2018 Revised Common Rule: Exemptions An Introduction to Regulatory Changes to Exempt Research Speaker: Cari Oliver, MPA, CIP Assistant Director, Office of the IRB

January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule.  This means that applications currently submitted and awaiting review may require revision based on the revised common rule requirements.

This session is being recorded and will be available on the IRB website shortly

This presentation is to inform you of changes made to the exemption categories. If you would like to schedule training for your faculty on the specifics of each, please email Cari Oliver at croliver@uab.edu.

Goals – Exempt Research Revised Categories New Categories Limited Review Resources

Levels of Review at UAB IRB Designation of Not Human Subjects Research (NHSR) Exempt Expedited Full

Levels of Review at UAB IRB NOTE: NHSR and Exempt are NOT synonymous DOUBLE, EXTRA SPECIAL NOTE: Exempt is a category – not a verb – it is a not a “Get Out of Jail Free” card. It still requires an application to the IRB.

Medical Record Reviews involving identifiers BURDEN REDUCTION The following previously Expedited research may now be reviewable under Exemption Review: Medical Record Reviews involving identifiers Surveys/Interviews involving sensitive and identifiable content Benign Behavioral Interventions

UAB IRB policy change, not regulatory change BURDEN REDUCTION Protocol Oversight Review Form no longer required for EXEMPT (still required for Expedited and Full) UAB IRB policy change, not regulatory change Departments can still require them, but the IRB will not be the gatekeeper.

GUIDEBOOK The GUIDEBOOK Great source of information Updating widely due to regulatory changes In-depth information Easily searchable

GUIDEBOOK The CHAPTERS Exempt Chapter is category-specific Extensively revised Format: Regulatory Citation Definitions Special Information Examples FAQs

Anything in red is a change or is new Format THE CATEGORIES Anything in red is a change or is new Format Actual regulatory citation What’s new in the regulation How we’ve revised the guidebook Any pertinent definitions for understanding

EXEMPT 1 – EDUCATIONAL RESEARCH “Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies and research on the effectiveness or the comparison among instructional techniques, curricula, or classroom management methods” §46.104(d)(1))

WHAT’S NEW - REGULATIONS? Research that involves potential negative effects on student learning or the assessment of the educators will not qualify.

WHAT’S NEW - GUIDEBOOK Better definitions for commonly accepted educational settings and normal educational practices More specific information on FERPA applicability

BEFORE WE GO ON Many of the Exemption categories are set up as follows: Category and it’s overall purpose “Parts” that identify specific ways in which the category can be applied In most cases, each Part can be thought of a separate, distinct application of the category.

EXEMPT 2 – SURVEYS/INTERVIEWS/EDUCATIONAL TESTS/OBSERVATION OF PUBLIC BEHAVIOR “Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:” §46.104(d)(2)) This is the Category and it’s overall purpose

EXEMPT 2 – SURVEYS/INTERVIEWS/EDUCATIONAL TESTS/OBSERVATION OF PUBLIC BEHAVIOR (i)The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, directly or through identifiers linked to the subject,  (ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation. These are Parts i and ii. Part i – anonymously collected Part ii – identifiably collected but nonsensitive

EXEMPT 2 – SURVEYS/INTERVIEWS/EDUCATIONAL TESTS/OBSERVATION OF PUBLIC BEHAVIOR (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).” This is Part iii. Part iii – identifiably collected and sensitive

WHAT’S NEW - REGULATIONS? Addition of the word ONLY to the overall category description: Exemption 2 can NOT involve any intervention. ONLY: Surveys Interviews Educational tests Observation of public behavior

WHAT’S CONSIDERED AN INTERVENTION? Typically prior to or in-between survey/interview The intent is to change the participant or to compare across different activities Intervention (not allowed): Read a diabetes nutrition pamphlet and survey participants prior to and after to see if diabetes knowledge improves Activity (allowed): Read a diabetes nutrition pamphlet and survey participants on format, content readability.

WHAT’S NEW - REGULATIONS? Part ii: Educational advancement has been added to an existing list of potential risks that are not allowed. This means that research that could affect a someone’s ability for educational advancement is not allowed under Category 2(ii).

WHAT’S NEW - REGULATIONS? Part iii is entirely new. Surveys/Interviews that are both identifiable AND sensitive may be included, but will require Limited Review. Previously – these were Expedited Category 7

WHAT’S LIMITED REVIEW? Conducted by an experienced reviewer assigned by the IRB Chair. Purpose is to determine that there are adequate provisions for protecting privacy and confidentiality It’s an extra step in the approval process

Better definitions of what is identifiable vs. anonymous. WHAT’S NEW - GUIDEBOOK? Better definitions of what is identifiable vs. anonymous. Full discussion, including several examples, of interventions vs. activities. Discussion of how HIPAA may apply in Part iii. Updated/expanded examples for each part.

EXEMPT 3: BENIGN BEHAVIORAL INTERVENTIONS “Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention” § 46.104(d)(3)(i) This is the Category and it’s overall purpose

EXEMPT 3 – BENIGN BEHAVIORAL INTERVENTIONS (A)The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, directly or through identifiers linked to the subject,  (B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation. These are Parts A and B. Part A – anonymously collected Part B – identifiably collected but nonsensitive

EXEMPT 3 – BENIGN BEHAVIORAL INTERVENTIONS (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).” This is Part C. Part C – identifiably collected and sensitive

SOUND FAMILIAR? The three parts are the same wording as Exempt 2

WHAT’S A BEHAVIORAL INTERVENTION? Cognitive, intellectual, educational, or behavioral task or the manipulation of the participant’s physical, sensory, social, or emotional environment. No medical tests, medical procedures, and/or the use of medical devices.

DECEPTION ALLOWED Participant must provide “prospective agreement” “As part of this project, I will be keeping certain information from you. Still want to be in it?”

DATA COLLECTION METHODS Only verbal or written responses (e.g., surveys or interviews, test responses, data entry), observation, or audiovisual recordings. Data cannot be collected via physical procedures such as blood pressure monitoring, EEG, activity trackers (e.g., Fitbit), eye trackers, or blood draws.

How deception may be allowable WHAT’S NEW - GUIDEBOOK? Everything Full definitions Specific regulatory requirement of what kinds of data collection can occur How deception may be allowable Discussion of how HIPAA may apply in Part C Examples for each part

EXEMPT 4 – SECONDARY RESEARCH “Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met” §46.104(d)(4)) This is the Category and it’s overall purpose

EXEMPT 4 – SECONDARY RESEARCH (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; These are Parts i and ii. Part i – Publically available Part ii – only dates/zip codes allowed

EXEMPT 4 – SECONDARY RESEARCH (iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 164.512(b); or This is Part iii. Part iii – it’s HIPAA regulated

EXEMPT 4 – SECONDARY RESEARCH (iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 164.512(b); or This is Part iv. Part iv – It’s regulated under other regulations involving data security and privacy

WHAT’S NEW - REGULATIONS? Addition of identifiable biospecimens Biospecimens were always allowed, but this addition aligns with an overall regulatory change addressing information and biospecimens separately.

WHAT’S NEW - REGULATIONS? Parts i and ii are the same as before but have been given their own “part”.

WHAT’S NEW - REGULATIONS? Previously only allowed if Publically available (unchanged – now Part i) Already in existence (changed – limitation removed entirely) At most, dates/zip codes (changed – this is still true for Part ii, but Part iii allows for any HIPAA identifier)

WAIT, ARE YOU SAYING WHAT I THINK YOU’RE SAYING, CARI…..? YES! CHART REVIEWS ARE EXEMPT!!!!!!!! A simple medical record review (electronic or paper) to address a single purpose will fall under Exempt 4(iii).

AND ARE YOU ALSO TELLING ME….? YES! YOU CAN PROSPECTIVELY COLLECT!!!!!!!! Collecting data to analyze a research question can be done retrospectively and prospectively. Keep in mind, this category is for secondary research only – no direct collection from participants is allowed.

WHAT’S NEW - REGULATIONS? Part iv: Allows for research collected under regulations that have their own strict privacy and confidentiality regulations eGovernment Act FISMA Paperwork Reduction Act of 1995

Pretty much everything Full definitions WHAT’S NEW - GUIDEBOOK? Pretty much everything Full definitions Discussion of how HIPAA may apply in Part iv Updated/expanded examples for each part

EXEMPT 5 – PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS) “Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. §46.104(d)(5)) This is the Category and it’s overall purpose

EXEMPT 5 – PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS) “Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.” §46.104(d)(5)) This is the Category and it’s overall purpose

EXEMPT 5 – PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS) (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. This is Part i. Part i – must be listed on a website

In 9 years at UAB – we’ve had one. A WORD ABOUT EXEMPT 5 Rarely applicable In 9 years at UAB – we’ve had one.

WHAT’S NEW - REGULATIONS? The research and demonstration project has to be published on a publically accessible Federal website.

WHAT’S NEW - GUIDEBOOK? Not much, but we will update with information as the Feds provide us with guidance

EXEMPT 6 – TASTE AND FOOD QUALITY “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 the use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.” §46.104(d)(6)) This is the Category and it’s overall purpose

WHAT’S NEW - REGULATIONS? NOTHING

EXEMPTION REVIEW: New Categories Category 7 – Storage/Maintenance of data/specimens for secondary research for which broad consent is required [§ 46.104(d)(7)]

EXEMPTION REVIEW: New Categories Category 8 – Secondary Research for which broad consent is required [§ 46.104(d)(8)]

Broad Consent – an (optional) alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research.   If a participant declines, the IRB may not waive consent for that participant on other projects; therefore, this requires the PI to record and track who has agreed to or refused consent in a manner that other investigators and the IRB can access.

The UAB IRB has determined that as currently interpreted, Broad Consent is not feasible at UAB and these 2 categories will NOT BE IMPLEMENTED at this time. We will be watching the discourse on this concept as the new regulations roll out.

MORE Application will be drastically changed Longer but asking more specific questions Should elicit needed information Guidebook is still under construction, but draft coming very soon

QUESTIONS?