AFTER THE AUDIT

Last month Funeka Sihlali, Research Quality Coordinator for the Bureau, described the process of conducting an audit of a research project. In this article she outlines what happens after the audit.

At the end of the audit the research team will be briefed about the findings. These findings are also discussed with the Director of Research Development and/or the IRB Chairperson. Finally, a  letter is issued by the IRB elaborating upon the same findings and informing the research team about discrepancies if any are found. The Principal Investigator or the Study Coordinator can respond to the findings if he or she is so inclined, otherwise the letter is filed as a permanent record without reply.

The following are steps that are usually taken by the IRB, depending on whether findings of 
significant discrepancies are noted.  The IRB Chair, Director of Research Development, Quality
Coordinator and the IRB Manager  may visit the research team to clarify some misunderstandings and myths, and to offer educational support.  The study may be placed under strict surveillance, the research team may be required to inform the IRB Quality Coordinator every time a patient is being recruited and consented. 
The following are some of the most common mistakes found:
 

   1)  Incomplete protocol on file.
   2)  Missing Curricula Vitae and IRB correspondence.
   3)  Personnel not listed with the IRB, but doing substantive work on the protocol with participants e.g., persons obtaining the consent may not included on the list of investigators.
  4)  The use of a consent that does not have the IRB approval stamp, or the use of an   outdated consent.
  5)  Relatives or family members signing the consent on behalf of their loved ones without documentation of the reason for the substitution. 
   6)  Including employees and pregnant women in the study when special populations had not been requested.
   7)  Not reporting adverse events on time and/or not reporting them at all.

Please refer to the Cook County Guidelines if you have any questions and feel free to call me at 572-3506 .

Wishing you happy holidays and a healthy, wealthy  New Year   
Funeka M. Sihlali
 

EDITOR'S NOTE

This is the 90th consecutive monthly Grants Newsletter for which I have acted as your editor, and it will also be the last.  Working for the Bureau has been a consistently challenging and rewarding experience.  Since I started here in 1993 the way the County offers health care to its residents has changed enormously, but the way in which Bureau people have adhered to a central principle of social justice in health care has remained steadfast. It is with a great deal of admiration and respect that I say goodbye.  I know that the future for the Bureau holds both continued growth in innovative comprehensive health care and continued constancy in the principle that this type of health care must be available to all.

My replacement, Lynda Brodsky, will introduce herself in the article below. I'm sure you will find that I am leaving the Office of Research Development in very capable hands.

Best to all and happy holidays.

Karen M. Smith, PhD

INTRODUCING LYNDA BRODSKY

I am delighted to be joining the Cook County system.  My introductory days have been extremely exciting as I begin to become acquainted with the people behind the mission.

I come most recently fro the University of Illinois at Chicago which I joined in 1984 as an assistant dean for research.  Later, I moved to the Office for Protection from Research Risks where, as director, I oversaw the use of humans, animals and recombinant DNA in research.   It may be interesting to know that my first professional position was with the New York City Health Services Administration where I worked with the health department and 14 public hospitals.  It's great to return to a commitment to serve the public.

With graduate training in both economics (University of Wisconsin, Madison) and epidemiology (University of California, Berkeley), my research background is broad and my interests are varied.  When you are near the Research Development office, please stop in to say hello.

Until then, happy holidays.

Lynda Brodsky   
 
 
 

[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] 

Options in Health Sciences Education will be offered February 11-16 in Albuquerque, NM, sponsored by the University of New Mexico College of Medicine. for more information call 505-272-3942 or go to http://hsc.unm.edu/som/TED/TEDHome.html

Outcome Evaluation for Nonprofit Organizations will be offered by the Donors Forum of Chicago on the following dates:
January 16, February 12, March 13 and April 19 in Chicago, and March 1 at the College of DuPage. For more information call 312-578-0090.

The ABCs of Proposal Preparation & Writing, also offered by the Donors Forum, will take place January 9 and 23, February 7 and 22, March 12, and  April 26. There will also be a session March 20 at the College of DuPage. Call 312-578-0090. For more information.

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
 

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. 

VACCINE AND IMMUNE THERAPY FOR ALZHEIMER'S DISEASE  (RFA-AG-01-003) National Institute on Aging, National Institute of Neurological Disorders and Stroke

NEW RESEARCH STRATEGIES IN OSTEOGENESIS IMPERFECTA  (RFA-AR-01-001) National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Aging, National Institute of Child Health and Human Development

PREVENTION OF ONSET, PROGRESSION, AND DISABILITY OF OSTEOARTHRITIS (RFA-AR-00-006) National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Center for Complementary and Alternative Medicine, National Center for Nursing Research

COMPREHENSIVE SICKLE CELL CENTERS (RFA-HL-01-015) National Heart, Lung, and Blood Institute

INTERNATIONAL TRAINING AND RESEARCH IN ENVIRONMENTAL AND OCCUPATIONAL HEALTH (RFA-TW-01-002) Fogarty International Center, National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health of the Centers for Disease
Control and Prevention

SPONDYLOARTHROPATHIES: NEW APPROACHES TO PATHOGENESIS (RFA-AR-00-008) National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Eye Institute

HEALTH DISPARITY IN PRETERM BIRTH: THE ROLE OF INFECTIOUS AND INFLAMMATORY PROCESSES (RFA-HD-01-005) National Institute of Child Health and Human Development

NEUROCOGNITIVE, NEUROIMAGING, AND NEUROPSYCHIATRIC CORRELATES OF HIV INFECTION (RFA-MH-01-007) National Institute of Mental Health, National Institute on Drug Abuse , National Institute of Child Health and Human Development

STATE FATALITY SURVEILLANCE AND FIELD INVESTIGATIONS OF OCCUPATIONAL INJURIES: FATALITY ASSESSMENT AND CONTROL EVALUATION (FACE)  (RFA-OH-01-003) National Institute for Occupational Safety and Health

EXPOSURE ASSESSMENT METHODS FOR CANCER RESEARCH (RFA-CA-01-018) National Cancer Institute
National Institute of Environmental Health Sciences
 

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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.

TRANSLATIONAL RESEARCH CENTERS IN BEHAVIORAL SCIENCE (TRCBS) (PAR-01-027) National Institute of Mental Health

RESEARCH ON PSYCHOPATHOLOGY IN MENTAL RETARDATION (PA-01-028) National Institute of Mental Health
National Institute of Child Health and Human Development

EXPLORATORY/DEVELOPMENTAL GRANTS FOR DIAGNOSTIC CANCER IMAGING (PA-01-030) National Cancer Institute

NIDDK SMALL GRANTS FOR UNDERREPRESENTED INVESTIGATORS (PA-01-031) National Institute of Diabetes and Digestive and Kidney Diseases

CAREER DEVELOPMENT GRANTS IN OCCUPATIONAL SAFETY AND HEALTH RESEARCH (PA-01-032) National Institute for Occupational Safety and Health

SMALL GRANTS IN OCCUPATIONAL SAFETY AND HEALTH RESEARCH (PA-01-033) National Institute for Occupational Safety and Health

NCRR SHARED INSTRUMENTATION GRANT (PAR-01-034) National Center for Research Resources

PATHOGENESIS AND TREATMENT OF LYMPHEDEMA (PA-01-035) National Heart, Lung, and Blood Institute, National Institute of Child Health and Human Development, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute

GENETIC TESTING AND THE CLINICAL MANAGEMENT OF NONSYNDROMIC HEREDITARY HEARING IMPAIRMENT (PAS-01-036)
National Institute on Deafness and Other Communication Disorders, National Human Genome Research Institute

NIA PILOT RESEARCH GRANT PROGRAM (PA-01-037) National Institute on Aging

DEVELOPMENTAL GRANTS FOR COLLABORATIVE INTERNATIONAL PROJECTS (PAR-01-038) National Institute on Alcohol Abuse and Alcoholism
 

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CENTERS FOR DISEASE CONTROL AND PREVENTION

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

Letter of Intent Due: February 6, 2001; Closing Date: March 6, 2001
Grants for Acute Care, Rehabilitation and Disability Prevention Research [Announcement Number 01013]

Letter of Intent Due: February 7, 2001; Closing Date: March 7, 2001
 Grants for Traumatic Injury Biomechanics Research [Announcement Number 01014]

Letter of Intent Due: February 8, 2001; Closing Date: March 8, 2001
Grants for Unintentional Injury Prevention Research [Announcement Number 01015]

Letter of Intent Due: February 9, 2001; Closing Date: March 9, 2001
Grants for Violence-Related Injury Prevention Research [Announcement Number 01016]
          

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/

February 20, 2001
Special Demonstration Programs, Rehabilitation Services (202-205-8292)

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

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.html 

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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

March 21, 2001
Prostate Cancer Research

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

NATIONAL SCIENCE FOUNDATION
Information on NSF programs can be found at http://www.nsf.gov/home/programs/recent.htm
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/02/baa/

09/30/2001
Basic and Applied Medical Research In Military Operational Medicine, 00-008

09/30/2001
 Basic and Applied Medical Research In Combat Casualty Care, 00-003

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

Open
Investigator-Initiated Research

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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.

February 15, August 15 and October 15
HEREDITARY DISEASE RESEARCH, Hereditary Disease Foundation (310-575-9656 or http://www.hdfoundation.org) 
 

February 19
Geriatrics Fellowship Program,  John A. Hartford/American Federation for Aging Research  (212- 752-2327 or http://www.afar.org)
 

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