Darcy K. Weidemann, MD, MHS

Program Director, Pediatric Nephrology Fellowship; Associate Professor of Pediatrics, University of Missouri-Kansas City School of Medicine; Education Assistant Professor of Pediatrics, University of Kansas School of Medicine

Full Biography

Behind the scenes, the Office of Research Integrity (ORI) team at Children’s Mercy Research Institute (CMRI) collaborates with researchers to ensure research is safe, ethical and of the highest possible quality. Saskia Miller, CIP, ORI Director, recently went above and beyond her usual role to advocate for the research community on a national level.

Leading with the CM value of curiosity, Saskia identified a roadblock that prevented some researchers from attaining a higher level of privacy protections for study participants. Her work to correct this oversight will help safeguard the privacy of sensitive participant information.

In January, the National Institutes of Health (NIH) announced it revised the process to obtain a Certificate of Confidentiality (CoC) after Saskia pointed out an issue with one of the requirements for the CoC. The revised process impacts researchers and research participants at not only CMRI but throughout the United States.

“The action that Saskia helped initiate will make it easier for researchers to provide additional privacy protections for research participants,” said J. Steven Leeder, PharmD, PhD, CMRI Executive Director,  Executive Vice President and Chief Scientific Officer.

What is a Certificate of Confidentiality (CoC)?

The NIH CoC protects the privacy of research participants by prohibiting the release of identifiable, sensitive information to anyone not connected to the research unless the participant agrees to the release. This protection extends to legal proceedings (civil, criminal, administrative, legislative, etc.) at all levels of government.

NIH-funded research automatically receives these protections. For research not funded by the NIH, researchers can apply for a CoC if their research includes identifiable, sensitive information. Regulations do not limit the availability of these protections by type of research being conducted. 

What is an Institutional Assurance Statement?

The NIH requires an Institutional Assurance Statement before it will accept a researcher’s request for a CoC. In this statement, the organization (in this case, CMRI) attests that it will abide by the NIH’s requirements for a CoC.  Prior to January, this included a statement that the researcher would notify participants of the CoC unless the researcher had obtained a waiver of consent for the research.

Catch-22

Darcy Weidemann, MD, MHS, Nephrology, is the Program Director of the Nephrology Fellowship Training Program and the Co-Program Director of the Quality Safety & Operational Excellence Improvement Program. She is also the principal investigator of a multi-site retrospective cohort analysis through the Pediatric Nephrology Research Consortium that studies the long-term outcomes of children with an ultra-rare condition called Tubulointerstitial Nephritis with Uveitis (TINU). This condition affects the kidneys and eyes.

Dr. Weidemann applied for a CoC for the research project because the research data contains identifiable, sensitive information.

As Candice Foster, Senior Manager, Pre-Award Administration, and Saskia assisted Dr. Weidemann with the CoC process, they ran into a Catch-22 situation. To obtain the CoC, CMRI needed to submit an Institutional Assurance Statement, which confirms the researcher obtained participant consent or was granted a waiver of consent instead.

Dr. Weidemann’s retrospective analysis involves a common research method of using existing data from medical charts, and regulations do not require consent or a waiver of consent for her study. This means that CMRI could not provide the Institutional Assurance Statement to confirm participant consent or a waiver of consent because neither is required for her study. Yet, without an Institutional Assurance Statement, Dr. Weidemann’s CoC application could not be submitted to the NIH for review and approval. In short, this made it impossible for Dr. Weidemann to apply for the CoC.

“This seemed counter to the regulations and to the spirit of the protections provided, which should be available to all research participants regardless of type of research conducted,” said Saskia. “This holds especially true in a day and age when we see research carry informational risks alongside its more traditional physical risks.”

Advocating for a solution

In October 2024, Saskia reached out to the NIH to ask for the agency’s guidance on how to make these important additional protections available to all types of research, including research without a regulatory consent requirement. Last month, the NIH responded to her and stated that it had revised their Institutional Assurance Statement to now allow for inclusion of all types of research, including research without a regulatory consent requirement.

“Thanks to efforts led by Saskia — and in the spirit of the regulations, participants in all types of research conducted with identifiable, sensitive information throughout the United States are now able to enjoy the additional privacy protections of a Certificate of Confidentiality,” said Dr. Leeder.