POST-TEST/EVALUATION FORM

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TUFTS-NEW ENGLAND MEDICAL CENTER

RESEARCH INTEGRITY SERIES

A Practical Guide to HIPAA Issues for Research at

T-NEMC and TUHSC

Presented by Steven Schwaitzberg MD – February 24, 2004

Participant Information

Name: ______Degree:______

Department: ______

Phone Number: ______

E-mail Address: ______

Check the one that best describes your position:

1. Principal Investigator ___2. Co-Investigator ___

3. Study Coordinator ___4. Data Manager ___5. Admin. Manger ___

6. Other_____

If you checked 2-5, please indicate the principal investigator or supervisor for whom you work: ______

Goals of Presentation

This presentation is intended to educate principal investigators and others involved in the conduct of clinical research regarding the impact that the HIPAA Privacy Regulations (Heath Insurance Portability and Accounting Act of 1996) have on the conduct of clinical research, and the use of individuals protected health information at Tufts-New England Medical Center.

Objectives of Presentation

  1. Overview of HIPAA Privacy Regulations and Specific Challenges Presented for Researchers: Give seminar participants general background information on the HIPAA Privacy Regulations and how those regulations, final as of August 14, 2002, challenge the way researchers have traditionally conducted clinical trials.
  1. Patient Authorization for Research Under HIPAA: Give seminar participants an overview of HIPAA's requirements for obtaining patient authorization to use or disclose protected health information in the research context, and when researchers may use or disclose protected health information without patient authorization.
  1. De-Identified Data Under HIPAA and Limited Data Sets: Explain the specific requirements under HIPAA for de-identifying data and how those requirements differ from the Common Rule. Explore the new concept of "limited data sets" available under HIPAA, and how those can be used by researchers in lieu of full de-identification of data.
  1. Databases and Accounting of Research Disclosures: Explain how databases for research purposes should be approached under HIPAA. Review HIPAA's requirements regarding accounting for disclosures of protected health information for research purposes.
  1. Practical Compliance Issues for Implementing HIPAA in the Research Context: Explore from a practical perspective how HIPAA compliance should be integrated into researchers' existing compliance efforts and give seminar participants suggestions on a best-practices approach.

Substantive Questions on Seminar’s Objectives:

1.Overview of HIPAA Privacy Regulations and Specific Challenges Presented for Researchers.

The law requires that Protected Health Information (PHI) be kept confidential and:

  1. ______
  2. ______
  3. ______

2.Patient Authorization for Research Under HIPAA.

Authorization for use of PHI must be obtained unless ______.

Remember he only way a patient/subject can withdraw research authorization is in writing.

3.De-Identified Data Under HIPAA and Limited Data Sets.

In order for your data to be de-identified all _____categories must be removed or else you need a ______ to manipulate the data.

4.Databases and Accounting of Research Disclosures.

Individual accounting is required if it is a disclosure of 10 or less patients' records. If more then 10 records are accessed then only the category of records used (i.e. diabetic males between the ages of 18-75 with COPD) needs to be maintained.

True ______False ______

5.Practical Compliance Issues for Implementing HIPAA in the Research Context.

Can the informed consent form be combined with the HIPAA research authorization? Y ______N ____

Does the Tufts-NEMC policy allow these to be combined? Y _____ N _______ (not at this point in time)

Evaluation of Program

Content_____ Good_____ Fair_____ Poor

Presentation_____ Good_____ Fair_____ Poor

Speaker: Schwaitzberg _____ Good_____ Fair_____ Poor

Was the content non-biased and balanced?_____ Yes_____ No

Were the educational objectives listed below identified and met?

  1. Overview of HIPAA Privacy Regulations and Specific

Challenges Presented for Researchers_____Yes _____No

  1. Patient Authorization for Research under HIPAA_____Yes _____No
  1. De-Identified Data Under HIPAA & Limited Data Sets ____Yes ____No
  1. Databases and Accounting of Research Disclosures______Yes _____No

5. Practical Compliance Issues for Implementing HIPAA

in the Research Context______Yes _____No

Please list any topics that you would like to see covered in future presentations: ______

______

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