Institutional Review Board

What is the NDNU Institutional Review Board (IRB)?

The NDNU IRB safeguards the rights and welfare of human research participants for research conducted in association with NDNU. The NDNU IRB is a committee comprised of members appointed via the Provost’s Office that reports directly to the Provost. It does not fall under the faculty governance structure due to its legal and ethical responsibilities, for which the Provost’s Office is ultimately responsible.

Members of IRB Committee:

Michael Drexler, PhD; Robynn Battle, EdD, Lu Chang, EdD; Jeff Charles, PhD; Lesley Higgins, PhD; Samuel Johnson Jr., MA; Kim Tolley, EdD

Purpose of the IRB:

The purpose of the IRB is to ensure that the legal and ethical rights, dignity, and well-being of all human participants are safeguarded for any type of research that is conducted by any constituents of the NDNU community, or by external parties at NDNU, encompassing NDNU community members as participants. The IRB works to ensure that the principles of respect for persons, beneficence, and justice are upheld as outlined in the Belmont Report (1979) created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

To this end, the IRB is obligated and authorized to:

Ensure that participants are adequately informed of the nature of the study.
Ensure that participation is voluntary.
Ensure that the benefits of a study outweigh its risks.
Ensure that the risks and benefits of the study are evenly distributed among the possible participant populations; and
Suspend human participant activity that violates regulations, policies, procedures, or an approved protocol, and report such violation and suspension to the provost of the university.

Message from the IRB Chair:

IRB approval is not a given right, but rather a privilege – we are under federal, ethical, and legal mandates that preclude automatic acceptance of all proposals. We rely on the information that is presented to us as being true and accurate and make our decisions based on such information. Ultimately, the responsible investigator and/ or supervisor/ research advisor are expected to uphold the rights of the participants in the project. Similarly, we appreciate the responsible party (ies) taking initiative and accountability to ensure that all participants’ rights are upheld and that no discriminatory, unethical, or illegal issues arise. Understanding and cooperation are expected.

Please note that physically invasive studies at NDNU are extremely rare and will require full review and possible external consultation in the review process. Similarly, the NDNU IRB will reject any proposal that places the mental/emotional well-being of participants at jeopardy.

General Overview:

NDNU has a comprehensive, user-friendly Canvas Course which guides our students and faculty through the process of determining whether their research needs to go through an expedited or full IRB review or qualifies for an exempt review. The course enables a prospective researcher to complete and submit their proposal, to receive Board member reviews, and to submit updates or information throughout the project’s lifecycle.

While proposals and related information (application form cover sheet, checklist) are submitted for IRB review through the Canvas portal, an overview of the process is available below within the Reference Links.

The University’s policies, procedures and guidelines have been drafted in compliance with federal guidelines set forth by the Office of Research Integrity (ORI), Department of Health and Human Services Office for Human Research Protections (OHRP), and the Belmont Report. All parties conducting any type of research with human participants, whether exempt or non-exempt status are responsible for reading and abiding by these policies, procedures, and guidelines.

Reference Links:

Contact Us:

Michael Drexler, PhD, CPRP,
Chair, NDNU IRB Committee
Faculty, Psychology Department
School of Psychology
mdrexler@ndnu.edu

Greg White, PhD
Provost
provost@ndnu.edu
650-508-3494

Notre Dame de Namur University is an equal opportunity employer firmly committed to non-discrimination in its hiring and other employment practices and personnel policies. In compliance with all applicable federal and state laws, except where a bona fide occupational qualification exists, NDNU will make employment decisions irrespective of the staff member’s race, color, religion, religious creed, ancestry, national origin, age (except for minors), sex, marital status, citizenship status, military service status, sexual orientation, medical condition (a cancer-related or genetic condition), disability and/or any another status protected by law. When necessary, the NDNU will reasonably accommodate individuals with disabilities if they are otherwise qualified to perform all essential functions safely and do it without undue hardship to the NDNU. Inquiries regarding the College’s equal opportunity policies should be directed to the Human Resources Department via email at hr@ndnu.edu. NDNU admits students of any race, color, national and ethnic origin to all the rights, privileges, programs, and activities generally accorded or made available to students at the school. It does not discriminate on the basis of race, color, national and ethnic origin in administration of its educational policies, admissions policies, scholarship and loan programs, and athletic and other school administered programs.

Mark Dee

Magellan Solutions USA launched under the visionary leadership of Mark A. K. Dee, Chief Executive Officer – a consultant and service provider for healthcare administrative support, IT development, energy, call center, and business process outsourcing. Mark has served in various multi-level management positions in his 21 years of service in the United States Air Force (USAF). He performed as Immunology and Microbiology department manager, Medical Laboratory Assistant Director, Facility and Security Manager, and finally retiring in the military in 2008 as Superintendent/Assistant Chief of Operations of 330 personnel Medical Group. Mark has experiences in the services industries since he retired, including running a restaurant chain as the CEO. He has also developed other businesses in the Martials Arts studio and 3d-printing industries. He has a BS in Health Sciences and Hospital Administration, Board Certified in Clinical Laboratory Sciences, Graduated in the Senior Executive Leadership School from the USAF, Master’s in Business Administration, and a Master’s of Science in Systems Management at Notre Dame De Namur University.

Chosen Cheng

Chosen Cheng is owner of CMC Group, a privately held engineering and marketing consultancy for small business startup ventures. He currently works with project teams developing patented award-winning solar roofing systems and patent pending drone-based augmented reality geological and thermal mapping solutions. He was formerly a Silicon Valley marketing and innovative corporate training manager. As an avocation and a way to “pay it forward” he enjoys teaching and career coaching college and graduate MBA students many of whom are pioneering first generation college students from underserved communities. He and his wife, a Notre Dame alum, celebrated their wedding reception at the Ralston Mansion in the 70’s and have two stupendously successful, married adult children who between them have four stupendously adorable grandchildren.

Arthur Chait

Entrepreneur, Executive, Engineer, Investor, Professor, Mentor. Founder & CEO EoPlex Inc. ($31 million VC funded startup acquired by ASTI Singapore). President Stanford Research Institute (SRI) Consulting Division (800 staff worldwide). SVP Flextronics (responsible for $8 Billion in global accounts). President Zitel Software. Principal Booz Allen. R&D Director Halliburton. Adjunct Professor Menlo College, Visiting Professor Universidad Francisco Marroquin (Guatemala), Mentor Draper University, Judge Startup Chile. BS Engineering Rutgers, MBA Strategy University Pittsburgh.

Kelly Cansler

Kelly completed both her BS (Finance/Economics) and MBA from NDNU. She utilized her business education to launch an insurance agency in 2008 with Farmers Insurance. It’s grown into multi-million-dollar agency, organically and through acquisition. She has been recognized by Farmers Insurance being ranked within the top 10% of agents nationwide, but also as a speaker, trainer, and mentor within the Farmers Insurance Community. Kelly is extremely connected with local businessowners through several networking channels.

Cliff Burnette

Cliff is the senior vice president and chief human resources officer at Rambus, a global chip and IP provider that advances data center connectivity and solves the bottleneck between memory and processing. Cliff has over 20 years of experience leading global human resources operations for publicly traded companies with expertise in employee relations, organizational development, and compensation strategy. Prior to Rambus, Cliff worked for several other high-tech companies in the semiconductor and medical device space and holds a bachelor’s degree in Business Management and Marketing from Texas State University and a master’s degree in Human Resources Management and Organization Development from the University of Texas at Austin.

Memo Morantes

Memo Morantes has been a San Mateo County resident for more than 45 years. He has been a three-term San Mateo County Board of Education incumbent, a Redwood City/San Mateo County Chamber of Commerce board member, a Sequoia Hospital Foundation member, a co-chair of the Latino Leadership Council of San Mateo, and a civic/community activist.

Sheryl Young

Sheryl serves as a director for Philanthropic Ventures Foundation, which provides $10M each year for innovative teachers and social entrepreneurs throughout the Bay Area. Prior Sheryl served as CEO of Community Gatepath and AbilityPath.org. She has over 30 years of managerial experience in operations, finance, and marketing. Young is a graduate of the Stanford University Graduate School of Business Executive Program for Non-Profit Leaders, earned an M.A. of Public Health from UC Berkeley, an M.A. in Special Education from Ball State University and a B.A. in Political Science from Purdue University.

Brian Schumacker

Brian manages South San Francisco-San Bruno’s wastewater treatment plant and with a dedicated staff of over 40 professionals who safeguard community health and protect the fragile San Francisco Bay ecosystem. Brian holds a Master’s Degree in Public Administration and a Bachelor of Arts Degree in Business Administration, both from Notre Dame de Namur University. Brian has also earned the highest levels of professional certifications in wastewater treatment.

Mario Rendon

Mario Rendon serves as District Director for State Assemblymember Kevin Mullin. He develops the communications, public relations and constituent service strategy for the office and supervises a small team that represents Mr. Mullin in the 22nd Assembly District within San Mateo County. He has over twenty year’s experience working with elected officials at the local, state and federal level developing public policy.

Jerry Hill

Jerry’s public service started with his local neighborhood association that progressed to the California State Assembly and Senate where he authored legislation resulting in laws on issues related to consumer protection, utility safety, coastal protection, public health, education and the environment. Jerry was born and raised in San Francisco, receiving his BA from the University of California, Berkeley and a Teaching Credential from San Francisco State University.

Magda Gonzalez

Magda was most recently the City Manager for the City of Half Moon Bay, California. Prior she was the City Manager of East Palo Alto, California and Assistant City Manager, Redwood City. Magda was President of Cal-ICMA, representing the Local Government Hispanic Network and serves on the Board of Directors for the San Mateo Credit Union and the Latino Leadership Council of San Mateo County. Magda is also a member of ICMA and the State Bar of California and received several awards and recognitions, including Career Excellence Award (WLG) and the Ethical Hero Award from Cal-ICMA.

Jeremy Dennis

Jeremy currently serves as Portola Valley Town Manager. Previously, he’s worked for elected officials at all governance levels, including twice as District Director for local assemblymembers. He worked as the Palo Alto Long Range Planning Director, and for San Mateo County in management roles. Jeremy has a Masters in Urban Planning from the London School of Economics, and graduated from UC Davis studying US History/Political Science.

Kate Comfort-Harr

Kate is Executive Director of HIP Housing, a nonprofit specializing in creative affordable housing solutions throughout San Mateo County. Kate is a frequent speaker on a wide array of affordable housing topics and is passionate about the cultivation of collaborations between the private, public and social sectors. She serves on the Board of Directors for the San Mateo Credit Union and was awarded the Chamber San Mateo County’s 2020 Business Woman of the Year Award.

Jeff Cox

Program Director for Master of Public Administration

Jerome Nadel

Jerome Nadel is Internationally experienced design-led marketing executive (CMO and GM) with a track record of improved market position, revenue growth, and M&A. He is an advance degreed psychologist and user experience product/service design expert, board member and advisor. Jerome recently retired from Rambus as where he was CMO and GM of the security software division that he led the sale to Visa. He has had a variety of chief marketing officer and chief user experience officer roles at companies including Human Factors International, SLP InfoWare, Gemplus, and Sagem. He started his career in the IBM Human Factors Labs. He is also an avid cyclist with National and multiple California State Champion titles.