tasha osafo, cip assistant director irb office exempt review
TRANSCRIPT
Tasha Osafo, CIPAssistant Director
IRB Office
Exempt Review
OBJECTIVES
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Review Basic IRB Concepts Overview of Exempt
Categories
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“I’m not interacting with humans. My project is exempt from the IRB.”
“The PI is receiving de-identified data; her project is exempt.”
“I’m doing a QI project; is my project exempt?”
WHAT IS WRONG HERE?
COMMON EXPRESSIONS
Misuse of the term “Exempt” when referring to “Non-human subjects research”
From IRB perspective, the project is either
Non-human subjects researchor Human subjects research that meets Exempt, Expedited, or Full Board review criteria
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Basic Decision Tree
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Step 1: Research? Yes No No IRB
Step 2: Human Subjects? Yes No No IRB
Step 3: Exempt, Expedited or Full Board?
Step 4: Submit to IRB for final determination
Quick Facts about Exempt Research
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No continuing review requiredAt NU, IRB Reviewer makes Exempt
determination6 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
OVERVIEW OF EXEMPT CATEGORIES
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Review the Exempt Categories and overlapping Expedited Categories.
Case Scenarios
Exempt Category 1
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Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(i)research on regular and special education instructional strategies, or
(ii)research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Exempt Category 1
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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 from NU wishes to study the impact of these workshops on SAT scores in the schools.
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Not Human Subjects Research ScenarioThe schools will give Dr. Kim de-identified SAT scores from 2006 to 2011 for her research. Neither Dr. Kim or the schools will be able to link the scores back to the students. She will collect basic demographics about the school from their websites.
KEY POINTS: Dr. Kim is receiving a de-identified dataset that was not originally collected for her study. Human subjects are not involved; therefore, IRB review is not required.
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Exempt ScenarioDr. 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).
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Not Exempt Scenario Dr. Kim will assess if the workshops would be
more effective if held outdoors by randomizing ½ the students to the normal workshop in the classroom; the other ½ are randomized to the woods.
Key Points: While Dr. Kim is still studying a normal educational practice (the workshops), the setting in the woods is not considered a commonly accepted educational setting and the research does not qualify for Exempt status. Expedited review or Full Board review is required.
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Exempt Category 2
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Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i)information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Exempt Category 2
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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
processFocus group to study impact of exercise on QOL
Exempt Category 2 v Expedited Category 7Expedited Category 7Research on individual or group
characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
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Exemption applies ifData is identifiable but not sensitiveData is sensitive but recorded without identifiersChildren are only undergoing educational tests or observation of public behavior without interaction with the investigator Expedited applies if:Data is identifiable and sensitive but measures are in place to protect confidentialityChildren are to be surveyed, interviewed, or observed with interaction by the investigator
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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.
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Not Human Subjects Research Scenario
Dr. Jones does not plan to disseminate the results of his interviews. The results will be used within the IRB Office to assess what changes can be made to improve the review process. Key Points: While Dr. Jones is interacting with individuals, this is not research (a systematic investigation designed to develop or contribute to generalizable knowledge). It is a QI project and does not need IRB review.
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Exempt ScenarioDr. 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.
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Not Exempt Scenario
Dr. Jones plans to retain identifiers on the surveys so that he can send out a second survey to those researchers who score extremely high on the dissatisfaction scale. Key Points: This project does not qualify for Exempt review due to retention of identifiers. Expedited Category 7 may apply if the IRB reviewer believes there are adequate measures in place to protect confidentiality and the risk is minimal.
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Exempt Category 3
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Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:(i) the human subjects are elected or appointed public officials or candidates for public office; or
(ii) 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 3Key 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; orfederal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
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Exempt Category 4
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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.
Exempt Category 4
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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.Examples:Analysis of existing dataset in which the PI immediately removes MR#
Exempt Category 4 v Expedited Category 5
Expedited Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
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Exemption applies if:All data is existing, andImmediately recorded without identifiers or codesExpedited applies if:Data is existing but identifiers retained, and/orData will be prospectively collected for non-research purposes (identifiers can be kept)
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Case ScenarioDr. 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.
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Not Human Subjects Research ScenarioA researcher wishes to use the samples for his own study (non-FDA regulated). Dr. Adams removes the patient code from the samples before giving the samples to the researcher. Key Points: The researcher is conducting research. However, the samples were not originally collected for his project, and he is not receiving identifiable information. Therefore, he is not conducting human subjects research and does not need IRB review.
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Exempt ScenarioDr. 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.
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Non-Exempt Scenario
The researcher retains the patient code just in case he needs to contact the patient for follow-up information. Key Points: Exempt Category 4 does not apply as the researcher retains the patient code. The study may qualify for Expedited Category 5 (research involving materials that have been collected), as well as Expedited Category 7 if he eventually contacts subjects for follow-up information.
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Exempt Category 5
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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.
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Exempt Category 6 (overlaps with FDA)
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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
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Taste testing whole grain food products
Comparing taste or smell of molasses, cheese or milk
Sampling texture of ice cream
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Questions?
Contact Information
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Tasha K Osafo, BA, CIPAssistant DirectorInstitutional Review Board Office
Email: [email protected]: 312-503-4225Fax: 312-503-0555