445 Ohrp PPTs View free & download

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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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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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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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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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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OHRS Submit to Activation: Where does the paperwork go and what are the common hold ups in reviewact

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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 - 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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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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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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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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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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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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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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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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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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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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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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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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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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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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The QA/QI Process Human Research Subjects Protection Human Investigation Committee Tracy Rightmer, JD, CIP Compliance Manager PowerPoint PPT Presentation

The QA/QI Process Human Research Subjects Protection Human Investigation Committee Tracy Rightmer, JD, CIP Compliance Manager - ... conduct of research involving human research subjects Current HIC Compliance Program Two Critical Program Processes Quality Assurance QA ... University policy ...

... conduct of research involving human research subjects Current HIC Compliance Program Two Critical Program Processes Quality Assurance QA ... University policy ...

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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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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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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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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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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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Identifying and Reporting Adverse Events and Unanticipated Problems PowerPoint PPT Presentation

Identifying and Reporting Adverse Events and Unanticipated Problems - Study amendments, for example: revision of the Consent Form; ... event later than 10 working days after the investigator first learns of the effect. ...

Study amendments, for example: revision of the Consent Form; ... event later than 10 working days after the investigator first learns of the effect. ...

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TRAINING FOR RESEARCHERS: HOW TO CONDUCT RESEARCH IN AIAN COMMUNITIES PowerPoint PPT Presentation

TRAINING FOR RESEARCHERS: HOW TO CONDUCT RESEARCH IN AIAN COMMUNITIES - Relationship between human subjects research and other activities ... 3. Human Subject research can overlap with other activities. ...

Relationship between human subjects research and other activities ... 3. Human Subject research can overlap with other activities. ...

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Identifying and Reporting Adverse Events and Unanticipated Problems - Because it's the law. The Common Rule Requires: ... surgical, behavioral, social, or other intervention to prevent any of the above ...

Because it's the law. The Common Rule Requires: ... surgical, behavioral, social, or other intervention to prevent any of the above ...

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COMPLIANCE ISSUES: OBSERVED IN ORO REVIEWS 2003-2004 PowerPoint PPT Presentation

COMPLIANCE ISSUES: OBSERVED IN ORO REVIEWS 2003-2004 - ... CFG55-57, 69,70 Reviews of SAE by R&D and IRB not documented 21CFR56.101(a), ... Thus, NCQA accreditation is based on what the facilities have accomplished.

... CFG55-57, 69,70 Reviews of SAE by R&D and IRB not documented 21CFR56.101(a), ... Thus, NCQA accreditation is based on what the facilities have accomplished.

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Multisite Studies: Communication Among IRBs, Investigators, and Sponsors PowerPoint PPT Presentation

Multisite Studies: Communication Among IRBs, Investigators, and Sponsors - ... medical history, physical examination, assessment of adverse events, blood test, ... (b) the clinical trial-related medical services are typically provided by the ...

... medical history, physical examination, assessment of adverse events, blood test, ... (b) the clinical trial-related medical services are typically provided by the ...

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IRB-Investigator/ Research Coordinator Mtg. PowerPoint PPT Presentation

IRB-Investigator/ Research Coordinator Mtg. - Columbia University Medical Center IRB. IRB Investigator ... ascertained by the investigator or associated. with the information) in order for obtaining ...

Columbia University Medical Center IRB. IRB Investigator ... ascertained by the investigator or associated. with the information) in order for obtaining ...

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History%20of%20research%20on%20children PowerPoint PPT Presentation

History%20of%20research%20on%20children - Title: Author: REZA Last modified by: pc05 Created Date: 10/22/2006 6:14:51 AM Document presentation format

Title: Author: REZA Last modified by: pc05 Created Date: 10/22/2006 6:14:51 AM Document presentation format

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Regulatory Issues in Clinical Research PowerPoint PPT Presentation

Regulatory Issues in Clinical Research - list of qualified personnel who are delegated duties *(ICH 4.1-9) 36 ... summary of recent literature, findings amendments, modifications since last review ...

list of qualified personnel who are delegated duties *(ICH 4.1-9) 36 ... summary of recent literature, findings amendments, modifications since last review ...

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Institutional Review Board PowerPoint PPT Presentation

Institutional Review Board - Institutional Review Board Nuts and Bolts of CGU IRB Procedures Hours: 8:30AM-5:00PM Phone: 909-607-9406 Email: irb@cgu.edu Website: http://www.cgu.edu/pages/1075.asp

Institutional Review Board Nuts and Bolts of CGU IRB Procedures Hours: 8:30AM-5:00PM Phone: 909-607-9406 Email: irb@cgu.edu Website: http://www.cgu.edu/pages/1075.asp

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What is an IRB and Why Should I Care? PowerPoint PPT Presentation

What is an IRB and Why Should I Care? - Title: What is an IRB and Why Should I Care? Author: TTUHSC Last modified by: Taraban, Beth Created Date: 2/28/2006 4:43:20 PM Document presentation format

Title: What is an IRB and Why Should I Care? Author: TTUHSC Last modified by: Taraban, Beth Created Date: 2/28/2006 4:43:20 PM Document presentation format

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COMPLIANCE ISSUES: Observed in ORO Reviews 200304 OFFICE OF RESEARCH OVERSIGHT ORO DEPT' OF VETERANS PowerPoint PPT Presentation

COMPLIANCE ISSUES: Observed in ORO Reviews 200304 OFFICE OF RESEARCH OVERSIGHT ORO DEPT' OF VETERANS - Facility develops action plan. Continuous follow-up until ... Handbook 1200.5, Requirements for the Protection of Human Subjects in Research (July 15, 2003) ...

Facility develops action plan. Continuous follow-up until ... Handbook 1200.5, Requirements for the Protection of Human Subjects in Research (July 15, 2003) ...

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History, Ethics, and Regulations of Human Subjects Research PowerPoint PPT Presentation

History, Ethics, and Regulations of Human Subjects Research - New information shared with participants. Welfare carefully monitored ... Went into effect April 14, 2003. Why Ethics, Guidance, and IRBs? Oct 30, 2003: ...

New information shared with participants. Welfare carefully monitored ... Went into effect April 14, 2003. Why Ethics, Guidance, and IRBs? Oct 30, 2003: ...

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Institutional Review Board for Human Research (IRB) Human Subject Protections PowerPoint PPT Presentation

Institutional Review Board for Human Research (IRB) Human Subject Protections - Institutional Review Board for Human Research (IRB) Human Subject Protections Susan Sonne, PharmD, BCPP Chair, MUSC IRB II Nuremberg Code first major control on ...

Institutional Review Board for Human Research (IRB) Human Subject Protections Susan Sonne, PharmD, BCPP Chair, MUSC IRB II Nuremberg Code first major control on ...

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Ethical Review Committees PowerPoint PPT Presentation

Ethical Review Committees - ... Daniel Wikler, World Health Organization and University of Wisconsin, Madison ... National regulations may or may not provide a role for ERCs ...

... Daniel Wikler, World Health Organization and University of Wisconsin, Madison ... National regulations may or may not provide a role for ERCs ...

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International Conference on Harmonization Good Clinical Practices for Clinical Research PowerPoint PPT Presentation

International Conference on Harmonization Good Clinical Practices for Clinical Research - FDA 'recommends' ICH GCPs is not law, but use is expected as a minimum standard ... Mt. Sinai School of Medicine & City University of New York 5/99 (FDA) ...

FDA 'recommends' ICH GCPs is not law, but use is expected as a minimum standard ... Mt. Sinai School of Medicine & City University of New York 5/99 (FDA) ...

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Human Subjects Do You or Do You Not Have Human Subject Involvement PowerPoint PPT Presentation

Human Subjects Do You or Do You Not Have Human Subject Involvement - Subpart A--Federal Policy for the Protection of Human Subjects ... Section 5. Completing PHS398 Components (pgs. I-83, I-85) ... Tests, Surveys, Interviews...

Subpart A--Federal Policy for the Protection of Human Subjects ... Section 5. Completing PHS398 Components (pgs. I-83, I-85) ... Tests, Surveys, Interviews...

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Public Health Practice vs. Research PowerPoint PPT Presentation

Public Health Practice vs. Research - Associate Professor, Johns Hopkins Bloomberg School of Public Health ... They may be justified as laudable, communal activities that further the public good ...

Associate Professor, Johns Hopkins Bloomberg School of Public Health ... They may be justified as laudable, communal activities that further the public good ...

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Warning Warning Warning Letters PowerPoint PPT Presentation

Warning Warning Warning Letters - A post FDA ... University of Pittsburgh School of Medicine. Mitchell. Creinin. FDA ... The Gazette On-Line. http://www.jhu.edu/~gazette/ Hopkins ...

A post FDA ... University of Pittsburgh School of Medicine. Mitchell. Creinin. FDA ... The Gazette On-Line. http://www.jhu.edu/~gazette/ Hopkins ...

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Good Clinical Practice GCP PowerPoint PPT Presentation

Good Clinical Practice GCP - Research & Development Process ... Clinical trial can be halted at one site or all ... that the data and reported results are credible and accurate, and that the ...

Research & Development Process ... Clinical trial can be halted at one site or all ... that the data and reported results are credible and accurate, and that the ...

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Informed Consent in Emergency Research PowerPoint PPT Presentation

Informed Consent in Emergency Research - 'The distinction between research and practice is blurred partly because both ... Beneficence. Maximize benefits and minimize harms. Justice ...

'The distinction between research and practice is blurred partly because both ... Beneficence. Maximize benefits and minimize harms. Justice ...

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IRB Assessment and Management of QI Projects PowerPoint PPT Presentation

IRB Assessment and Management of QI Projects - Glennan Center for Geriatrics and Gerontology. Eastern Virginia Medical School ... Review relevant terminology regarding quality improvement (QI) project review ...

Glennan Center for Geriatrics and Gerontology. Eastern Virginia Medical School ... Review relevant terminology regarding quality improvement (QI) project review ...

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Human Specimen PowerPoint PPT Presentation

Human Specimen - (1) identifying information (such as name or social security number) that would ... De-identified dataset ... Specimens/data distributed without identifiers ...

(1) identifying information (such as name or social security number) that would ... De-identified dataset ... Specimens/data distributed without identifiers ...

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Basic Track: Nuts and Bolts of Informed Consent PowerPoint PPT Presentation

Basic Track: Nuts and Bolts of Informed Consent - ... Social Security Administration*, CIA, and the Consumer Product ... Which Regulations Apply? HHS research conducted or supported by HHS; or covered by FWA ...

... Social Security Administration*, CIA, and the Consumer Product ... Which Regulations Apply? HHS research conducted or supported by HHS; or covered by FWA ...

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Human Specimen Repositories: Requirements of 45 CFR part 46 PRIM PowerPoint PPT Presentation

Human Specimen Repositories: Requirements of 45 CFR part 46 PRIM - Creating a research repository/database through intervention or interaction with ... the repository storage and data management center; and. the recipient ...

Creating a research repository/database through intervention or interaction with ... the repository storage and data management center; and. the recipient ...

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ETHICAL AND REGULATORY ASPECTS OF USE OF TISSUE SAMPLES FOR RESEARCH PowerPoint PPT Presentation

ETHICAL AND REGULATORY ASPECTS OF USE OF TISSUE SAMPLES FOR RESEARCH - ... subject is or may readily be ascertained by the investigator or associated with the information. ... INVESTIGATORS CANNOT READILY ASCERTAIN THE IDENTITY OF ...

... subject is or may readily be ascertained by the investigator or associated with the information. ... INVESTIGATORS CANNOT READILY ASCERTAIN THE IDENTITY OF ...

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Ohrp PowerPoint PPT Presentations