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Health Insurance Portability and Accountability Act (HIPAA) and Research

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the HITECH Act (2013) are federal laws governing the way certain health information is collected, maintained, used and disclosed by a covered entity. Carle, as a covered entity, is subject to these regulations.

Protected Health Information (PHI) is that which is individually identifiable and created or held by a covered entity. Health information is individually identifiable if it identifies an individual or there is a reasonable basis to believe the information could be used to identify an individual including past, present and future health information (mental and physical) about the condition of an individual, the provision of care, or payment for an individual’s care. Under HIPAA, entities can use and disclose PHI for research only with the individual’s authorization, except under limited circumstances. For information on how HIPAA affects research at Carle, email Carle's Human Subject Protection Program.

Public Health Service (PHS) Funded Research

As required by federal regulation, PHS-funded investigators must disclose sponsored or reimbursed travel. To disclose sponsored or reimbursed travel:

  • Complete the Conflict of Interest Disclosure form
  • Or submit the Travel Log for PHS Funded Researchers
Note: Once Investigators have made their initial disclosure, they are required to update their disclosures within 30 days of discovering or acquiring a new significant financial interest and annually during the period of award. For more information, visit NIH Policy Clarification.

Federal regulations also require all investigators involved in the design, conduct or reporting of any research funded by the Public Health Service (such as grants from National Institutes of Health), to complete Financial Conflict of Interest training prior to engaging in PHS-funded research. “Investigator” includes any person, regardless of title or position, responsible for the design, conduct or reporting of research. To complete the Financial Conflict of Interest training:

  • Log onto and complete the Conflict of Interest module under Carle Foundation Hospital.
  • Upon completion of this module, both you and Carle will receive a certificate of completion. Please keep this certificate for your records.

Most PHS funded projects are through the National Institutes of Health (NIH) but may also come from other agencies under the Department of Health and Human Services as well such as the Agency for Healthcare Research and Quality, Centers for Disease Control, Health Resources and Services Administration, and Substance Abuse and Mental Health Services Administration.

Carle expects institutions who receive federal sub-awards to comply with either their own Conflict of Interest policy or Carle’s Research Conflict of Interest policy.

If complying with their own Conflict of Interest policy, the sub-recipient institution must provide a publicly accessible policy that complies with PHS regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).

A number of non-PHS agencies funding research have also elected to adopt the PHS Financial Conflict of Interest regulations. These include:

  • Alliance for Lupus Research
  • Alpha-I Foundation
  • American Asthma Foundation
  • American Cancer Society
  • American Heart Association
  • American Lung Association
  • Arthritis Foundation
  • CurePSP
  • Juvenile Diabetes Research Foundation
  • Lupus Foundation of America
  • Patient-Centered Outcomes Research Institute
  • Susan G. Komen for the Cure

To disclose significant financial interest related to PHS funding, email