Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program
Harvard Catalyst Search is currently experiencing problems. We are working to restore it as quickly as possible. Thank you for your patience.
We are experiencing problems with system email notifications. If you have questions please email feedback@catalyst.harvard.edu.

How We Work

  • Identify Initiatives
    Local stakeholders (investigators, IRBs, research administrators, community members) identify opportunities—and challenges—for collaboration.
  • Form Working Groups
    Drawing from local expertise across our institutions and communities, working groups drive the development of new initiatives.
  • Pilot Solutions
    Following an iterative development cycle, working groups incorporate key stakeholder input through built-in feedback processes.
  • Implement Locally
    Working groups and stakeholders spearhead implementation at Harvard Catalyst's participating institutions, with an eye toward broad adoption.
  • Support Broad Adoption
    Resources and offerings are made available locally, regionally, and nationally, as appropriate and feasible.

Regulatory Committee and Subcommittees

Read More

The Regulatory Committee is comprised of institutional officials, compliance officers, and directors of human research protections from Harvard Catalyst-participating institutions as well as ex officio members from Harvard University Provost's Office and Harvard Medical School's Office for Professional Standards and Integrity. The committee meets monthly and serves as the effector arm for a broad array of initiatives and support processes, including issues related to IRBs, HRPPs, research subject advocacy, privacy and data-sharing, education and training, and compliance with regulatory requirements. Committee members spearhead the implementation of recommendations at their home institutions and identify any issues with implementation that may require further analysis and solutions.

The program has also convened subcommittees, task forces, working groups, and advisory bodies to explore and make recommendations concerning issues that pose special challenges, risks, or opportunities for Harvard Catalyst and its participating institutions. These include:

Community-Engaged Research (CEnR) Subcommittee

The Community-Engaged Research (CEnR) Subcommittee facilitates bi-directional communication among communities, organizations, investigators, and regulatory leadership, while building partnerships that support research. The subcommittee is a partnership between the Regulatory Foundations, Ethics, and Law Program and the Community Health Innovation and Research Program's Community Advisory Board, bringing together a broad array of expertise and disciplines to reduce traditional silos in research. The CEnR subcommittee develops tools, training materials, and education programs to help IRBs, investigators, and communities promote reciprocal teaching and learning.

To join the CEnR Subcommittee please email us.

CEnR Subcommittee Leadership

Claude-Alix Jacob, MPH (Co-Chair)
Chief Public Health Officer, Cambridge Public Health Department, Cambridge Health Alliance
Email

Jennifer A. Graf (Co-chair)
Manager, Human Research Protection Program and Research Integrity, Cambridge Health Alliance
Email

Barbara Bierer, MD (CEnR Subcommittee Sponsor)
Program Director, Regulatory Foundations, Ethics, and Law, Harvard Catalyst

CEnR Subcommittee Membership

Alex Pirie, BA
Coordinator of Immigrant Service, Providers Group/Health

Shalini Tendulkar, ScD, ScM
Research and Evaluation Scientist, Institute for Community Health
Instructor in Medicine, Harvard Medical School

Robleinscky Dominguez
IRB Administrator, Boston Children's Hospital

Keren-Nicole Insalaco, MS, CIP
IRB Review Specialist, Harvard T.H. Chan School of Public Health

Ex Officio Members

Enrico Cagliero, MD
Director, Research Subject Advocacy, Harvard Catalyst
Assistant Professor of Medicine, Harvard Medical School

Milagro Grullón, MM
Executive Director, Lawrence Community Connections

Karen Hacker, MD, MPH
Director of the Allegheny County Health Department
Pittsburgh, PA

Roderick King, MD, MPH, FAAP
Executive Director, Florida Public Health Institute
Instructor of Medicine, Department of Global Health and Social Medicine, Harvard Medical School
Senior Faculty, Massachusetts General Hospital Disparities Solutions Center

CEnR Subcommittee Support

Hila Bernstein
Regulatory Affairs Officer, Harvard Catalyst
Email

Sabune Winkler, JD
Director, Regulatory Affairs Operations, Harvard Catalyst
Email

Jessica Biggers
Regulatory Affairs Coordinator, Harvard Catalyst
Email

Return to top

Data Protection Subcommittee

The Data Protection subcommittee seeks to protect individuals' privacy and confidentiality interests while facilitating collaborative research initiatives. Where variable interpretations of regulations operate as barriers to research, we offer practical solutions for researchers and associated stakeholders to use sensitive information legally, ethically, and responsibly.

To join the Data Protection Subcommittee, please email us.

Data Protection Subcommittee Leadership

Ian Poynter
Data Security Officer, Broad Institute
Email

Kristen Bolt (Co-Chair)
Research Data and Conflict of Interest Officer, Harvard University
Email

Barbara Bierer, MD (Data Protection Subcommittee Sponsor)
Program Director, Regulatory Foundations, Ethics, and Law, Harvard Catalyst

Data Protection Subcommittee Membership

Steve Berry
Director, Academic and Research Computing, Beth Israel Deaconess Medical Center

Gina Prochilo-Cawston
Senior Research Compliance Specialist, Beth Israel Deaconess Medical Center

Jonathan Bickel, MD, MS
Director of Clinical Research Informatics, Boston Children's Hospital

Lisa Griffin, JD, MPH
Research Compliance Associate, Brigham and Women's Hospital

Emily Corcoran
Project and Data Compliance Officer, Harvard Medical School

Lisa Gabel
QA/QI Specialist, Harvard Medical School

Denise Chouinard
Application Consultant, Harvard Pilgrim Health Care

Sheila Fireman
Director, Research Integrity and Compliance, Harvard Pilgrim Health Care

Paula Tebeau
IRB Administrator, Harvard Pilgrim Health Care

Jason Rightmyer, MS
Director, Research Informatics, Hebrew Senior Life

Heather Shea
Privacy Specialist, Partners HealthCare

Megan Morash
Operations Consultant, Partners HealthCare

Ex Officio Members

Thomas Land
Director of Data Management and Outcomes Assessment, Massachusetts Department of Public Health

Stacey Donnelly
Director of Sponsored Research and Planning, Broad Institute

Data Protection Subcommittee Support

Sabune Winkler, JD
Director, Regulatory Affairs Operations, Harvard Catalyst
Email

Joanna Myerson
Regulatory Affairs Officer, Harvard Catalyst
Email

Jessica Biggers
Regulatory Affairs Coordinator, Harvard Catalyst
Email

Return to top

Investigational Drugs & Devices (IND/IDE) Subcommittee

The Harvard Catalyst IND/IDE Subcommittee includes recognized IND/IDE compliance leaders and those new to the regulatory compliance arena who offer fresh perspective and novel approaches to assist IRBs as well as faculty who are sponsor-investigators under the FDA regulations related to investigational new drugs and devices. Each member brings to the table a range of experience and familiarity. Participation in the IND/IDE Subcommittee provides an opportunity to collaborate with and learn from area experts around IND/IDE issues.

The breadth of membership makes the IND/IDE Subcommittee uniquely qualified to facilitate regulatory compliance with federal regulations, institutional policies, and best practice guidelines by providing Harvard Catalyst Investigators and IRBs with a centralized resource for expertise and support related to the conduct of clinical research studies conducted under Harvard Catalyst-based, sponsor-investigator Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.

To join the IND/IDE Subcommittee please email us.

Connect with IND/IDE Contacts at Participating Institutions via the Harvard Catalyst Regulatory Atlas.

IND/IDE Subcommittee Leadership

Emily Ouellette, JD
QA/QI Specialist, Partners HealthCare
Email

Stanley Estime, MSCI, CIP (Co-Chair)
QA/QI Specialist, Harvard T.H. Chan School of Public Health
Email

Barbara Bierer, MD (SBER Subcommittee Sponsor)
Program Director, Regulatory Foundations, Ethics, and Law, Harvard Catalyst

IND/IDE Subcommittee Membership

Angela Lavoie, RN, CIP, CCRP
Manager, Human Subjects Protection Office, Beth Israel Deaconess Medical Center

Ashley Kuniholm, CIP
IRB Administrator, Boston Children's Hospital

Michele Russell-Einhorn, JD
Senior Director, Office for Human Research Studies, Dana-Farber Cancer Institute & Dana-Farber/Harvard Cancer Center

Emily Eldh, CIP
Assistant Director of Clinical Research, Dana-Farber Cancer Institute & Dana-Farber/Harvard Cancer Center

Marie Iannone
Clinical Trials Education Coordinator, Dana-Farber/Harvard Cancer Center

Emily Ouellette, JD
QA/QI Specialist, Partners Healthcare

Sarah White, MPH, CIP, RAC
Director of Human Research Quality Improvement Program, Partners Healthcare

IND/IDE Subcommittee Support

Sabune Winkler, JD
Director, Regulatory Affairs Operations, Harvard Catalyst
Email

Hila Bernstein
Regulatory Affairs Officer, Harvard Catalyst
Email

Jessica Biggers
Regulatory Affairs Coordinator, Harvard Catalyst
Email

Return to top

International Research Task Force

The International Research task force comes together as needed to address regulatory issues in international research and reduce barriers for investigators and IRBs.

For more information please email us.

IRB-IT Taskforce

The IRB-IT Task Force works to identify and develop models of IRB-IT collaboration as well as to create practical tools to enhance the data security reviews and human subjects protection in research involving novel technologies (i.e. Cloud Platforms, Apps, inter-connected smart devices, and other Big Data research initiatives).

IRB-IT Taskforce Leadership

IT (Research Computing/Security)

Joe Zurba (IRB-IT Task Force Co-Chairs)
Information Security and IT Compliance Officer, Harvard Medical School
Email

IRB (Human Subjects Protection Officers)

Kristen Bolt (Co-Chair)
Research Data and Conflict of Interest Officer, Harvard University
Email

IRB-IT Taskforce Membership

IT (Research Computing/Security)

Steve Berry
Director of Research Computing, Beth Israel Deaconess Medical Center

Paul Scheib
Information Security Officer, Boston Children's Hospital

Ian Poynter
Data Security Officer, Broad Institute

Mark Tomilson
Information Security Officer, Dana-Farber Cancer Institute & Dana-Farber/Harvard Cancer Center

Miguel Sanchez
Information Security Officer, Harvard University

Sandra Silk
Director of IT Security Education and Consulting, Harvard University

Ingrid Skoog
HUIT Information Security Specialist, Harvard University

Jason Rightmyer
Director Research Informatics, Hebrew Senior Life

Heather Fowles
Director of Information Security, Massachusetts Eye and Ear

Lynn Simpson
Research Data Security Manager, Partners HealthCare

IRB (Human Subjects Protection Officers)

Michelle Auerbach
Director of Research Compliance, Beth Israel Deaconess Medical Center

Sara Harnish
Assistant Director, Office of Human Research Studies, Dana-Farber Cancer Institute & Dana-Farber/Harvard Cancer Center

Maryann Cugini
Senior Clinical Investigator, Forsyth Institute

Paula Tebeau
IRB Administrator, Harvard Pilgrim Health Care

Betsy Draper
Assistant Director, IRB Administrator, Harvard University

Pamela Richmond
Director of IRB Operations, Hebrew Senior Life

Lisa Gabel
QA/QI Specialist, Harvard T.H. Chan School of Public Health

Fariba Houman
Director of Human Research Protections Program, Massachusetts Eye and Ear

Pearl O'Rourke
Director of Human Research Affairs, Partners HealthCare

Sarah White
Senior QA/QI Specialist, Partners HealthCare

IRB-IT Taskforce Support

Sabune Winkler, JD
Director, Regulatory Affairs Operations, Harvard Catalyst
Email

Joanna Myerson
Regulatory Affairs Officer, Harvard Catalyst
Email

Jessica Biggers
Regulatory Affairs Coordinator, Harvard Catalyst
Email

Return to top

Quality Assurance/Quality Improvement (QA/QI) Subcommittee

The Harvard Catalyst QA/QI Subcommittee includes recognized QA/QI leaders and IRB members from participating Harvard Catalyst institutions. Including not only pioneers in the field, the Subcommittee also engages those new to the regulatory compliance arena who offer fresh perspectives and novel approaches to a problem. Each member brings a range of experience and familiarity: from social behavioral to biomedical or the single-site to the multi-center, international study.

The breadth of membership makes the QA/QI Subcommittee uniquely qualified to facilitate regulatory compliance with federal regulations, institutional policies, and recommend best practice guidelines by providing Harvard Catalyst Investigators and Human Research Protection Programs with innovative resources as well as guidance and tools for tracking documentation associated with studies involving human subjects.

To join the QA/QI Subcommittee please email us.

Connect with a QA/QI expert via the Harvard Catalyst Regulatory Atlas.

QA/QI Subcommittee Leadership

Leslie Howes, MPH, CIP (Co-Chair)
Director of Quality Improvement Program (QIP), Harvard T.H. Chan School of Public Health, Harvard Medical School
Email

Sarah White, MPH, CIP, RAC (Co-Chair)
Director of Human Research Quality Improvement Program, Partners Healthcare
Email

Barbara Bierer, MD (SBER Subcommittee Sponsor)
Program Director, Regulatory Foundations, Ethics, and Law, Harvard Catalyst

QA/QI Subcommittee Membership

Angela Lavoie, RN
Quality Assurance Specialist, Beth Israel Deaconess Medical Center

Jennifer Hutchinson
Senior Research Compliance Specialist, Beth Israel Deaconess Medical Center

Carol Antonelli
Quality Assurance Manager, TIMI Study Group, Partners HealthCare

Michele Gomez, CIP
Senior QA/QI Analyst, Partners Healthcare

Susan Corl, MSW, MPH, CIP, CCRP
Research Quality Improvement Specialist, Boston Children's Hospital

Eunice Newbert, MPH
Manager, Quality Improvement Clinical Research, Boston Children's Hospital

Jennifer Graf
Manager, Human Research Protection Program and Research Integrity, Cambridge Health Alliance

Nareg Grigorian
QACT Data Monitoring Manager, Dana-Farber Cancer Institute & Dana-Farber/Harvard Cancer Center

Laura Henderson
IRB Administrator, Harvard University

Shannon Sewards
Director of IRB Administration, Harvard University

Grace Kennedy
Research Compliance/Programs Administrator, Joslin Diabetes Center

Maureen English
Quality and Education Manager, Massachusetts Eye and Ear

Elizabeth Bowie, JD, MPH, MSc
Staff Attorney/IRB Specialist, Mount Auburn

Catherine Sutherland, CIP
IRB Administrator/Administrative Chair, Spaulding Rehabilitation Hospital

QA/QI Subcommittee Support

Sabune Winkler, JD
Director, Regulatory Affairs Operations, Harvard Catalyst
Email

Hila Bernstein
Regulatory Affairs Officer, Harvard Catalyst
Email

Jessica Biggers
Regulatory Affairs Coordinator, Harvard Catalyst
Email

Return to top

Regional Research Subject Advocacy (RSA) Group - New England

The New England RSA group is a voluntary forum comprised of representatives from Harvard Catalyst, and the Clinical and Translational Science Centers at Boston University, Dartmouth College, Tufts University, University of Massachusetts, and Yale University. The group meets quarterly to explore common issues, interests, and concerns related to research participants, and research subject advocacy.

New England RSA Group Membership

Boston University - Mary-Tara Roth
Dartmouth College - Sheila Noone
Harvard Catalyst - Barbara Bierer, Enrico Cagliero, Sabune Winkler, Elizabeth Witte, Joanna Myerson
The Ottawa Hospital - Jonathan Roland
Tufts University - Aaron Kirby
University of Massachusetts - Worcester - Meg Johnson, Marsha Fox, Sarah Rulnick
Yale University - Alyssa Gateman, Helen Seow

Research Subject Advocacy (RSA) Advisory Board

The RSA Advisory Board is comprised of leaders from community development organizations, members of a local community ethics committee, partnering hospital research nurses, research coordinators, researcher/staff educators, RSAs, health disparities experts, a community engagement liaison, and an expert in cultural competency in research.

The RSA Advisory Board meets quarterly to guide the Regulatory Foundations, Ethics, and Law Program, identify areas for collaboration, and, most importantly, bring to the table relevant and current issues for the program to consider and address as appropriate.

To join the RSA Advisory Board please email us.

RSA Advisory Board Leadership

Enrico Cagliero, MD
Director, Research Subject Advocacy, Harvard Catalyst
Assistant Professor of Medicine, Harvard Medical School

Sabune Winkler, JD
Director, Regulatory Affairs Operations, Harvard Catalyst

RSA Advisory Board Membership

Michelle Beck
Administrative Director, Clinical Research Center, Beth Israel Deaconess Medical Center

Rajna Filip-Dhima
Research Manager, Boston Children's Hospital

Andrea Saltzman
Assistant Director, Office of Research Subject Protection, Broad Institute

Paul McLean
Vice President, Community Voices in Medical Ethics; Fellow, Center for Bioethics, Harvard Medical School

Karen Burns White, MS
Deputy Associate Director, Initiative to Eliminate Cancer Disparities, Office of Research, Dana-Farber Cancer Institute & Dana-Farber/Harvard Cancer Center

Kathy Eklund, RDH, MHP
Patient and Research Subject Advocate, Forsyth Institute

Lisa Chin
Independent Contractor in Clinical Research

Stacey Grabert
Assistant Director, Education Unit, Massachusetts General Hospital

Mary Larkin, RN, MS, CDE
Assistant Director, Diabetes Research Center, Massachusetts General Hospital

Wen Ni
Research Assistant, AIDS Clinical Trials Unit, Massachusetts General Hospital

Jonathan Roland, MS, BSN, RN, TNCC
Critical Care Nurse, The Ottawa Hospital

RSA Advisory Board Support

Joanna Myerson
Regulatory Affairs Officer, Harvard Catalyst
Email

Return to top

Social, Behavioral, and Economic Research (SBER)

Members of the Harvard Catalyst SBER Subcommittee bring to the table their experiences in research policy, review, and compliance, as well as education initiatives and engagement with community members. The subcommittee is composed of experts from within and beyond the Harvard Catalyst community who share experiences in the review of SBE research, discuss emerging issues in this field, and develop common resources and guidance for investigators and institutions. The ultimate goals of the subcommittee activities are to support ethical, regulatory compliant research endeavors and protect research participants.

To join the SBER Subcommittee please email us.

SBER Subcommittee Leadership

Cynthia Monahan (Co-Chair)
IRB Director, Boston University Charles River Campus
Email

Matthew Stafford (Co-Chair)
Manager, Office of Clinical Investigation, Boston Children's Hospital
Email

Barbara Bierer, MD (SBER Subcommittee Sponsor)
Program Director, Regulatory Foundations, Ethics, and Law, Harvard Catalyst

SBER Subcommittee Membership

Fanny Ennever
Manger, Regulatory Policy and Development, BU Medical Campus

Sara Harnish, JD
Assistant Director for Non-Clinical Research, Dana-Farber Cancer Institute & Dana-Farber/Harvard Cancer Center

Alyssa Speier, MS, CIP
QA/QI Education Specialist, Office of Regulatory Affairs & Research Compliance, Harvard T.H. Chan School of Public Health

Glover Taylor
Chief Compliance Officer, Cambridge Health Alliance

Jennifer A. Graf
Manager, Human Research Protection Program and Research Integrity, Cambridge Health Alliance

Jennifer Campbell, PhD
Manager of Research Integrity and Compliance, The Fenway Institute, Fenway Health

Kirby Johnson
Director of Program Development & Associate Professor of Pediatrics, Tufts University

SBER Subcommittee Support

Sabune Winkler, JD
Director, Regulatory Affairs Operations, Regulatory Foundations, Ethics, and Law Program, Harvard Catalyst
Email

Joanna Myerson
Regulatory Affairs Operations Officer, Regulatory Foundations, Ethics, and Law Program, Harvard Catalyst
Email

Jessica Biggers
Regulatory Affairs Coordinator, Harvard Catalyst
Email

Return to top

Regulatory Internship Program

Read More

Regulatory interns are invaluable members of our team. The internship program is open to students currently enrolled in undergraduate, graduate, or professional studies programs who have an interest in the legal, regulatory, policy, and ethical issues associated with human subjects protections and the conduct of clinical and translational research.

By interning with the Regulatory Foundations, Ethics, and Law Program, interns gain first-hand experience helping us in our work to reduce barriers in conducting clinical research, and accelerate the translation of medical discovery to clinical care.

The Regulatory Internship Program offers:

Exposure to world-class researchers and policy teams at leading Boston teaching hospitals, academic medical centers, and Harvard University affiliates.

Experience helping to develop tools and policies supporting innovative research.

Skill Development, including critical thinking, reading, writing, organization, and administrative skills required in the conduct of clinical and translational research.

Access to a network fostering connections among regulatory intern alumni.

Harvard Catalyst has provided me opportunities to meet with many experts in the regulatory area of clinical research. I've gained extensive clinical regulatory experience by drafting educational brochures, conducting gap analyses, organizing regulatory documentation, and more. Interning at Harvard Catalyst has not only enriched my work experience, but also broadened my horizons by providing many unexpected and wonderful opportunities for education and training.
—Wen Ni
Candidate for MS in Pharmacology, Northeastern University

Interns have come from academic programs focused on regulatory affairs or the sciences, but individuals pursuing other related areas of study may apply. Interviews are conducted on a rolling basis throughout the semester. Internships are typically 20 hours per week and may last from three months to one year and are unpaid. Interns most often receive academic credit for the internships.

Please contact us with your letter of interest and resume. We look forward to hearing from you!

Return to top

A Network of Research Expertise

Over 200 Harvard professionals collaborate to inform best practices in research oversight