Celebrating 60 Years of the IRB Protecting Research Participants
For 60 years, the Hennepin Healthcare Institutional Review Board (IRB) has helped ensure research is conducted safely and ethically, with the rights and well-being of participants at the forefront. Since its beginnings in 1966 as the Research Advisory Committee, the IRB has evolved alongside Hennepin Healthcare’s research enterprise and remains a key part of the Human Research Protection Program (HRPP). Today, a diverse group of physicians, scientists, nonscientists and community representatives helps ensure research is ethical, thoughtful and focused on participant safety. Hennepin Healthcare’s HRPP is accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), reflecting its commitment to rigorous standards and protecting research participants. As we celebrate six decades of ethical research oversight, the IRB’s mission remains clear: We advance research. We support discovery. Most importantly, we protect people.
Hennepin Healthcare Institutional Review Board (IRB) History
City Hospital established
1897
The hospital known today as Hennepin Healthcare HCMC began as City Hospital.
Minneapolis General Hospital
1905
City Hospital became Minneapolis General Hospital.
The Nuremberg Prosecution/Trials
1945-46
People responsible for war crimes and crimes against humanity during the World War II were brought to trial in Nuremberg, Germany. These crimes included performing medical experiments without the subjects’ consent and committing inhuman acts during the experiments. A set of research ethics principles called the Nuremberg Code was established because of the trials.
Minneapolis Medical Research Foundation established
1952
In August 1952, the Minneapolis Medical Research Foundation (MMRF) was incorporated with the mission to improve patient care and community health through research and education. The MMRF was located on the Minneapolis General Hospital campus.
Hennepin County General Hospital
1963
Hennepin County assumed ownership of Minneapolis General Hospital and it was renamed Hennepin County General Hospital (HCGH).
Declaration of Helsinki adopted
1964
The World Medical Association (WMA) developed the Declaration of Helsinki, establishing international ethical principles for medical research involving human participants. Widely recognized as the cornerstone document on human research ethics, it ensures that people are treated safely, fairly and respectfully when they take part in research studies. The Declaration of Helsinki has been revised several times since it was adopted to reflect evolving research standards, societal values and new technologies.
Laying the foundation for modern human research protections in the U.S.
1966
Henry K. Beecher, MD, published "Ethics and Clinical Research" in the New England Journal of Medicine, drawing national attention to unethical research practices, laying the foundation for implementation of federal rules on experimentation involving human subjects and informed consent.
U.S. public health grant policy creates the basis for IRBs
1966
The U.S. Surgeon General implemented a new policy requiring federally funded human subjects research to undergo prior ethical review by an independent committee. This policy created the basis for Institutional Review Boards (IRBs).
Research Advisory Committee (IRB) formed at MMRF and HCGH
1966
In May 1966, MMRF and Hennepin County General Hospital established the Research Advisory Committee, the organization's first IRB.
Tuskegee Syphilis Study exposed
1972
Public disclosure of the 40-year Tuskegee Syphilis Study led to sweeping reforms in the oversight of human subjects research in the United States.
The U.S. Public Health Service and Tuskegee Institute conducted a nontherapeutic study of untreated syphilis in African American men in rural Alabama. Many participants were poor and had limited literacy, and they were offered free health care in exchange for taking part. The study lacked adequate safeguards to protect their safety and well-being.
National Research Act enacted
1974
In response to public outrage about the Tuskegee Syphilis Study, the National Research Act was signed into federal law and led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission identified ethical standards for human research and drafted the "Belmont Report," which established core principles for research involving human subjects.
Hennepin County Medical Center established
1976
Hennepin County General Hospital became Hennepin County Medical Center (HCMC).
Belmont Report published
1978
The "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" established the fundamental ethical principles for research involving people. Its three main principles—respect for persons, beneficence and justice—form the foundation for conducting human subjects research. The report is an essential guide for IRBs.
Research Advisory Committee renamed HSRC
1987
The Research Advisory Committee was renamed the Human Subjects Research Committee (HSRC) to better reflect its mission. A research coordinator position was also added to support committee operations.
Vice chair position created
1994
The HSRC added its first vice chair position, strengthening committee leadership and governance.
HCMC's governance changes
2007
On Jan. 1, 2007, HCMC’s operational oversight transitioned from Hennepin County to a separate Public Benefit Corporation, Hennepin Healthcare System (HHS) doing business as HCMC.
AAHRPP awards us full accreditation
2011
MMRF underwent a rigorous process to earn accreditation from the leading, independent organization that accredits institutions that conduct medical research trials on human subjects—the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Earning accreditation from this organization is indicative of our commitment to maintaining the highest level of ethical standards and practices in our medical research programs.
MMRF becomes a subsidiary of the Hennepin Healthcare System
2012
Hennepin Faculty Associates (HFA) and Hennepin Healthcare System (HHS), which had shared a 28-year history of collaboration in providing health care and medical education, integrated in 2012. Minneapolis Medical Research Foundation (MMRF), which was part of HFA, became a non-profit subsidiary of HHS. While accountable to HHS under the new governance structure, MMRF operates with relative administrative and financial autonomy.
Hennepin Healthcare IRB celebrates 50 years
2016
The HSRC commemorated 50 years of independent ethical oversight of human subject research at Hennepin Healthcare. The board, led by HSRC Chair Frederick Langendorf, MD, reflected on this milestone and honored committee member Robert Sherman, PhD, who served for 48 years on the IRB.
Leading the way the first 50 years
1966-2016
Six Chairs led the Hennepin Healthcare IRB during its first five decades.
- Milton Ettinger, MD (1966 to 1972)
- Claude Hitchcock, MD (1972 to 1984)
- LoAnn Peterson, MD (1984 to 1987)
- John Haglin, MD (1987 to 1993)
- Dean Tsukayama, MD (1994 to 1997)
- Frederick Langendorf, MD (1998 to 2017)
Continued stewardship during a period of growth
2016-2021
Following the IRB's 50th anniversary, committee leadership continued guiding the program through an evolving research environment, including changing federal regulations, increasing research complexity and the transition toward more comprehensive human research protections.
Dr. Craig Peine appointed IRB Chair
2017
Fred Langendorf, MD, retired in early 2017 after serving as IRB Chair since 1998. Craig Peine, MD, a gastroenterologist specializing in the mechanisms and treatment of chronic liver disease, is named his successor.
MMRF rebrands as Hennepin Healthcare Research Institute (HHRI)
2018
In March 2018, Hennepin County Medical Center (HCMC) rebranded as Hennepin Healthcare to better describe its full system of care that includes Hennepin Healthcare HCMC hospital, as well as a clinic system with primary care clinics.
In August 2018, Minneapolis Medical Research Foundation (MMRF) changed its name to Hennepin Healthcare Research Institute (HHRI) to better align with its parent and affiliate organizations.
Hennepin Healthcare earns full AAHRPP reaccreditation
2019
Hennepin Healthcare’s Human Research Protection Program received full reaccreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), recognizing its commitment to high standards for ethical research and participant protections. Hennepin Healthcare has been accredited by AAHRPP since 2011.
Cayuse Human Ethics implemented
2021
In January 2021, the Hennepin Healthcare IRB moved from paper-based workflows to Cayuse Human Ethics (HE), a cloud-based platform for drafting, submitting, reviewing and managing IRB protocols for human subjects research. The transition modernized the IRB’s processes and made it easier to manage protocols electronically.
Karen Heim-Duthoy, PharmD, retires after decades of IRB service
2021
After 33 years as an IRB member and 27 years as vice chair, Karen Heim-Duthoy, PharmD, retired from Hennepin Healthcare on Jan. 5, 2021. Her longstanding leadership and expertise helped shape the IRB’s commitment to ethical research and participant protections.
Dr. Allyson Hart named IRB chair
2021
In July 2021, Allyson Hart, MD, MS, began serving as chair of the Hennepin Healthcare Institutional Review Board. During her tenure, the Human Research Protection Office implemented a new staffing structure and updated policies and procedures to support workflows associated with the transition to Cayuse Human Ethics, the electronic IRB management system implemented in late 2020.
Expanding transparency, engagement and support
2021-2025
Under Hart's leadership, the IRB continued strengthening its role within Hennepin Healthcare's Human Research Protection Program, emphasizing ethical research oversight, community representation and support for investigators navigating human subjects protections.
Tzivia Leviton appointed IRB vice chair
2022
In July 2022, Tzivia Leviton, who had served as an IRB member for 25 years, was appointed IRB vice chair.
Human research protection program reaccredited
2024
Hennepin Healthcare’s Human Research Protection Program was reaccredited by AAHRPP, reaffirming the organization’s commitment to ethical research practices and protecting the rights, safety and well-being of research participants.
Dr. Mark Oswood promoted to IRB chair
2025
In October 2025, Mark Oswood, MD, PhD, was promoted to chair of the Hennepin Healthcare Institutional Review Board after serving as vice chair for one year. Dr. Hart transitioned to the vice chair role while recruitment began for a new physician vice chair.
Dr. Kerri Sheets appointed IRB physician vice chair
2026
In April 2026, Kerri Sheets, MD, accepted the appointment as the IRB physician vice chair.
Celebrating 60 years of ethical research oversight
2026
For six decades, the Hennepin Healthcare IRB has remained committed to protecting the rights, safety and well-being of research participants while supporting research that advances patient care and improves the health of the community.