Main Menu - Harvard Catalyst Main Menu – Harvard Catalyst
Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

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

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:

Clinical Trials Registration & Results Reporting (CTR3) Subcommittee

The CTR3 subcommittee evaluates and recommends best practices and procedures related to the informed consent process. The subcommittee examines common challenges encountered by biomedical and social behavioral researchers when obtaining and documenting informed consent and will develop current tools and resources to effectively communicate study information to participants.

Consent subcommittee members identify key topics for discussion, evaluation, and review. The subcommittee promotes a strategic, effective, and cooperative approach to evaluating policies, processes, and procedures governing the informed consent process.

CTR3 Subcommittee Leadership

Isabel Chico-Calero, DVM, PhD (Co-Chair)
Regulatory Specialist, Partners HealthCare
Email

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

CTR3 Subcommittee Membership

Amy Ben-Arieh
Manager of Research Integrity and Compliance, The Fenway Institute

Rebecca Betensky, PhD
Biostatistics Professor, Harvard T.H. Chan School of Public Health

Alan Fossa
Biostatistician, Beth Israel Deaconess Medical Center

Eleanor Greene
Senior Research Compliance Specialist, Beth Israel Deaconess Medical Center

Susanna Jacobus
Biostatistician, Dana-Farber Cancer Institute

Odette Lobo
Joslin Diabetes Center

Ian McGovern, MPH
Clinical Research Coordinator III, Massachusetts General Hospital Cancer Center

Lauren Robertson, MSM, MA
Assistant Director of Research Administration, Boston Children's Hospital

Alyssa Speier
Associate Director for Regulatory Affairs & Research Compliance, Harvard T.H. Chan School of Public Health

Sarah White
Director, Quality Improvement Program, Partners HealthCare

Return to top

Community-Engaged Research (CEnR) Task Force

The Community-Engaged Research (CEnR) Task Force comes together as needed to help IRBs, investigators, and communities in supporting community research.

For more information, please email us.

Consent Subcommittee

The Consent Subcommittee works to evaluate and recommend best practices and procedures related to the informed consent process. The subcommittee examines common challenges encountered by biomedical and social behavioral researchers when obtaining and documenting informed consent and will develop current tools and resources to effectively communicate study information to participants.

Consent subcommittee members identify key topics for discussion, evaluation, and review. The subcommittee promotes a strategic, effective, and cooperative approach to evaluating policies, processes, and procedures governing the informed consent process.

Consent Subcommittee Leadership

Luke Gelinas, MA, PhD (Co-Chair)
Harvard Law School
Email

Jennifer Graf (Co-Chair)
Cambridge Health Alliance
Email

Consent Subcommittee Membership

Kathryn Bean
IRB Administrator, Harvard University

David Christiani, MD, MPH, MS
Professor of Occupational Medicine and Epidemiology, Harvard T.H. Chan School of Public Health

Betsy Draper
Manager, Research Protections and Operations, New England Baptist Hospital

Rosalyn Gray
Director, Human Research Review & Compliance, Partners HealthCare

Shana Haynes-Harp
Project Manager, Brigham & Women's Hospital

Justeen Hyde, PhD
Investigator, Center for Healthcare Organization & Implementation Research (CHOIR), VA Boston Healthcare System

Daniel Jones
QA/QI Specialist, Partners HealthCare

Susan Kornetsky, MPH
Director, Clinical Research Compliance, Boston Children's Hospital

Dan Kronish
Associate Director of Medical Review, Dana-Farber/Harvard Cancer Center

Cynthia Monahan, MBA, CIP
IRB Director, Boston University

Rita Monahan, CIP
Clinical Trials Specialist, Beth Israel Deaconess Medical Center

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

Yemi Talabi-Oates, MBA
Administrative Director, Center for Clinical Investigation, Brigham & Women's Hospital

Beth Watters
Attorney, Partners HealthCare

Delia Wolf
Associate Dean, Regulatory Affairs & Research Compliance, Harvard T.H. Chan School of Public Health

Return to top

Investigational Drugs & Devices (IND/IDE) Task Force

The Harvard Catalyst IND/IDE Task Force comes together as needed to assist IRBs as well as faculty who are sponsor-investigators under the FDA regulations related to investigational new drugs and devices.

For more information, please email us.

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

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.

Emerging Technologies, Ethics, and Research Data Subcommittee

The Emerging Technologies, Ethics, and Research Data Subcommittee 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).

Emerging Technologies, Ethics, and Research Data Subcommittee Leadership

IT (Research Computing/Security)

Joe Zurba, CISSP, CISA (Emerging Technologies, Ethics, and Research Data Co-Chair)
Information Security and IT Compliance Officer, Harvard Medical School
Email

IRB (Human Subjects Protection Officers)

Kim Serpico (Co-Chair)
Assistant Director, IRB Operations, Harvard Longwood Medical Area (LMA)
Email

Emerging Technologies, Ethics, and Research Data Subcommittee Membership

IT (Research Computing/Security)

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

Kele Piper, MS, CIP, CHRC
Director Research Compliance, Beth Israel Deaconess Medical Center

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

Michelle Irick, JD
Research Compliance Manager, Brigham and Women's Hospital

Ryan Callahan, MBA
IT Manager, Boston Children's Hospital

Paul Scheib
Information Security Officer, Boston Children's Hospital

Bruce Kozuma
Senior Systems Analyst, Broad Institute

Jean Chang, PhD
Principal Systems Analyst, 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

Scott Edmiston, JD, CIPP/US
Director of Research Privacy and Security Compliance, Harvard Medical School

Robert Wolf
Biostatistician/Senior Programmer, Harvard University

Paul Avillach MD, PhD
Assistant Professor, Department of Biomedical Informatics, Harvard Medical School

Amy Hudspeth Cabell, JD, MBA
Research Integrity & Compliance Officer, Harvard Pilgrim Health Care Institute

Sam (Tracy) Potter
Office of Sponsored Programs Training Specialist, Harvard Pilgrim Health Care Institute

Chris Grasso
Associate Director, Health Informatics and Data Services, Fenway Community Health Center

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

Fabio Martins
Research Information Security Officer, Partners HealthCare

Arpita Husain
Research Data Analyst, Partners HealthCare

Heather Shea
Information Security Officer, Partners HealthCare at Home & Spaulding Rehabilitation Network

Megan Morash
Chair - Partners Research Committee, Partners HealthCare

IRB (Human Subjects Protection Officers)

Jessica Ripton, MPH
Director of IRB Operations, Committee on Clinical Investigation, Beth Israel Deaconess Medical Center

Tonya Ferraro
Senior IRB Administrator, Harvard University

Pamela Richmond
Director of IRB Operations, Hebrew Senior Life

Kim Serpico, MEd, CIP
Assistant Director of IRB Operations, Harvard T.H. Chan School of Public Health

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

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

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

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

Eunice Newbert, MPH (Co-Chair)
Manager of Quality Improvement Clinical Research, Boston Children's Hospital

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

QA/QI Subcommittee Membership

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

Amy Hudspeth Cabell, JD, MBA
Research Integrity & Compliance Officer, Harvard Pilgrim Health Care Institute

Meghan Cashman, MFA
IRB Manager, St. Elizabeth's Medical Center

Gina Daniels, BS
Human Research Quality Manager, Boston University

Maureen English
Quality and Education Manager, Massachusetts Eye and Ear

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

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

Laura Henderson
IRB Administrator, Harvard University

Leslie Howes, MPH, CIP
Director, Office of Human Research Administration, Harvard T.H. Chan School of Public Health

Daniel Jones, RN, MSN
Senior QI Specialist, Human Research QIP, Partners HealthCare

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

Fiona Rice, MPH
Human Research Quality Manager, Boston University

Mary-Tara Roth, RN, MSN, MPH
Director, Clinical Research Resources Office, Boston University

Alyssa Speier, MS, CIP
Associate Director, Regulatory Affairs & Research Compliance, Harvard T.H. Chan School of Public Health

Return to top

Research Subject Advocacy (RSA) Program

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.

RSA Advisory Board Membership

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

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

Lisa Chin
Independent Contractor in Clinical Research

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

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

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

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

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

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

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

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, MBA, CIP (Co-Chair)
IRB Director, Boston University Charles River Campus
Email

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

SBER Subcommittee Membership

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

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

Meghan Pronovost
IRB Administrator, Harvard University

Glover Taylor, MPA
Chief Compliance Officer, Cambridge Health Alliance

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

Amy Ben-Arieh
Manager of Research Integrity and Compliance, The Fenway Institute, Fenway Community Health

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

Lara Sloboda
Manager of IRB Operations, Tufts University

Return to top

A Network of Research Expertise

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

Footer - Harvard Catalyst Footer – Harvard Catalyst