HIPAA Will Affect Research At Hopkins

You may have heard that "HIPAA" will affect research activities at Hopkins in the near future. What you have heard is correct! The privacy regulations under the Health Insurance Portability and Accountability Act, better known as HIPAA, are intended to protect the privacy of identifiable health information ("protected health information" or "PHI") which health care providers use or disclose in the course of their activities. Most Hopkins entities are "covered entities" under the regulations, including the School of Medicine, the School of Nursing and parts of the Bloomberg School of Public Health and Whiting School of Engineering. Research is one of the activities that is covered under these new regulations for the Hopkins entities.

The University and the Health System have set up a centralized HIPAA Office which will, in the next two to three months, help researchers, IRBs, administrators, and staff understand the rules and how they will apply to research activities. There will be meetings, brochures, and on-line teaching modules to assist in the education process. Because the regulations become effective April 14, 2003, time is of the essence.

As a preview, following are some of the things which HIPAA will require as Hopkins addresses these new rules:

• In addition to the informed consent currently required under the Common Rule, researchers also will need to get, and IRBs will need to approve, a privacy authorization from research participants.
• For ongoing research protocols that will be enrolling participants on or after April 14, 2003, researchers will need to use this new privacy authorization. (The HIPAA and IRB Offices are establishing a streamlined process to help this happen on time.)
• If a researcher requests a waiver of consent or a waiver of written consent under the Common Rule, the IRB will need to make special privacy findings in addition to those findings necessary under the Common Rule.
• If researchers wish to look at patients’ records in their preparation for research, researchers will need to make some simple, straightforward representations to the IRB as to the research purposes for their use of the patients’ records.
• Even though research on decedents’ records generally does not require IRB review under the Common Rule, under the HIPAA regulations, researchers will need to make some simple, straightforward representations to the IRB as to the research purpose for their use or disclosure of decedents’ files in research.
• Researchers must use and disclose only the protected health information (PHI) needed for their research purposes -- and no more. This is referred to as the "minimum necessary" rule.
• If a researcher has created a separate research database and the principal purpose of the database is availability for future research, the creation of the database needs to be acknowledged and "grandfathered" through a waiver by the IRB. (Again, the IRB and HIPAA Offices are working on a streamlined form for this activity.)
• Hopkins needs to keep a record of disclosures of PHI that are made in connection with waived research, research using decedents’ records, and reviews preparatory to research. (The IRB Offices and the HIPAA Office will need the help of researchers and are working on streamlined ways to do this.)

There will be a lot of information coming to you on HIPAA and on the privacy regulations in the near future. In the meantime, if you would like more information click here: http://www.insidehopkinsmedicine.org/hipaa/

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