RESEARCH TRAINING DEADLINE: NIH OFFERS AN INTERIM SOLUTION
 

As readers of this Newsletter are aware, new federal rules and regulations will mandate that all persons involved in research receive documented training in the ethical conduct of research. Wide-reaching federal policies are still being finalized, and the full response of the Bureau to these mandates will continue to be developed over the next year.
 

However, the first rule with which we must comply goes into effect October 1. As of that date all key personnel named in applications for human research funding to the National Institutes of Health must attest that they have received appropriate training in the protection of human research subjects. This rule will apply to applications for renewed funding of ongoing projects as well as to new applications.
 

As described below, an online certification program is under development by a Bureau Task Force on Research Training. The target date for implementing the new program is mid September. However, those who expect to apply for NIH funding in October have another option which is accessible now: NIH has an online tutorial on human subject protection which can be used in lieu of institutional certification, at least until the new federal policy is in full force. The tutorial can be reached at http://ohsr.od.nih.gov/ . You may register to be certified, and will receive a certificate directly from NIH upon completion. This certificate will satisfy the NIH requirement until it is superceded by a broader HHS policy in November. 

If you have questions about how the NIH alternative will work, go to ask your program officer or email Belinda Seto (bs11e@nih.gov).

ONLINE CERTIFICATION FOR BUREAU INVESTIGATORS
 

A new online certification program is expected to be available in mid-September to inaugurate a key part of the overall training program being planned by the Bureau Task Force.
 

The online certification program is designed to document that an investigator is familiar with basic expectations for human subject protection, research integrity, and conflict of interest in research. The material to be covered is contained in the Bureau "Guidebook for Grants and Research" issued last winter. An investigator who wishes to be certified will read the guidelines, then go to the online certification site to register and take a short test (35 questions). The test will be a multiple choice, open book exam covering the topics identified by the Bureau Task Force on Investigator Training as most essential for investigator training. As an aid to reviewing the Guidelines, the list of these key topics is found at the end of this article.
 

To be certified, an investigator will be required to get all the questions correct on the exam. Three equivalent versions of the exam will be available for each person who registers for certification. If he or she does not pass the first exam, a second, and then a third version will be available.
 

When an individual has achieved a 100% score, a certificate will be sent within two weeks which will document that person's familiarity with these areas of ethical research conduct. 
 

Within the year, certification of all research personnel will become a requirement for obtaining IRB approval for new and continuing projects. To meet the expanded scope of training mandated by the new HHS policy, online certification will be supplemented with other educational activities, plans for which have not yet been finalized.
 

Here are the answers to some questions that you may have about this program:

Why a test and not a one-hour review session as is done with fire safety, for instance?

As you can see from the list of key topics, the subject matter which must be mastered is entirely too broad and complex to be adequately covered in a one-hour session. Rather than use time and resources in an exercise which may not lead to any demonstrable competence, the Task Force felt it was more valid to ask individuals to study at their own pace and then demonstrate their competence in a format that is both fair and flexible. 

The goal is to demonstrate familiarity with rules, concepts and expectations about human subject protection, scientific misconduct, and conflict of interest. We don't expect all persons involved in research to become experts in these areas. Demonstrating familiarity can be accomplished as readily by looking up the right answer as by memorizing it.

The test has intentionally been kept short to make it possible for a test taker to complete it quickly in his or her spare time. A short test necessarily focuses on only the most important areas of competence. For that reason all questions must be answered correctly. The opportunity to correct one's answers within the hour -- and to take additional versions of the test if necessary -- should make it feasible for all who attempt it to achieve a perfect score.

At present, all persons named as "key personnel" on NIH grant applications for human research. However, within the next few months, this requirement will be broadened to include all persons who participate in research. After a deadline (not yet set) all applications for IRB review of new or continuing projects will carry the requirement that study personnel be certified. In addition, within the year, new federal regulations will require documented training for all persons involved in research. This requirement is expected to be fulfilled in part by the online certification program. Alternative training may be offered for those who do not play a central role in research, such as data entry personnel.

Guidelines for this will be clarified when certification becomes a requirement for IRB approval. At the least, a central role is played by any person taking scientific responsibility for a project, including design, oversight of research activities, or authorship, and any person obtaining informed consent or having other substantial interactions with human subjects as part of a research project.

Certification is only the first of several required activities that are likely to be mandated by new federal policy. The Bureau Task Force intends to pilot one-hour case discussion sessions as a supplement to certification, to be offered on an optional basis during the next year. Mandated attendance will be required in the second year (those who attend an optional session will be credited with having fulfilled this requirement). In addition, the new federal policy most likely will expand the topic areas for investigator training, so new materials will be made available to supplement the Guidelines. Finally, the new policy will also most likely require some kind of "refresher" on a regular basis. 

The new policy that drives this effort is expected to be issued November 1. Until then, we can only plan based on the draft policy that has already been released. We expect that the federal policy will allow us until next summer to finalize our program.

Yes, if you plan to carry out research at a Bureau institution. Investigator training will be a condition for institutions to receive federal research funds. As with many other regulations pertaining to research, the Bureau will be expected to apply these expectations to all researchers if we are to continue to receive federal research funding.

The program is still being pretested, so the address cannot be released as yet. We expect to be able to announce it mid-September. 

Guidelines are available in Room 602 Durand from 8:00 am to 4:00 pm daily (call first, 312-633-7792, to make sure the room is open). You can also pick up a copy outside Room 277 Hektoen.

Investigators at Oak Forest or Provident Hospitals can pick up a copy from the Medical Director's Office. Others not on the CCH campus can call 312-633-4941 and ask for a copy to be sent. The Guidelines are also online at http://cookcountyresearch.net.

I don't have web access in my office or home.  How will I be able to complete certification? 

The libraries of the Bureau hospitals all have web access, as do many public libraries. If you are unable to obtain access to the program through one of those routes, call the Office of Research Development. 

[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] 

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. 
 

CONSENT FORM CLINIC 

The Clinic is a one-on-one session designed to help investigators to:

• Insure that all the required elements of informed consent are included;
• Check that the document is written at an appropriate literacy level;
• Identify lay terms that can be substituted for medical terminology;
• Review the ways the risks and benefits of the study are described to make sure they are clearly communicated;
• Make sure the local situation is reflected in consent forms that have been supplied by a study sponsor

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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. 

TECHNOLOGIES FOR COMPREHENSIVE, SENSITIVE, AND QUANTITATIVE PROTEIN ANALYSIS IN HUMAN TUMORS: PHASED INNOVATION  (RFA-CA-01-011) National Cancer Institute, National Human Genome Research Institute

GENE THERAPY APPROACHES FOR DIABETES AND ITS COMPLICATIONS (RFA-DK-01-006) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Heart, Lung, and Blood Institute

SMALL ANIMAL IMAGING RESOURCE PROGRAMS (RFA-CA-01-012) National Cancer Institute

PROMOTION AND DISEASE PREVENTION: HEALTH COMMUNICATION, DEVELOPMENT, AND DISSEMINATION (RFA-DC-00-003) National Institute on Deafness and Other Communication Disorders

ANCILLARY STUDIES IN CONJUNCTION WITH SHOW TRIAL (RFA-DK-00-017) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR)

SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH (RFA-HD-00-022) National Institute of Child Health and Human Development

BOTANICAL/DRUG INTERACTIONS (RFA-AT-00-004) National Center for Complementary and Alternative Medicine, National Cancer Institute

IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICs)  (RFA-CA-01-014) National Cancer Institute

ROLE OF HORMONES AND GROWTH FACTORS IN PROSTATE CANCER (RFA-DK-01-008) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Cancer Institute, National Institute of Environmental Health Sciences

FETAL ORIGINS OF ADULT DISEASE (RFA-HD-00-021) National Institute of Child Health and Human Development, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences

MOLECULAR AND NEURAL MECHANISMS UNDERLYING THE EFFECTS 0F CALORIC RESTRICTION ON HEALTH & LONGEVITY (RFA-AG-01-002) National Institute on Aging

CANCER CARE OUTCOMES RESEARCH AND SURVEILLANCE CONSORTIUM (RFA-CA-01-013) National Cancer Institute

NATIVE AMERICAN RESEARCH CENTERS FOR HEALTH (RFA-GM-00-007) Indian Health Service
National Institute of General Medical Sciences

GENETIC MODIFIERS OF SINGLE GENE DEFECT DISEASES (RFA-HL-01-001) National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases

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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.

INTERDISCIPLINARY BEHAVIORAL SCIENCE CENTERS FOR MENTAL HEALTH (PAR-00-130) National Institute of Mental Health

RESEARCH ON RESEARCH INTEGRITY (RFA-NS-01-008) Office of Research Integrity, National Institute of Neurological Disorders and Stroke

EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS (PAR-00-129) National Center for Research Resources

QUALITY OF LIFE FOR INDIVIDUALS AT THE END-OF-LIFE (PA-00-127) National Institute of Nursing Research, National Cancer Institute, National Center for Complementary and Alternative Medicine, National Institute of Allergy and Infectious Diseases, National Institute of Dental and Craniofacial Research, National Institute of Mental Health, National Institute on Aging

NATIONAL INSTITUTE ON AGING SUPPORT OF SCIENTIFIC MEETINGS AS COOPERATIVE AGREEMENTS PA-00-128) National Institute on Aging

NIH NATIONAL RESEARCH SERVICE AWARDS FOR SENIOR FELLOWS (F33) (PA-00-131) National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, National Institute of Child Health and Human Development, National Institute of Deafness and other Communication Disorders, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases,,National Institute of Environmental Health Sciences, National Eye Institute, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, National Institute of Neurological Disorders and Stroke, National Institute of Nursing Research,National Center for Human Genome Research, National Center for Research Resources, National Center for Complementary and Alternative Medicine
 

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CENTERS FOR DISEASE CONTROL AND PREVENTION

For more information, go to http://www.cdc.gov/od/pgo/funding/grantmain.htm
 

HEALTH RESOURCES AND SERVICES ADMINISTRATION 

Training, service and research grant opportunities for the next six months are summarized in the current HRSA Preview, which can be found at http://www.hrsa.dhhs.gov/grantsf.htm, or can be ordered by calling 1-877-477-2123.
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DEPARTMENT OF EDUCATION 
Details on open opportunities can be found at http://www.ed.gov/GrantApps/
 

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION 
Details on grant opportunities can be found at http://www.samhsa.gov/GRANT/0100titles.htm

August 29
Disparities in Access to Substance Abuse Prevention, Treatment and Mental Health Services in Racial/Ethnic Minority Communities 

ENVIRONMENTAL PROTECTION AGENCY 
Details on grant opportunities can be found at: http://es.epa.gov/ncerqa/rfa/

JUSTICE DEPARTMENT
Details on grant opportunities can be found at:  http://www.ncjrs.org/fedgrant.htm#nij

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ADMINISTRATION FOR CHILDREN AND FAMILIES
Office of Community Services
Details on grant opportunities can be found at: http://www.acf.dhhs.gov/programs/ocs/kits1.html

U.S. ARMY MEDICAL RESEARCH AND MATERIEL COMMAND 
Details on grant opportunities can be found at:  http://cdmrp.army.mil
 

OFFICE OF POPULATION AFFAIRS
Details on grant opportunities can be found at: http://www.hhs.gov/progorg/opa/grnt-ann.html

NATIONAL SCIENCE FOUNDATION
Information on NSF programs can be found at http://www.nsf.gov/
Note:   NSF strongly favors basic research not closely tied to clinical applications

OFFICE OF NAVAL RESEARCH
Details on grant opportunties can be found at:  http://www.onr.navy.mil/

FOOD AND DRUG ADMINISTRATION
Details on grant opportunties can be found at: http://www.fda.gov/oc/ofacs/grants/default.htm

August 24
FOOD SAFETY RESEARCH (301-827-7183)

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Note:  Hundreds of  biomedical research grants may be searched by going to the AAAS/Howard Hughes Medical Institute at http://www.grantsnet.org/   This site includes many grants offered by professional societies. You must register to use the search engine, but the service is free.

10/01/00 
TRANSLATIONAL RESEARCH IN ATAXIA-TELANGIECTASIA., A-T Children's Project (561-395-2621, or http://ww2.med.jhu.edu/ataxia/guidlin.htm)

10/01/00 
CLINICAL RESEARCH PROFESSORSHIPS, American Cancer Society, Inc.(http://www.cancer.org/research/)

10/01/00 
MULTIPLE RESEARCH & TRAINING GRANTS
American College of Obstetricians & Gynecologists (202-863-2479 or http://www.acog.org/)

10/01/00
MULTIPLE RESEARCH & TRAINING GRANTS,
American Lung Association (212-315-8793 or http://www.lungusa.org/research)

10/01/00 
MULTIPLE RESEARCH & TRAINING GRANTS
American Society for Microbiology (202-942-9292 or http://www.asmusa.org)

10/01/00 
MULTIPLE RESEARCH & TRAINING GRANTS
American Society for Reproductive Medicine (205-978-5000 x137 or http://www.asrm.org/Professionals/Research_Grants/grants)

10/01/00
MULTIPLE RESEARCH & TRAINING GRANTS
Berlex Foundation (415-476-9047 or http://www.berlex-foundation.com/aw04/asp)

10/01/00
POSTDOCTORAL FELLOWSHIPS IN CANCER IMMUNOLOGY OR GENERAL IMMUNOLOGY, Cancer Research Institute, Inc.( 212-688-7515 or http://www.cancerresearch.org)

10/01/00
MULTIPLE RESEARCH & TRAINING GRANTS
Cystic Fibrosis Foundation (301-951-4422 or http://www.cff.org/research42.htm)

10/01/00 
MULTIPLE RESEARCH & TRAINING GRANTS
Gerontological Society of America (202-842-1275 or http://www.geron.org/awards.html)

10/01/00
POSTDOCTORAL FELLOWSHIPS IN THE LIFE SCIENCES, Life Sciences Research Foundation (609-258-3551 or http://lsrf.org/lsrfgeninfo.html)

10/01/00 
MULTIPLE RESEARCH & TRAINING GRANTS 
Pharmaceutical Research & Manufacturers of America ( 202-835-3470 or http://www.phrmafoundation.org)

10/01/00
MATERNAL-FETAL MEDICINE FOUNDATION FELLOWSHIP, Society for Maternal-Fetal Medicine (202-863-2476)

10/02/00 
CAREER AWARDS IN THE BIOMEDICAL SCIENCES, Burroughs Wellcome Fund ( 919-991-5100 or http://www.bwfund.org)

10/02/00
AGING AND QUALITY OF LIFE INITIATIVE (RESIDENCY TRAINING), Donald W. Reynolds Foundation ( 800-481-8780 or http://www.dwreynolds.org/main/guidelines/aging_initiative.html)

10/13/00
MULTIPLE RESEARCH & TRAINING GRANTS
Tourette Syndrome Association, Inc. (718-224-2999 or http://www.tsa.mgh.harvard.edu)

10/15/00 
TARGETED RESEARCH PROJECT GRANT (CANCER IN POOR AND UNDERSERVED POPULATIONS), American Cancer Society, Inc.(404-329-7717 or http://www.cancer.org/research/grants/targetResearch.html)

10/15/00 
ACOG WARREN PEARSE/WYETH-AYERST WOMEN'S HEALTH POLICY RESEARCH AWARD, American College of Obstetricians & Gynecologists (202-863-2479 or http://www.acog.org/)

10/15/00
DAVID A. WINSTON HEALTH POLICY FELLOWSHIP, Association of University Programs in Health Administration (202-638-1448 x131 or http://www.aupha.org/fellowsh.htm)

10/15/00
MULTIPLE RESEARCH & TRAINING GRANTS, Dermatology Foundation (847-328-2256)

10/15/00 
HEREDITARY DISEASE FOUNDATION JOHN WASMUTH POSTDOCTORAL FELLOWSHIPS, Hereditary Disease Foundation (310-575-9656 or http://www.hdfoundation.org/funding/postdoct.htm)

10/16/00 
ALZHEIMER'S DISEASE RESEARCH GRANTS, American Health Assistance Foundation (301-948-3244 or http://www.ahaf.org)

10/16/00 
PARKER B. FRANCIS FELLOWSHIPS IN PULMONARY RESEARCH, Francis Families Foundation (617-432-4099 or http://www.hsph.harvard.edu/pbf/)

10/20/00 
SKIN CANCER RESEARCH GRANTS PROGRAM, Skin Cancer Foundation (212-725-5176 or http://www.skincancer.org)

11/01/00
ACC/MERCK ADULT CARDIOLOGY RESEARCH FELLOWSHIP AWARDS, American College of Cardiology (800-253-4636 or http://www.acc.org)

11/01/00 
RESEARCH FELLOWSHIPS, American College of Surgeons (312-202-5000 or http://www.facs.org)

11/01/00 
AHAF--NATIONAL HEART FOUNDATION STARTER GRANTS, American Health Assistance Foundation (301-948-3244 or http://www.ahaf.org/descnhf.htm)

11/01/00 (nominations)
ROBERT F. ALLEN SYMBOL OF H.O.P.E. AWARD, American Journal of Health Promotion (248-682-0707 or http://www.healthpromotionjournal.com)

11/01/00 
MULTIPLE RESEARCH GRANTS
American Lung Association (212-315-8793 or http://www.lungusa.org/research)

11/01/00
MULTIPLE RESEARCH & TRAINING GRANTS
American Society for Clinical Nutrition (301-530-7113 or http://www.faseb.org/ascn/awardsinfo.htm)

11/01/00 
MULTIPLE RESEARCH GRANTS
Burroughs Wellcome Fund (919-991-5100 or http://www.bwfund.org)

11/01/00
ROBERT S. MORISON FELLOWSHIP IN PATIENT-ORIENTED RESEARCH, Grass Foundation (781-843-0219 or http://www.mbl.edu/grassfdn/Morison_1.html)

11/01/00 
MYASTHENIA GRAVIS POSTDOCTORAL FELLOWSHIP, Myasthenia Gravis Foundation of America, Inc. (312-853-0522 or http://www.myasthenia.org/research/osserman_fellowships.htm)

11/01/00
FELLOWSHIPS IN CARDIAC PACING AND/OR ELECTROPHYSIOLOGY, North American Society of Pacing & Electrophysiology (508-647-0100 or http://www.naspe.org/community/fellowship/awards.html)

11/01/00 
MULTIPLE RESEARCH & TRAINING GRANTS
Oncology Nursing Foundation/Society ( 412-921-7373 or http://www.ons.org)

11/01/00 
PEW SCHOLARS PROGRAM IN THE BIOMEDICAL SCIENCES, Pew Charitable Trusts (http://futurehealth.ucsf.edu/biomed/scholdes.html)

11/02/00 
JOSE CARRERAS INTERNATIONAL LEUKEMIA FOUNDATION FELLOWSHIP, Fundacion Internacional Jose Carreras (43 93 201 05 88 or http://www.fcarreras.es/Welcomei.html)

11/03/00 
MULTIPLE RESEARCH GRANTS
American Society of Clinical Oncology (703-299-1070 or http://www.asco.org)

11/08/00 
CLINICAL NUTRITION YOUNG INVESTIGATOR AWARD, American Society for Clinical Nutrition (301-530-7113 or http://www.faseb.org/ascn)

11/15/00 
PAUL BEESON PHYSICIAN FACULTY SCHOLARS IN AGING, American Federation for Aging Research (212-752-2327 or http://www.beeson.org)

11/15/00 
GLAUCOMA RESEARCH GRANTS, American Health Assistance Foundation (301-948-3244 or http://www.ahaf.org/descngr.htm)

11/15/00
POSTDOCTORAL RESESEARCH IN INFECTIOUS DISEASE/PUBLIC HEALTH, American Society for Microbiology (202-942-9295 or http://www.asmusa.org/edusrc/edu23e.htm)

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