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Module 16 · Part 5 · Partnerships

Working with Academia

Build productive research collaborations with academic institutions that advance science, produce publications, and respect advocacy organization interests.

Patient Registries 101 · Dr. Danielle Boyce · EpilepsyLive

Why academic partnerships matter

Academic collaborators bring
Scientific credibility , peer reviewed publications require academic coauthors
IRB access , academic institutions can provide IRB coverage for registry research
Technical resources , biostatisticians, bioinformaticians, data scientists
Funding access , NIH grants, foundation grants, and clinical trial networks
Clinical expertise , disease specialists, rare disease centers of excellence

Data access agreements

Academic researchers accessing your registry need a signed Data Use Agreement covering
Permitted analyses and publications
Prohibition on reidentification
Data security requirements
Publication notification and co-authorship expectations
Data return and destruction upon project completion

IRB coordination

Define who holds IRB coverage for registry-linked research
Your central IRB covers the registry; academic collaborators add a linked study under their own IRB
Academic institution provides a master IRB agreement covering all affiliated analyses
Consider using a single central IRB (CIRB or NCI CIRB) for multisite academic networks

Authorship policy

Establish your authorship policy before the first paper
Registry team members are coauthors on all publications using registry data
A participant coauthor is included on all publications (identify and support interested participants)
Acknowledge registry participants in every paper
First and last authorship for key papers goes to whom?

NIH grants

Many registries are supported by NIH funding
R01: Standard research grant; advocacy organizations can be co-investigators with an academic lead PI
U01/U34: Cooperative agreements; common for multisite registry networks
PAR funding opportunities: NIH periodically issues targeted PARs for rare disease registries
Key resource: NIH Research Portfolio Online Reporting Tools (RePORTER)

PCORI

PCORI funds patient-centered outcomes research with a strong emphasis on participant engagement.
pcori.org/funding

Foundation and advocacy funding

Many disease foundations provide seed funding for registry development.

Building a productive collaboration

Define deliverables and timelines in writing at the start
Hold regular (monthly or quarterly) working group calls
Share data access promptly once agreements are in place
Be explicit about publication timelines, academic timelines can be very slow
Provide administrative support for grant applications that use your registry as a resource

Key resources

NIH Office of Rare Diseases Research
PCORI
CTSA Hub Network , Academic clinical research network
Rare Disease Clinical Research Network (RDCRN)
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