On April 14, 2003, regulations that are part of the Health Insurance Portability and Accountability Act (HIPAA) went into effect. These regulations (Privacy Rule) govern how health care providers and health plans can use or disclosure personally identifiable health information on their patients, including for research purposes.
These regulations may impact researchers if:
- Their current research studies involve the use of personally identifiable health information maintained by a hospital, clinic, physician, professional association, or other HIPAA-covered health care provider, or a private, state, or federal health insurance plan (e.g., Medicaid), or
- They plan to conduct a study involving the use of personally identifiable health information obtained from the entities mentioned in the above bullet.
As research involving personally identifiable health information qualifies as human subjects research, such research conducted by UNH agents must be reviewed and approved by the UNH Institutional Review Board for the Protection of Human Subjects in Research (IRB) prior to commencing.
In addition, UNH researchers who plan to obtain personally identifiable health information from HIPAA-covered health care entities should check with those covered health care entities as early as possible to find out any requirements for review by their own IRBs. UNH researchers are strongly encouraged to contact the Privacy Officer in the covered health care entity to obtain the most accurate information on the entity’s specific HIPAA requirements.
The UNH IRB has developed the following documents to assist researchers in understanding the new requirements and complying with them when conducting research studies:
- HIPAA Impacts on Research Involving Human Subjects
- HIPAA Sample Research Authorization Form
- HIPAA Sample Authorization Language for Consent Forms (RTF)
- HIPAA Sample Authorization Language for Consent Forms (PDF)
- HIPAA Authorization Waiver Request Form
For more information please contact Melissa McGee at (603) 862-2005 or Julie Simpson at (603) 862-2003.
View Human Subjects Knowledge Base
The Knowledge Base contains forms, instruction and training material, policies, guidance, tools, and other resources to support your research efforts by topic area.
Melissa McGee, Assistant Director
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-2005
Email: melissa.mcgee@unh.edu
Susan Jalbert, Compliance Officer
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-3536
Email: susan.jalbert@unh.edu
Julie Simpson, Director
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-2003
Email: julie.simpson@unh.edu
