FEDERAL REGULATORS 
RAISE THE BAR

On May 23, 2000, Department of Health and Human Services Secretary Donna E. Shalala announced new federal initiatives to strengthen protections of human research subjects. As had been generally expected, institutions receiving federal funds for research will now be required to provide training in research bioethics training and human subjects protection for all clinical investigators, research administrators, IRB members and IRB staff, and will also be required to carry out audits of approved research to insure that subjects' rights are being protected. Two aspects of the new initiative which had not been anticipated are new steps to enforce conflict of interest rules which will extend to revealing to subjects any financial stake an investigator has in the research -- and the intent to enact civil penalties against individual researchers and institutions who fail to protect research participants.

This is the description of the new actions, taken from Secretary Shalala's press release:

Education and Training. HHS will undertake an aggressive effort to improve the education and training of clinical investigators, IRB members, and associated IRB and institutional staff. NIH, FDA and the Office for Protection from Research Risks (OPRR) will work closely together to ensure that all clinical investigators, research administrators, IRB members and IRB staff receive appropriate research bioethics training and human subjects research training. Such training will be a requirement of all clinical investigators receiving NIH funds and will be a condition of the NIH grant award process and of the OPRR assurance process.
 

Informed Consent. NIH and FDA will issue specific guidance on informed consent, clarifying that research institutions and sponsors are expected to audit records for evidence of compliance with informed consent requirements. For particularly risky or complex clinical trials, IRBs will be expected to take additional measures, which, for example, could include third-party observation of the informed consent process. The guidance will also reassert the obligation of investigators to reconfirm informed consent of participants upon the occurrence of any significant trial-related event that may affect a subject's willingness to participate in the trial. 

Improved Monitoring. NIH will now require investigators conducting smaller-scale early clinical trials (Phase I and Phase II) to submit clinical trial monitoring plans to the NIH at the time of grant application, and will expect investigators to share these plans with IRBs. The NIH already requires investigators to have such plans and they also require large scale (Phase III) trials to have Data and Safety Monitoring Boards (DSMBs). For research on medical products intended to be marketed, FDA will also issue guidelines for DSMBs that will delineate the relationship between DSMBs and IRBs, and define when DSMBs should be required, when they should be independent, their responsibilities, confidentiality issues, operational issues and qualified membership.

Conflict of Interest. NIH will issue additional guidance to clarify its regulations regarding conflict of interest, which will apply to all NIH-funded research. HHS will also hold public discussions this summer to find new ways to manage conflicts of interest so that research subjects are appropriately informed, and to further ensure that research results are analyzed and presented objectively. In addition, these public discussions also will focus on clarifying and enhancing the informed consent process. Based on these public forums, NIH and FDA will work together to develop new policies for the broader biomedical research community, which will require, for example, that any researchers' financial interest in a clinical trial be disclosed to potential participants.

Civil Monetary Penalties. HHS will pursue legislation to enable FDA to levy civil monetary penalties for violations of informed consent and other important research practices-up to $250,000 per clinical investigator and up to $1 million per research institution. While FDA can currently issue warning letters or impose regulatory sanctions that halt research until problems are rectified, financial penalties will give the agency additional tools to sanction research institutions, sponsors and researchers who do not follow federal guidelines. As an interim step, NIH, OPRR and FDA will work more closely together to enforce and target existing penalties.

As reported in the May 24 New York Times, the move to assess fines against researchers requires Congressional action, and there is expected to be resistance to this idea from some members of Congress, as well as from universities, medical centers and others with a stake in research. The idea of monetary penalties is intended to be an intermediate step that pinpoints particular culprits, somewhere between ineffective slaps on the wrist and the wholesale closure of research programs, such as have been seen across the country in the past two years. 

How Will This Affect County Researchers?

With the exception of the new civil penalties, all these changes take effect immediately. One of the new requirements, that the consent process be closely monitored, is already in force in the County system, with the initiation last summer of the our Research Quality Assurance Program. Other requirements, such as disclosure of financial interests to research subjects, will be the subject of policies not yet published. The most immediate way in which researchers will be affected is in the requirement for explicit training in research bioethics. Indications from federal regulators are that it will not be enough to ask researchers to read a set of guidelines, as we do now; there will also have to be some formal way to verify that individual researchers are knowledgeable about their responsibilities for protecting human subjects. Other institutions have adopted mandatory training sessions, web-based tutorials, or qualifying exams to accomplish this end. These and other options will be explored in the near future, with the goal of having a program to meet this new requirement before the end of summer. If you have any suggestions, or if you would like to work on the group that will design the program, please call Karen Smith at 312-633-4940 or email at kmsmith@wwa.com.

...AND NIH EASES UP (JUST A LITTLE) 

On April , NIH announced that it will no longer require IRB review to be under way at the time a grant application is made. Since no more than 50% of grant applications even reach the final review stage, and perhaps 20% actually are funded, having IRB reviews up front results in a great deal of wasted effort on the part of both researchers and IRBs. 

As of June 1 applications to NIH, you will no longer have to complete your application to the IRB at the time you submit your application to NIH. You can wait until you receive your NIH peer review and notification of priority score/percentile before starting the IRB review, and then only if your score falls in a "fundable" range. Guidelines on what constitutes a "fundable" range are now being developed, and will be published ere as soon as they are available.

In any case, no NIH grant award will be made without IRB approval. You should have about two or three months after you receive your score to complete IRB review, which in most cases will be adequate.
 

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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] 
 

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 Consent Form Clinic is offered by Funeka Sihlali, RN, CRC, the Research Quality Coordinator for the Bureau.  Among other things, Ms. Sihlali can help you 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

Reservations will be required to insure that you will get individual attention. The schedule of Consent Form Clinics for  is given below, with the workshop schedule.  To make an appointment, please call 312-572-3506.

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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. 

RESEARCH ON ALCOHOL AND SLEEP (RFA-AA-00-005) National Institute on Alcohol Abuse and Alcoholism

COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP (RFA-CA-01-002) National Cancer Institute

PLANNING GRANT FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATION (RFA-CA-01-003) National Cancer Institute

COOPERATIVE PLANNING GRANT FOR COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER  PARTNERSHIP (RFA-CA-01-008) National Cancer Institute

THE ROLE OF PARKIN AND RELATED PROTEINS IN PARKINSON’S DISEASE (RFA-NS-01-005) National Institute of Neurological Disorders and Stroke

PLANNING GRANTS: IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (PRE-ICMICs) (RFA-CA-01-010) National Cancer Institute

DEVELOPMENT OF BEHAVIORAL METHODS FOR DRUG ABUSE STUDIES IN THE MOUSE (RFA-DA-01-002) National Institute on Drug Abuse

NICHD INSTITUTIONAL TRAINING IN EPIDEMIOLOGY AND CLINICAL TRIALS FOR OBSTETRICIANS AND GYNECOLOGISTS (RFA-HD-00-014) National Institute of Child Health and Human Development

ALZHEIMER'S DISEASE CORE CENTERS (RFA-AG-00-002) National Institute on Aging

EPIDEMIOLOGIC RESEARCH ON FEMALE PELVIC FLOOR DISORDERS  (RFA-HD-00-012) National Institute of Child Health and Human Development

PEDIATRIC HEART DISEASE CLINICAL RESEARCH NETWORK  (RFA-HL-00-013) National Heart, Lung, and Blood Institute

RESEARCH ON DEPRESSION COMORBID WITH EXTERNALIZING PROBLEMS IN CHILDREN  (RFA-MH-01-002) National Institute of Mental Health, National Institute on Drug Abuse

NURSING RESEARCH EXPLORATORY CENTER GRANTS (RFA-NR-01-001) National Institute of Nursing Research

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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.
 
 

INTERVENTIONS AND PRACTICE RESEARCH INFRASTRUCTURE PROGRAM (IP-RISP)  (PAR-00-096) National Institute of Mental Health

NIDCR SCHOLAR DEVELOPMENT AND FACULTY TRANSITION AWARD (K22) (PAR-00-097) National Institute of Dental and Craniofacial Research

NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM (PAR-00-098) National Institute of Allergy and Infectious Diseases, National Institute of Mental Health

INTEGRATIVE AND COLLABORATIVE APPROACHES TO RESEARCH (PA-00-099) National Institute of General Medical Sciences

SECONDARY ANALYSIS OF EXISTING HEALTH SERVICES DATA SETS (PA-00-100) National Institute on Alcohol Abuse and Alcoholism

DEVELOPMENT OF NOVEL IMAGING TECHNOLOGIES (PHASED INNOVATION AWARD) (PAR-00-089) National Cancer Institute, National Center for Research Resources

DEVELOPMENT OF NOVEL IMAGING TECHNOLOGIES: (SBIR/STTR) INITIATIVE (PAR-00-090) National Cancer Institute
National Center for Research Resources

RESEARCH STUDIES ON THE HEREDITARY CALCIUM OXALATE STONE DISEASES (PA-00-091) National Institute of Diabetes and Digestive and Kidney Diseases

THE NIDA SCHOLARS PROGRAM (PAR-00-092) National Institute on Drug Abuse

HIV VACCINE RESEARCH AND DESIGN (PAR-00-093) National Institute of Allergy and Infectious DiseasesPROGRAM ANNOUNCEMENTS

EARLY IDENTIFICATION AND TREATMENT OF MENTAL DISORDERS IN CHILDREN AND ADOLESCENTS (PA-00-094) National Institute of Mental Health

ANCILLARY STUDIES TO NIMH MULTI-SITE CLINICAL TRIALS (PAR-00-095) National Institute of Mental Health

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CENTERS FOR DISEASE CONTROL AND PREVENTION

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

July 14, 2000     Mind / Body Research Program [Announcement Number 00118]

July 11, 2000    Prevention Epicenters Program [Announcement Number 00059]

Letter of Intent Due June 12, 2000; Closing Date: July 14, 2000   Optimizing Strategies to Provide Sexually Transmitted Disease (STD) Partner Services [Announcement Number 00080 ]

Letter of Intent Due June 23, 2000; Closing Date: July 14, 2000  Cooperative Agreement for Collaborating Centers for Public Health Law [Announcement Number 00053]

July 3, 2000    Grant for Education Programs in Occupational Safety and Health [Announcement Number 01001]

July 10, 2000   Assessment of Micronutrient Status 

July 10, 2000    Intervention & Prevention of Sexual & Partner Violence Among Racial & Ethnic Minorities

Letter of Intent Due June 15, 2000; Closing Date: July 15, 2000   Public health Leadership Institute

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. Some upcoming HRSA deadlines are:

July 16     CDC/HRSA Cooperative Agreements for HIV/AIDS Intervention, Prevention, and Continuity of Care Demonstration Projects for Incarcerated individuals Within Correctional Settings and the Community

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DEPARTMENT OF EDUCATION 
Details on open opportunities can be found at http://www.ed.gov/GrantApps/

July 17     Special Education--Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities

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

July 12    Community Youth Mental Health Promotion and Violence/Substance Abuse Prevention Partnership Program 

July 21    Co-Occurring and Justice Center 

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

Office of Refugee Resttlement
Details on grant opportunities can be found at: http://www.acf.dhhs.gov/program/orr/

07/05/00   FUNDS FOR REFUGEE COMMUNITY/FAMILY STRENGTHENING (202-401-1196)

07/05/00   TECHNICAL ASSISTANCE FOR INTEGRATION OF REFUGEES INTO AMERICAN COMMUNITIES  (202-401-1196)

Administration on Children, Youth and Families
Details on grant opportunities can be found at:  http://www.acf.dhhs.gov/programsFYSB

07/3/00 - 08/3/00  Programs for Runaway and Homeless Youth

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

Various dates  FY00 Ovarian Cancer Research Program Announcement

09/20/00    Neurotoxin Exposure Treatment Research

07/14/00    Epidermolysis Bullosa  Research  (301-619-2036)

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 rsearch not closely tied to clinical applications

07/10/00    Molecular & Cellular Biosciences Grants, National Science Foundation (703-306-1440 or http://www.nsf.gov/bio/mcb/mcbdates.htm)

07/15/00    Child Learning and Development, National Science Foundation (703-306-1732 or http://www.nsf.gov/sbe/bcs/cld/start.htm)

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

07/15/00    MEDICAL SCIENCE AND TECHNOLOGY DIVISION PROGRAMS (703-696-4055)

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

07/15/00    SMALL SCIENTIFIC CONFERENCE GRANT PROGRAM (301-827-7180)

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.

07/01/00    ATAXIA-TELANGIECTASIA. RESEARCH GRANT PROGRAM, A-T Children's Project Program (561-395-2621 or: http://ww2.med.jhu.edu/ataxia/guidlin.htm)

07/01/00    AACN CLINICAL INQUIRY GRANTS, American Association of Critical Care Nurses (800-899-2226 or http://aacn2.org/awards/grants.htm)

07/01/00    AACN INNOVISION GRANTS, American Association of Critical Care Nurses
(800-899-2226 or http://aacn2.org/awards/g-38.htm)

07/01/00    AACN/HEWLETT-PACKARD CRITICAL CARE NURSING RESEARCH GRANT, American Association of Critical Care Nurses (800-899-2226 or http://www.aacn.org)

07/01/00    GRANTS FOR PROGRESSIVE SOCIAL CHANGE, Ben & Jerry's Foundation (802-846-6828 or http://www.benjerry.com/foundation/guidelines.html)

07/01/00    BWF RESEARCH TRAVEL GRANTS, Burroughs Wellcome Fund (919-991-5100 or http://www.bwfund.org)

07/01/00    CHILDREN'S BRAIN TUMOR FOUNDATION GRANTS PROGRAM, Children's Brain Tumor Foundation Inc. (212-448-9494 or http://www.cbtf.org)

07/01/00    CAREER DEVELOPMENT AWARDS; FIRST AWARD; RESEARCH FELLOWSHIP AWARDS; RESEARCH GRANTS PROGRAM, Crohn's & Colitis Foundation of America (212-685-3440 or  http://www.ccfa.org/)

07/01/00    FACULTY SCHOLARS PROGRAM IN CHILD DEVELOPMENT RESEARCH, William T Grant Foundation (212-752-0071  or http://fdncenter.org/grantmaker/wtgrant/index.html  )

07/01/00    CONFLICT RESOLUTION, William & Flora Hewlett Foundation (650-329-1070  or http://www.hewlett.org/)

07/01/00    YAMAGIWA-YOSHIDA MEMORIAL INTERNATIONAL CANCER STUDY, International Union Against Cancer (4122 809 18 40 or http://fellows.uicc.org)

07/01/00    MELANOMA RESEARCH GRANTS, Melanoma Research Foundation (800-673-1290 or http://www.melanoma.org/)

07/01/00    RETT SYNDROME RESEARCH, Rett Syndrome Research Foundation (513-874-3020 or http://www.rsrf.org/research_grants_available.htm)

07/03/00    SAMUEL LEONARD SIMPSON FELLOWSHIP IN ENDOCRINOLOGY, Royal College of Physicians of London (0171 935 1174 or http://www.rcplondon.ac.uk)

07/05/00    SOCIAL SERVICE & YOUTH GRANTS, Patrick and Anna M Cudahy Fund (847-866-0760  or  http://jefferson.village.virginia.edu/readings/cudahy.html)

07/07/00    POSTDOCTORAL FELLOWSHIPS IN IMMUNOLOGY, Irvington Institute for Immunological Research (212-758-8250 or http://www.irvingtonresearch.org)

07/14/00    SENIOR COMPANIONS FOR THE FRAIL ELDERLY, Corporation for National Service Program (202-606-5000 x285 http://www.cns.gov/)

07/15/00    FELLOWSHIP IN GYNECOLOGIC ONCOLOGY, Gynecologic Cancer Foundation (919-966-1196 or http://www.sgo.org/gcf/ )

07/15/00   YOUTH DEVELOPMENT, Edward W Hazen Foundation (212-889-3034 or http://www.hazenfoundation.org/ )

07/15/00    MDA RESEARCH GRANTS, Muscular Dystrophy Association (520-529-2000 or http://www.mdausa.org/research/guidelines.html)

07/15/00    ROENTGEN CENTENNIAL FELLOW PROGRAM, Radiological Society of North America (630-571-7816 or http://www.rsna.org)

07/17/00    INFECTIOUS DISEASES IN THE DEVELOPING WORLD, Wellcome Trust (020 7611 8856 or http://www.wellcome.ac.uk)

07/19/00   PEDIATRIC AIDS RESEARCH GRANTS, PEDIATRIC SCHOLAR AWARDS Elizabeth Glaser Pediatric AIDS Foundation (310-314-1459 or http://www.pedaids.org/rfa01.html) 

07/24/00    NONVIOLENT SOCIAL CHANGE, A.J. Muste Memorial Institute (212-533-4335 or http://www.nonviolence.org/ajmuste)

07/25/00    GRANTS IN MEDICINE & PHARMACY, Gustavus & Louise Pfeiffer Research Foundation (973-983-0480 or http://www.ospa.umn.edu/rr/97-1/gustavus.htm)

08/01/00    IMPLANT DENTISTRY SMALL GRANT PROGRAM, American Academy of Implant Dentistry (312-335-1550 or http://www.aaid-implant.org/Homepage.htm )

08/01/00    SURGERY RESEARCH SCHOLARSHIP, RESEARCH CAREER DEVELOPMENT AWARD; RESIDENT RESEARCH SCHOLARSHIPS; American College of Surgeons (312-202-5000 or http://www.facs.org) 

08/01/00   RESEARCH ON OPHTHALMIC LENSES, American Optometric Foundation (301-984-4734 x3007 or http://www.aaoptom.org)

08/01/00    DEAFNESS RESEARCH GRANTS, Deafness Research Foundation (212-599-0027 or http://www.drf.org/grants/index.asp?/section=grants)

08/01/00    CLINICAL MEDICINE PERSON-IN-TRAINING AWARD, NEW INVESTIGATOR RESEARCH AWARD, Gerontological Society of America (202-842-1275 or http://www.geron.org)

08/01/00    MEDICAL RESEARCH AND BIOETHICS Greenwall Foundation ( 212-679-7266 or http://www.greenwall.org)

08/01/00    VIOLENCE RESEARCH, Harry Frank Guggenheim Foundation (212-644-4907 or http://www.hfg.org/html.pages/grants.htm) 

08/01/00     SHORT-TERM SCIENTIFIC EXCHANGE AWARD, Leukemia Society of America, Inc. (212-450-8843 or http://www.leukemia-lymphoma.org)

08/01/00    MS RESEARCH GRANTS, National Multiple Sclerosis Society (212-986-3240 or http://www.nmss.org)

08/01/00     FELLOWSHIP IN HEALTH SERVICES RESEARCH; CAREER DEVELOPMENT AWARDS ; EDUCATIONAL AWARDS; FRED W. HARK, M.D. AND WILLIAM A. HARK, M.D. LECTURESHIP; OSTEOTECH AWARD FOR EXCELLENCE IN BONE ALLOGRAFT; PROSPECTIVE CLINICAL RESEARCH GRANTS; RESEARCH GRANTS; RESIDENT RESEARCH AWARDS; SULZER ORTHOPAEDICS RESIDENT GRANT FOR GROWTH FACTOR RESEARCH, Orthopaedic Research & Education Foundation (847-384-4348 or http://www.oref.org/researchapp.htm)

08/01/00     RETIREMENT RESEARCH FOUNDATION GRANTS PROGRAM, Retirement Research Foundation (773-714-8080 or http://fdncenter.org/grantmaker/rrf/index.html)

08/01/00     BIOMEDICAL ENGINEERING RESEARCH GRANTS, Whitaker Foundation (703-528-2430 or http://www.whitaker.org/grants/rganc.html)

08/02/00     ALZHEIMER'S DISEASE AND DEMENTIA, Helen Bader Foundation (414-224-6464 or http://www.hbf.org/usapply.html)

08/10/00     STUDENT RESEARCH GRANT COMPETITION, American Occupational Therapy Foundation (301-652-6611 x2554 or http://www.aotf.org/html/research_grants.html)

08/15/00     SCHOLARSHIPS IN MEDICAL SCIENCE, Rockefeller Brothers Fund  (212) 812-4200 or http://www.culpeper.org/scholar.html 

09/16/00 (nominations only):    COMMUNITY HEALTH LEADERSHIP PROGRAM,  Robert Wood Johnson Foundation (617-426-9772 or  http://www.communityhealthleaders.org)

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