IRB, Office of Research Development COOK COUNTY BUREAU OF HEALTH SERVICES
Office of Research Development

      
Thursday, Jul 29, 2010
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COOK COUNTY BUREAU OF HEALTH SERVICES

GRANTS NEWSLETTER



Volume 8, Number 6 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~June, 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

 

MANDATORY INVESTIGATOR TRAINING: FIRST PHASE 
 

As of October 1, all applicants to the National Institutes of Health for new grants for human research must attest that they have received training in human subject protection. This is the first enforcement step taken by the Department of Health and Human Services after its adoption of an initiative, announced May 23, to make such training mandatory. In the future it will be required for all investigators doing federally funded human research and for investigators at institutions that maintain Multiple Project Assurances with the federal government.

Applicants to NIH for new funding for human research will be required to submit a cover letter describing the specific education completed in human subject protection. Funds will not be awarded if this documentation is not provided. Applicants for non-competing renewals will be required to provide a description of their training with their progress reports. The requirement applies to all persons named as "key personnel" in the grant application.

A Task Force has been established in the Bureau, with representation from all three Bureau IRBs, to design and implement a training course which will meet the new federal requirements. This training will be available in time for Bureau applicants to comply with the October 1 deadline. 

The announcement of this new rule can be found in the June 9 edition of the NIH Guide to Grants and Contracts at http://grants.nih.gov/grants/guide
If you have questions or suggestions about the new Bureau training program, contact Karen Smith at 312-633-4940 or kmsmith@wwa.com.



CAUTIONARY TALES

Funeka Sihlali, RN, CRC

[Editor's note -- As readers of this Newsletter are aware, the Bureau adopted a program of research quality assurance in the summer of 1999. The Coordinator of the research QA program, Funeka Sihlali, has prepared the following fictional (but not far from the truth) cautionary tale from her experience so far in auditing our research projects. 

The tale is presented below. Please read it and ask yourself how this project might have been handled better, and how it might deviate from either good research practice or research regulations. At the end of the Newsletter you will find a discussion of the problems this study poses and the lessons to be learned from it.]
 

Dr. Chicago (an attending physician) is listed as the Principal Investigator, and Dr Michigan (a resident) is listed as the co-investigator on project Lake, which will study an Investigational New Drug (IND). Everything is fine, with ten subjects enrolled into the study. 

Dr. Michigan leaves the institution 4 months after the beginning of the project. Drs La Salle and State (also residents) take over Michigan's responsibilities and start obtaining consents from subjects.

Because St. Elsewhere Hospital has a few of their copiers broken, the residents ask the subjects to sign three different copies of the consent form which are distributed as follows: 1) filed in the subject's medical chart; 2) inserted in the investigator's binder; 3) sent to Pharmacy Services.

Dr. Chicago received new correspondence from the sponsor informing him of new risks recently uncovered: this drug may damage the kidneys if the subjects do not drink 8-10 glasses of water a day. Dr Chicago shares this new risk with the residents, who in turn write in this added risk on the consent with a ballpoint pen. When Drs La Salle and State enroll new subjects they emphasize the importance of drinking water.

Once a week Dr Chicago reviews the consents of the new recruits enrolled by the residents and signs the forms as the Principal Investigator.

The first ten subjects were pleasantly surprised when at the sixth month visit they were awarded a $75 Jewel coupon and $25 worth of CTA tokens. The information about payment was not 
included in the protocol or in the consent form.

Mrs Shift, a participant in the study, faints at a family reunion. Her out-of town daughter, who is a Physicians Assistant, knows that her mom is on research medication, but she does not know who to contact because her mother does not have a copy of the consent form at home.
 

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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

New Research Conflict of Interest Requirements will be the topic of a workshop sponsored by NIH August 15-16 in Rockville. For information call 202-205-8830.

Ethical Research in the New Millennium - What the Belmont Report Didn't Anticipate, will take place in Portland, OR, August 14-16. Call 503-494-2351 for information.

Regional Workshop on Effective IRBs - The Fundamentals will be offered by Public Responsibility in Medicine & Research in Rosement, IL on September 18. Call 202-828-0952 for information.

Town Hall Meeting with the Office for Human Research Protection and the FDA will take place in October in St. Louis. For dates and other information call 314-568-6841.

Ethics - Intensive Training Course will be offered October 16-19 in St. Petersburg, FL. Call 813-974-7623 for more information.
 



Office of Research Development Workshops 

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
          WORKSHOP SCHEDULE,  2000
TITLE Grant Writing  Grant Budgeting  All These Forms (interacting with the IRB)
LENGTH 3 hours 3 hours 2 hours
PLACE Conference Room, 
219 Hektoen
Research Development Office, 277 Hektoen Conference Room, 
219 Hektoen
ENROLLMENT Limited to 15 Limited to 6 Limited to 15
DATE & TIME By arrangement By arrangement November 9
1:30 PM

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CONSENT FORM CLINIC  SCHEDULE

All sessions are from 8:00AM to Noon
To make a reservation, call Funeka Sihlali at 312-572-3506 


July: 
Thursday, July 13
Monday, July 17
September: 
Thursday, September 14
Monday, September 18
August: 
Thursday, August 10
Monday, August 21
October: 
Thursday, October 12
Monday, October 16

 


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. 

INNOVATIVE REHABILITATION INTERVENTIONS (RFA-HD-00-016) National Institute of Child Health and Human Development, National Institute on Aging, National Institute on Deafness and Other Communication Disorders

BOTANICAL PRODUCTS DEVELOPMENT: SBIR AND STTR (RFA-AT-00-003)National Center for Complementary and Alternative Medicine, National Institute of Diabetes and Digestive and Kidney Diseases

STATE MODELS FOR ORAL CANCER PREVENTION AND EARLY DETECTION (RFA-DE-00-005) National Institute of Dental and Craniofacial Research, National Cancer Institute

ANCILLARY STUDIES IN HEART, LUNG, AND BLOOD DISEASE TRIALS (RFA-HL-00-012) National Heart, Lung, and Blood Institute

ENDOCRINE DISRUPTORS: EPIDEMIOLOGIC APPROACHES (RFA-OH-01-001) National Institute for Occupational Safety and Health (NIOSH), Center for Disease Control and Prevention (CDC), National Center for Environmental Research (NCER), U.S. Environmental Protection Agency (EPA), National Cancer Institute, National Institute of Environmental Health Sciences

EXPLORATORY PROGRAM GRANTS FOR FRONTIER MEDICINE RESEARCH (RFA-AT-00-002) National Center for Complementary and Alternative Medicine

NHLBI MENTORED MINORITY FACULTY DEVELOPMENT AWARD (K01) (RFA-HL-00-016) National Heart, Lung, and Blood Institute

IMMUNOPATHOGENESIS OF CHRONIC GRAFT REJECTION (RFA-AI-00-013)National Institute of Allergy and Infectious Diseases, National Heart, Lung, and Blood Institute

BIOLOGICAL MECHANISMS OF NOISE-INDUCED HEARING LOSS (RFA-DC-00-002) National Institute on Deafness and Other Communication Disorders, National Institute on Aging

ADVANCED RESEARCH COOPERATION IN ENVIRONMENTAL HEALTH SCIENCES (RFA-ES-00-006) National Institute of Environmental Health Sciences

ENVIRONMENTAL JUSTICE: PARTNERSHIPS FOR COMMUNICATION (RFA-ES-00-007)National Institute of Environmental Health Sciences

INTERNATIONAL STUDIES ON HEALTH AND ECONOMIC DEVELOPMENT (RFA-TW-01-001) Fogarty International Center, World Bank, National Institute on Aging, National Institute of Mental Health,  National Institute of Dental and Craniofacial Research, National Eye Institute, Office of Behavioral and Social Sciences 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.

NIH NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL RESEARCH TRAINING GRANTS (PA-00-103) National Institutes of Health

NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL POSTDOCTORAL FELLOWS (F32) (PA-00-104) National Institutes of Health

BASIC AND TRANSLATIONAL RESEARCH IN EMOTION (R01) (PA-00-105) National Institute of Mental Health, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Cancer Institute, National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute of Neurological Disorders and Stroke

BASIC AND TRANSLATIONAL RESEARCH IN EMOTION: SMALL GRANTS (PA-00-106) National Institute of Mental Health, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Cancer Institute, National Institute of Child Health and Human Development, National Institute on Drug Abuse

NIDCD INVESTIGATOR-INITIATED CLINICAL TRIALS (PA-00-107)National Institute on Deafness and Other Communication Disorders

THE SCIENCE AND ECOLOGY OF EARLY DEVELOPMENT (SEED) (PAS-00-108)National Institute of Child Health and Human Development, National Institute of Mental Health

SELF-MANAGEMENT STRATEGIES ACROSS CHRONIC DISEASES (PA-00-109)National Institute of Nursing Research, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases,National Institute of Mental Health, National Institute of Neurological Disorders and Stroke

NIDCD SMALL GRANT PROGRAM (PAR-00-110)National Institute on Deafness and Other Communication Disorders

AHRQ HEALTH SERVICES RESEARCH (PA-00-111)Agency for Healthcare Research and Quality

DIABETES SELF-MANAGEMENT IN MINORITY POPULATIONS (PA-00-113) National Institute of Nursing Research, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences

DEVELOPMENTAL PSYCHOPHARMACOLOGY (PA-00-114) National Institute of Mental Health, National Institute of Child Health and Human Development, National Institute on Drug Abuse

MOLECULAR GENETICS OF DRUG ADDICTION VULNERABILITY (PA-00-115)National Institute on Drug Abuse

NIDCR NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL RESEARCH TRAINING GRANTS (PA-00-116) National Institute of Dental and Craniofacial Research
 
 

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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 31
Invasive Fungal Infections in Transplant Recipients

August 7, 2000
Community-Based Strategies to Increase HIV Testing of Persons at High Risk in Communitiesof Color [Announcement Number 00100]

August 21, 2000
Youth-Focused HIV/AIDS Prevention Program Development and Technical Assistance Collaboration with Countries Targeted by the Leadership and Investment in Fighting the Epidemic (LIFE) Initiative [Announcement Number 00138]

July 21, 2000
Uniform Population-Based Approach to Case Ascertainment, Typology, Surveillance, and Research on Childhood Diabetes [Announcement Number 00097]

August 10, 2000
Asthma Surveillance and Interventions in Hospital Emergency Departments [Announcement Number 00010]

November 1, 2000
Grants for Injury Control Research Centers [Announcement Number 01007]

July 24
Health Needs of Gay Men of Color (contract, http://cbdnet.gpo.gov/)


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:

Letter of Intent July 31; due date August 25, 2000 
Center for School-based Health Care

Letter of Intent  July 17;  due August 11, 2000 
Training and Technical Assistance Centers for Mental Health in Schools

August 1
Maternal Child Health Research

Letter of Intent  August 15;  September 1, 2000 
Marrow Transplant Research

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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

July 28
HIV Services Integration Planning

September 10
Community Action Grants for Service Systems Change

September 10
Community-Initiated Interventions 


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


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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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.

09/01/00 
ALS RESEARCH GRANTS,  Amyotrophic Lateral Sclerosis Association(818-880-9007 x222 or
http://www.alsa.org)

09/01/00 
CLINICAL TRIALS PROGRAM:  MELANOMA INITIATIVE,  Cancer Research Institute, Inc. (212-688-7515 or http://www.cancerres.org)

09/01/00
CF CLINICAL FELLOWSHIPS (THIRD YEAR AND FOURTH YEAR)
CF POSTDOCTORAL RESEARCH FELLOWSHIPS 
Cystic Fibrosis Foundation (301-951-4422 or http://www.cff.org/research42.htm)

09/01/00
CF RESEARCH GRANTS
HARRY SHWACHMAN CLINICAL INVESTIGATOR AWARD
LEROY MATTHEWS PHYSICIAN/SCIENTIST AWARD
PILOT AND FEASIBILITY AWARDS
Cystic Fibrosis Foundation (301-951-4422 or http://www.cff.org/research40.htm)

09/01/00
ENA FOUNDATION DOCTORAL SCHOLARSHIP 
ADVANCED NURSING PRACTICE  SCHOLARSHIP
UNDERGRADUATE SCHOLARSHIPS
Emergency Nurses Association (ENA) Foundation (800-900-9659 or http://www.ena.org/foundation/scholar/main.htm)

09/01/00
REPRODUCTIVE HEALTH AND RIGHTS, General Service Foundation (970-920-6834 or http://www.generalservice.org)

09/01/00
PREVENTION OF FAMILY DYSFUNCTION, Harris Foundation (312-621-0566)

09/01/00
RESEARCH PROJECT GRANTS
SCHOLARSHIPS 
TRAINING COURSES FOR ALLIED HEALTH PROFESSIONALS
VISITING EXPERT
International Cystic Fibrosis Association (34 96349 1414 or http://www.fibrosis.org)

09/01/00
AIDS, MENTAL HEALTH, SOCIAL WELFARE,  Ittleson Foundation, Inc. (212-794-2008 or
http://www.ittlesonfoundation.org)

09/01/00
ADVANCED POSTDOCTORAL FELLOWSHIP 
CLINICAL SCHOLAR AWARD 
POSTDOCTORAL FELLOWSHIPS
RESEARCH GRANTS 
SPECIAL RESEARCH GRANT PROGRAM
Juvenile Diabetes Foundation International (212-479-7529 or http://www.jdf.org/research/appinstructions599.html)

09/01/00
OVERSEAS SENIOR RESEARCH FELLOWSHIP IN BIOMEDICAL SCIENCE,  Wellcome
Trust (44 (0)20 7611 8410 or  http://www.wellcome.ac.uk)

09/01/00
POSTDOCTORAL FELLOWSHIPS  IN NEUROBIOLOGY FOR HUNTINGTON'S DISEASE, Wills Foundation (713-965-9043)

09/03/00
ENDOSCOPIC RESEARCH AWARDS, American Digestive Health Foundation (301-654-2635
or http://www.adhf.org)

09/08/00
MEDICINE AND PHARMACY, Pfeiffer Research Foundation (973-983-0480)

09/13/00 
GROWTH, DEVELOPMENT, AND ADULT GROWTH HORMONE, Genentech Center for Clinical Research and Education (650-225-2902)

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09/15/00
PHARMACOLOGY OF ANTIEPILEPTIC DRUGS
HARRY GOLD AWARD
TORALD SOLLMANN AWARD IN PHARMACOLOGY
American Society for Pharmacology/Experimental Therapy ( http://www.faseb.org/aspet)

09/15/00
RESEARCH AND EDUCATIONAL GRANTS &  RESEARCH FELLOWSHIPS, Cancer
Research Foundation of America (703-836-4412 or http://www.preventcancer.org)

09/15/00
SEED GRANTS, Radiological Society of North America (630-571-7816 or http://www.rsna.org)

09/15/00
CANCER, HEART DISEASE OR AIDS PROGRAMS, W. W. Smith Charitable Trust (610-359-1811)

09/30/00
BIRTH DEFECTS RESEARCH GRANTS, March of Dimes (http://www.modimes.org/Research2/RFPs/rfp.htm)

09/30/00 
PEDIATRIC NURSE PRACTITIONER SCHOLARSHIPS, National Association of Pediatric Nurse Associates/Practitioners (856-667-1773 or http://www.napnap.org)

Open
Recovery Services, Jacob & Valeria Langeloth Foundation (212- 687-1133 or; http://www.langeloth.org)

Open
Substance Abuse Policy Research Robert Wood Johnson Foundation  (336 -716-9748) 

Open
Computer Hardware and Software, NewDeal Foundation (800-310-9122 or http://www.newdeal.org)

August 1
Local Initiative Funding Partners, Robert Wood Johnson Foundation (609- 275-4128 or http://www.rwjf.org)

August 31
Research on Alcoholism/Substance Abuse, Peter F. McManus Charitable Trust (610-279-3370)

September 8 (nominations)
John P. Hubbard Award in Medical Education and Testing, National Board of Medical Examiners (215-590-9535)

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CAUTIONARY TALES


     
    PROBLEMS WITH THIS STUDY: 

    The IRB was not informed when Dr. Michigan left the institution. The IRB is not aware of the new members of the research team, their qualifications and their level of understanding of the project.

    Participants were not given copies of the consent to take home or to discuss their options with their families. Not having a consent form on hand hampers ongoing review by the participants and their families. 

    Lack of a consent form at home gave Mrs. Shift's daughter no quick way to respond to what could be an emergency related to the investigational drug.

    Shouldn't the IRB have the opportunity to review new information about the risks and decide if the risks and the benefits are still appropriate?

    Shouldn't the already enrolled participants have a chance to make a decision based on the new information? 

    If Dr. Chicago signs the consent forms, doesn't that imply that he was present for the informed consent discussion? If he signs -- but was not present -- doesn't this cast doubt on the validity of the consent form as documentation of that discussion?

    The payment of subjects is not mentioned in the consent form -- hence the surprise. Can participants trust that the investigators will do what they promised they would do or will there be other surprises? Would the IRB members have considered payments coercive if they had known about the amount to be paid out to the participants ?
     

    LESSONS LEARNT FROM THIS TALE

    There must be ongoing communication between the Investigators and the IRB. Whenever there is change in personnel among those listed as investigators in the original application to the IRB, the IRB must be informed.

    The P.I. must take full responsibility for all study personnel, give full orientation to the new residents and also inform the IRB of all the changes in personnel. 

    The consent form exists as documentation of a verbal explanation and discussion. Signatures on the form attest that this interaction took place. Persons who cannot attest to this fact should not sign the form.

    Participants are not always aware of their rights, or of the information and time they are entitled to. 
    Without their own copy of the consent, participants may not know about or remember these rights , the risks of participating, or whom to call in case there is a problem.

    Changes in the known risks and benefits must be submitted to the IRB for evaluation. It may be necessary to reconsent previously enrolled participants. 

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