Research Integrity, Compliance, & Ethics

Mission

The mission of the Research Integrity, Compliance, and Ethics (RICE) unit is to promote integrity in research; compliance with relevant laws and policies; and adherence to the highest ethical standards in research conducted by all investigators affiliated to SPH. RICE strives to improve knowledge and practice on Research integrity, compliance, and ethics within SPH through information, training workshops, seminars and other ways. RICE continues to work on new and innovative tools and strategies for compliance in ongoing research.

This unit manages the ethics and compliance functions at GWSPH for GW. It is instrumental to the development of regulatory and ethics related processes at GWSPH. This unit reviews all research related standard operating procedures, works to strengthen responsible conduct of research, and develops the internal capacity for ethics review within GWSPH. The RICE Unit is also responsible for oversight of student projects including coordinating the submission portal.

This page will highlight key policies and guidances all PIs, research staff, and administrators should be aware of; Student Ethics activities; and other activities that the RICE unit is responsible for.

Questions: [email protected]

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        - Pre-Award
        - Post-Award
        - Past Webinars

Policies & Guidance

GW UNIVERSITY POLICIES

The following categories include relevant GW University policies that impact research. Policies are categorized by when a researcher may need to reference a policy during the sponsored projects lifecycle. Certain policies may be duplicated as they pertain to multiple phases of the lifecycle.

Pre-Award

The pre-award phase of the sponsored projects lifecycle includes proposal development and submission followed by award negotiation and acceptance.

Define Funding

There are currently no GW policies that directly impact research at this early stage in the grant life cycle.

Proposal Development & Submission

Allegations of Research Misconduct

Animal Care and Use

Categorization of External Funding

Classified Research - GW's stance on conducting classified research

Compliance Regarding Select Agents and Pathogens

Compliance with Laws when Conducting University Activities Overseas

Conflict of Interest for Non-Faculty Employees

Conflicts of Interest & Commitment for Faculty and Investigators

Direct Charging of Administrative Costs Associated with Sponsored Projects

FCOI Supplemental Disclosure Form

Internal Questionnaire Administration

Personal Information and Privacy Policy

Protection of Minors

Signing of Contracts and Agreements - describes which roles at the university have signing authority

Treatment of Human Research Subjects

Award Negotiation & Acceptance

Material Transfer Agreement

Post-Award

The post award phase of the sponsored projects lifecycle includes award set-up, award administration and management, and award closeout. Issues of research integrity generally occur during post-award administration and a separate section is included to address the relevant policies.

Award Set-Up

Administrative Establishment - allows temporary set up of an award before final execution of award documents

Award Administration & Management

Allegations of Research Misconduct

Animal Care and Use

Award Management and Closeout

Bloodborne Pathogens Exposure Control

Chemical Hygiene (Laboratory Safety)

Compliance Regarding Select Agents and Pathogens

Compliance with Laws when Conducting University Activities Overseas

Conflict of Interest for Non-Faculty Employees

Copyright

Cost Sharing on Sponsored Projects

Cost Transfers on Sponsored Projects

Conflicts of Interest & Commitment for Faculty and Investigators

Direct Charging of Administrative Costs Associated with Sponsored Projects

Export Control

General Safety

Hazardous Waste Management

Health Information Privacy

Information Security

Patents and Scholarly Works

Personal Information and Privacy Policy

Personal Protective Equipment

Protection of Minors

Public Access to NIH-Funded Publications

Media - outlines best practice for engaging with the media

Records Management

Respiratory Protection

Signing of Contracts and Agreements

Social Media

Sub-recipient Monitoring

Treatment of Human Research Subjects

Use of Radioactive Materials

Award Closeout

Cost Transfers on Sponsored Projects

Liquidating Funds - disencumbering purchase orders

Research Integrity

Allegations of Research Misconduct

Animal Care and Use

Compliance with Laws when Conducting University Activities Overseas

Conflict of Interest for Non-Faculty Employees

Conflicts of Interest & Commitment for Faculty and Investigators

Personal Information and Privacy Policy

Protection of Minors

Treatment of Human Research Subjects

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MILKEN INSTITUTE SCHOOL OF PUBLIC HEALTH POLICIES

The following policies are internal to the Milken Institute School of Public Health and may be more specific than the University counterpart.

SPH Policies

Conflict of Interest FAQs

Conduct of Human Subjects Research by Milken Institute SPH Students Without Prior IRB Review

HIPAA Training​

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RICE Initiatives

SUPPORT FOR SPH STUDENT RESEARCH ACTIVITIES


ORE is responsible for oversight of student projects to ensure compliance with federal regulations, GWU policies concerning human research protections and ethical standards. In order to facilitate this, ORE has developed a portal that SPH students should use in submitting their project proposals to ORE for review and clearance. All student projects outside of activities limited to the classroom need to be entered into the portal. This includes CE projects, practicum, field lab placements, independent studies and other projects for school credit. The oversight process allows the Dean's Office of Research Excellence (ORE) to support students' educational journey while ensuring compliance with GWU policies. It also helps ORE keep track of the great work our students are doing.


In order to ensure compliance with federal regulations and GWU policies concerning human research protections, SPH students may not begin their projects until they have received a determination by email from ORE that they are approved to do so. Students should submit their project proposals to ORE through the Student Project Oversight Portal. ORE has prepared a Guidance Document for Faculty Advisors that provides detailed information on how faculty advisors should assist their students in navigating the processes. ORE has also prepared a Guidance Document for students that provides detailed instructions that students should follow in preparing for and submitting their proposals through the portal. ORE has exempted certain types of projects from being submitted through the portal. ORE issues blanket determinations (memos) on such activities and these memos can be obtained by emailing [email protected]. Any questions regarding oversight of student projects should also be addressed to [email protected].
 

In order to ensure compliance with federal regulations and GWU policies concerning human research protections, you may not begin your project until you have received a determination by email from ORE that you are approved to do so.

Questions: [email protected]

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BIOETHICS INTEREST GROUP (BIG)

The Bioethics Interest Group is tasked with bringing together individuals who can further promote discourse on ethical decision-making and practice in the context of public health. BIG is comprised of students, faculty, and staff from all SPH departments. It is co-chaired by Adnan Hyder and Melissa Goldstein.

The BIG at SPH's main objectives are:

  • To facilitate discussion, debate, and active discourse on topics of interest in ethics in the practice, research, policies, and management of health issues.
  • To assist members and the SPH community to better understand ethics and its practical application in public health practice and decision-making.
  • To develop learning materials and resources on individual and public health ethics for SPH faculty, staff, and students.

For more information: Paul Ndebele, Secretary; [email protected]

Ethics & COVID-19: A Webinar Series

COVID-19 has raised a plethora of ethical issues - from prevention and containment, to cure and management. Join leading experts to discuss these issues in a Bioethics Interest Group (BIG) webinar series focused on COVID-19 ethical considerations. Hosted by the Office of Research Excellence and moderated by Adnan Hyder, Senior Associate Dean for Research, these webinars will host ethics experts from GW, the United States, and abroad to discuss key ethical dilemmas and principles precipitated by the pandemic. Participants will have the opportunity to ask questions brought about during unprecedented crisis.

Open to faculty, staff, students, alumni, and public health professionals, this webinar series will lay the foundations for raising and discussing ethical concerns in an e-hall format. Please join us! Upcoming dates and topics:

Upcoming Webinars:

Save the Date for future Ethics and Public Health webinars:  TBD

Past Webinars

Ethics & COVID-19: Introduction

Held April 14, 2020

Panelists:
Melissa Goldstein, JD
Teaching Associate Professor, The George Washington University
 
Paul Ndebele, Ph.D.
GWSPH Compliance & Professorial Lecturer in Global Health
Research Regulatory Specialist

Skip to 2:15 mark for start.

Link: Webinar 1 - Introduction

Ethics & COVID-19: Clinical Ethics

Held April 28, 2020

Panelists:
Melissa Goldstein, JD
Teaching Associate Professor, The George Washington University
 
Vanessa Madrigal, MD, MSCE
Director, Ethics Program; Critical Care Specialist, Children's National
 
Katalin Roth, MD, JD
Professor of Medicine, The George Washington University
Director of the Division of Geriatrics and Palliative Medicine

Link: Webinar 2 - Clinical Ethics

Ethics & COVID-19: Scarce Resource Allocation

Held May 12, 2020

Panelists:
Sarah Vittone, DBe, MSN, RN
Assistant Professor, Georgetown University
Bioethicist at Pellegrino Center for Clinical Bioethics at Georgetown University
 
Govind Persad, JD, Ph.D
Assistant Professor, The University of Denver Sturm College of Law
Greenwall Foundation Faculty Scholar in Bioethics

Link: Webinar 3 - Scarce Resource Allocation

Ethics & COVID-19: Maternal and Child Health

Held May 26, 2020

Panelists:
Leana Wen, MD, MSc
Visiting Professor, The George Washington University
Distinguished Fellow at the Fitzhugh Mullan Institute of Health Workforce Equity
 
Amita Vyas, PhD, MHS
Associate Professor, The George Washington University

Link: Webinar 4 - Maternal and Child Health

Ethics & COVID-19: Research Ethics

Held June 9, 2020

Panelists:
Debra Paxton, MS, CIP
Director of the Office of Human Research, The George Washington University
 
Julia Slutsman, PhD
Director of Research Affairs, Children's National Hospital
Assistant Professor, Dept. of Pediatrics, School of Medicine and Health Sciences, 
The George Washington University

Link: Webinar 5 - Research Ethics

Ethics & COVID-19: Vaccine Ethics (part 1)

Held June 23, 2020

Panelists:
Saad Omer, MBBS, MPH, PhD, FIDSA
Director of the Yale Institute for Global Health
Professor of Medicine and Epidemiology at Schools of Medicine and Public Health, Yale University
 
Alexandra Phelan, SJD, LLM, LLB
Assistant Professor, Center for Global Health Sciences and Security
Assistant Professor, Dept. of Microbiology and Immunology, Georgetown University
Adjunct Professor of Law, Georgetown University Law Center

Link: Webinar 6 - Vaccine Ethics

Ethics & COVID-19: Ethnic and Racial Disparity

Held July 7, 2020

Panelists:
Jim Lavery, PhD
Conrad N. Hilton Chair in Global Health Ethics
Professor, Hubert Department of Global Health, Rollins School of Public Health
Faculty, Center for Ethics, Emory University
 
Ruqaiijah Yearby, JD, MPH
Professor, School of Law, Saint Louis University
Co-Director, Center for Equity, Saint Louis University
Co-Founder, Institute for Healing Justice and Equity, Saint Louis University

Link: Webinar 7 - Ethnic and Racial Disparity

Ethics & COVID-19: Domestic and Family Violence

Held July 21, 2020

Panelists:
Nicole V. Lang, MD
President and CEO, Washington Pediatric Associates, Premier Pediatric Concierge Care
Assistant Professor of Pediatric Medicine, School of Medicine and Health Sciences,
The George Washington University
 
Joan S. Meier, Esq.
Professor of Clinical Law and Director of the National Family Violence Law Center,
The George Washington University School of Law

Link: Webinar 8 - Domestic and Family Violence

Ethics & COVID-19: Digital Privacy

Held August 4, 2020

Panelists:
Ross Upshur, MA, MD, MSc
Dalla Lana Chair in Clinical Public Health
Head, Division of Clinical Public Health, Dalla Lana School of Public Health
Scientific Director, Bridgepoint Collaboratory for Research and Innovation
Associate Director, Lunenfeld Tanenbaum Research Institute, Sinai Health
Professor, Department of Family and Community Medicine, Dalla Lana School of Public Health, University of Toronto
 
Melissa Goldstein, JD
Associate Professor, Department of Health Policy and Management, Milken Institute School of Public Health, The George Washington University

Link: Webinar 9 - Digital Privacy

Ethics & COVID-19: International Context

Held August 18, 2020

Panelists:
Katherine Litter
Co-Lead, Global Health Ethics and Government Unit, Research for Health Department
World Health Organiziation (WHO)
 
Carla Saenz, PhD
Regional Bioethics Advisor, Department of Health Systems and Services, Pan American
Health Organization (PAHO)

Link: Webinar 10 - International Context

Ethics & COVID-19: Refugee Populations

Held September 1, 2020

Panelists:
Ron Waldman, MD
Professor of Global Health
Milken Institute School of Public Health, The George Washington University
 
Serena Parekh, PhD
Associate Professor
Director of the Politics, Philosophy, and Economics (PPE) Program
Co-Editor, Feminist Philosophy Quarterly
Northeastern University

Link: Webinar 11 - Refugee Populations

Ethics & COVID-19: Regional Perspectives - East Asia

Held September 15, 2020

Panelists:
Calvin W.L. Ho, JSD, LLM, MSc, LLB
Associate Professor of Law, University of Hong Kong
 
Yonghui Ma, PhD
Associate Director of the Centre for Bioethics, Medical College, Xiamen University
Associate Professor, Xiamen University

Link: Webinar 12 - Regional Perspectives - East Asia

Ethics & COVID-19: Publication Ethics

Held September 29, 2020

Panelists:
Dr Laragh Gollogly 
Editor in Chief, Bulletin of the World Health Organization
 
Prof Keymanthri Moodley
Professor and Director, Centre for Medical Ethics and Law, WHO Collaborating Centre in Bioethics
Department of Medicine, Faculty of Health Sciences, Stellenbosch University, South Africa

Link: Webinar 13 - Publication Ethics

Ethics & COVID-19: Adolescent Health

Held October 13, 2020

Panelists:
Zulfiqar Bhutta, FRS MBBS FRCPCH FAAP Phd
Founding Director, Institute for Global Health and Development
Founding Director, Center of Excellence in Women and Child Health, the Aga Khan University
South Central Asia, East Africa & United Kingdom
 
Ann Strode, BA LLB LLM PhD
Professor, School of Socio Legal Studies, Pietermaritzburg, University of KwaZulu-Natal, South Africa

Link: Webinar 14 - Adolescent Health

Ethics & COVID-19: Regional Perspective - South Asia

Held October 27, 2020

Panelists:
Anant Bhan, PhD Researcher, Bioethics and Global Health
Senior Research Consultant, ESC Program for Global Health
Adjunct Visiting Professor in the Department of Community Medicine, Yenepoya Medical College and Centre for Ethics
Yenepoya University, Mangaluru, India
 
Farhat Moazam, M.D., FACS, PhD
Professor and Chairperson, Center of Biomedical Ethics and Culture (CBEC), Karachi, Pakistan

Link: Webinar 15 - Regional Perspective - South Asia

Ethics & COVID-19: Mental Health

Held November 10, 2020

Panelists:
Shekhar Saxena, MD, FRCPsych, DAB, MRC, Psych
Director of the Department of Mental Health and Substance Abuse at World Health Organization's Headquarters Office
in Geneva, Switzerland from 2010 to 2018. Professor of the Practice of Global Mental Health at the Department of
Global Health and Population at the Harvard T. H. Chan School of Public Health
 
Charmaine Chitiyo, BSc, MSc
Project Coordinator and Community Volunteer Trainer for the Friendship Bench, Department of Psychiatry
University of Zimbabwe

Link: Webinar 16 - Mental Health

Ethics & COVID-19: Regional Perspectives - West Africa

Held November 24, 2020

Panelists:
Morenike Ukpong-Folayan
Professor of Paediatric Dentistry, Obafemi Awolowo University, Ile Ife, Nigeria
Convener for 2020 Nigeria Bioethics Conference
Member Guttmacher Institute Institutional Review Board
 
Seydou Doumbia, MD PhD
Dean, Medical School and Dentistry
Director of University Clinical Research Center (UCRC), University of Sciences, Technique, and Technology
of Bamako (USTTB), Mali

Link: Webinar 17 - Regional Perspectives - West Africa

Ethics and COVID-19: Islam & Judaism

Held December 8, 2020

Panelists:
Zainab Chaudry, Pharm.D.
Director of Maryland Outreach at the Council on American-Islamic Relations (CAIR)
Member of the Advisory Board of the Interfaith Action for Human Rights
Liaison to Shoulder-to-Shoulder - an interfaith campaign founded to counter anti-Muslim bigotry in America
 
Laurie Zoloth, Ph.D
Margaret E. Burton Professor and Dean at the University of Chicago Divinity School
Author of Health Care and the Ethics of Encounter: A Jewish Discussion of Social Justice
Co-founder of The Ethics Practice

Link: Webinar 18 - Islam & Judaism

Ethics and COVID-19: Vaccine Ethics (Part 2)

Held January 26, 2021

Panelists:
Melissa Goldstein, JD
Associate Professor in the Department of Health Policy and Management,
Milken Institute School of Public Health, The George Washington University
Advisory Board Member of the Future of Privacy Forum (FPF),
Member of the National Committee on Vital and Health Statistics
 
Jerome Singh, LLB LLM MHSc PhD
Adjunct Professor of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Canada
Director of the Ethical, Legal, and Social Issues (ELSI) Advisory Services on Global Health
Research and Development

Link: Webinar 19 - Vaccine Ethics (Part 2)

Ethics and COVID-19: Christianity & Buddhism

Held February 23, 2021

Panelists:
Karma Lekshe Tsomo, PhD
Co-founder of Sakyadhita International Association of Buddhist Women, founding director of the Jamyang Foundation Professor, Theology and Religious Studies professor, University of San Diego
 
Rev. Dr. Isaac Mwase, PhD
Associate Pastor of Youth, Children, and Missions & Outreach at University Baptist Church, Baltimore, Maryland

Link: Webinar 20 - Christianity & Buddhism

Ethics and COVID-19: Vaccine Ethics (Part 3 - Human Challenge Trials)

Held March 30, 2021

Panelists:
Holly Fernandez Lynch, JD, MBE
John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of
Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania.
 
Josh Morrison, JD
Executive Director of 1Day Sooner, an advocacy group for research participants, including those in
COVID-19 challenge studies. Founder of Waitlist Zero and the Rikers Debate Project.
 
Paul Ndebele, PhD
Senior Research Regulatory Specialist, Office of Research Excellence and Professorial Lecturer,
Department of Global health, Milken Institute School of Public Health, The George Washington University.

Link: Webinar 21 - Vaccine Ethics (Part 3 - Human Challenge Trials)

Ethics and COVID-19: Regional Perspectives - Africa

Held April 20, 2021

Panelists:
Bartholomew Dicky Akanmori, PhD
Regional Advisor for Vaccine Regulation, Communicable and Non-Communicable Diseases (UCN) Cluster, and the Vaccine Preventable Diseases (VPD) Program at WHO, Regional Office for Africa.
 
Yimtubezinash Woldeamanuel Mulate , MD, M.Sc., PhD
Associate Professor in the Department of Microbiology, Immunology, and Parasitology at the Addis Ababa University (AAU) School of Medicine, College of Health Sciences.

Link: Webinar 22 - Regional Perspectives - Africa

Ethics and COVID-19: Gender & COVID-19

Held May 25, 2021

Panelists:
Roopa Dhatt, MD, MPA
Executive Director and co-founder of Women in Global Health.
 
Mary Ellsberg, PhD
Founding Director of the Global Women's Institute and professor of Global Health at GWU and member of the Core Technical Team of the WHO Multi-County Study on Women's Health and Domestic Violence against Women.

Link: Webinar 23 - Gender & COVID-19

Ethics and COVID-19: Mandatory COVID-19 Vaccination for Healthcare Personnel

Held July 27, 2021

Panelists:
Khurram Nasir, M.D.,MPH
Professor of Cardiology, Academic Institute and Chief, Division of Cardiovascular Prevention and Wellness, Co-director of Center for Outcomes Research, Houston Methodist, and Weil Cornell Medical College.
 
Bryan Thomas, B.A.(Hons), M.A., BCL/JD, SJD
Senior Researcher and Adjunct Professor, University of Ottawa's Centre for Health Law, Policy and Ethics.
 
Preeti.R.John, MD, MPH, FACS, HEC-C
Critical Care and Palliative Care Surgeon, Certified Health Care Ethics Consultant, VA Maryland Health Care System, Adjunct Assistant Professor, Department of Surgery, University of Maryland School of Medicine.

Link: Webinar 24 - Mandatory Covid-19 Vaccination for Healthcare Personnel

Ethics and COVID-19: Vaccine Misinformation

Held October 26, 2021

Panelists:
Nahid Bhadelia, M.D.,MALD
Founding Director, Center for Emerging Infectious Diseases Policy & Research (CEID). Associate Professor, Section of Infectious Diseases, Boston University School of Medicine.
 
David A. Broniatowski, Ph.D., FPsyS
Associate Professor, Department of Engineering Management and Systems Engineering, GWU.
 

Link: Webinar 25 - Vaccine Misinformation

Ethics and COVID-19: Global Vaccine Equity

Held November 30, 2021

Panelists:
Louise Ivers, M.B., Bch.,MD., MPH., DTM&H
Executive Director of the Massachusetts General Hospital Center for Global Health, Professor of Medicine at Harvard Medical School.
 
Emily R. Smith, ScD., MPH
Assistant Professor, Departments of Global Health & Exercise & Nutrition Sciences, Milken Institute School of Public Health, GWU.

Ethics and COVID-19: Omicron and Quarantine Ethics

Held January 25, 2022

Panelists:
Mark Aulisio, PhD
Susan E. Watson Professor and Chair, Department of Bioethics, Case Western Reserve University - School of Medicine and Director, Center for Biomedical Ethics MetroHealth Medical Center.
 
Renuga Vivekanandan, MD
Associate Professor, Division Chief of Infectious Disease, Assistant Dean for Strategy and Accreditation CUSOM and Medical Director for Antimicrobial Stewardship & Hospital Epidemiology CHI Health - Creighton University.

Ethics and COVID-19: Strategic Lessons from COVID19 for Global Health

Held March 1,2022

Panelists:
Olusoji Adeyi, MD, MBA, DrPH
President, Resilient Health Systems and Senior Associate, Johns Hopkins Bloomberg School of Public Health.
 
Ana B. Amaya, DrPH MPH
Assistant Professor, Health Science Program, College of Health Professions- Pace University and Associate Research Fellow, United Nations University – CRIS.

Ethics and COVID-19: Regional Perspective - Latin America

Held April 5,2022

Panelists:
 
Carla Saenz, PhD
Regional Bioethics Advisor, Department of Health Systems and Services - Pan American Health Organization.
 
Sofia Salas Ibarra, MD
Research Professor, Center for Bioethics, Faculty of Medicine, Clínica Alemana Universidad del Desarrollo.

 


Research Guidance & Resources

FCOI Supplemental Disclosure Form

Single PI for Multi-department Awards

Graduate Assistants (GA, GRA) and Fellowships Policy

Cost Share Approvals

Principal Investigator Eligibility Exception Request

 

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