Arizona Translational Resource Network (AZTransNet)

Policy Development Retreats

In Arizona, advancing translational research requires "collaboration" across the broad base of universities, non-profit research institutions, hospitals and medical centers. The concept of the retreat is that through education and dialogue Arizona's institutions involved in clinical and translational research can develop a common understanding, language and, hopefully, approaches for addressing key policy issues in clinical and translational research. The outcomes of the retreat is more than just workshop presentations and dialogue, but follow on efforts to create policy guidelines, template forms and training materials.

Jump to your area of interest using the links below:

Compliance Challenges for Clinical Research Sites: An Educational Workshop Series 2010

Clinical research sites across Arizona continue to face challenges in complying with the plethora of federal laws that govern clinical research and in handling the risks involved in conducting clinical trials. The workshop series was designed to provide in-depth training and an opportunity for discussion with other clinical research sites on some of the most sticky compliance challenges for clinical research sites. Each half-day seminar came with written materials, including template forms, and was taught by attorneys from Coppersmith Schermer & Brockelman PLC and clinical research specialists from Arizona hospitals. The series was held at Phoenix Children's Hospital.

Clinical Trials Reimbursement and Payment
Speakers: Julie Nelson, JD and Kristen Rosati, JD, Coppersmith Schermer & Brockelman PLC (CSB) and Ashley Lopez, MS, Director of Research, Phoenix Children's Hospital
February 9, 2010

  • Obtaining Medicare and Medicaid reimbursement for services and investigational items.
  • Dealing with the "Medicare as a Secondary Payer" issue.
  • Establishing a system to ensure appropriate billing.
  • Making sure the site is paid fair market value for its services and is paying fair market value to physicians.

Clinical Trials Contracting
Speakers: Mayan Tahan, JD and Kristen Rosati, JD, CSB and Jeremy Stoloff, JD, MS, Associate General Counsel, Banner Health
February 23, 2010

Working from a template clinical trial agreement as a platform for discussing problem issues in clinical trial contracting, this session covered problem issues in clinical trials contracting. Participants understood clinical trial contracting issues, including:

  • Indemnification.
  • Reimbursement for subject injury.
  • Subject information confidentiality.
  • Intellectual property protection.
  • Special challenges with contracting through CROs.
  • Stark and Anti-Kickback compliance in physician subcontracts.

Conflicts of Interest in Clinical Research
Speakers: Beth Schermer, JD and Kristen Rosati, JD, CSB
March 2, 2010

New financial relationship disclosure requirements for the pharmaceutical and medical device industries are driving a renewed interest in identifying and managing conflicts of interest in clinical research. This session discussed new regulatory requirements, ways for research sites to identify both investigator and institutional conflicts, and practical methods for managing those conflicts.

Clinical Research Privacy and Security
Speaker: Kristen Rosati, JD, CSB
April 6, 2010

This session focused on new challenges related to the privacy and security of subject information in research. Participants learned how to handle complex issues in HIPAA and Common Rule privacy and security requirements, such as research collaborations and storage of information for future research. In addition, participants learned about:

  • The Genetic Information Nondiscrimination Act.
  • HITECH Act's new restrictions on charging for information in research.
  • Rigorous new security breach reporting regulations.

Biospecimens in Clinical Research
Speakers: Kristen Rosati, JD, CSB and Joan Shapiro, PhD, Vice President of Clinical Research, St. Joseph's Hospital and Medical Center
April 27, 2010

An increasing number of clinical trials and other research protocols seek contribution of participant biospecimens to store in research repositories. At the conclusion of this session, participants understood a variety of topics relating to biospecimen banking, including:

  • Appropriate informed consent.
  • HIPAA compliance.
  • Ownership/custody of samples.

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Grantsmanship and Clinical Research Skills Development Workshop

This two day workshop was held Thursday, March 12 and Friday, March 13, 2009. Topics addressed included development of clinical research skills and grantsmanship strategies needed for successful grant applications. The workshop was be led by Dr. Holly Falk-Krzesinski, Director of the Office for Research Development at Northwestern University, and drew upon other national experts.

The Clinical Research Skills Development Session covered:

  • Principles of Epidemiology.
  • Biostatistics in Clinical Research.
  • Clinical Trials.
  • Responsible Conduct for Human Subjects Research.
  • Career Development.
  • Using electronic search tools to effectively identify appropriate funding opportunities.

The Grantsmanship for the Research Professional Session addressed:

  • Mastering fundamental principles of grant proposal writing.
  • Developing proposals that meet an agency's mission.
  • Incorporating review criteria into your proposal writing.
  • Detailed overview and first-hand advice from agency officers with oversight of their organizations' review process.
  • Developing the hypothesis and specific aims sections of proposals.
  • Mastering electronic proposal submission.
  • Increasing the opportunity of getting a proposal funded.

Workshop documents:

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PRIM&R "At Your Doorstep" Research Educational Institutional Review Board (IRB)

Phoenix Children's Hospital hosted IRB 250, PRIM&R "At Your Doorstep" Research Educational Institutional Review Board (IRB), on Friday, October 31, 2008. This program was taught by Helen McGough and Ernest D. Prentice, IRB/HRPP experts who are also recognized leaders in the fields of human research protections and research ethics. The IRB 250 covered an array of highly practical strategies for enhancing an institution's IRB/HRPP operations via the use of best practices.

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Patient Registries: An Innovative Tool for Advancing Clinical and Translational Research

This policy retreat on June 4, 2008, was designed to explore facets of patient registries including:

  • Value of Patient Registries for Clinical Research: from the perspective of hospitals, physicians, researchers, patients and industry.
  • How to Create and Operate Patient Registries: to get the most out of advances in database and Internet technologies to make patient registries an effective tool for identification, outreach, and tracking of patients for clinical trials, as well as a patient-friendly communications tool.
  • How to Comply with Regulatory Requirements: Informed Consent, HIPAA Privacy, and Data Ownership…to address patient consent to participate in registries, to comply with privacy requirements, and to anticipate data ownership issues.
  • Unique Arizona Resources: from database resources to identify populations and key physicians, to patient advocacy resources.

Retreat documents:

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The Tissue Issue: Ethical and legal issues in Biorepository Research

Tissue Issue: Ethical and Legal Issues in Biorepository Research retreat was held on January 30, 2007. Biorepositories are a growing area of activity in biomedical research. However, many hospitals, physician practices, and research sites were uncertain of the legal and ethical issues involved in providing biospecimens to third party research repositories or in storing biospecimens in their own repositories. The Retreat involved national speakers from the National Cancer Institute (Dr. Anna Barker was the keynote speaker), Faster Cures, Cleveland Clinic, University of Michigan, Partners Healthcare, and others. The retreat was a huge success with 129 Arizona participants. Subsequent survey of participants revealed very positive response to the retreat.

Retreat documents:

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Ongoing Activities

  • IRB Policy Workgroup is working to develop template policies and procedures, informed consent documents and HIPAA authorization forms to harmonize Arizona IRB approaches to biospecimen research.
  • Business Work Group is developing template clinical trial agreement provisions, material transfer agreements, and policies on the business aspects of biorepository research. We expect that these template documents will be widely used across the state. To learn more about these work group activities, please contact Julie Robbins.

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