National Advisory Committee on Human Research Protections (NACHRP): Interview with Julie Kaneshiro

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Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

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Today, we are going to learn about National Advisory Committee on Human Research Protections (NACHRP).

In this candid interview with Julie Kaneshiro, we will learn about her journey when she first started in federal human research oversight. Then, we will shift the discussion towards NACHRP and what we can expect from this new organization.

As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

Table of Contents:

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I see you’ve worked in the federal government industry throughout your entire career, specifically with OHRP from 2002 until June this year. What initially drew you into human research oversight?

Julie suspects that her childhood exposure to the National Institutes of Health (NIH) through her mother’s role as a social worker in the NIH Clinical Center that led to her interest in human research protections. In the early 1990s, she became an NIH management intern at NIH. Through this internship program, she learned about the Office of Human Research Protections’ (OHRP) predecessor office, the Office for Protection from Research Risks (OPRR).  The typical career path for a management intern at the time was research administration.

However, she was interested in public policy and bioethics.

Once she learned about OPRR’s mission to protect research participants, she knew this is where she wanted to be. She expressed gratitude towards the people at OPRR who became her mentors, including Gary Ellis, Joan Porter, Bill Dommel, and Tom Puglisi. Julie joined soon after the Common Rule was adopted. The OPRR staff gave her invaluable experiences and opportunities to learn about these regulations and ethical issues that were present.

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I’d like to learn how you became engaged with SACHRP (The Secretary’s Advisory Committee for Human Research Protections, but first why don’t you give us a brief overview of who SACHRP was and their mission?

SACHRP was created in 2003. This organization advised the Secretary of HHS about issues related to human research protections. Unfortunately, SACHRP was terminated in March 2025. SACHRP’s recommendations were of great value to HHS, and especially to OHRP over this 22-year period.  The members of SACHRP and its subcommittees were some of the most knowledgeable people working in human research protections. They provided valuable recommendations to OHRP and other entities within HHS that have a role in the participant protections. HHS agencies include the Food and Drug Administration (FDA), NIH and the Office for Civil Rights (OCR).  OHRP was responsible for the management and support of SACHRP. Specifically, OHRP staff were involved with identifying topics that institutions would benefit from SACHRP and their subcommittees’ experience and expertise. 

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When SACHRP was terminated in March 2025, how did you feel about this? Was the termination a surprise to you?

Naturally, Julie was disappointed to learn about SACHRP’s termination, but was not surprised.  It is not unusual for advisory committees to undergo change or be eliminated with a change in administration.  Prior to the establishment of SACHRP, there was the National Human Research Protections Advisory Committee which existed from 2000-2003. Their mission was comparable to SACHRP.

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What were the main consequences (intended or unintended) of dissolving SACHRP for the human research protections community?

The loss of SACHRP was not just a loss for OHRP and HHS, but also to:

• The other Common Rule department and agencies,
• The broader human research protections community and
• The public more generally. 

Though SACHRP wasn’t the only entity engaged in these crucial discussions, its important voice gave OHRP and others valuable insights. It is key that SACHRP was a FACA committee.

FACA committees conduct meetings and deliberations in public, with the opportunity for public input.

All of SACHRP’s recommendations are available to the public. These recommendations remain an important resource for the human research protections community.

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Let’s shift the discussion to NACHRP (The National Advisory Committee on Human Research Protections). What is NACHRP?

NACHRP is a volunteer-driven organization that aims to continue the tradition of the U.S. Department of Health and Human Services, Secretary’s Advisory Committee on Human Research Protections (SACHRP). NACHRP will:

• Provide expert advice and practical recommendations to the human research community based on established ethical principles, including the Belmont Report and the Declaration of Helsinki.
• Promote consistent interpretation and application of federal regulations and guidance in coordination with Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs).
• Respond to emerging challenges arising from advances in science, medicine, and technology, while anticipating future developments and supporting responsible innovation.
• Commit to ethical vigilance and innovation in participant protections, and to honoring the trust placed in research with transparency, respect, and integrity.
• Provide opportunities for community input and participation.

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As we enter 2026, given current research trends, are these specific topics NACHRP is seeking to provide guidance on? What should IRBs be on the lookout for and start to educate themselves on? E.g., there have been multiple AI guidance documents and frameworks published this year.

NACHRP is just beginning its work and is eager for input about what topics would be useful to address.

NACHRP’s first Town Hall meeting will be on Monday, December 8th from 10:00-11:30 PT (1:00-2:30 ET) on The Importance of “Unchecking the Box”:  A Primer on the Power of Regulatory Flexibility.

This Town Hall will be hosted by the organization, Public Responsibility in Medicine and Research: Event Link

• NACHRP appreciates and acknowledges the incredible breadth of subject matter expertise, creativity, and skill among those in the human research community.
• If folks are interested in volunteering, NACHRP will issue periodic calls for those with specific, topical subject matter expertise to also help develop guidance.
• Folks are welcome to submit their CV and top two specific areas of expertise at any time.

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I hope you enjoyed this interview with Julie Kaneshiro!