Forms

No. There are three types of research, each of which receives a different level of review.

1. Exempt Research

   The University of Washington applies the federal regulations and guidance about exemption to all UW human subjects research, regardless of funding or funding source. The staff of the Human Subjects Division (HSD) are the only individuals authorized to determine that research activity is exempt from federal regulations. In addition to the federal criteria, HSD requires that exempt research involve no more than minimal risk and that interactions with subjects must include some type of consent process that provides the subjects with basic information about the research.

   Researchers do not have the authority to determine that their own research qualifies for exempt status. The research may not begin until the researcher has received notification from HSD that the research qualifies for exemption. Exempt status is granted for a five-year period.

2. Minimal Risk Research

   Research falling into minimal risk categories is reviewed by a subcommittee of the IRB (use form UW 13-11). You may also hear the term “expedited review” used in conjunction with the review of minimal risk research; describing the ability of the research to be reviewed by a subcommittee – not that the review process is necessarily faster.

3. More than Minimal Risk Research

   Research falling into categories considered to be of more than minimal risk requires review by the full Committee (use form UW 13-11).

If you are a faculty or staff member, or a student at the University of Washington, and your research involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), your research requires human subjects review and approval before beginning the research.

Multiple factors affect the time required for IRB review. They include:

• type of application
• level of review (e.g., exempt, minimal risk, full committee)
• complexity of the study
• involvement of other compliance offices or institutions
• quality and completeness of the application when first submitted

We encourage researchers to plan for sufficient time for review based on the research and their particular situation. Here are some general recommendations based on HSD’s current workload:

• Allocate adequate preparation time before submission, in most cases a minimum of two weeks to one month.
• For full IRB review, plan for at least 12 to 16 weeks for the review and approval process.
• For Minimal Risk review, plan for at least 6 to 8 weeks.
• For Exempt review, plan for at least 2 to 3 weeks.

Yes, and no...

Please see OHRP guidance on this issue

Any kind of research conducted under the auspices of the UW and UW Medicine that creates or uses protected health information is subject to the HIPAA regulations. This includes such research activities as clinical trials, chart reviews, epidemiological studies, behavioral, and social science studies, as well as basic science research activities. It includes research that involves the provision of treatment as well as research that provides neither treatment nor diagnosis.

All researchers, whether or not they are directly connected with UW Medicine, who wish to conduct research involving protected health information must complete HIPAA training before they will be allowed to have access to individually identifiable health information in any form.