Compliance

Conflict of Interest

Fairview Health Services has a research conflict of interest (COI) policy that reflects federal regulations regarding objectivity in research. The policy has two main requirements:

  1. COI Training
    COI training is initially due prior to federal grant or IRB submission, and renewed every 3 years.
  2. COI Disclosures
    COI disclosures are initially due prior to federal grant or IRB submission, and renewed by the first of each year. Disclosures must be updated at the time of change in institutional responsibilities or financial or business interests as well.

FAQ:

Why are you asking for this information?
Federal Regulations require institutions collect this information from any individual responsible for the design, conduct, or reporting of research. Most of the questions on this form are excerpted from the regulations: 42 CFR Part 50 Subpart F - Promoting Objectivity in Research.

What will you do with this information?
We will review each disclosed interest against the research studies in which you participate. When you open a new study, we will review your role in the study against your current studies. If we believe there may be a potential conflict of interest, we will contact you. You may provide a summary of the relationship and how it may or may not affect your research role. We will forward the summary with the interest disclosure and study information to the Conflict of Interest Committee.

When is an updated disclosure needed?
Disclosures must be renewed annually. Research Administration will email renewal reminders 2 months, 1 month and 2 weeks as needed before the annual renewal is due.

An updated disclosure is needed if you acquire a new business or financial interest, have travel reimbursed or paid for by a business entity, or if your institutional responsibilities change.

You do not need to submit an updated form when you start a new study as long as the new study does not cause a change in your institutional responsibilities. An example: you currently work as a cardiology research nurse but are starting a new study in music therapy. A financial interest in a music production company was previously not relevant but may be now.

Required Training and Education – GCP and Human Subjects Protection

M Health Fairview community researchers conducting research involving human subjects with M Health Fairview patients or records/data must complete human subjects' protection training and education as required by M Health Fairview and the University of Minnesota Institutional Review Board (IRB).

M Health Fairview requires documentation of current (within 3 years) training completion for each researcher before studies are reviewed by the IRB. Research Administration will confirm training is accurate and current prior to or during the M Health Fairview ancillary review.

Collaborative Institutional Training Initiative (CITI)

CITI provides the required Good Clinical Practice and human subjects' protection training for M Health Fairview. It is a web-based program that allows users to register with their institution (e.g. Fairview Health Services). More information may be obtained on the CITI Website.

Initial Training

Register using Fairview Health Services as your institution. Then select and complete “Good Clinical Practice and Human Research Protections for Biomedical Study Teams.”

Training Renewal

M Health Fairview community researchers must renew human subjects protection training every three years. CITI will send automatic email reminders before the user's training lapses.

HIPAA and Research

Parts of the Health Insurance Portability and Accountability Act (HIPAA) regulations are designed to ensure our patients' privacy and the security of the information we use and retain within M Health Fairview. Researchers accessing, using or retaining protected health information (PHI) of M Health Fairview patients must abide by all HIPAA-related policies.

Reporting Privacy Breaches

If a patient’s privacy (such as PHI) is breached to an unauthorized individual or entity, then federal law requires that the breach be evaluated to determine if the patient should be notified. In order to comply with this law, Fairview Health Services requires that all breaches involving Fairview patients or research participants immediately be reported as follows:

  • Report privacy breaches relating to participation in a research study to research@fairvew.org.
  • Breaches relating to patient care, separate from research participation, must be reported to Fairview’s Privacy Office at 612-672-5647.

Minnesota state statute requirements

In addition to HIPAA compliance, M Health Fairview abides by Minnesota state law concerning the release of health records for research purposes. Minnesota law (Minnesota Health Records Act, sections 144.291 to 144.298) contains restrictions on access to PHI that are more protective of patient rights than HIPAA and therefore must be followed. Researchers must ensure compliance with both HIPAA and Minnesota law.

The Minnesota Health Records Act requires that patients authorize the release of their health records to external researchers. M Health Fairview obtains authorization on the Consent for Services through the patient registration process.

Research-related Policies

Research Administration is responsible for the oversight and management of research-related policies, including the following:

  • Investigational Drug Policy
  • Research Involving Human Subjects Policy
  • Research and Education Enabling Policy
  • Research Conflict of Interest Policy
  • Research Misconduct Policy
  • Access to Protected Health Information (PHI) for Research Activities Policy
  • Confidential Information Access via Information Systems Policy
  • Non-Employed Research Staff (NERS) Policy
  • Fairview Research Scientific Review Committee Policy
  • Research Billing Policy

Questions or concerns? Contact Research Administration at research@fairview.org