Confidentiality Issues

• Confidentiality Issues for IRB Applications - Version date 4/2/04
• Medical Records Review Research - Version date 4/1/04
• Certificates of Confidentiality for Research
  • NIH Certificate of Confidentiality Kiosk
    This page includes detailed information about certificates, explains eligibility for certificates and provides NIH contacts.
  • FDA's Certificates of Confidentiality Application Instructions
    If a Certificate of Confidentiality is needed for a study involving investigational new drugs (IND) use this application process . If a study is also NIH funded, applications for both agencies may be required. Coordinate with the FDA first.

Privacy Protection and HIPAA(Health Insurance Portability and Accountability Act) Compliance

• How does the HIPAA privacy rule apply to my research?
  Definitions and elements that make health information identifiable (PHI)
• How does the HIPAA Security Rule that protects electronic information apply to my research?
• NIH Resources for Understanding the HIPAA Privacy Rule

 Forms for Privacy Protection

• Data Use Agreement - Version date 8/19/06 - Use of Limited Data Set that may include town, city, zip code, dates, age
• Request for Research on Decedent's Information - Version date 10/21/03 - Use of health information or tissue from deceased persons
• Business Associate Agreement for Research - A non HIPAA covered entity uses PHI while functioning on behalf of an HMC/COM researcher
• Authorization wording - See the 'Use of Private Health Information' section of the Model Consent Form
• Instructions for Tracking of Disclosures - For research not obtaining written authorization - Version date 1/6/06
• Confidentiality Agreement - For use by external investigators who will be on site at HMC

Privacy Policies and Notice

• PSHMC/COM Privacy Policy - For Hershey Medical Center and College of Medicine
  • HMC Privacy Notice - For subjects who did not receive the notice as a patient
  • Acknowledgement of Receipt of Privacy Notice by Research Participant
• Penn State Privacy Policy - For all campuses other than HMC/COM