RUSH/CCH COLLABORATIVE RESEARCH AWARDS ANNOUNCED

Four projects have received funding from the 2000 round of competition for Collaborative Research Awards. The funded projects are:
 

Title: Investigation of Gait in the Spectrum of Calcium Pyrophosphate Dihydrate Deposition (CPPD)-Associated Disease
Principal Investigator:    John Case, MD (CCH  Medicine/ Rheumatology) 

Title:    Use of Acellular Dermal Matrix in the Treatment of Venous Stasis Ulcers
Principal Investigator:    Mark D. Hoffman, MD (Rush Dermatology) 

Title:   Antioxident Modulation of Acute and Chronic Pancreatitis
Principal Investigator:   Mary Jo Atten, MD (CCH Medicine/Gastroenterology)

Title:    Social and Cultural Barriers to Papanicolau Smear Screening in an Urban Population
Principal Investigator:    Kian Behbakht, MD (Rush OB/GYN Gynecologic Oncology)
 

WHAT ABOUT INVESTIGATOR TRAINING?

The investigator certification program described in the last Newsletter is still under development. We expect that it will become available in October. Those who need to fulfill the NIH training requirement for all key personnel should complete the on line NIH tutorial, which NIH will accept in lieu of institutional training. 

Please be aware that this is an interim strategy for meeting upcoming NIH deadlines. Once the Bureau certification program is operational, all investigators will need certification before IRB approval for studies will be granted, and the NIH tutorial will not be a substitute for that certification.

The NIH tutorial can be reached at  http://ohsr.od.nih.gov/ . You can register to be certified, and will receive a certificate directly from NIH upon completion.

PRIVACY IN RESEARCH: ARE YOU READY FOR HIPAA?

Most health providers are aware that several new sets of rules about handling patient information are being formulated by the Department of Health and Human Services under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. The potential impact on research is being energetically debated as investigators await announcement of the final HIPAA rules. 

The new rule most likely to affect research is the "Standards for Privacy of Individually Identifiable Health Information". In announcing the proposed rule last November, DHHS outlined a number of proposed changes in the ways research information will be reviewed, handled and disposed of.

The new rule will apply only to health care providers, health care payers, and health care clearinghouses. For this reason, most of the onus of complying with the rule will fall on the sources of health-related information, not on the researcher recipients of it, if different. It also only applies to individually identifiable information that is or has been maintained or transmitted electronically, including information maintained on personal computers and in research databases. The proposed rule also makes a distinction between information that is related to an individual's health care, and information that is gathered purely for research purposes.

Much of the proposed rule explicitly related to research revolves around what authorization, if any, must be given by a patient before his/her information can be used for research purposes.  The proposed rule will prohibit the use or disclosure of protected health information for research without individual authorization unless there is documentation that all of the following criteria have been  met:
 

• the use or disclosure of protected health information involves no more than minimal risk to the subjects; 

• the waiver or alteration will not adversely affect the rights and welfare of the subjects; 

• the research could not practicably be carried out without the waiver alteration; 

• whenever appropriate, the subjects will be provided with additional pertinent information after participation; 

• the research would be impracticable to conduct without the protected health information; 

• the research project is of sufficient importance to outweigh the intrusion into the privacy of the individual whose information would be disclosed; 

• there is an adequate plan to protect the identifiers from improper use and disclosure; 

• there is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers. 
 

The body which will judge whether the criteria have been met will be either an IRB or a "privacy board", a new type of board formed to review and approve the privacy protections contained in proposes research. Where IRB's already exist they will be permitted to take on the role of the privacy board by adding to their review the new privacy criteria.

When carrying out research with patient's consent and authorization to use his/her personal information, there will be additional privacy-related requirements. A notice of privacy protections will be given to research participants which spell out their control of and access to their personal information. If a researcher wants to withhold information from subjects until the end of the study an IRB must review and approve such withholding, and the need to withhold information must be clearly stated in the consent form.
 

• In general, patient/participants must be given access to all their information, including that gathered specifically for research, unless:

• inspection could be reasonably likely to endanger the life of physical safety of the patient or another person;

• information identifies another individual and inspection is reasonably likely to cause substantial harm to that other individual;

• disclosure is likely to reveal the source of information provided under a promise of confidentiality;

• while the research study is in progress, and an IRB has approved denial of access and the participant has agreed to the denial when consenting to participate in the study;

• information was compiled for a legal proceeding.
 

In addition to documenting the participant's explicit authorization to use private health information, and/or the participant's consent not to have access to information while the study is in progress, health care institutions will be required to document the release of private information for research purposes. Before releasing personal health information, the institution will have to document the date of the disclosure, the name and address of the person receiving the information; a description of the information disclosed; a copy of the patient's authorization, and the documented approval of the IRB or privacy board.

Clearly, the new rules will place new restrictions and burdens on both researchers and health care organizations. The consent process will be expanded to include more explicit discussion of who will have access to the information to be generated in research, IRB's will expand the scope of their reviews somewhat, and new procedures for documenting the use of private information for research will have to be instituted. 

The new rule discussed here
 is one of seven to be issued under the HIPAA legislation. The first, which established standards for electronic health information, was issued in August. It is not known how soon the Standards for Privacy of Individually Identifiable Health Information will be finalized, but researchers are well advised to be prepared for changes in how they do business.

The portion of the proposed standards applicable to research can be found at: 
http://aspe.os.dhhs.gov/admnsimp/nprm/pvc27.htm .

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[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] 

Bridging the Gap: Harm Reduction in Substance Abuse will be offered November 2-3 by the Mayor's Office of Substance Abuse Policy. Call 312-747-2606 for more information.

Research Conference & Grant Writing Workshop on  Research Integrity will be held November 18-20, 2000, sponsored by the Office on Research Integrity. For more information call 301- 670-4990.

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. 
 

COOPERATIVE STUDY GROUP FOR AUTOIMMUNE DISEASE PREVENTION  (RFA-AI-00-016) National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and  Human Development, National Institute of Dental and Craniofacial Research, National Institute of Arthritis and Musculoskeletal and  Skin Diseases, Office of Research on Women's Health, National Institutes of Health, The Juvenile Diabetes Foundation International

SERVICES RESEARCH ON THE NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK 
(RFA-DA-01-003)  National Institute on Drug Abuse

STUDY OF VIRAL RESISTANCE TO ANTIVIRAL THERAPY OF CHRONIC HEPATITIS C (VIRAHEP-C): CLINICAL CENTERS, DATA COORDINATING CENTER, ANCILLARY STUDIES (RFA-DK-01-007) National Institute of Diabetes and  Digestive and Kidney Diseases

PILOT CLINICAL TRIAL GRANTS FOR PHARMACOLOGICAL INTERVENTIONS IN PEDIATRIC TBI (RFA-HD-00-024)  National Institute of Child Health and Human Development, National Institute of Neurological Disorders and Stroke

GENETIC ASPECTS OF TUBERCULOSIS IN THE LUNG (RFA-HL-00-014) National Heart, Lung, and Blood Institute, National Institute of Allergy and Infectious Diseases

PEDIATRIC CLINICAL TRIALS PROGRAM FOR AIDS (RFA-AI-00-015) National Institute of Allergy and Infectious Diseases

MOLECULAR PATHOGENESIS AND NEW INTERVENTIONS IN SCLERODERMA (RFA-AR-00-007) National Institute of  Arthritis and Musculoskeletal and Skin Diseases, Office of Research of Women's Health

DEVELOPMENT OF TECHNOLOGY-DRIVEN PRODUCTS/DEVICES/BIOMARKERS FOR MEASURING EXPOSURE TO  ENVIRONMENTAL AGENTS: SBIR INITIATIVE (RFA-ES-00-009) 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.
 

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CENTERS FOR DISEASE CONTROL AND PREVENTION

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

October 15
COOPERATIVE AGREEMENT FOR RESEARCH ON THE ECOLOGY OF LYME DISEASE IN THE UNITED STATES

October 15
COOPERATIVE AGREEMENTS TO PREVENT LYME DISEASE IN THE UNITED STATES

October 15
COOPERATIVE AGREEMENT FOR RESEARCH ON THE LABORATORY DIAGNOSIS AND PATHOGENESIS OF LYME DISEASE IN THE UNITED STATES

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/

Various Deadlines
RESEARCH AND INNOVATION TO IMPROVE SERVICES AND RESULTS FOR CHILDREN WITH DISABILITIES
 (202-260-9182)

October 27
NATIONAL INSTITUTE ON DISABILITY AND REHABILITATION RESEARCH: FIELD INITIATED RESEARCH PROJECTS (202- 205-5880)

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/

January 17, 2001 
Health Effects of Particulate Matter 

January 2001
Issues in Human Health Risk Assessment 

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
 
 

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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.

January 23
ALZHEMIER'S DISEASE RESEARCH, Illinois Department of Public Health (217-782-3300)

October 16 
ALZHEIMER'S DISEASE AND DEMENTIA RESEARCH, American Federation for Aging Research (212- 752-2327 or http://www.afar.org)

November 1
JUNIOR INVESTIGATOR AWARDS IN GERIATRIC CLINICAL PHARMACOLOGY , Merck/American Federation for Aging Research (212-752-2327 or http://www.afar.org)

December 7
FAMILY-LITERACY PROGRAMS (IN-KIND SUPPORT),  Laubach Literacy  (315- 422-9121 or  http://www.laubach.org/nbsf/indexnbs.html )

December 15
AGING RESEARCH , American Federation for Aging Research  (212-752-2327 or http://www.afar.org)

December 15
SLEEP DISORDERS POSTDOCTORAL FELLOWSHIPS, National Sleep Foundation (202-347-3471 or http://www.sleepfoundation.org)

February 19
GERIATRICS RESEARCH AND EDUCATION FELLOWSHIPS, John A. Hartford Foundation/American Federation for Aging Research  (212-752-2327 or  http://www.afar.org )
 
 
 

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