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OHRP Update PowerPoint PPT Presentation
OHRP Update - Office for Human Research Protections. 3rd Annual Medical Research Summit ... OHRP Update - Presentation ... Dr. Kristina Borror, Director, Division of ...
Office for Human Research Protections. 3rd Annual Medical Research Summit ... OHRP Update - Presentation ... Dr. Kristina Borror, Director, Division of ...
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OHRP International Activities PowerPoint PPT Presentation
OHRP International Activities - Ensure all HHS research matches ethical principles. OHRP International ... Trends in Parasitology 2002; 18(5): 231-234. What can the researchers do? Conclusion ...
Ensure all HHS research matches ethical principles. OHRP International ... Trends in Parasitology 2002; 18(5): 231-234. What can the researchers do? Conclusion ...
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Regulatory Compliance Update:  OHRP PowerPoint PPT Presentation
Regulatory Compliance Update: OHRP - Regulatory Compliance Update: OHRP Freda E. Yoder Division of Education & Development Office for Human Research Protections (OHRP) Department of Health and Human ...
Regulatory Compliance Update: OHRP Freda E. Yoder Division of Education & Development Office for Human Research Protections (OHRP) Department of Health and Human ...
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OHRPs Compliance Oversight Procedures PowerPoint PPT Presentation
OHRPs Compliance Oversight Procedures - Findings ... OHRP Compliance Activities: Common Findings and Guidance - 7/10/02 ... of IRB to make and document required findings for waiver of informed consent ...
Findings ... OHRP Compliance Activities: Common Findings and Guidance - 7/10/02 ... of IRB to make and document required findings for waiver of informed consent ...
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Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA  Secretary PowerPoint PPT Presentation
Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary - Title: Overview of the Basic Protections for Human Research Subjects Author: Michael Anthony Carome Last modified by: DREWG Created Date: 3/11/1998 2:59:18 PM
Title: Overview of the Basic Protections for Human Research Subjects Author: Michael Anthony Carome Last modified by: DREWG Created Date: 3/11/1998 2:59:18 PM
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NIH Minis: OHRP Human Subject Protections PowerPoint PPT Presentation
NIH Minis: OHRP Human Subject Protections - HHS - Office for Public ... Subpart A basic HHS Policy - 'The Common Rule' or ... http://www.hhs.gov/ohrp/humansubjects/assurance ...
HHS - Office for Public ... Subpart A basic HHS Policy - 'The Common Rule' or ... http://www.hhs.gov/ohrp/humansubjects/assurance ...
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Understanding OHRP regulations on engagement in research PowerPoint PPT Presentation
Understanding OHRP regulations on engagement in research - Private information: (a) non-public behavior; individuals assume no one is ... for an investigator from WU to conduct a research survey in the classroom. ...
Private information: (a) non-public behavior; individuals assume no one is ... for an investigator from WU to conduct a research survey in the classroom. ...
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Overview of OHRPs Compliance Oversight Activities PowerPoint PPT Presentation
Overview of OHRPs Compliance Oversight Activities - ... of institution report and relevant IRB ... Protections under an institution's Assurance are ... (92%) had at least one finding (range 0-53, median ...
... of institution report and relevant IRB ... Protections under an institution's Assurance are ... (92%) had at least one finding (range 0-53, median ...
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Research Involving Humans! OHRP- Office For Human Subject Protections PowerPoint PPT Presentation
Research Involving Humans! OHRP- Office For Human Subject Protections - Research Involving Humans! OHRP- Office For Human Subject Protections Freda E. Yoder, MA Division of Education Office for Human Research Protections (OHRP)
Research Involving Humans! OHRP- Office For Human Subject Protections Freda E. Yoder, MA Division of Education Office for Human Research Protections (OHRP)
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Medical Research in Times of Bioterrorism - OHRP PowerPoint PPT Presentation
Medical Research in Times of Bioterrorism - OHRP - ... shall also publish them in the Federal Register or in such manner as as provided ... the Common rule, including changes set forth in the memorandum. ...
... shall also publish them in the Federal Register or in such manner as as provided ... the Common rule, including changes set forth in the memorandum. ...
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An Office for Human Research Protection OHRP Overview PowerPoint PPT Presentation
An Office for Human Research Protection OHRP Overview - Research - a systematic investigation designed to develop or contribute to ... a living individual about whom an investigator conducting research obtains ...
Research - a systematic investigation designed to develop or contribute to ... a living individual about whom an investigator conducting research obtains ...
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Human Subject Protection Issues Thoughts from OHRP PowerPoint PPT Presentation
Human Subject Protection Issues Thoughts from OHRP - Director, Office for Human Research Protections. Department of Health and Human Services ... concepts of health, therapy, prevention, research. vulnerable groups ...
Director, Office for Human Research Protections. Department of Health and Human Services ... concepts of health, therapy, prevention, research. vulnerable groups ...
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IRB PowerPoint PPT Presentation
IRB - NIH Education Requirement. OHRP Guidance. OHRP Education ... http://grants.nih.gov/grants/ guide/notice-files/NOT-OD-00-039.html. Frequently Asked Questions ...
NIH Education Requirement. OHRP Guidance. OHRP Education ... http://grants.nih.gov/grants/ guide/notice-files/NOT-OD-00-039.html. Frequently Asked Questions ...
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Protecting Human Subjects: What everyone needs to know PowerPoint PPT Presentation
Protecting Human Subjects: What everyone needs to know - Protecting Human Subjects: What everyone needs to know Office for Human Research Studies (OHRS) September 2008 (617) 632-3029 ohrs@dfci.harvard.edu
Protecting Human Subjects: What everyone needs to know Office for Human Research Studies (OHRS) September 2008 (617) 632-3029 ohrs@dfci.harvard.edu
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Research Involving Human Subjects PowerPoint PPT Presentation
Research Involving Human Subjects - Research Involving Human Subjects Elyse I. Summers, J.D. Director, Division of Education and Development Office for Human Research Protections (OHRP)
Research Involving Human Subjects Elyse I. Summers, J.D. Director, Division of Education and Development Office for Human Research Protections (OHRP)
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Informed ConsentInternational PowerPoint PPT Presentation
Informed ConsentInternational - 1. Informed Consent/International. Melody Lin, Ph.D. Deputy Director, OHRP. Director, OIA ... Insure that HS understand risk-benefit associated with participation ...
1. Informed Consent/International. Melody Lin, Ph.D. Deputy Director, OHRP. Director, OIA ... Insure that HS understand risk-benefit associated with participation ...
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Office for Research PowerPoint PPT Presentation
Office for Research - OHRP issued a determination letter to the institution that criticized IRBs for ... Automatic recommendation of the mandatory and suggested guidelines for the protocol. ...
OHRP issued a determination letter to the institution that criticized IRBs for ... Automatic recommendation of the mandatory and suggested guidelines for the protocol. ...
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Human Subjects Working Group Spring Workshop May 7th, 2008 PowerPoint PPT Presentation
Human Subjects Working Group Spring Workshop May 7th, 2008 - Human Subjects Working Group Spring Workshop May 7th, 2008 Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP)
Human Subjects Working Group Spring Workshop May 7th, 2008 Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP)
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THE ETHICAL CONDUCT OF RESEARCH PowerPoint PPT Presentation
THE ETHICAL CONDUCT OF RESEARCH - THE ETHICAL CONDUCT OF RESEARCH Chapter 4 HISTORY OF ETHICAL PROTECTIONS The Nuremberg Code The Office for Human Research Protections (OHRP), United States http://www ...
THE ETHICAL CONDUCT OF RESEARCH Chapter 4 HISTORY OF ETHICAL PROTECTIONS The Nuremberg Code The Office for Human Research Protections (OHRP), United States http://www ...
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Human Subjects Working Group Spring Workshop May 7th, 2008 PowerPoint PPT Presentation
Human Subjects Working Group Spring Workshop May 7th, 2008 - online guided self assessment tool. 2) consultation with OHRP ... Respond to IRB requests in a timely fashion. Investigator Responsibility #4 ...
online guided self assessment tool. 2) consultation with OHRP ... Respond to IRB requests in a timely fashion. Investigator Responsibility #4 ...
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How the Past Influenced Human Research Protection Regulations PowerPoint PPT Presentation
How the Past Influenced Human Research Protection Regulations - Title: IRB Workshop Author: OHRP Last modified by: ccphuw Created Date: 6/29/2005 1:14:10 PM Document presentation format: On-screen Show Company
Title: IRB Workshop Author: OHRP Last modified by: ccphuw Created Date: 6/29/2005 1:14:10 PM Document presentation format: On-screen Show Company
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Office for Protection from Research Risks (OPRR) PowerPoint PPT Presentation
Office for Protection from Research Risks (OPRR) - Office for Protection from Research Risks (OPRR) Department of Health and Human Services National Institutes of Health Office for Human Research Protections (OHRP ...
Office for Protection from Research Risks (OPRR) Department of Health and Human Services National Institutes of Health Office for Human Research Protections (OHRP ...
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Research, Program Evaluation, and Quality Improvement or Assurance: What PowerPoint PPT Presentation
Research, Program Evaluation, and Quality Improvement or Assurance: What - Research, Program Evaluation, and Quality Improvement or Assurance: What s in a Name? Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP
Research, Program Evaluation, and Quality Improvement or Assurance: What s in a Name? Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP
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Issues Surrounding Human Research Subject Protections PowerPoint PPT Presentation
Issues Surrounding Human Research Subject Protections - Office for Human Research Protections (OHRP) Department of Health & Human ... identifiable (i.e., identity of subject is or may readily be ascertained by the ...
Office for Human Research Protections (OHRP) Department of Health & Human ... identifiable (i.e., identity of subject is or may readily be ascertained by the ...
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Board Member Training: Unanticipated Problems PowerPoint PPT Presentation
Board Member Training: Unanticipated Problems - OHRP released new guidance in January 2007 and FDA has released draft guidance. ... IRB is inundated with information, much of which does not assist them in ...
OHRP released new guidance in January 2007 and FDA has released draft guidance. ... IRB is inundated with information, much of which does not assist them in ...
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CUNY Human Subjects Protections Program: Moving Forward PowerPoint PPT Presentation
CUNY Human Subjects Protections Program: Moving Forward - P&Ps will be in compliance with OHRP requirements and accreditation standards ... (1) That the only record linking the subject and the research would be the ...
P&Ps will be in compliance with OHRP requirements and accreditation standards ... (1) That the only record linking the subject and the research would be the ...
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Reportable Events in Research PowerPoint PPT Presentation
Reportable Events in Research - Reportable Events in Research Nancy C. LeGros Vinson & Elkins LLP Houston, TX 2885446 Background Office for Human Research Protections OHRP is an administrative unit ...
Reportable Events in Research Nancy C. LeGros Vinson & Elkins LLP Houston, TX 2885446 Background Office for Human Research Protections OHRP is an administrative unit ...
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Federalwide Assurance PowerPoint PPT Presentation
Federalwide Assurance - UCI Health Centers Anaheim, Santa Ana, and Westminster. Terms in the FWA ... To view recent Determination letters or for a list of common OHRP Compliance ...
UCI Health Centers Anaheim, Santa Ana, and Westminster. Terms in the FWA ... To view recent Determination letters or for a list of common OHRP Compliance ...
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New Resources from the NIH Office of Biotechnology Activities PowerPoint PPT Presentation
New Resources from the NIH Office of Biotechnology Activities - A public database of human gene transfer trials registered with the National ... Diane Wara. University of California, SF. Kristina Borror (OHRP) Cynthia Rask (FDA) ...
A public database of human gene transfer trials registered with the National ... Diane Wara. University of California, SF. Kristina Borror (OHRP) Cynthia Rask (FDA) ...
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Exception from Informed Consent for Emergency Research Brief Highlights PowerPoint PPT Presentation
Exception from Informed Consent for Emergency Research Brief Highlights - ... them from harm, but also by making efforts to secure their well-being ... OHRP plans to seek public comment on the current Secretarial waiver of informed ...
... them from harm, but also by making efforts to secure their well-being ... OHRP plans to seek public comment on the current Secretarial waiver of informed ...
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Responsibility in Human PowerPoint PPT Presentation
Responsibility in Human - National Institutes of Health NIH. Health Insurance Portability and ... 38 CFR 16 (Veteran Affairs) OHRP regs for all research in FWA institutions ...
National Institutes of Health NIH. Health Insurance Portability and ... 38 CFR 16 (Veteran Affairs) OHRP regs for all research in FWA institutions ...
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IRB Guidelines for CourseRelated Research on Human Subjects PowerPoint PPT Presentation
IRB Guidelines for CourseRelated Research on Human Subjects - www.hhs.gov/ohrp/humansubjects ... http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections. asp ... http://www.cdc.gov/od/ads/opspoll1.htm ...
www.hhs.gov/ohrp/humansubjects ... http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections. asp ... http://www.cdc.gov/od/ads/opspoll1.htm ...
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CTSA Alternative IRB models Working Group Update PowerPoint PPT Presentation
CTSA Alternative IRB models Working Group Update - CTSA Alternative IRB models Working Group Update. Mike Joyner: Mayo Clinic ... Input from OHRP et al essential, regulatory coordination will be the ultimate key ...
CTSA Alternative IRB models Working Group Update. Mike Joyner: Mayo Clinic ... Input from OHRP et al essential, regulatory coordination will be the ultimate key ...
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Social and Behavioral Science Research: Where Weve Been and Where Were Going PowerPoint PPT Presentation
Social and Behavioral Science Research: Where Weve Been and Where Were Going - communications with the Oral History Association. Qs & As OHRP website ... Flexibility is needed 'one size doesn't fit all' for biomedical or social and ...
communications with the Oral History Association. Qs & As OHRP website ... Flexibility is needed 'one size doesn't fit all' for biomedical or social and ...
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Federalwide Assurance PowerPoint PPT Presentation
Federalwide Assurance - Title: UCI s Federalwide Assurance Author: karena Last modified by: Joey Ly Created Date: 9/30/2004 4:05:37 PM Document presentation format: On-screen Show (4:3)
Title: UCI s Federalwide Assurance Author: karena Last modified by: Joey Ly Created Date: 9/30/2004 4:05:37 PM Document presentation format: On-screen Show (4:3)
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Expedited Review Procedure PowerPoint PPT Presentation
Expedited Review Procedure - Title: Expedited Review Procedure Last modified by: rballard Document presentation format: Custom Other titles: Palatino ProN W3 Arial American ...
Title: Expedited Review Procedure Last modified by: rballard Document presentation format: Custom Other titles: Palatino ProN W3 Arial American ...
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General PowerPoint PPT Presentation
General - Title: General Author: Clifford C. Scharke Last modified by: subevaluasi Created Date: 5/28/2000 9:18:12 PM Document presentation format: On-screen Show
Title: General Author: Clifford C. Scharke Last modified by: subevaluasi Created Date: 5/28/2000 9:18:12 PM Document presentation format: On-screen Show
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Common Rule and FDA Regulation Comparison PowerPoint PPT Presentation
Common Rule and FDA Regulation Comparison - Common Rule and FDA Regulation Comparison David Forster Jeff Cooper Gary Chadwick Outline Genesis of Panel Other topics considered Topics for today s panel Genesis ...
Common Rule and FDA Regulation Comparison David Forster Jeff Cooper Gary Chadwick Outline Genesis of Panel Other topics considered Topics for today s panel Genesis ...
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Mark Barnes PowerPoint PPT Presentation
Mark Barnes - Subcommittee on Harmonization (SOH) Update Mark Barnes David Forster July 21, 2010 Mark Barnes, J.D., LL.M. - Co-Chair Jeff Botkin, M.D., MPH David Forster, J.D., MA ...
Subcommittee on Harmonization (SOH) Update Mark Barnes David Forster July 21, 2010 Mark Barnes, J.D., LL.M. - Co-Chair Jeff Botkin, M.D., MPH David Forster, J.D., MA ...
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Montclair State University, Montclair, NJ PowerPoint PPT Presentation
Montclair State University, Montclair, NJ - Montclair State University, Montclair, NJ The Human Subjects Protection Regulations and You: What Everyone Should Know January 19, 2011 Elyse I. Summers, J.D.
Montclair State University, Montclair, NJ The Human Subjects Protection Regulations and You: What Everyone Should Know January 19, 2011 Elyse I. Summers, J.D.
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Expedited Review Procedure PowerPoint PPT Presentation
Expedited Review Procedure - Title: Expedited Review Procedure Last modified by: rballard Document presentation format: Custom Other titles: Palatino ProN W3 Arial American ...
Title: Expedited Review Procedure Last modified by: rballard Document presentation format: Custom Other titles: Palatino ProN W3 Arial American ...
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Secretary PowerPoint PPT Presentation
Secretary - Advanced Notice of Proposed Rulemaking (ANPRM) on Holding Institutional Review Boards Directly Accountable Julie Kaneshiro Policy Team Leader
Advanced Notice of Proposed Rulemaking (ANPRM) on Holding Institutional Review Boards Directly Accountable Julie Kaneshiro Policy Team Leader
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VHA Research Compliance Reporting Requirements PowerPoint PPT Presentation
VHA Research Compliance Reporting Requirements - Title VHA Research Compliance Reporting Requirements Subject VHA Research Compliance Reporting Requirements Author: Department of Veterans Affairs
Title VHA Research Compliance Reporting Requirements Subject VHA Research Compliance Reporting Requirements Author: Department of Veterans Affairs
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Repositories, Tissue Storage, and Data Banks PowerPoint PPT Presentation
Repositories, Tissue Storage, and Data Banks - ... review and approval before beginning non-exempt human subjects research (45 CFR ... that no investigator conduct non-exempt human subjects research without ...
... review and approval before beginning non-exempt human subjects research (45 CFR ... that no investigator conduct non-exempt human subjects research without ...
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General PowerPoint PPT Presentation
General - SBIR/STTR Application ... Funding authority identifies the need for and seeks ... for you; know when it isn't & confirm with funding authority ...
SBIR/STTR Application ... Funding authority identifies the need for and seeks ... for you; know when it isn't & confirm with funding authority ...
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Adverse Events PowerPoint PPT Presentation
Adverse Events - Title: Informed Consent, Adverse Events, and Protocol Deviations Author: Tony Last modified by: Simmons, Shannon D Created Date: 3/27/2008 2:52:03 PM
Title: Informed Consent, Adverse Events, and Protocol Deviations Author: Tony Last modified by: Simmons, Shannon D Created Date: 3/27/2008 2:52:03 PM
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Human Subjects Research PowerPoint PPT Presentation
Human Subjects Research - a systematic investigation. research development, testing, and. evaluation. designed to ... Use/Disclosure of Samples/Data is a research activity ...
a systematic investigation. research development, testing, and. evaluation. designed to ... Use/Disclosure of Samples/Data is a research activity ...
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SACHRP Task Force Report: Prioritization of SACHRP Recommendations PowerPoint PPT Presentation
SACHRP Task Force Report: Prioritization of SACHRP Recommendations - Title: PowerPoint Presentation Author: Barbara Bierer Last modified by: DREWG Created Date: 3/21/2005 3:29:58 AM Document presentation format: On-screen Show
Title: PowerPoint Presentation Author: Barbara Bierer Last modified by: DREWG Created Date: 3/21/2005 3:29:58 AM Document presentation format: On-screen Show
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Does Your Research Need IRB Approval? PowerPoint PPT Presentation
Does Your Research Need IRB Approval? - Does Your Research Need IRB Approval? Presenters: Beverley Esparza, CIP . Assistant Director. Human Research Protections. Office of Research. UC Irvine
Does Your Research Need IRB Approval? Presenters: Beverley Esparza, CIP . Assistant Director. Human Research Protections. Office of Research. UC Irvine
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Overview of Research Oversight: U.S. Perspective PowerPoint PPT Presentation
Overview of Research Oversight: U.S. Perspective - Generally, as risk increases in relation to the presence or absence of direct ... The relation of anticipated benefit is at least as favorable to subjects as that ...
Generally, as risk increases in relation to the presence or absence of direct ... The relation of anticipated benefit is at least as favorable to subjects as that ...
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Overview%20of%20Good%20Clinical%20Practices%20(GCPs) PowerPoint PPT Presentation
Overview%20of%20Good%20Clinical%20Practices%20(GCPs) - Good Clinical Practices (GCPs) ... aware of and compliant with GCPs and applicable regs. permit monitoring ... GCPs. Protocol. DAIT/DAIDS procedures. Local regulations ...
Good Clinical Practices (GCPs) ... aware of and compliant with GCPs and applicable regs. permit monitoring ... GCPs. Protocol. DAIT/DAIDS procedures. Local regulations ...
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Prisoners as Human Research Subjects PowerPoint PPT Presentation
Prisoners as Human Research Subjects - Prisoners as Human Research Subjects Presentation for IRB Members 45 CFR Part 46 - DHHS Policy for Protection of Human Research Subjects- Subpart A Adopted January 13 ...
Prisoners as Human Research Subjects Presentation for IRB Members 45 CFR Part 46 - DHHS Policy for Protection of Human Research Subjects- Subpart A Adopted January 13 ...
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2008 NIH REGIONAL SEMINAR Program Funding PowerPoint PPT Presentation
2008 NIH REGIONAL SEMINAR Program Funding - ... Administration (only in part), CIA, and the Consumer Product ... None apply to Subpart C. Exemption #2 does not apply to research with children except...
... Administration (only in part), CIA, and the Consumer Product ... None apply to Subpart C. Exemption #2 does not apply to research with children except...
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Mark Barnes PowerPoint PPT Presentation
Mark Barnes - Title: Slide 1 Author: Vwasman Last modified by: DREWG Created Date: 7/8/2010 8:47:22 PM Document presentation format: On-screen Show Company: Western Institutional ...
Title: Slide 1 Author: Vwasman Last modified by: DREWG Created Date: 7/8/2010 8:47:22 PM Document presentation format: On-screen Show Company: Western Institutional ...
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HUMAN SUBJECTS RESEARCH PowerPoint PPT Presentation
HUMAN SUBJECTS RESEARCH - 23 physicians and administrators were indicted before the War Crimes Tribunal at ... 'The experiment should be so conducted as to avoid all unnecessary physical and ...
23 physicians and administrators were indicted before the War Crimes Tribunal at ... 'The experiment should be so conducted as to avoid all unnecessary physical and ...
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CUMC IRB Investigator Meeting  IRB Frequently Asked Questions  October 11, 2005 PowerPoint PPT Presentation
CUMC IRB Investigator Meeting IRB Frequently Asked Questions October 11, 2005 - Collaborative research not conducted under an IRB Authorization Agreement ... In addition, if the research will be federally conducted or supported: ...
Collaborative research not conducted under an IRB Authorization Agreement ... In addition, if the research will be federally conducted or supported: ...
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