Quick Facts about Exempt Research No continuing review required IRB Reviewer makes Exempt determination 6 OHRP & 4 FDA categories(1 category overlaps) No prisoners; pregnant women allowed; minors allowed, but restrictions apply (Subpart B & D determination not needed) HIPAA requirements apply if PHI used or disclosed

Exempt Category 1 Key Points: Research in established or commonly accepted educational settings, and Research of normal education practices Examples: Evaluating the use of accepted or revised standardized tests A program evaluation of pharmacy continuing education

Case Scenario Chicago public schools have offered SAT preparation workshops to its students for the last 10 years. The school tracks SAT results for its own purposes. Professor Kim wishes to study the impact of these workshops on SAT scores in the schools. Dr. Kim plans to administer a pre and post workshop survey to participating students to measure satisfaction and effectiveness of the workshop. Key Points: Dr. Kim is conducting research with human subjects due to administration of the survey. However, it meets Exempt category 1 as it is in a commonly accepted education setting (high school) and is studying the effectiveness of standard instruction techniques (the workshops).

Exempt Category 2 Key Points: Minors cannot be surveyed or interviewed. Investigator may observe public behavior of children, but cannot participate in that behavior or activity. Identifiers can be recorded if disclosure of the subject’s responses will not place them at risk Examples: Survey of physicians regarding new pt. triage process Focus group to study impact of exercise on QOL

CASE SCENARIO Dr. Jones, the Chair of the IRB, plans to survey researchers at his institution to assess satisfaction with the IRB review process. Approximately 50 researchers will be randomly selected to complete an online survey. Dr. Jones and his colleagues at other sites believe there is a correlation between satisfaction with the IRB and departmental support. Each site will send surveys to 50 researchers. The surveys will be anonymous. Key Points: Dr. Jones is engaged in research with human subjects and IRB review is required. Even though the survey may ask sensitive information, he meets Exempt Category 2 because results are recorded without identifiers.

Key Points: Research that otherwise doesn’t qualify for exemption under Category 2 due to collection of identifiable information that could place subjects at risk, qualifies under this category if the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Exempt Category 3

Exempt Category 4 Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Key Points: Existing is defined as “on the shelf” at the time of initial IRB review. Information must be immediately recorded without identifiers & codes. Nobody should be able to link the data back to the subjects.

Dr. Adams has a freezer of blood samples that were originally collected for a research study which ended several years ago. Patient codes (which can be linked to the Medical Record) remain on the samples. The consent form originally signed by the subjects of Dr. Adams indicated whether or not their stored blood could be used for future research. Dr. Adams gives the researcher the samples with the patient code. The researcher immediately removes the code upon receipt of the samples. Key Points: Because he is given samples with the patient code, the researcher is engaged in human subjects research. However, Exempt Category 4 applies as he is using existing samples and he plans to immediately remove the patient code.

Exempt Category 5 Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Exempt Category 5 requirements The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). The research or demonstration project must be conducted pursuant to specific federal statutory authority. There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB). The project must not involve significant physical invasions or intrusions upon the privacy of participants.

Exempt Category 6 (overlaps with FDA) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Exempt Category 6 Examples Taste testing whole grain food products Comparing taste or smell of molasses, cheese or milk Sampling texture of ice cream