Policy & Procedures

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).

The HIPAA regulations use the term \"authorization\" to describe the process through which a patient allows researchers to access protected health information (PHI). The information must include:

• a description of the information to be used for research purposes;
• who may use or disclose the information;
• who may receive the information;
• purpose of the use or disclosure;
• expiration date or event (if the information will be kept indefinitely, the authorization states that there is no expiration date);
• individual\'s signature and date;
• right to revoke authorization;
• right to refuse to sign authorization (if this happens, the individual may be excluded from the research and any treatment associated with the research);
• if relevant, that the research subject\'s access rights are to be suspended while the clinical trial is in progress, and that the right to access PHI will be reinstated at the conclusion of the clinical trial.

Blanket authorizations for research to be conducted in the future are not permitted. Each new use requires a specific authorization.

The UW IRB Committees use specific criteria in reviewing requests for a waiver of HIPAA authorization for research. In completing the Human Subjects Review Application (UW 13-11), researchers should explain how:

• The use or disclosure of protected health information involves no more than minimal risk to the privacy, safety, and welfare of the individual;
• The research could not practicably be conducted without the waiver or alteration;
• The research could not practicably be conducted without access to the protected health information;
• There is an adequate plan to protect the identifiers from improper use or disclosure;
• There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
• There are adequate written assurances that the protected health information will not be re-used or disclosed to a third party except as required by law, for authorized oversight of the research, or as permitted by an authorization signed by the research subject

In requesting this waiver, researchers should also provide the following information:

• Detailed information about the types of protected health information that will be used, including how it will be used, who will have access to it, and when it will be destroyed;
• What risks are posed by the use of the data, and how they have been minimized
• The justification for access to the data and why they are necessary to conduct the research.

"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for the purposes of the regulations that guide and govern how research is conducted in the United States, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. It may be important to understand the following about research:

• It is basically a study that is done to answer a question.
• Scientists do research because they don't know for sure what works best or to better understand why or how things happen.
• Some other words that describe research are clinical trial, protocol, survey, or experiment.
• Research is not the same as treatment.

Guidance is available regarding consent, including sample forms, on the Consent, Assent and Waivers topic page.