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Clinical Research Staff (58)
- Monday, 9:45 amA New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine
- Monday, 11:30 amPanel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
- Monday, 11:30 amPanel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
- Monday, 11:30 amPanel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
- Monday, 2:30 pmA1 – A Dialogue with the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission)
- Monday, 2:30 pmA10 – Updated International Guidelines for Stem Cell Research: Implications for IRBs, Stem Cell Research Oversight Committees (SCROs), and Institutions
- Monday, 2:30 pmA16 – Designing and Implementing Expanded Access Programs
- Monday, 2:30 pmA19 – The ABCs of Genetics, DNA, and Related Research Issues
- Monday, 2:30 pmA2 – A Dialogue with the Secretary's Advisory Committee on Human Research Protections (SACHRP)
- Monday, 2:30 pmA20 – Defining Vulnerability: Regulations and Beyond
- Monday, 2:30 pmA21 – Nuts and Bolts of Investigator Site Audits
- Monday, 2:30 pmA25 – Mandatory Reporting
- Monday, 2:30 pmA3 – Tips on Involvement of US Army Personnel as Human Subjects
- Monday, 2:30 pmA5 – Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff
- Monday, 2:30 pmA6 – Examining Participant Perspectives on Social and Structural Constraints on Research Involving Vulnerable Populations
- Monday, 2:30 pmA7 – Introduction to Ethical Principles for Research Involving Human Participants as Study Subjects
- Monday, 2:30 pmA9 – Different Models of Review: A Global Comparison
- Monday, 4:00 pmB1 – A Dialogue With the Office for Human Research Protections (OHRP)
- Monday, 4:00 pmB10 – Competence Standardization, Development as a Means to Improving Patient Safety and Clinical Trial Operations
- Monday, 4:00 pmB19 – Consenting Subjects for Bio/Data Repositories: Evaluating Approaches and Their Implications for Future Solutions
- Monday, 4:00 pmB2 – A Dialogue With the Department of Energy (DOE)
- Monday, 4:00 pmB20 – Research With Children: Regulations and Beyond
- Monday, 4:00 pmB8 – FDA Oversight and IRB Review of Investigational In Vitro Diagnostics (IVDs)
- Tuesday, 11:15 amC1 – A Dialogue With the Food and Drug Administration (FDA)
- Tuesday, 11:15 amC16 – Patient-Centric Trial Design and Conduct
- Tuesday, 11:15 amC18 – Statistics Without Tears
- Tuesday, 11:15 amC19 – Return of Individual Research Results - Complex Considerations for a Not So Simple Request: Perspectives from Scientists, Subjects, and Regulators
- Tuesday, 11:15 amC2 – A Dialogue With the Office for Research Integrity (ORI)
- Tuesday, 11:15 amC22 – The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Health and Mobile Health (mHealth) Research
- Tuesday, 11:15 amC24 – College Students and Research: Challenges and Issues for IRBs
- Tuesday, 11:15 amC3 – Risky Business: Exposing Children to Potential Harm Without Compensating Clinical Benefit
- Tuesday, 11:15 amC4 – Crossing the Line: When Does Innovative Care Become Research?
- Tuesday, 11:15 amC6 – Preventive Misconception in HIV Prevention: What it Is and How to (Try to) Measure it
- Tuesday, 11:15 amC7 – Ethical and Regulatory Review of Research: Case Studies
- Tuesday, 11:15 amC8 – What Are Dietary Supplements and How Are They Regulated by the FDA?
- Tuesday, 2:00 pmPanel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
- Tuesday, 2:00 pmPanel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
- Tuesday, 2:00 pmPanel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist
- Tuesday, 3:30 pmD1 – A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
- Tuesday, 3:30 pmD16 – Making Risk-Based Quality “Fit for Purpose” for Your Organization
- Tuesday, 3:30 pmD17 – You’ve Heard the Noise, Now What Are the Facts? The Legal Underpinnings of Fetal Tissue Research
- Tuesday, 3:30 pmD22 – Ethical Issues in Patient-Led and Crowdsourced Clinical Research
- Tuesday, 3:30 pmD4 – The Seven Habits of Highly Effective and Flexible IRBs
- Tuesday, 3:30 pmD7 – The International Conference for Harmonization (ICH) E6 Integrated Addendum: What Do the Proposed Changes to the Good Clinical Practice (GCP) Guidelines Mean for the Clinical Research Community?
- Tuesday, 3:30 pmD8 – Expanded Access and Off-Label Use of Medical Devices
- Tuesday, 3:30 pmD9 – Cutting-Edge Challenges in HIV Research Ethics in the Resource Limited Settings: Lessons from the Ethics Working Group (EWG) of the HIV Prevention Trial Network (HPTN)
- Wednesday, 9:45 amPanel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence
- Wednesday, 9:45 amPanel VII: Amplifying the Challenges: Return of Results in Pediatric Research
- Wednesday, 9:45 amPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
- Wednesday, 11:15 amE1 – A Dialogue With the National Institutes of Health (NIH)
- Wednesday, 11:15 amE13 – Unanticipated Problems (UPs) and Adverse Events (AEs): A Practical Approach for IRBs
- Wednesday, 11:15 amE16 – New Frontiers in Collaboration: Emerging Models of Collaboration Between Industry and Academic Organizations
- Wednesday, 11:15 amE19 – Beyond Basic Biobanking: Issues Related to the Collection, Storage, and Future Research Uses of Pediatric Biospecimens, Newborn Blood Spots, and Fetal Tissue
- Wednesday, 11:15 amE3 – When Exception Does Not Apply: Practical Strategies for Ethical Enrollment of Situationally Impaired Subjects in Clinical Trials in the Emergency Setting
- Wednesday, 11:15 amE4 – IRB Oversight and the Boundaries Between Evidence-Based Practice (EBP), Performance Improvement, and Research
- Wednesday, 11:15 amE8 – An Overview of FDA’s Program Alignment and What it Means for Your Next Inspection
- Wednesday, 11:15 amE9 – Data Access Versus Patient Privacy in the European Union (EU): Ethical Mandates in the Crucible of Public Debate
- Wednesday, 2:00 pmClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
Compliance, Regulatory, and QA/QI Professionals (47)
- Monday, 9:45 amA New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine
- Monday, 11:30 amPanel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
- Monday, 11:30 amPanel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
- Monday, 11:30 amPanel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
- Monday, 2:30 pmA1 – A Dialogue with the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission)
- Monday, 2:30 pmA10 – Updated International Guidelines for Stem Cell Research: Implications for IRBs, Stem Cell Research Oversight Committees (SCROs), and Institutions
- Monday, 2:30 pmA12 – How Do We Assess the Quality of an HRPP?
- Monday, 2:30 pmA16 – Designing and Implementing Expanded Access Programs
- Monday, 2:30 pmA2 – A Dialogue with the Secretary's Advisory Committee on Human Research Protections (SACHRP)
- Monday, 2:30 pmA20 – Defining Vulnerability: Regulations and Beyond
- Monday, 2:30 pmA21 – Nuts and Bolts of Investigator Site Audits
- Monday, 2:30 pmA25 – Mandatory Reporting
- Monday, 2:30 pmA3 – Tips on Involvement of US Army Personnel as Human Subjects
- Monday, 2:30 pmA4 – You'll Know it When You See it: Defining "Human Subjects Research" Under the DHHS Regulations
- Monday, 2:30 pmA5 – Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff
- Monday, 2:30 pmA7 – Introduction to Ethical Principles for Research Involving Human Participants as Study Subjects
- Monday, 2:30 pmA8 – A Primer in Determining When an Investigational New Drug (IND) Application Is Needed for Studies Involving Drugs or Biologics
- Monday, 2:30 pmA9 – Different Models of Review: A Global Comparison
- Monday, 4:00 pmB1 – A Dialogue With the Office for Human Research Protections (OHRP)
- Monday, 4:00 pmB12 – The Characteristics of "High Performance" HRPPs
- Monday, 4:00 pmB15 – Case Studies in IRB Quality Improvement Initiatives
- Monday, 4:00 pmB17 – Certificates of Confidentiality (CoCs): When, Why, and So What?
- Monday, 4:00 pmB2 – A Dialogue With the Department of Energy (DOE)
- Monday, 4:00 pmB21 – Nuts and Bolts of Assessing IRB Compliance
- Monday, 4:00 pmB9 – Ensuring Research Compliance of Multicenter and International Research
- Tuesday, 11:15 amC1 – A Dialogue With the Food and Drug Administration (FDA)
- Tuesday, 11:15 amC2 – A Dialogue With the Office for Research Integrity (ORI)
- Tuesday, 11:15 amC21 – Novel Methods, Approaches, and Tools for QA/QI, Including Electronic Systems and Technology
- Tuesday, 2:00 pmPanel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
- Tuesday, 2:00 pmPanel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
- Tuesday, 2:00 pmPanel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist
- Tuesday, 3:30 pmD1 – A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
- Tuesday, 3:30 pmD17 – You’ve Heard the Noise, Now What Are the Facts? The Legal Underpinnings of Fetal Tissue Research
- Tuesday, 3:30 pmD21 – Beyond Auditing and Monitoring and Towards Quality Improvement
- Tuesday, 3:30 pmD23 – All By Myself: Where Can You Go for Mentorship When You Are the Only Person in the IRB Office?
- Tuesday, 3:30 pmD7 – The International Conference for Harmonization (ICH) E6 Integrated Addendum: What Do the Proposed Changes to the Good Clinical Practice (GCP) Guidelines Mean for the Clinical Research Community?
- Wednesday, 9:45 amPanel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence
- Wednesday, 9:45 amPanel VII: Amplifying the Challenges: Return of Results in Pediatric Research
- Wednesday, 9:45 amPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
- Wednesday, 11:15 amE1 – A Dialogue With the National Institutes of Health (NIH)
- Wednesday, 11:15 amE13 – Unanticipated Problems (UPs) and Adverse Events (AEs): A Practical Approach for IRBs
- Wednesday, 11:15 amE17 – O…R...I Have No Idea What You’re Talking About!
- Wednesday, 11:15 amE2 – A Dialogue With the Association for the Accreditation of Human Research Protection Programs (AAHRPP, Inc.)
- Wednesday, 11:15 amE21 – Development of an Effective QA/QI Program at Your Institution
- Wednesday, 11:15 amE8 – An Overview of FDA’s Program Alignment and What it Means for Your Next Inspection
- Wednesday, 11:15 amE9 – Data Access Versus Patient Privacy in the European Union (EU): Ethical Mandates in the Crucible of Public Debate
- Wednesday, 2:00 pmClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
Diversity (21)
- Monday, 11:30 amPanel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
- Monday, 2:30 pmA14 – IRB Chairs and Members: Recruiting, Developing, Training, and Managing
- Monday, 2:30 pmA20 – Defining Vulnerability: Regulations and Beyond
- Monday, 2:30 pmA5 – Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff
- Monday, 2:30 pmA6 – Examining Participant Perspectives on Social and Structural Constraints on Research Involving Vulnerable Populations
- Monday, 2:30 pmA9 – Different Models of Review: A Global Comparison
- Monday, 4:00 pmB3 – Things that Keep an Institutional Official (IO) Up at Night
- Monday, 4:00 pmB7 – Ethical Issues in Community-Based Participatory Research (CBPR)
- Monday, 4:00 pmB9 – Ensuring Research Compliance of Multicenter and International Research
- Tuesday, 11:15 amC16 – Patient-Centric Trial Design and Conduct
- Tuesday, 11:15 amC20 – Populations on the Edge: The Homeless, Substance Abusers, the Lesbian, Gay, Bisexual, and Transgender (LGBT) Community, and More
- Tuesday, 11:15 amC5 – Recruiting, Educating, and Retaining Non-Scientist/Community IRB Members
- Tuesday, 11:15 amC6 – Preventive Misconception in HIV Prevention: What it Is and How to (Try to) Measure it
- Tuesday, 11:15 amC9 – Determining Vulnerable Populations and Associated Risks in Developing Country Settings: Additional Ethical Considerations
- Tuesday, 2:00 pmPanel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
- Tuesday, 3:30 pmD18 – It Takes a Village: Community Members as Research Partners in Community-Based Participatory Research (CBPR)
- Tuesday, 3:30 pmD20 – Meeting of the Minds: Research and Consent with Subjects with Impaired Decisional Capacity
- Tuesday, 3:30 pmD7 – The International Conference for Harmonization (ICH) E6 Integrated Addendum: What Do the Proposed Changes to the Good Clinical Practice (GCP) Guidelines Mean for the Clinical Research Community?
- Wednesday, 9:45 amPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
- Wednesday, 11:15 amE20 – Representing Prisoners: Insights from an IRB Member Who Has Been Incarcerated
- Wednesday, 2:00 pmClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
HRPP Leadership and Institutional Officials (67)
- Monday, 9:45 amA New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine
- Monday, 11:30 amPanel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
- Monday, 11:30 amPanel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
- Monday, 11:30 amPanel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
- Monday, 2:30 pmA1 – A Dialogue with the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission)
- Monday, 2:30 pmA10 – Updated International Guidelines for Stem Cell Research: Implications for IRBs, Stem Cell Research Oversight Committees (SCROs), and Institutions
- Monday, 2:30 pmA12 – How Do We Assess the Quality of an HRPP?
- Monday, 2:30 pmA15 – Re-Evaluating Risk Tolerance: Are You Overdoing It?
- Monday, 2:30 pmA16 – Designing and Implementing Expanded Access Programs
- Monday, 2:30 pmA2 – A Dialogue with the Secretary's Advisory Committee on Human Research Protections (SACHRP)
- Monday, 2:30 pmA20 – Defining Vulnerability: Regulations and Beyond
- Monday, 2:30 pmA21 – Nuts and Bolts of Investigator Site Audits
- Monday, 2:30 pmA25 – Mandatory Reporting
- Monday, 2:30 pmA3 – Tips on Involvement of US Army Personnel as Human Subjects
- Monday, 2:30 pmA4 – You'll Know it When You See it: Defining "Human Subjects Research" Under the DHHS Regulations
- Monday, 2:30 pmA5 – Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff
- Monday, 2:30 pmA7 – Introduction to Ethical Principles for Research Involving Human Participants as Study Subjects
- Monday, 2:30 pmA9 – Different Models of Review: A Global Comparison
- Monday, 4:00 pmB1 – A Dialogue With the Office for Human Research Protections (OHRP)
- Monday, 4:00 pmB12 – The Characteristics of "High Performance" HRPPs
- Monday, 4:00 pmB14 – Evaluating Members, Chairs, and Staff: What Works and What Doesn’t?
- Monday, 4:00 pmB17 – Certificates of Confidentiality (CoCs): When, Why, and So What?
- Monday, 4:00 pmB2 – A Dialogue With the Department of Energy (DOE)
- Monday, 4:00 pmB21 – Nuts and Bolts of Assessing IRB Compliance
- Monday, 4:00 pmB23 – Building and Maintaining an HRPP Within a Primarily SBER Institution with a Small Research Portfolio
- Monday, 4:00 pmB3 – Things that Keep an Institutional Official (IO) Up at Night
- Monday, 4:00 pmB4 – Opposing Forces: How to Align Flexibility and Consistency in Reliance Agreements
- Tuesday, 11:15 amC1 – A Dialogue With the Food and Drug Administration (FDA)
- Tuesday, 11:15 amC12 – Ethical and Operational Issues Related to Clinical Trial Billing: What HRPPs and IRBs Should Consider
- Tuesday, 11:15 amC14 – IRB Chairs Forum: A Structured Discussion for IRB Chairs
- Tuesday, 11:15 amC15 – Operationalizing Collaborative IRB Review
- Tuesday, 11:15 amC16 – Patient-Centric Trial Design and Conduct
- Tuesday, 11:15 amC19 – Return of Individual Research Results - Complex Considerations for a Not So Simple Request: Perspectives from Scientists, Subjects, and Regulators
- Tuesday, 11:15 amC2 – A Dialogue With the Office for Research Integrity (ORI)
- Tuesday, 11:15 amC24 – College Students and Research: Challenges and Issues for IRBs
- Tuesday, 11:15 amC4 – Crossing the Line: When Does Innovative Care Become Research?
- Tuesday, 11:15 amC7 – Ethical and Regulatory Review of Research: Case Studies
- Tuesday, 2:00 pmPanel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
- Tuesday, 2:00 pmPanel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
- Tuesday, 2:00 pmPanel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist
- Tuesday, 3:30 pmD1 – A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
- Tuesday, 3:30 pmD10 – IRB Considerations When Conducting Research During Public Health Emergencies: Ebola, Influenza, Zika and Whatever Is Next...
- Tuesday, 3:30 pmD12 – Potential Litigation and Enforcement Actions: Past, Present, and Future, Under the NIH Single IRB Review Policy and Highly Anticipated Revised Common Rule
- Tuesday, 3:30 pmD17 – You’ve Heard the Noise, Now What Are the Facts? The Legal Underpinnings of Fetal Tissue Research
- Tuesday, 3:30 pmD19 – In the ERA of Big Data: Data Sharing
- Tuesday, 3:30 pmD21 – Beyond Auditing and Monitoring and Towards Quality Improvement
- Tuesday, 3:30 pmD23 – All By Myself: Where Can You Go for Mentorship When You Are the Only Person in the IRB Office?
- Tuesday, 3:30 pmD25 – Yours, Mine, and Ours: IRB Arrangements for Multiple Institutions Involving Research With Vulnerable Populations and Sensitive Topics
- Tuesday, 3:30 pmD3 – Moving From Fossils to Young Blood for the HRPP/IRB Engine
- Tuesday, 3:30 pmD4 – The Seven Habits of Highly Effective and Flexible IRBs
- Tuesday, 3:30 pmD7 – The International Conference for Harmonization (ICH) E6 Integrated Addendum: What Do the Proposed Changes to the Good Clinical Practice (GCP) Guidelines Mean for the Clinical Research Community?
- Wednesday, 9:45 amPanel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence
- Wednesday, 9:45 amPanel VII: Amplifying the Challenges: Return of Results in Pediatric Research
- Wednesday, 9:45 amPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
- Wednesday, 11:15 amE1 – A Dialogue With the National Institutes of Health (NIH)
- Wednesday, 11:15 amE10 – Study Review Using Single IRBs (sIRBs)
- Wednesday, 11:15 amE12 – Top Considerations for Leadership When Accepting Department of Defense (DOD)-Supported Research
- Wednesday, 11:15 amE13 – Unanticipated Problems (UPs) and Adverse Events (AEs): A Practical Approach for IRBs
- Wednesday, 11:15 amE14 – IRB Chair Responsibilities and Roles: Beyond the IRB Meeting
- Wednesday, 11:15 amE16 – New Frontiers in Collaboration: Emerging Models of Collaboration Between Industry and Academic Organizations
- Wednesday, 11:15 amE17 – O…R...I Have No Idea What You’re Talking About!
- Wednesday, 11:15 amE2 – A Dialogue With the Association for the Accreditation of Human Research Protection Programs (AAHRPP, Inc.)
- Wednesday, 11:15 amE21 – Development of an Effective QA/QI Program at Your Institution
- Wednesday, 11:15 amE5 – Exploring Strategies on How to Effectively Provide Education on Human Research Protections to Investigators
- Wednesday, 11:15 amE8 – An Overview of FDA’s Program Alignment and What it Means for Your Next Inspection
- Wednesday, 11:15 amE9 – Data Access Versus Patient Privacy in the European Union (EU): Ethical Mandates in the Crucible of Public Debate
- Wednesday, 2:00 pmClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
IRB Administrators, Managers, and Staff (86)
- Monday, 9:45 amA New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine
- Monday, 11:30 amPanel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
- Monday, 11:30 amPanel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
- Monday, 11:30 amPanel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
- Monday, 2:30 pmA1 – A Dialogue with the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission)
- Monday, 2:30 pmA10 – Updated International Guidelines for Stem Cell Research: Implications for IRBs, Stem Cell Research Oversight Committees (SCROs), and Institutions
- Monday, 2:30 pmA12 – How Do We Assess the Quality of an HRPP?
- Monday, 2:30 pmA13 – Pre-IRB Review: IRB Ready or Not?
- Monday, 2:30 pmA14 – IRB Chairs and Members: Recruiting, Developing, Training, and Managing
- Monday, 2:30 pmA19 – The ABCs of Genetics, DNA, and Related Research Issues
- Monday, 2:30 pmA2 – A Dialogue with the Secretary's Advisory Committee on Human Research Protections (SACHRP)
- Monday, 2:30 pmA20 – Defining Vulnerability: Regulations and Beyond
- Monday, 2:30 pmA21 – Nuts and Bolts of Investigator Site Audits
- Monday, 2:30 pmA23 – Does Anyone Here Get What I Do? Educating Your Institution on What the HRPP Is All About
- Monday, 2:30 pmA24 – Best Practices for Assessing Risks and Benefits in SBER
- Monday, 2:30 pmA3 – Tips on Involvement of US Army Personnel as Human Subjects
- Monday, 2:30 pmA4 – You'll Know it When You See it: Defining "Human Subjects Research" Under the DHHS Regulations
- Monday, 2:30 pmA5 – Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff
- Monday, 2:30 pmA7 – Introduction to Ethical Principles for Research Involving Human Participants as Study Subjects
- Monday, 2:30 pmA8 – A Primer in Determining When an Investigational New Drug (IND) Application Is Needed for Studies Involving Drugs or Biologics
- Monday, 2:30 pmA9 – Different Models of Review: A Global Comparison
- Monday, 4:00 pmB1 – A Dialogue With the Office for Human Research Protections (OHRP)
- Monday, 4:00 pmB13 – Essential Documentation: IRB Membership, Record Keeping, Minutes, and More
- Monday, 4:00 pmB15 – Case Studies in IRB Quality Improvement Initiatives
- Monday, 4:00 pmB16 – Considerations for Effective IRB Review and Management of Protocol Deviations and Violations
- Monday, 4:00 pmB17 – Certificates of Confidentiality (CoCs): When, Why, and So What?
- Monday, 4:00 pmB18 – Keys to the Magic Kingdom: Defining Roles, Expectations, and Challenges for the Non-Scientist IRB Member
- Monday, 4:00 pmB19 – Consenting Subjects for Bio/Data Repositories: Evaluating Approaches and Their Implications for Future Solutions
- Monday, 4:00 pmB2 – A Dialogue With the Department of Energy (DOE)
- Monday, 4:00 pmB21 – Nuts and Bolts of Assessing IRB Compliance
- Monday, 4:00 pmB23 – Building and Maintaining an HRPP Within a Primarily SBER Institution with a Small Research Portfolio
- Monday, 4:00 pmB24 – Scientific Merit, Generalizability, and Risks in Qualitative Research: A Case Study Approach
- Monday, 4:00 pmB3 – Things that Keep an Institutional Official (IO) Up at Night
- Monday, 4:00 pmB4 – Opposing Forces: How to Align Flexibility and Consistency in Reliance Agreements
- Monday, 4:00 pmB5 – Training for Success: Tools and Educational Methods for IRB Staff
- Monday, 4:00 pmB7 – Ethical Issues in Community-Based Participatory Research (CBPR)
- Monday, 4:00 pmB9 – Ensuring Research Compliance of Multicenter and International Research
- Tuesday, 11:15 amC1 – A Dialogue With the Food and Drug Administration (FDA)
- Tuesday, 11:15 amC10 – The Certified IRB Professional (CIP®) Credential: What Is it About?
- Tuesday, 11:15 amC13 – Let's Review a Protocol: Regulatory Considerations in the IRB Review Process
- Tuesday, 11:15 amC15 – Operationalizing Collaborative IRB Review
- Tuesday, 11:15 amC18 – Statistics Without Tears
- Tuesday, 11:15 amC19 – Return of Individual Research Results - Complex Considerations for a Not So Simple Request: Perspectives from Scientists, Subjects, and Regulators
- Tuesday, 11:15 amC2 – A Dialogue With the Office for Research Integrity (ORI)
- Tuesday, 11:15 amC21 – Novel Methods, Approaches, and Tools for QA/QI, Including Electronic Systems and Technology
- Tuesday, 11:15 amC23 – Flying Solo: A Moderated Discussion on Challenges Encountered by Single Staff IRB Offices
- Tuesday, 11:15 amC25 – FDA Oversight, SBER, and the IRB
- Tuesday, 11:15 amC5 – Recruiting, Educating, and Retaining Non-Scientist/Community IRB Members
- Tuesday, 11:15 amC7 – Ethical and Regulatory Review of Research: Case Studies
- Tuesday, 2:00 pmPanel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
- Tuesday, 2:00 pmPanel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
- Tuesday, 2:00 pmPanel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist
- Tuesday, 3:30 pmD1 – A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
- Tuesday, 3:30 pmD10 – IRB Considerations When Conducting Research During Public Health Emergencies: Ebola, Influenza, Zika and Whatever Is Next...
- Tuesday, 3:30 pmD13 – The ABCs of Writing Standard Operating Procedures (SOPs)
- Tuesday, 3:30 pmD15 – True Stories from the IRB and their Impact on IRB Operations
- Tuesday, 3:30 pmD18 – It Takes a Village: Community Members as Research Partners in Community-Based Participatory Research (CBPR)
- Tuesday, 3:30 pmD19 – In the ERA of Big Data: Data Sharing
- Tuesday, 3:30 pmD23 – All By Myself: Where Can You Go for Mentorship When You Are the Only Person in the IRB Office?
- Tuesday, 3:30 pmD24 – School Rules! Conducting Research in Elementary and Secondary Public Schools
- Tuesday, 3:30 pmD25 – Yours, Mine, and Ours: IRB Arrangements for Multiple Institutions Involving Research With Vulnerable Populations and Sensitive Topics
- Tuesday, 3:30 pmD3 – Moving From Fossils to Young Blood for the HRPP/IRB Engine
- Tuesday, 3:30 pmD4 – The Seven Habits of Highly Effective and Flexible IRBs
- Tuesday, 3:30 pmD5 – Recruitment Strategies: Sharing Our Secrets for Success
- Tuesday, 3:30 pmD6 – Strategies for Incorporating Empirical Research into IRB Member Education
- Tuesday, 3:30 pmD7 – The International Conference for Harmonization (ICH) E6 Integrated Addendum: What Do the Proposed Changes to the Good Clinical Practice (GCP) Guidelines Mean for the Clinical Research Community?
- Wednesday, 9:45 amPanel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence
- Wednesday, 9:45 amPanel VII: Amplifying the Challenges: Return of Results in Pediatric Research
- Wednesday, 9:45 amPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
- Wednesday, 11:15 amE1 – A Dialogue With the National Institutes of Health (NIH)
- Wednesday, 11:15 amE10 – Study Review Using Single IRBs (sIRBs)
- Wednesday, 11:15 amE13 – Unanticipated Problems (UPs) and Adverse Events (AEs): A Practical Approach for IRBs
- Wednesday, 11:15 amE15 – Enhancing Effective Communications Between IRBs and Investigators
- Wednesday, 11:15 amE17 – O…R...I Have No Idea What You’re Talking About!
- Wednesday, 11:15 amE18 – Scientific Aspects of Study Design: A Primer for Non-Scientist IRB Members
- Wednesday, 11:15 amE2 – A Dialogue With the Association for the Accreditation of Human Research Protection Programs (AAHRPP, Inc.)
- Wednesday, 11:15 amE20 – Representing Prisoners: Insights from an IRB Member Who Has Been Incarcerated
- Wednesday, 11:15 amE21 – Development of an Effective QA/QI Program at Your Institution
- Wednesday, 11:15 amE23 – Building and Maintaining HRPP in a Large Health System With a Small Research Portfolio
- Wednesday, 11:15 amE24 – Social Media and Participant Recruitment in SBER
- Wednesday, 11:15 amE25 – You Want to Do What? Developing Best Practices for IRB Review of Research Investigating Illegal/Illicit Behaviors
- Wednesday, 11:15 amE3 – When Exception Does Not Apply: Practical Strategies for Ethical Enrollment of Situationally Impaired Subjects in Clinical Trials in the Emergency Setting
- Wednesday, 11:15 amE4 – IRB Oversight and the Boundaries Between Evidence-Based Practice (EBP), Performance Improvement, and Research
- Wednesday, 11:15 amE5 – Exploring Strategies on How to Effectively Provide Education on Human Research Protections to Investigators
- Wednesday, 11:15 amE8 – An Overview of FDA’s Program Alignment and What it Means for Your Next Inspection
- Wednesday, 2:00 pmClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
IRB Members, Chairs, and Vice Chairs (117)
- Monday, 9:45 amA New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine
- Monday, 11:30 amPanel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
- Monday, 11:30 amPanel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
- Monday, 11:30 amPanel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
- Monday, 2:30 pmA1 – A Dialogue with the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission)
- Monday, 2:30 pmA10 – Updated International Guidelines for Stem Cell Research: Implications for IRBs, Stem Cell Research Oversight Committees (SCROs), and Institutions
- Monday, 2:30 pmA12 – How Do We Assess the Quality of an HRPP?
- Monday, 2:30 pmA13 – Pre-IRB Review: IRB Ready or Not?
- Monday, 2:30 pmA14 – IRB Chairs and Members: Recruiting, Developing, Training, and Managing
- Monday, 2:30 pmA15 – Re-Evaluating Risk Tolerance: Are You Overdoing It?
- Monday, 2:30 pmA16 – Designing and Implementing Expanded Access Programs
- Monday, 2:30 pmA18 – The Inside Scoop: What Every Non-Scientist IRB Member Should Know
- Monday, 2:30 pmA19 – The ABCs of Genetics, DNA, and Related Research Issues
- Monday, 2:30 pmA2 – A Dialogue with the Secretary's Advisory Committee on Human Research Protections (SACHRP)
- Monday, 2:30 pmA20 – Defining Vulnerability: Regulations and Beyond
- Monday, 2:30 pmA21 – Nuts and Bolts of Investigator Site Audits
- Monday, 2:30 pmA22 – IRB Review of Big Data Research
- Monday, 2:30 pmA23 – Does Anyone Here Get What I Do? Educating Your Institution on What the HRPP Is All About
- Monday, 2:30 pmA24 – Best Practices for Assessing Risks and Benefits in SBER
- Monday, 2:30 pmA25 – Mandatory Reporting
- Monday, 2:30 pmA3 – Tips on Involvement of US Army Personnel as Human Subjects
- Monday, 2:30 pmA4 – You'll Know it When You See it: Defining "Human Subjects Research" Under the DHHS Regulations
- Monday, 2:30 pmA5 – Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff
- Monday, 2:30 pmA6 – Examining Participant Perspectives on Social and Structural Constraints on Research Involving Vulnerable Populations
- Monday, 2:30 pmA7 – Introduction to Ethical Principles for Research Involving Human Participants as Study Subjects
- Monday, 2:30 pmA8 – A Primer in Determining When an Investigational New Drug (IND) Application Is Needed for Studies Involving Drugs or Biologics
- Monday, 2:30 pmA9 – Different Models of Review: A Global Comparison
- Monday, 4:00 pmB1 – A Dialogue With the Office for Human Research Protections (OHRP)
- Monday, 4:00 pmB12 – The Characteristics of "High Performance" HRPPs
- Monday, 4:00 pmB13 – Essential Documentation: IRB Membership, Record Keeping, Minutes, and More
- Monday, 4:00 pmB14 – Evaluating Members, Chairs, and Staff: What Works and What Doesn’t?
- Monday, 4:00 pmB16 – Considerations for Effective IRB Review and Management of Protocol Deviations and Violations
- Monday, 4:00 pmB17 – Certificates of Confidentiality (CoCs): When, Why, and So What?
- Monday, 4:00 pmB18 – Keys to the Magic Kingdom: Defining Roles, Expectations, and Challenges for the Non-Scientist IRB Member
- Monday, 4:00 pmB19 – Consenting Subjects for Bio/Data Repositories: Evaluating Approaches and Their Implications for Future Solutions
- Monday, 4:00 pmB2 – A Dialogue With the Department of Energy (DOE)
- Monday, 4:00 pmB20 – Research With Children: Regulations and Beyond
- Monday, 4:00 pmB21 – Nuts and Bolts of Assessing IRB Compliance
- Monday, 4:00 pmB22 – Clinical Research in the Age of Digital Health: Best Practices for IRBs
- Monday, 4:00 pmB23 – Building and Maintaining an HRPP Within a Primarily SBER Institution with a Small Research Portfolio
- Monday, 4:00 pmB24 – Scientific Merit, Generalizability, and Risks in Qualitative Research: A Case Study Approach
- Monday, 4:00 pmB25 – Understanding Qualitative Research and Associated Ethical Issues to Protect Research Participants from Harm
- Monday, 4:00 pmB3 – Things that Keep an Institutional Official (IO) Up at Night
- Monday, 4:00 pmB4 – Opposing Forces: How to Align Flexibility and Consistency in Reliance Agreements
- Monday, 4:00 pmB5 – Training for Success: Tools and Educational Methods for IRB Staff
- Monday, 4:00 pmB7 – Ethical Issues in Community-Based Participatory Research (CBPR)
- Monday, 4:00 pmB8 – FDA Oversight and IRB Review of Investigational In Vitro Diagnostics (IVDs)
- Monday, 4:00 pmB9 – Ensuring Research Compliance of Multicenter and International Research
- Tuesday, 11:15 amC1 – A Dialogue With the Food and Drug Administration (FDA)
- Tuesday, 11:15 amC13 – Let's Review a Protocol: Regulatory Considerations in the IRB Review Process
- Tuesday, 11:15 amC14 – IRB Chairs Forum: A Structured Discussion for IRB Chairs
- Tuesday, 11:15 amC15 – Operationalizing Collaborative IRB Review
- Tuesday, 11:15 amC16 – Patient-Centric Trial Design and Conduct
- Tuesday, 11:15 amC17 – When it Happens to You: Preparing for Phase II Health Insurance Portability and Accountability Act (HIPAA) Audits and Identifying and Managing Privacy Breaches in Research
- Tuesday, 11:15 amC18 – Statistics Without Tears
- Tuesday, 11:15 amC19 – Return of Individual Research Results - Complex Considerations for a Not So Simple Request: Perspectives from Scientists, Subjects, and Regulators
- Tuesday, 11:15 amC2 – A Dialogue With the Office for Research Integrity (ORI)
- Tuesday, 11:15 amC20 – Populations on the Edge: The Homeless, Substance Abusers, the Lesbian, Gay, Bisexual, and Transgender (LGBT) Community, and More
- Tuesday, 11:15 amC21 – Novel Methods, Approaches, and Tools for QA/QI, Including Electronic Systems and Technology
- Tuesday, 11:15 amC22 – The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Health and Mobile Health (mHealth) Research
- Tuesday, 11:15 amC23 – Flying Solo: A Moderated Discussion on Challenges Encountered by Single Staff IRB Offices
- Tuesday, 11:15 amC24 – College Students and Research: Challenges and Issues for IRBs
- Tuesday, 11:15 amC25 – FDA Oversight, SBER, and the IRB
- Tuesday, 11:15 amC3 – Risky Business: Exposing Children to Potential Harm Without Compensating Clinical Benefit
- Tuesday, 11:15 amC4 – Crossing the Line: When Does Innovative Care Become Research?
- Tuesday, 11:15 amC5 – Recruiting, Educating, and Retaining Non-Scientist/Community IRB Members
- Tuesday, 11:15 amC6 – Preventive Misconception in HIV Prevention: What it Is and How to (Try to) Measure it
- Tuesday, 11:15 amC7 – Ethical and Regulatory Review of Research: Case Studies
- Tuesday, 11:15 amC8 – What Are Dietary Supplements and How Are They Regulated by the FDA?
- Tuesday, 11:15 amC9 – Determining Vulnerable Populations and Associated Risks in Developing Country Settings: Additional Ethical Considerations
- Tuesday, 2:00 pmPanel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
- Tuesday, 2:00 pmPanel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
- Tuesday, 2:00 pmPanel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist
- Tuesday, 3:30 pmD1 – A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
- Tuesday, 3:30 pmD10 – IRB Considerations When Conducting Research During Public Health Emergencies: Ebola, Influenza, Zika and Whatever Is Next...
- Tuesday, 3:30 pmD12 – Potential Litigation and Enforcement Actions: Past, Present, and Future, Under the NIH Single IRB Review Policy and Highly Anticipated Revised Common Rule
- Tuesday, 3:30 pmD13 – The ABCs of Writing Standard Operating Procedures (SOPs)
- Tuesday, 3:30 pmD14 – Meeting Management for IRB Chairs
- Tuesday, 3:30 pmD15 – True Stories from the IRB and their Impact on IRB Operations
- Tuesday, 3:30 pmD16 – Making Risk-Based Quality “Fit for Purpose” for Your Organization
- Tuesday, 3:30 pmD17 – You’ve Heard the Noise, Now What Are the Facts? The Legal Underpinnings of Fetal Tissue Research
- Tuesday, 3:30 pmD18 – It Takes a Village: Community Members as Research Partners in Community-Based Participatory Research (CBPR)
- Tuesday, 3:30 pmD19 – In the ERA of Big Data: Data Sharing
- Tuesday, 3:30 pmD20 – Meeting of the Minds: Research and Consent with Subjects with Impaired Decisional Capacity
- Tuesday, 3:30 pmD22 – Ethical Issues in Patient-Led and Crowdsourced Clinical Research
- Tuesday, 3:30 pmD24 – School Rules! Conducting Research in Elementary and Secondary Public Schools
- Tuesday, 3:30 pmD3 – Moving From Fossils to Young Blood for the HRPP/IRB Engine
- Tuesday, 3:30 pmD4 – The Seven Habits of Highly Effective and Flexible IRBs
- Tuesday, 3:30 pmD5 – Recruitment Strategies: Sharing Our Secrets for Success
- Tuesday, 3:30 pmD6 – Strategies for Incorporating Empirical Research into IRB Member Education
- Tuesday, 3:30 pmD7 – The International Conference for Harmonization (ICH) E6 Integrated Addendum: What Do the Proposed Changes to the Good Clinical Practice (GCP) Guidelines Mean for the Clinical Research Community?
- Tuesday, 3:30 pmD8 – Expanded Access and Off-Label Use of Medical Devices
- Tuesday, 3:30 pmD9 – Cutting-Edge Challenges in HIV Research Ethics in the Resource Limited Settings: Lessons from the Ethics Working Group (EWG) of the HIV Prevention Trial Network (HPTN)
- Wednesday, 9:45 amPanel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence
- Wednesday, 9:45 amPanel VII: Amplifying the Challenges: Return of Results in Pediatric Research
- Wednesday, 9:45 amPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
- Wednesday, 11:15 amE1 – A Dialogue With the National Institutes of Health (NIH)
- Wednesday, 11:15 amE10 – Study Review Using Single IRBs (sIRBs)
- Wednesday, 11:15 amE13 – Unanticipated Problems (UPs) and Adverse Events (AEs): A Practical Approach for IRBs
- Wednesday, 11:15 amE14 – IRB Chair Responsibilities and Roles: Beyond the IRB Meeting
- Wednesday, 11:15 amE15 – Enhancing Effective Communications Between IRBs and Investigators
- Wednesday, 11:15 amE17 – O…R...I Have No Idea What You’re Talking About!
- Wednesday, 11:15 amE18 – Scientific Aspects of Study Design: A Primer for Non-Scientist IRB Members
- Wednesday, 11:15 amE19 – Beyond Basic Biobanking: Issues Related to the Collection, Storage, and Future Research Uses of Pediatric Biospecimens, Newborn Blood Spots, and Fetal Tissue
- Wednesday, 11:15 amE2 – A Dialogue With the Association for the Accreditation of Human Research Protection Programs (AAHRPP, Inc.)
- Wednesday, 11:15 amE20 – Representing Prisoners: Insights from an IRB Member Who Has Been Incarcerated
- Wednesday, 11:15 amE21 – Development of an Effective QA/QI Program at Your Institution
- Wednesday, 11:15 amE22 – Crawling in the Dark: The Ethics of Research Use of Data from the Dark Web
- Wednesday, 11:15 amE23 – Building and Maintaining HRPP in a Large Health System With a Small Research Portfolio
- Wednesday, 11:15 amE24 – Social Media and Participant Recruitment in SBER
- Wednesday, 11:15 amE25 – You Want to Do What? Developing Best Practices for IRB Review of Research Investigating Illegal/Illicit Behaviors
- Wednesday, 11:15 amE3 – When Exception Does Not Apply: Practical Strategies for Ethical Enrollment of Situationally Impaired Subjects in Clinical Trials in the Emergency Setting
- Wednesday, 11:15 amE4 – IRB Oversight and the Boundaries Between Evidence-Based Practice (EBP), Performance Improvement, and Research
- Wednesday, 11:15 amE6 – Ethical Risks and Remedies for Recruiting and Obtaining Consent in Adolescent Risk Research Involving Sexual and Gender Minority Youth (SGMY)
- Wednesday, 11:15 amE8 – An Overview of FDA’s Program Alignment and What it Means for Your Next Inspection
- Wednesday, 11:15 amE9 – Data Access Versus Patient Privacy in the European Union (EU): Ethical Mandates in the Crucible of Public Debate
- Wednesday, 2:00 pmClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
