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Background

Clinical research involving human subjects has come under increasing scrutiny in recent years, and as a consequence, has become the focus of increasing demands for oversight, enhanced protections, and increased education for those conducting the research. Institutions are now aware of the need to ensure greater patient protection, to promote patients' rights and the understanding of the research of which they are part of, and to train their investigative teams in the ethical as well as scientific aspects of human subjects research. However, these added procedures and safeguards create a burden for institutions in providing adequate resources. The NIH developed this S07 program to provide institutions conducting clinical research with infrastructure support for managing all aspect of clinical studies involving human subjects.

This award is intended to:

1. Provide short-term support for institutional activities that will strengthen oversight of human subjects research at institutions that receive significant NIH support for clinical research.
2. Support new human subject advocacy programs or to improve or expand existing programs

Program Description

Although there is considerable flexibility in the types of activities that could be supported under the S07 Human Subjects Research Enhancement Awards program, it is important that these projects enhance the protection of research subjects through projects that will be sustained by the institution after the award period ends. The scope of activity for this award may include, but is not limited to:

• Development of educational initiatives for investigators, administrators and IRB members in the safe and ethical conduct of clinical research.
• Development of educational initiatives for clinical trials participants, their families and the general public.
• Creation of tracking systems for monitoring and coordinating adverse event reporting, site monitoring, human subjects protocols, secure records retention, and electronic protocol submission.
• Computer or web-based systems to coordinate the activities of IRBs, to allow for the approval of consent forms used in multiple institutions, and to coordinating activities of multiple IRBs when participating in multi-center clinical trials.

The following links are available relating to Human Subjects Protections:

• S07 Human Subjects Research Enhancement Program - RFA-OD-02-003
• S07 Human Subjects Research Enhancement Program - RFA-OD-03-007
• Office for Human Research Protections (OHRP)
• OHSR - Office of Human Subjects Research
• NIH Mandates Training in Human Subjects (MS Word)

In addition, a listing of NIH Centers and Institutes is available, which includes the NIH Center managing this award and the NIH Institutes and Centers sponsoring this award.

HSREA Database Queries

A database of all HSREA (S07) awards funded in FY 2002 and 2003 has been developed for public access. See below for running ad hoc queries. Just clicking the "Run Query" button without changing the default parameters will run a list of all Principal Investigators (PIs) at All Institutions in FY 2003. The "Select Individual(s)" drop-down box allows you to select "All Principal Investigators" (FY 2002, 2003 or both) or to select an individual investigator. You may also limit your search by selecting a specific Institution from the "Select Institution(s)" drop-down list, or by entering key words for searching Institution Names and Grant Titles. The "Contents of the Listing" defaults to "Selected Fields", or you may select "All Database Fields" for a more complete listing. Listings may be sorted by Investigator or Institution Name, Title or Grant Number. When desired parameters are selected, click the "Run Query" button to generate the list. The "Reset Fields" button will re-set all query fields to the original (default) parameters.

If your query finds more than one grant record, the resulting listing will display a summary table showing the Principal Investigator, Institution, Grant # and Grant Title. You may then click on the "Principal Investigator" name link to display detailed information about the PI, such as mailing address, phone, fax and e-mail. Links in the "Grant #" column lead to Grant Abstracts from Computer Retrieval of Information on Scientific Projects (CRISP) system. Other links may also be available, as provided by the PI. If your query finds only one record, it will take you directly to the grant detail screen showing PI information, as well as all other related links.

    Select from Options below then Click "Run Query" Button    

 Select Individual(s):    All Principal Investigators   (FY 2003 Awards) All Principal Investigators   (FY 2002 Awards) All Principal Investigators   (FY 2002 & 2003 Awards)       Abramson, Ruth G. Adams, Perrie M. Addis, Marsha E. Altman, Norman H. Anderson, Gail V. Applegate, William B. Ashe, Warren K. Austin, Faye C. Barchi, Robert L. Bernard, Gordon R. Beyer, Daniel R. Black, Henry R. Bloedel, James R. Boccanfuso, Anthony M. Bogan, Patrick F. Botkin, Jeffrey R. Brenner, Mark L. Breton, Michael E. Brown, Sharon A. Burke, John M. Burnett, John C. Burnside, Mary B. Carlo, Jose R. Carlo-Izquierdo, Jose R. Carpenter, Robert W. Carr, Frances E. Chanaud, Cheryl M. Chiorazzi, Nicholas Cicero, Theodore J. Cole, Jonathan R. Coleman, James S. Coller, Barry S. Collins, Delwood C. Cottington, Eric M. Crapo, James D. Dahl, Rebecca W. Davies, Peter J. Dimagno, Eugene P. Dockter, Michael E. Dorsa, Daniel M. Estrup, Peder J. Ewert, Donald L. Feigelson, Eugene B. Firn, Leigh Freedman, Steven D. Garrod, Peter Geller, Kenneth N. Gesteland, Raymond F. Gislason, Eric A. Glickman, Robert M. Goldenberg, David M. Gomez, R. A. Goodson, J. M. Greger, Janet L. Guerinot, Mary L. Gutmann, Amy Guzick, David S. Habicht, Gail S. Hajjar, David P. Hall, Robert D. Hamilton, David W. Harrison, Donald C. Hendee, William R. Henney, Jane E. Holmes, Edward W. Hyman, Steven E. Infante, Anthony J. Irwin, David Isom, Gary E. Johnson, David Kelly, Carolyn J. Kelly, Regis B. Kincaid, Harold King, Boyd P. King, George L. King, Nancy R. Klein, Barry M. Kruger, Charles H. Lampiris, Harry W. Lindsey, Bruce G. Lodico, Barbara J. Lorden, Joan F. Louis, Charles F. Lowman, Robert P. Mandell, James Martin, Nancy C. Mckinney, Ross E. Melmed, Shlomo R. Moore, C B. Moore, Thomas J. Moskowitz, Jay Mulcahy, R. T. Murthy, Sreekant Nasca, Thomas J. Nathanson, Neal Nebeker, Camille Neidig, Judith L. Neubauer, Deane New, William G. Newbower, Ronald S. Newell, Margaret E. Noffsinger, Thomas O'Connor, John D. Omdahl, John L. Palmer, Barton W. Parker, William H. Parks, Malcolm R. Paskevich, Peter A. Patel, Gordhan L. Patrick, James W. Patterson, Wayne R. Pell, Eva J. Peterson, R. J. Phillips, M I. Phillips, Winfred M. Pickens, Roy W. Poehler, Theodore O. Prentice, Ernest D. Purpura, Dominick P. Raskob, Gary E. Raymond, John R. Reichlin, Morris Rich, Robert R. Rivera, Roberto Rivlin, Richard S. Rome, Leonard H. Rosner, William Russell, Thomas R. Rutledge, Charles O. Samaha, Frederick J. Schold, S. C. Scott, Thomas Shapiro, Larry J. Sheridan, Mary E. Skorton, David J. Sladek, John R. Slogoff, Stephen Spangler, Stephanie S. Staiano-coico, Lisa Stancel, George M. Stinson, E. R. Storer, Barry E. Strauss, David H. Sullivan, Cornelius W. Sullivan, John L. Townsel, James G. Trump, Donald L. Turkkan, Jaylan S. Ulaby, Fawwaz T. Van Dam, Andries Visscher, Wendy A. Webster, Robert O. Welch, K. M. Whelton, Paul K. Williams, John F. Williams, R. S. Wilson, Donald E. Wilson, I. D. Wilson, Roger R. Wilson, Roger S. Winston, Arnold Wolfson, Bob E. Wynes, David Young, Robert C. Zasloff, Michael A. Zwelling, Leonard A.

 Select Institution(s):   All Institutions American College of Surgeons American Health Foundation Baylor College of Medicine Beth Israel Deaconess Medical Center Beth Israel Medical Ctr (New York) Boston University Boston University Medical Campus Brown University Case Western Reserve University Cedars-Sinai Medical Center Children's Hospital (Boston) Children's Hospital Med Ctr (Cincinnati) City of Hope National Medical Center Cleveland Clinic Foundation Columbia Univ New York Morningside Dana-Farber Cancer Institute Dartmouth College Drexel University Duke University Emory University Family Health International Forsyth Institute Fox Chase Cancer Center Fred Hutchinson Cancer Research Center Friends Research Institute, Inc. Garden St Cncr Ctr/Ctr Mol Med & Immunology George Washington University Georgetown University Georgia State University Harbor-Ucla Research & Educ Inst Harvard University (Medical School) Howard University Indiana Univ-Purdue Univ at Indianapolis Institute for Cancer Prevention Iowa State University of Science & Tech Johns Hopkins University Joslin Diabetes Center Kaiser Foundation Research Institute Loyola University Medical Center Massachusetts General Hospital Massachusetts Institute of Technology Mayo Clinic Coll of Medicine, Rochester Mayo Clinic Rochester Mc Lean Hospital (Belmont, MA) Mcp Hahnemann University Medical College of Wisconsin Medical University of South Carolina Meharry Medical College Miriam Hospital Mount Sinai School of Medicine of NYU National Jewish Medical & Res Ctr New England Medical Center Hospitals New York State Psychiatric Institute New York University School of Medicine North Shore University Hospital North Shore-Long Island Jewish Res Inst Northern California Institute Res & Educ Northwestern University Ohio State University Oklahoma Medical Research Foundation Oregon Health & Science University Pacific Institute for Res and Evaluation Pennsylvania State Univ Hershey Med Ctr Pennsylvania State University-Univ Park Princeton University Public Health Institute Purdue University West Lafayette Research Triangle Institute Rockefeller University Roswell Park Cancer Institute Corp Rush University Medical Center Rush-Presbyterian-St Lukes Medical Ctr Rutgers the St Univ of NJ New Brunswick San Diego State University Sloan-Kettering Institute for Cancer Res St. Jude Children's Research Hospital St. Louis University St. Luke's-Roosevelt Inst for Hlth Scis Stanford University State University New York Stony Brook State University of New York at Buffalo Suny Downstate Medical Center Temple University Thomas Jefferson University Tufts University Boston Tulane University of Louisiana Univ of Massachusetts Med Sch Worcester Univ of Med/Dent Nj Newark University of Alabama at Birmingham University of Arizona University of Arkansas Med Scis Ltl Rock University of California Berkeley University of California Davis University of California Irvine University of California Los Angeles University of California San Diego University of California San Francisco University of Chicago University of Cincinnati University of Colorado at Boulder University of Colorado Hlth Sciences Ctr University of Connecticut Storrs University of Florida University of Georgia University of Hawaii at Manoa University of Illinois at Chicago University of Iowa University of Kansas Medical Center University of Kentucky University of Louisville University of Maryland Balt Prof School University of Maryland College Pk Campus University of Miami University of Miami-Medical University of Michigan at Ann Arbor University of Minnesota Twin Cities University of Missouri Columbia University of Nebraska Medical Center University of New Mexico Albuquerque University of North Carolina Chapel Hill University of Oklahoma Hlth Sciences Ctr University of Pennsylvania University of Pittsburgh at Pittsburgh University of Puerto Rico Med Sciences University of Rochester University of South Carolina at Columbia University of South Florida University of Southern California University of Tennessee Health Sci Ctr University of Texas Austin University of Texas Hlth Sci Ctr Houston University of Texas Hlth Sci Ctr San Ant University of Texas MD Anderson Can Ctr University of Texas Medical Br Galveston University of Texas Southwestern Medical Center University of Utah University of Vermont & St Agric College University of Virginia Charlottesville University of Washington University of Wisconsin Madison Vanderbilt University Veterans Medical Research Fdn/San Diego Virginia Commonwealth University Wake Forest University Wake Forest University Health Sciences Washington University Wayne State University Weill Medical College of Cornell Univ Wistar Institute Yale University Yeshiva University

 Institution Name Contains:     (Enter Full or Partial Name)

 Grant Title Contains:              (Enter Full or Partial Title)

  Contents of Listing:  Selected Database Fields  All Database Fields
  Listing Sorted by:    Investigator's Last Name   Institution   Title   Grant Number   Fiscal Year, Name

FY 2003 HSREA E-Mail Lists - Click this link to run E-mail distribution lists of FY 2003 HSREA Principal Investigators. This lists can be sent from your Browser e-mail or copied and pasted into your local e-mail program to facilitate communication among the HSREA community.

HSREA Contacts - Please send your questions, comments and/or updates relating to this HSREA page to one of the Programmatic or Grants Management Contacts listed on the HSREA Contacts page. Updated Grant/PI information is welcome. If you experience technical problems accessing site pages or links, or if you have general questions or comments about the OER Grants web site, please contact the OER Webmaster.

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