An Institutional Review Board (IRB) is an administrative committee designated to provide ethical and regulatory oversight of research that involves human subjects.
IRBs exist to protect the rights, safety, and welfare of human subjects involved in research projects, consistent with ethical principles and federal, state, and local regulations. For human subject research conducted internationally, additional local regulations and international standards apply.
Human subjects research at IPA is guided by the ethical principles set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56.
In 2007, IPA established an IRB that would provide ethical oversight to international studies that were primarily randomized trials with vulnerable populations in low- and middle-income countries where IPA operates. The IRB is hosted by IPA and its administrative functions are handled by IPA staff, but it is independent of IPA staff, management, and researchers. The membership of the IPA IRB is diverse in affiliations and is composed of members who are external to IPA. The IRB convenes on a monthly basis. For additional information on meeting dates, please see IPA IRB Meeting Dates.
IRB approval is a fundamental part of IPA’s research quality protocols. To submit a study protocol for review, download the relevant IRB Form and submit via the appropriate link in the right sidebar. IPA requires that all IPA-implemented projects be reviewed by a U.S. or a similar IRB institution, as well as a nationally recognized (or equal) IRB in the country where research is taking place (if such an IRB exists) before the start of any human subject research activities. This process is the responsibility of the Principal Investigator. The IPA IRB is available to review studies conducted, managed, or funded by IPA in any of the following situations:
- where another institution is not providing a review.
- where another institution chooses to defer to the IPA IRB as a primary approver. The institution will send IPA IRB an IRB Authorization Agreement on their institutional letterhead.
- where the PI’s university, donor, or partner organization requires it. In this instance, IPA IRB will review the study as a secondary approver pending the primary institution’s approval.
Studies that receive federal funding must be reviewed by an IRB registered with the U.S. Department of Health and Human Services’ Office of Human Research Protections (OHRP). Institutions engaged in research that is federally funded must file and maintain a Federalwide Assurance (FWA) with OHRP, identifying in the FWA the IRBs on which it is reliant. In addition, the Institution must have in place a current IRB Authorization Agreement with the named IRB.
If any member of the public wishes to raise a concern about the safety of human subjects participating in IPA IRB-approved activities or to request submission and approval documentation related to an IPA IRB-approved study, they may contact firstname.lastname@example.org.
All requests for exemptions will be reviewed along with the initial application submission.
IRB Meeting Dates
|Deadline for submission of materials for IPA IRB full review
(non-minimal risk studies)
|IPA IRB Meeting Dates
(2 PM-3 PM EST)
|Wednesday, January 11, 2023, COB||Thursday, January 27, 2023|
|Wednesday, February 8, 2023, COB||Thursday, February 23, 2023|
|Wednesday, March 8, 2023, COB||Thursday, March 23, 2023|
|Wednesday, April 12, 2023, COB||Thursday, April 27, 2023|
|Wednesday, May 10, 2023, COB||Thursday, May 25, 2023|
|Wednesday, June 14, 2023, COB||Thursday, June 29, 2023|
|Wednesday, July 11, 2023, COB||Thursday, July 27, 2023|
|Wednesday, August 9, 2023, COB||Thursday, August 24, 2023|
|Wednesday, September 13, 2023, COB||Thursday, September 28, 2023|
|Wednesday, October 11, 2023, COB||Thursday, October 26, 2023|
|Wednesday, November 15, 2023, COB||Thursday, November 30, 2023|
|Wednesday, December 6, 2023, COB||Thursday, December 21, 2023|
Wesley G. Byerly, Pharm.D, CIP, IPA IRB Chair
Wesley G. Byerly is the Associate Vice President for Research Compliance for UConn Health. Dr. Byerly oversees research compliance at UConn Health, including animal subjects/Institutional Animal Care and Use Committee, biological safety/Institutional Biosafety Committee, financial conflict of interest, research integrity, responsible conduct of research, and works directly with the Human Research Subjects Protection Office to ensure the responsible conduct of research and compliance with applicable federal and state regulations. He also holds an appointment as Associate Research Professor in the Department of Pharmacy Practice.
Dr. Byerly has previously held research administrative positions at The University of Texas System, The University of North Carolina at Chapel, Duke University School of Medicine, and Wake Forest University School of Medicine. He received his undergraduate and Pharm.D. degrees from the University of North Carolina at Chapel Hill. He is a certified IRB Professional through PRIM&R, certified in Heath Care Research Compliance through the Health Care Compliance Association and maintains an active pharmacy license.
Megan Cottone, JD, Corporate Counsel at Globus Medical (Alternate Board Member)
Megan Cottone is Corporate Counsel for Globus Medical, and she is responsible for supporting multiple business functions, including research, operations, and sales, as well as advising on a wide variety of corporate and employment matters. Prior to Globus, she worked at a life sciences consulting and recruiting firm where she counseled CEOs and R&D leaders in pharmaceutical and biotech organizations regarding marketplace trends and talent acquisition. Before entering the life sciences community, Megan worked for many years at IPA as in-house counsel. During this time she supported the contract review and negotiation process, corporate compliance, and internal investigations. Megan obtained her J.D. from Villanova University School of Law and an undergraduate degree from the University of Miami. She is a certified conflict resolution mediator and Pennsylvania attorney.
Michael F. Craft, MA, Evaluation Officer at United Nations Secretariat
Michael F. Craft currently serves as an Evaluation Officer at the Office of Internal Oversight Services where he performs assessment of entities within the United Nations Secretariat. This has included evaluating advocacy work of the UN related to children and armed conflict as well as conflict-related sexual violence. Prior to his current position, he carried out programmatic and thematic evaluations at the Independent Evaluation Office of the UN Development Programme. He has extensive experience in designing research systems of evaluation functions in the UN system. Mr. Craft has also worked as a consultant for the UN Institute of Training and Research Multilateral Diplomacy Programme and supported local conflict transformation initiatives in the Democratic Republic of Congo. Mr. Craft holds a dual Master’s degree in International Affairs from Columbia University and Sciences Po (Paris).
Silke Hofer, PhD Candidate, Independent Evaluation and Social Development Consultant
Silke Hofer is an international social development and evaluation researcher and practitioner. She works with academic and multilateral organizations, including United Nations organizations and International Financial Institutions. Silke’s areas of specialization include international cooperation, public policy, organizational learning, program management, and monitoring and evaluation. She has lived and worked in Central Asia, Southeast Asia, West Africa, Europe, and the U.S. She holds Master’s degrees in Development Studies and German Literature from the University of Vienna in Austria and is currently working on a Professional Doctorate in Policy Research and Practice at the Department for Social & Policy Sciences at the University of Bath in England. She is particularly interested in policies to influence behavior change.
Niall Keleher, MA, PhD Candidate, University of California, Berkeley
Niall Keleher is a PhD student at the University of California, Berkeley's School of Information. Niall's research interests are in labor economics, social networks and new methods of data collection. Prior to starting his PhD at the University of Washington, Niall worked as Senior Director of Research Methods and Knowledge Management at Innovations for Poverty Action (IPA), where he directed IPA’s corps of over 500 research staff and oversaw the development of resources for high-quality research and training. He has worked to design and carry out more than a dozen research projects in the fields of rural finance, agriculture, transportation, and business training. He has extensive experience conducting research in rural and urban Malawi, where he served as Country Director for IPA from 2009 to 2012. Niall holds a Bachelor's degree in Economics and International Studies from the Johns Hopkins University and a Master's in Public Administration in International Development from the Harvard Kennedy School.
Boyla Mainsah, PhD, Research Scientist at Duke University
Boyla Mainsah is currently a Research Scientist in the Department of Electrical and Computer Engineering at Duke University, where she conducts extensive research on signal processing and machine learning with brain-computer interfaces (BCI). Additionally, her MSc in biomedical engineering has influenced her research interests in cochlear implants, heart sound analysis, implanted heart pumps, and non-invasive acoustic diagnostics. Boyla is a peer reviewer for a number of engineering journals and is a review panelist for the Massachusetts Institute of Technology’s summer research program.
Paul Newton, JD, CIP, Senior Research Regulatory Specialist, Legacy Research Institute (Prisoner Representative)
Paul Newton is an Oregon attorney with over 20 years of experience in law and litigation, investigation, trials and appeals, regulatory affairs, ethics and compliance, bioethics, institutional review board oversight (IRB), regulatory experience in animal research care and protection (IACUC), intellectual property, and visas. He first received his professional IRB certificate (CIP) in 2006. He has been the Senior Research Regulatory Specialist at Legacy Health since 2014, which entails overseeing IRB, IACUC, IP and Visa programs for Legacy Health in Portland, Oregon.
Prior to being involved in IRB work, Paul spent fifteen years as a criminal defense lawyer. Since beginning work in the IRB field in 1998, he has served on numerous IRB ethics committees—Oregon Health Division IRB, Oregon Health Sciences University IRB, Legacy Research Institute IRB, Western IRB, Portland State University IRB, Hummingbird IRB, and IPA IRB. He has also served as a bioethics advisor to a large pharmaceutical company, sat on hospital medical ethics committees, served on a genetics privacy committee, and conducted countless training sessions for lawyers, investigators, ethicists, IRB members, college students, researchers, and international Fellows.
Kristianna Post, MSc, Program Manager at Harvard T. H. Chan School of Public Health
Kristianna Post (Kristi) is currently a program manager at the Global Initiative for Neuropsychiatric Genetics Education in Research (GINGER), where she supports both curriculum development and the execution of various trainings. Before joining GINGER, Kristi worked for many years at Innovations for Poverty Action, first facilitating the implementation of randomized controlled trials in Kenya and later supporting research staff from the United States. In the context of her later work at IPA, she managed IPA’s Research Review Committee (RRC), Global Staff Trainings (GSTs), and Institutional Review Board (IRB). As a member of IPA IRB, Kristi brings her in-depth knowledge of the practicalities, constraints, and opportunities of IPA’s research portfolio.
Yandisa Sikweyiya, PhD, Associate Professor at University of the Witwatersrand (Alternate Board Member)
Yandisa Sikweyiya is a Specialist Scientist at the Gender and Health Research Unit of the South African Medical Research Council and provides teaching, post-graduate supervision, and research support as an Associate Professor at the School of Public Health, University of the Witwatersrand. Yandisa has served on various research ethics committees in South Africa including the University of Pretoria’s Health Sciences Research Ethics Committee, the South African Medical Research Council’s Human Research Ethics Committee, and the DMTS Health Research Ethics Committee. He has also served as a member of the National Health Research Ethics Council of South Africa. His research interests include research ethics, gender-based violence, men and masculinities, and social aspects of HIV. He holds a PhD in Public Health from the University of the Witwatersrand, a Master’s degree in Public Health from Umeå University, Sweden, and a post-graduate certificate in research ethics from the University of KwaZulu-Natal. He obtained his junior degree in Health Promotion from the University of Transkei.