Institutional Review Board IRB solutions in a Dental PBRN

1
Institutional Review Board (IRB) solutions
in a Dental PBRN
Gilbert GH 1, Urthaler F 1,
Moore SD 1, Rindal DB 2, Fellows JL 3, for the
DPBRN Investigator Group 1 University of
Alabama at Birmingham 2 HealthPartners Research
Foundation 3 Kaiser Permanente Northwest

Abstract
Results
What is DPBRN?
IRB solutions for DPBRN Study 2, a prospective
study of routine dental treatment Alabama and
Mississippi First iteration 6-page informed
consent form and 1-page HIPAA form patient signs
both. Feedback from practitioners and patients in
the field suggested that the process was
cumbersome and created suspicion. Final 1-page
information sheet, document that consent obtained
verbally sign HIPAA form HIPAA form modified to
DPBRN context following UAB Legal Office
approval. HealthPartners Waiver of consent
because the study involves routine
treatment. Kaiser Permanente/Permanente Dental
Associates First iteration 4-page informed
consent with modified HIPAA language patient
signs both Final 2-page consent with NCR carbon
attached so patient can be given a copy at the
time of the signature. Florida and
Georgia First iteration 9-page informed consent
form and HIPPA form patient required to
sign. Results from UAB solution created openness
to further revisions. Final 2-page form that
requires patient to sign. Denmark First
iteration application to Ethics
Committees. Second iteration referred to Data
Protection Agencies (do not have FWAs). Third
iteration Catch 22 situation, led to
suggestion for a conference call between the
Danish ethics committee and the UAB IRB. Fourth
iteration UAB IRB serves as the Danish IRB of
record. UAB procedures apply with local
context taken into account.

• An affiliation of dental practitioners in
  private practice that investigates research
  questions.
• This network of dental professionals works with
  dental schools and organizations that serve as
  administrative bases.
• DPBRN conducts research that is relevant to the
  real world of private practice, where the
  majority of the population receives its dental
  care.

Objective Describe issues and solutions to
human protection issues in a dental
practice-based research network (PBRN) that has
multiple IRBs. Methods A dental PBRN called
"DPBRN" comprises practitioner-investigators in
two health maintenance organizations (HMOs
Permanente Dental Associates (PDA) with the
Kaiser Permanente Northwest (KPNW) organization,
another at HealthPartners (HP)), 5 U.S. states,
and three Scandinavian countries. DPBRN is
administratively based at the University of
Alabama at Birmingham (UAB), with sub-contracts
to the University of Florida (UF), HP, and KPNW.
We describe (1) the various human subjects and
HIPAA requirements and solutions for each DPBRN
region (2) IRB impacts on study protocols and
implementation and (3) lessons learned from this
evolving process. Results Following numerous
discussions with each IRB, HMO dentists are
attached to their IRBs via sub-contracts between
their organizations and UAB. Private
practitioners are attached to their IRBs (either
UAB, UF, or HP) via Individual Investigator
Agreements, and affiliated with UAB via Memoranda
of Agreement. IRBs approve general network
operations under one approval number, but review
specific research projects via separate approval
numbers. In discussions over a 2-year period,
these arrangements and others have been
developed. For example, a modified HIPAA form
has been customized to the DPBRN context in one
region. The IRB in this region also approved
documentation of informed consent obtained
verbally, instead of requiring lengthy written
forms. This occurred following feedback in
DPBRN's first clinical study in which patients
and practitioners judged that lengthy written
consent forms impeded the research process and
raised suspicion, instead of decreasing it.
Another regions IRB approved a waiver of
consent. An amendment for one IRB to serve as
the IRB of record for practitioners in one
Scandinavian country was also approved.
Conclusions Instead of viewing IRBs as
potentially adversarial, solutions for
minimal-risk, observational studies can be
identified by engaging IRBs in collegial
discussions that identify common ground within
regulatory bounds. These solutions can improve
acceptability of research to patients,
practitioners, and university researchers.
How DPBRN is structured
Conclusions
PDA Permanente Dental Associates, with Kaiser
Permanente Northwest HP/MN HealthPartners
Research Foundation and Minnesota private
practitioners SK practitioners in Denmark,
Norway, Sweden FL/GA practitioners in Florida
and Georgia, with the Univ. of Florida AL/MS
practitioners in Alabama and Mississippi, with
the UAB
Instead of viewing IRBs as potentially
adversarial, customized solutions for
minimal-risk, observational PBRN studies can be
identified by engaging IRBs in collegial
discussions that identify common ground within
regulatory bounds. These solutions can improve
acceptability of PBRN research to patients,
practitioners, and university researchers.
Our Mission
Acknowledgments
Co-authors in the DPBRN Investigator Group are
listed at our web site. Supported by NIH grants
U01-DE-16746, U01-DE-16747. Please visit our
web site at www.DentalPBRN.org.
Improving oral health by conducting dental
practice-based research and by serving dental
professionals and their patients.