Newsletter, October, 2000 | OFFICE OF RESEARCH DEVELOPMENT | COOK COUNTY BUREAU OF HEALTH SERVICES

COOK COUNTY BUREAU OF HEALTH SERVICES
Office of Research Development

Thursday, Feb 09, 2012

Home | Print this page | Email this page to a friend |

Institutional Links:

CCH Intranet Links

Cook County Bureau of Health Services

John Stroger Hospital

Department of Medicine

Educational Programs

Email Access:

CCHIL, RUSH & CCBHS

IRB
CCBHS
627 S. Wood Street
Chicago, IL 60612
Phone: 312-864-0716
Fax: 312-864-9210

COOK COUNTY BUREAU OF HEALTH SERVICES

GRANTS NEWSLETTER

Volume 8, Number 10 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~October, 2000
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

WHO IS "ENGAGED" IN RESEARCH?

The task of staying in compliance with federal regulations when you do research can be daunting. Among the welter of acronyms the investigator must recognize are "MPA" and SPA". These refer to assurances made between institutions and the federal government, represented, for human research, by the Office for Human Research Protection (OHRP, the regulators formerly known as OPRR).

Readers of this Newsletter know that the Bureau maintains a Multiple Project Assurance or MPA, which covers all the research carried out at Bureau sites, or by Bureau employees when they carry out research as employees or agents of the Bureau. This assurance is like a contract that spells out how we will oversee our research to protect research participants. With this assurance, affiliates of the Bureau can carry out federally funded research with oversight from our local Institutional Review Boards (IRBs).

But what happens when a Bureau investigator collaborates with another institution? Suppose you're carrying out a study which involves schools, or clinics operated by another health system. Does the Bureau MPA apply? If you're acting in your capacity as an employee or agent of the Bureau, then yes, your activities are covered by our MPA (and must be approved by one of our IRBs), even if they take place off-site. But the story doesn't end there. If the research is federally funded, the other institutions may also need to have or obtain assurances before they can participate in the research.

With any federal research grant, if the research is not eligible for an exemption from review, all the institutions judged to be "engaged" in the research must have an assurance with OHRP . The responsibility for making sure all collaborators have assurances rests in large part on the institution that receives the grant. This institution bears ultimate responsibility for protecting human subjects under the award, at its own and at its collaborators' sites. Indeed, this institution must document that all collaborating sites have assurances before the grant money is released. If the collaborating sites don't have their own MPA, then a Single Project Assurance (SPA) must be applied for. An SPA is a special assurance, made for this study only, that details how local oversight of human subject protection will take place.

So far, so good. But how far does the need for an assurance reach? If a clinic site will only be involved to the extent of telling potential participants about the existence of the study, and giving them a phone number to call, does that clinic need an assurance? If a community organization provides a space for holding focus groups, is it "engaged" in the research? What about the hospital that releases a subject's records after the subject has signed a release for this information?

The questions about who is or is not "engaged", and therefore who needs an assurance, are so convoluted that a guidance letter was issued by the former OPRR in 1999 (see http://ohrp.osophs.dhhs.gov/humansubjects/assurance/engage.htm) to clarify the distinction between "engaged" and not. What follows is a summary of the main points of this letter, to help you determine if your federally funded research needs additional assurances:

An Institution is "Engaged In Research"...

Any institution which receives a direct award from the Department of Health and Human Services to carry out non-exempt human research is automatically considered to be "engaged". This applies even where all activities involving human subjects are carried out by a subcontractor or collaborator.

Additionally, an institutions is engaged in research if, for research purposes, the institution's employees or agents¹:

• Perform invasive or noninvasive procedures with living individuals. Examples include drawing blood; collecting other biological samples; dispensing drugs; or administering other treatments.
• Intervene with by manipulate the environment of living persons. Examples include controlling environmental light, sound, or temperature; presenting sensory stimuli; orchestrating environmental events or social interactions; making voice, digital, or image recordings.
• Interact with living individuals. Examples include engaging in protocol-dictated communication or interpersonal contact; conducting research interviews; and obtaining informed consent. (As detailed below, there are some other personal interactions -- involving informing prospective subjects about research -- which don't constitute "engagement" in research.)
• Release individually identifiable private information, or permit investigators to obtain individually identifiable private information, without subjects' explicit written permission. Examples include releasing patient names to investigators to recruit them for a study; or permitting investigators to record private information from medical records in individually identifiable form. Exceptions would be when the subject has given prior written permission for the release, or some cases in which information is released to a State Health Department (see below)
• Obtain, receive, or possess private information that is individually identifiable (either directly or indirectly through coding systems) for research purposes. An example of this type of information would be information from medical records in an individually identifiable form. Exceptions may be made when information is in a form that doesn't permit identification of individuals. (see below)
• Maintain a "statistical center" for multi-site collaborative research that obtains, receives, or possesses private information that is individually identifiable (either directly or indirectly through coding systems). Where institutional activities involve no interaction or intervention with subjects, and the principal risk associated with institutional activities is that of breach of confidentiality, the institution's IRB need not review each collaborative protocol. However, the IRB must review the center itself. That is, the IRB determines and documents that the statistical center can ensure that:
(i) the privacy of subjects and the confidentiality of data are adequately maintained, given the sensitivity of the data involved;
(ii) each collaborating institution holds an applicable OPRR-approved Assurance;
(iii) each protocol is reviewed and approved by the IRB at the collaborating institution prior to the enrollment of subjects; and
(iv) informed consent is obtained from each subject in compliance with HHS regulations.
• Maintain "operations centers" or "coordinating centers" for multi-site collaborative research. Where institutional activities involve no interaction or intervention with subjects, the IRB need not review each collaborative protocol. However, the IRB should determine and document that the operations or coordinating center can to ensure that:
(i) management, data analysis, and Data Safety and Monitoring (DSM) systems are adequate, given the nature of the research involved;
(ii) sample protocols and informed consent documents are developed and distributed to each collaborating institution;
(iii) each collaborating institution holds an applicable OPRR-approved Assurance;
(iv) each protocol is reviewed and approved by the IRB at the collaborating institution prior to the enrollment of subjects;
(v) any substantive modification by the collaborating institution of sample consent information related to risks or alternative procedures is appropriately justified; and
(vi) informed consent is obtained

¹Agents include all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility.

An Institution is NOT "Engaged In Research"...

Institutions would not be considered "engaged" in human subjects research (and would not need an Assurance) if their involvement is limited to the following:

If the institution's employees or agents:

• Act as consultants on research but at no time obtain, receive, or possess identifiable private information. Should a consultant access or utilize individually identifiable private information while visiting the research team's institution, the consultant's activities become subject to the oversight of the research team's Institutional Review Board (IRB). However, the consultant's institution is not considered to be "engaged" in the research and would not need an Assurance. However, should the consultant obtain "coded" (i.e.,with the potential to link back to identifiers) data for analysis at the consultant's home institution, that institution becomes "engaged" in human subjects research, and would need an Assurance, unless a written agreement unequivocally prohibits release of identifying codes to the consultant.

• Perform commercial services for the investigators and they adhere to commonly recognized professional standards for maintaining privacy and confidentiality. An example would be when a laboratory performs analyses of blood samples for investigators solely on a commercial basis.

• Provide information to prospective subjects, including:
(i) informing prospective subjects about the availability of research;
(ii) providing prospective subjects with written information about research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but not obtaining subjects' consent or acting as authoritative representatives of the investigators;
(iii) providing prospective subjects with information about contacting investigators for information or enrollment; or
(iv) obtaining and appropriately documenting prospective subjects' permission for investigators to contact them. As an example, a clinician provides patients with literature about a research study, including a copy of the informed consent document, and tells them how to contact the investigator if they want to enroll.

• Upon a subject's request, release identifiable private information to investigators with the prior written permission of the subject, An example would be when, with written permission of the subject, a clinician releases the subject's medical record to investigators.

• For public health purposes, release identifiable private information or specimens to a State or Local Health Department or its agent within the recognized authority of that Department. However, if the Department's investigators use the information or specimens for research purposes, then Department is engaged in research, and would need an Assurance.

• Release existing information and/or specimens to investigators in non-identifiable form, where such information/specimens have been obtained by the institution for purposes other than the investigators' research. As an example, a hospital pathology department releases excess tissue specimens and relevant medical record information to investigators, but these materials include no direct or indirect identifiers through which the identity of individual subjects could be ascertained, either by investigators or by hospital personnel, including the pathology department.

• Receive information or specimens for research from established repositories operating in accordance with (i) an approved Assurance; (ii) federal guidance (iii) and written agreements unequivocally prohibiting of release of identifying information to recipient investigators.

Additionally, an institution is not "engaged" if:

• It permits use of its facilities for intervention or interaction with subjects by research investigators. As an example, school permits investigators to test students whose parents have provided written permission for their participation.

• The institution, its clinical staff (or a private practitioner) provides protocol-related care and/or follow-up to subjects enrolled at distant sites by clinical trial investigators in officially recognized Cooperative Protocol Research Programs (CPRPs).

If you would like to know more about the process of helping your collaborators obtain an SPA, contact Karen Smith at 312-633-4940.

NEW HOST FOR THE CCBHS GRANTS & RESEARCH WEB SITE

The CCBHS web site:

http://cookcountyresearch.net

has moved to a new hosting service. This move should ensure less server down time and more reliable access to the site. The address remains the same – you will see no difference if you have been using the address above to reach the site. However, if you bookmarked the site when it first went up, with the address that included "herculeshosting", you should go to the site with its new name, and bookmark it again.

ONLINE RESEARCH CERTIFICATION GOES TO BETA TESTING

The online certification program for investigators, long promised on these pages, is currently undergoing online testing by members of the Task Force designing the program, after which it will be further evaluated by members of the Bureau IRBs. When these testers approve the final version, it will be made widely available to all.

Currently, the only situation in which you need to document that you have been trained is when applying for research funds from NIH. If that's your situation, go to http://ohsr.od.nih.gov/ to take the NIH tutorial and receive a certificate directly from NIH for this purpose.

The final federal rule that will mandate universal certification is expected to be released November 1. The rule most likely will require final implementation of the program by sometime next summer.

We will keep you posted.

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]

Office of Research Development Workshop

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.

The workshop will take place November 9, at 1:30 pm, in the second floor conference room of the Hektoen Building. To register, call Bennetta Anderson at 312-633-4941.

WORKSHOP SCHEDULE, 2000

TITLE	All These Forms (interacting with the IRB)
LENGTH	2 hours
PLACE	Conference Room, 219 Hektoen
ENROLLMENT	Limited to 15
DATE & TIME	November 9 1:30 PM

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.

CLINICAL TRIAL PLANNING GRANT (RFA-AR-00-010) National Institute of Arthritis and Musculoskeletal and Skin Diseases

TYPE 1 DIABETES TRIALNET: CLINICAL CENTERS (RFA-DK-01-003) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development

TYPE 1 DIABETES TRIALNET: CORE SUPPORT FACILITIES (RFA-DK-01-004) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development

PREVENTION AND TREATMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS-CLINICAL CENTERS (RFA-DK-01-010) National Institute of Diabetes and Digestive and Kidney Diseases

PREVENTION AND TREATMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS--COORDINATING CENTER (RFA-DK-01-011) National Institute of Diabetes and Digestive and Kidney Diseases

PREVENTION OF ALCOHOL-RELATED PROBLEMS AMONG ADOLESCENTS (RFA-AA-01-001) National Institute on Alcohol Abuse and Alcoholism

EXPLORATORY STUDIES OF SUSTAINED CALORIC RESTRICTION IN NON-OBESE PERSONS: PHYSIOLOGIC EFFECTS AND COMPARISONS/INTERACTIONS WITH PHYSICAL ACTIVITY (RFA-AG-01-001) National Institute on Aging

BETA CELL BIOLOGY CONSORTIUM (RFA-DK-01-014) National Institute of Diabetes and Digestive and Kidney Diseases

URINARY INCONTINENCE TREATMENT NETWORK: CONTINENCE TREATMENT CENTERS (RFA-DK-01-018) National Institute of Diabetes and Digestive and Kidney Diseases

CHILD HEALTH RESEARCH CAREER DEVELOPMENT AWARDS (RFA-HD-00-020) National Institute of Child Health and Human Development

PREPAREDNESS AGAINST ILLEGITIMATE USE OF BACTERIAL PATHOGENS (RFA-AI-01-002) National Institute of Allergy and Infectious Diseases

RESEARCH IN STATE AND COMMUNITY TOBACCO CONTROL INTERVENTIONS (RFA-CA-01-017) National Cancer Institute

HYPERACCELERATED AWARD/MECHANISMS IN IMMUNOMODULATION TRIALS (RFA-AI-01-001) National Institute of Allergy and Infectious Diseases, National Institute on Aging,,National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Neurological Disorders and Stroke

INTEGRATION OF COMPLEMENTARY AND ALTERNATIVE MEDICINE: A HEALTH SERVICES RESEARCH PERSPECTIVE (RFA-AT-01-001) National Center for Complementary and Alternative Medicine

CENTERS OF EXCELLENCE FOR PATIENT SAFETY RESEARCH AND PRACTICE (RFA-HS-01-002) Agency for Healthcare Research and Quality (formerly AHCPR)

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.

SMALL GRANT PROGRAM FOR CONFERENCE SUPPORT (PAR-00-141) Agency for Healthcare Research and Quality

AHRQ MINORITY RESEARCH INFRASTRUCTURE SUPPORT PROGRAM (PAR-01-001) Agency for Healthcare Research and Quality

AGE-RELATED CHANGES IN READING AND ORAL LANGUAGE COMPREHENSION (PA-01-002) National Institute on Aging, National Institute of Child Health and Human Development

INNOVATIVE TOXICOLOGY MODELS FOR DRUG EVALUATION: EXPLORATORY/DEVELOPMENTAL GRANTS (R21, R33) AND PHASED INNOVATION AWARD (R21/R33) (PAR-01-003) National Cancer Institute

REPRODUCTIVE GENETICS (PA-01-005) National Institute of Child Health and Human Development

NEI SMALL GRANTS FOR PILOT RESEARCH (R03)
(PAR-01-007) National Eye Institute
Back to top

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.
Back to top

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

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

2/28/2001
Children's Vulnerability to Toxic Substances in the Environment

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

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

OTHER OPPORTUNITIES

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.

12/01/2000
BIOMEDICAL ENGINEERING RESEARCH GRANTS FOR INVESTIGATORS EARLY IN THEIR CAREERS, Whitaker Foundation (703-528-2430 or http://www.whitaker.org/grants/rganc.html)

12/15/2000, 03/15/2001, 06/15/2001
FELLOWSHIPS IN SCIENCE AND ENGINEERING, David & Lucile Packard Foundation (650-948-7658 or http://www.packfound.org/)

12/15/2000
CAREER DEVELOPMENT AWARDS
GERTRUDE B. ELION CANCER RESEARCH AWARD
RESEARCH FELLOWSHIPS, American Association for Cancer Research (215-440-9300 or http://www.aacr.org/)

12/13/2000
POSTDOCTORAL RESEARCH FELLOWSHIPS FOR PHYSICIANS, Howard Hughes Medical Institute (301-215-8500 or http://www.hhmi.org/ )

12/01/2000
JUNIOR INVESTIGATOR AWARDS, National Tuberous Sclerosis Association (301-459-9888 or http://www.ntsa.org/guests/main.web)

12/15/2000
NUCLEAR MEDICINE PILOT RESEARCH GRANTS, Society of Nuclear Medicine (http://www.snmerf.org/)

12/15/2000, 06/15/2001
RESEARCH GRANTS, American Paralysis Association (http://paralysis.apacure.org/research/rschguide99.html)

12/01/2000
GRANTS IN RESEARCH RELEVANT TO SPINAL CORD INJURIES AND DISEASES, Paralyzed Veterans of America (202-416-7659 or http://www.pva.org/)

12/15/2000
HDSA GRANT AWARDS & RESEARCH FELLOWSHIP, Huntington's Disease Society of America (212-242-1968 or http://www.hdsa.org/)

12/04/2000
JAFFE FOUNDATION FELLOWSHIP AWARD & GLAXO WELLCOME RESPIRATORY DISEASES RESEARCH AWARD, American Academy of Allergy, Asthma & Immunology (http://www.aaaai.org/professional/grantsandawards/research/ )

12/15/2000
INNOVATION GRANTS COMPETITION, Merrill Lynch Forum (888-333-6786 or http://www.ml.com/woml/forum/innovation/overview.htm)

12/17/2000
SJOGREN'S SYNDROME RESEARCH FELLOWSHIPS, Sjogren's Syndrome Foundation, Inc.
(516-933-6365 or http://www.sjogrens.org/)

12/01/2000
JUDITH GRAHAM POOL POSTDOCTORAL RESEARCH FELLOWSHIPS, National Hemophilia Foundation (212-328-3700 or http://www.hemophilia.org/)

12/01/2000
THE MCKNIGHT TECHNOLOGICAL INNOVATIONS IN NEUROSCIENCE AWARDS, The McKnight Endowment Fund for Neuroscience (612-333-4220 or http://www.mcknight.org/neuroscience/)

12/01/2000
CLINICAL SCIENTIST AWARD & YOUNG INVESTIGATOR GRANTS, National Kidney Foundation (703-522-8544 or http://www.kidney.org/)

12/03/2000
YOUNG CLINICIAN INVESTIGATOR AWARD, The Research Foundation of the American Association of Neurological Surgeons (847-692-9500 or http://www.neurosurgery.org/aans/research/awards.html)

12/01/2000
GRADUATE WOMEN IN SCIENCE FELLOWSHIPS, Sigma Delta Epsilon Graduate Women in Science (PO Box 24076, Apple Valley 55124)

12/01/2000
NOF/MAZESS RESEARCH GRANT, National Osteoporosis Foundation (202-223-2226 or http://www.nof.org/)

12/30/2000
2001 MENKES/MARKHAM DYSTONIA FELLOWSHIP, Dystonia Medical Research Foundation (312-755-0198 or http://research.wustl.edu/ro/news/1999/med0799.html)

12/31/2000
IARC FELLOWSHIPS FOR RESEARCH TRAINING IN CANCER, International Agency for Research on Cancer (http://www.iarc.fr/)

12/01/2000
GRASS FELLOWSHIP IN NEUROSCIENCE, Grass Foundation (781-843-0219)

12/15/2000
RESEARCH GRANTS AND THE YOUNG INVESTIGATOR AWARDS, American Foundation for Suicide Prevention (888-333-2377 or http://www.afsp.org/index-1.htm)

12/10/2000
KIMMEL SCHOLAR AWARD, Sidney Kimmel Foundation for Cancer Research (215-994-1186 or http://www.kimmel.org/)

12/01/2000
INTERNATIONAL FELLOWSHIPS FOR BEGINNING INVESTIGATORS, American Cancer Society (404-329-7558 or http://www.cancer.org/research/)

12/01/2000
TRANSLATIONAL CANCER RESEARCH FELLOWSHIPS, International Union Against Cancer (http://fellows.uicc.org/)

12/01/2000
INTERNATIONAL RESEARCH GRANTS, Parkinson's Disease Foundation (800-457-6676 or http://www.parkinsons-foundation.org/)

LOST A LINK?
Look in the alphabetical index to links on this site

Home | Contact us | Privacy policy | Terms of use | Site Map

Copyright ©1998-2010 John Stroger Hospital. All rights reserved.
All information is not a substitute for medical advice or treatment for specific medical conditions.
If you have any health-care related questions or suspect you have a health problem, you should consult your health-care provider.