Dr. Lyric Jorgenson has co-authored this blog with NIH Deputy Director for Intramural Research, Dr. Nina Schor, NIH Deputy Director for Extramural Research, Dr. Michael Lauer and NIH Deputy Director for Management, Dr. Alfred Johnson 

The final policy incorporates and is responsive to the principles and directives of the Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking, Protecting the Integrity of Government Science, and A Framework for Federal Scientific Integrity Policy and Practice. The end goal of these efforts was to institutionalize a culture of scientific integrity across the federal government by requiring that agencies either develop or update their existing policies.

As you are most likely aware, NIH has for many years been a leader in promoting practices, policies, and procedures that help ensure the research it funds and conducts is done in accordance with the highest possible standards.  We already have in place a suite of complementary efforts to protect the integrity of research processes from bias and interference.  These efforts rely on transparent processes, diverse community engagement, management of real or apparent conflicts of interest, and robust and open dialogue.

However, we did see opportunities where we could strengthen our existing system.  These areas are articulated in the final policy and include:

• Defining the term “scientific integrity” for consistent use across the U.S. Government
• Establishing the new positions of NIH Chief Scientist and NIH Scientific Integrity Official and defining the roles and responsibilities of these positions
• Establishing the NIH Scientific Integrity Council to coordinate scientific integrity activities across the Agency; and
• Adding additional protections against inappropriate political interference

The above measures, in concert with NIH’s existing policies and procedures, will foster scientific integrity, by helping to ensure that (1) research findings are objective, credible, and readily available to the public, and (2) policies and programs are developed and implemented in a transparent, accountable, and evidence-based manner.

It is vital to recognize that the final policy is grounded in the philosophy that all NIH staff, and everyone within the biomedical research enterprise. have a role to play in supporting the integrity of the research we fund, conduct, manage, communicate, or use.  As such, all NIH researchers and staff are expected to: 

• Foster an organizational culture of scientific integrity.
• Protect the integrity of the research process, and
• Communicate science with integrity.

The Final NIH Scientific Integrity Policy will go into effect December 30, 2024. To ensure that NIH stays a leader in this space, we will reevaluate the policy one year after the effective date and then every two years after that. 

Finally, to mark this occasion, Dr. Monica Bertganolli has issued a NIH Director’s statement which can be found at https://www.nih.gov/about-nih/who-we-are/nih-director/statements/ensuring-trust-science-nih-s-commitment-scientific-integrity.

This is an excerpt from the October 11, 2024, issue of the NIH Record.  The article below was authored by Eric Bock and all photos were taken by Chia-Chi Charlie Change. The original article can be found at: https://nihrecord.nih.gov/2024/10/11/event-honors-nih-partnership-voices-our-fathers-legacy-foundation

NIH recently debuted a plaque honoring the memory of the African American men unethically treated in the U.S. Public Health Service (USPHS) Untreated Syphilis Study and the 50th anniversary of the National Research Act at the National Library of Medicine (NLM) herb garden, across from Bldg. 38, on Sept. 19.

“This plaque shines a light on the injustices of the past, not letting us forget them so they are never repeated,” said NIH Director Dr. Monica Bertagnolli during the dedication ceremony. “NIH is committed to making biomedical research inclusive and accessible for everyone.”

In 1932, the study began in Alabama. Originally called the “United States Public Health Service Study of Untreated Syphilis in the Negro Male at Tuskegee and Macon County, Alabama,” the study enrolled 625 African American men. Researchers conducting the study did not obtain informed consent and did not offer treatment, even after it was widely available.

“Much is known about the inhumane, immoral, unethical treatment of these men,” said Lillie Tyson Head, founding president of the Voices For Our Fathers Legacy Foundation, a nonprofit formed by the descendants of the men who were treated unethically in the study. “But little is known about their humanity.”

As Tyson Head noted, most of the participants were poor sharecroppers who had little time or money for doctor visits. During the growing season, they spent their time working in vegetable gardens, tending to farm animals and preparing fields for corn, beans and cotton. They had few opportunities to learn to read and write.

These men were sons, husbands, fathers and brothers. “The most important things to them were caring and providing for their families,” she said.

The study ended in 1972, after a reporter exposed it and a federal committee, which met at NIH among other locations, recommended the study be shut down. After a public outcry, the National Research Act was signed into law, creating federal rules to protect human research participants. The law was a direct response to the men who were mistreated in the study.

“We understand that history cannot be undone,” said Tyson Head. “We can construct bridges to trustworthiness and health care. By working together, we can make health equity a reality, dismantle racial and social injustices and advance biomedical research.”

Recently, the foundation met with NIH leadership to discuss how NIH could assist in uncovering the truths held within records that might be yet undiscovered, said Dr. Lyric Jorgenson, NIH’s associate director for science policy. NIH worked with the foundation to locate and preserve documents from the study.

“We are incredibly pleased that we could work with these leaders and help shed some additional light on this unjust effort so that we may never again repeat our past,” said Jorgenson.

Documents from the study are now publicly available on NLM’s website, said acting NLM Director Dr. Steven Sherry. Working closely with Fisk University, NLM digitized more than 3,000 records from the study. Examples of records include correspondence, meeting minutes, reports and scientific articles. Previously, these documents were only available in physical form.

“NLM’s stewardship of this collection supports our mission to enable biomedical research and support health care and public health through free online access to scholarly biomedical literature,” he said. “Our goal for this significant collection is to reach a broad audience and serve as a beacon of transparency with the biomedical and health care community.”

The National Research Act acknowledges the government’s past failures and commits health officials to a future where ethical principles are paramount to the conduct of research, said Department of Health and Human Services Assistant Secretary for Health ADM Rachel Levine in recorded remarks.

“The National Research Act is the U.S. government’s commitment to the American people that the pursuit of knowledge must not come at the cost of human dignity and human rights,” Levine concluded. She thanked everyone in attendance for partnering to ensure transparency and high ethical standards in research to create a healthier future for all who live in the U.S.

View the full collection of documents from the study at go.nih.gov/PCjiOXk.