# YOU GAVE CONSENT BUT DO I HAVE PERMISSION?

> **NIH NIH R03** · MAYO CLINIC ROCHESTER · 2024 · $161,400

## Abstract

PROJECT SUMMARY/ABSTRACT
Many people hesitate to contribute their biospecimens and data, including genomic data, for research because
they believe that misuse is likely. Biobanks have a tricky problem – that they must engender trust with
specimen contributors that they will protect biospecimens and data while simultaneously aiming to get
biospecimens and data to the investigators who can most use them. Most biobanks report underutilization of
their stored biospecimens and data (including genomic information) for reasons including underdeveloped,
unharmonized data management technologies. Without metadata to link permitted conditions for sharing and
reuse, biorepositories risk sharing resources which were impermissible to share or contributing to resource
inefficiencies by not sharing. The long-term goal of this research program is to respect and protect
biospecimen contributors’ autonomous choices and to promote transparency in how those choices are made
knowable across biorepositories’ information systems and expressed to individual investigators. The overall
objective of the proposed research is to empirically validate one or more standards-based models which make
permissions for biospecimen sharing and reuse understandable to machines. This study will include
examination of four information models and will be achieved through a single specific aim: to evaluate four
established machine-interpretable models for expressing permissions, restrictions, and obligations for
biospecimen and information sharing and reuse. Our rationale is: before biospecimen management
applications implement a model for labeling biospecimens and information resources according to permissions,
restrictions, and obligations which govern their reuse, that model must be vetted for accurate representation of
real-world consent forms and policy documents. This aim will be achieved through identifying and annotating
sentences from at least 20 consent forms which express permission or constraint regarding biospecimen and
data sharing and reuse, those sentences will be deconstructed according to the entities and processes within
each model, and the models will be evaluated in terms of their consistency, completeness, conciseness, and
interoperability. Additionally, the deconstructed sentences will be applied to each model’s response lists (or
value sets) and evaluated in terms of their integration with the model and coverage of the concepts. The
proposed research is innovative because it will be the first empirical validation of existing, potentially in-use
models using real-world consent forms. The proposed research is significant because more robust models
have the potential to enhance responsible stewardship of biospecimens and information, protect specimen
contributors’ autonomous choices, and engender trust between those contributors who gave consent and the
individual investigators who require permission to use biospecimens in research.

## Key facts

- **NIH application ID:** 10985203
- **Project number:** 1R03HG013341-01A1
- **Recipient organization:** MAYO CLINIC ROCHESTER
- **Principal Investigator:** Michelle L McGowan
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $161,400
- **Award type:** 1
- **Project period:** 2024-09-23 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10985203

## Citation

> US National Institutes of Health, RePORTER application 10985203, YOU GAVE CONSENT BUT DO I HAVE PERMISSION? (1R03HG013341-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10985203. Licensed CC0.

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