICS, Harvard Univseristy Program in Ethics and the Professions (617-495-1336 or http://www.ethics.harvard.edu

December 6 
VISITING FELLOWSHIPS IN ETHICS AND HUMAN VALUES, Princeton University (609-258-4798 or http://www.princeton.edu/values

February 11 
HEALTH CARE FOR PREGNANT WOMEN EXPERIENCING DOMESTIC VIOLENCE, Health Resources and Services Administration 9301-443-9991 or http://www.hrsa.dhhs.gov

April 1 
PEOPLE WITH DISABILITIES, Christopher Reeve Paralysis Foundation (973-379-2690 or http://www.paralysis.apacure.org/qol/index.html
 

February 1, June 1, October 1 
REPRODUCTIVE HEALTH, Open Society Institute (212-548-0600 or http://www.soros.org/repro/grant_guidelines.htm

Open 
BREAST CANCER 
The Breast Cancer Fund (415-543-2975 or http://www.breastcancerfund.org

January 24 
BREAST AND CERVICAL CANCER 
Illinois Department of Public health 9217-524-0688 or http://www.idph.state.il.us

November 15 
DEVELOPING OR EXPANDING SYSTEMS FOR INCREASING PHARMACEUTICAL ACCESS, Volunteers in Health Care (877-844-8442 or http://www.volunteersinhealthcare.org

December 6 
COMMUNITY FOOD/NUTRITION, Department of Health and Human Services (202-402-5252 or http://www.acf.dhhs.gov/programs/ocs/kits1.htm

November 15, January 15 
NUTRITION, FOOD SAFETY AND HEALTH, US Department of Agriculture (202-401-5178 or http://www.reeusda.gov.nri
 

Various deadlines, December 15 - February 25 
FELLOWSHIPS AND RESEARCH ON AGING, American Federation for Aging Research (212-752-2327 or http://www.afar.org)December 6 

POSTDOCTORAL RESEARCH FELLOWSHIPS FOR PHYSICIANS, Howard Hughes Medical Institute (301-215-8889 or http://www.hhmi.org/grants

January 10 
INNOVATIONS IN AMERICAN GOVERNMENT, Ford Foundation (800-722-0074 or http://www.innovations.harvard.edu

November5 (paper) or November 12 (electronic) 
CLINICAL RESEARCH CAREER DEVELOPMENT AWARD, American Society of Clinical Oncology (703-229-0150 or http://www.asco.org

November5 (paper) or November 12 (electronic) 
YOUNG INVESTIGATOR AWARD, American Society of Clinical Oncology (703-229-0150 or http://www.asco.org
 
 


SOLUTIONS TO QUIZ 

A)    IEC    Independent Ethics Committee 
B)    FDA    Food and Drug Administration 
C)    OPRR    Office of Protection from Research Risks 
D)    Beneficence    One of the three basic ethical principles from the Belmont Report 
E)    DESI    Drug Efficacy Study Implementation 
F)    DSMB    Data and Safety Monitoring Board 
G)    ICH    International Conference on Harmonization 
H)    ACRP    Association of Clinical Research Professionals 
I)     ADME    (Phase 1) Absorption, Distribution, Metabolism and Excretion 
J)     CFR     Code of Federal Regulations 
K)     IND     Investigational New Drug 
L)     NDA    New Drug Application 
 
 

If you're curious about how these terms are related to clinical research, call Funeka at 312-572-3506. 
 

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