New Exempt Categories

1. New Exempt Categories Melissa Epstein, PhD, MBE, IRB Director, Einstein IRB

2. Background on the changes to the Common Rule • What does Exempt mean? • Overview of the changes • Examples for the NEW Exempt 3 Category – Benign Behavioral Research

3. The Common Rule This term refers to subpart A of the Code of Federal Regulations (CFR) title 45 (public welfare), part 46 (protection of human subjects.) These regulations were released in 1981 by the Department of Health and Human Services in response to the Belmont Report. These core regulations were adopted by more than a dozen federal departments and agencies in 1991 (hence the term, “Common Rule"). The Common Rule describes the requirements for assuring compliance by research institutions; requirements for researchers obtaining and documenting informed consent; and requirements for IRB membership, function, operations, review of research, and recordkeeping.

4. A brief history of the regulatory changes • July 26, 2011--Advanced notice of proposed rulemaking (ANPRM) seeking comments on potential revisions to the Common Rule • September 8, 2015--Notice of Proposed Rulemaking (NPRM) seeking comments on proposals to comprehensively revise the Common Rule • January 19, 2017--Final rule implementing major revisions to the Common Rule effective January 22, 2018 • January 22, 2018--Interim final rule delaying the effective date and general compliance date of the revised Common Rule to July 19, 2018 • April 20, 2018 -- Delayed the general compliance date for the 2018 Requirements for an additional six months to January 21, 2019. • January 21, 2019 – Revised Common rule goes into effect. Known as the Final Rule.

5. What does Exempt mean? • Six categories of research exempt from the regulations at 45CFR46 (the Common rule) • The IRB must make this determination • NOT absolved from: • HIPAA • ClinicalTrials.gov • Certificate of Confidentiality requirements (NIH sponsored only) • Human subjects education requirements • We now issue three year “approvals”

6. Exempt Categories 1-3 • Research, conducted in established or commonly accepted educational settings • Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) of adults. • NEW CATEGORY: Research involving benign behavioral interventions with adult subjects if the subjects prospectively agrees to the intervention and information collection

7. Exempt Categories 4-6 • Secondary research uses of identifiable private information or identifiable biospecimens that have been or will be collected for some other ‘primary’ or ‘initial’ activity • Research and demonstration projects that are conducted or supported by a Federal department or agency • Taste and food quality evaluation and consumer acceptance studies

8. What changed? • Exempt 1 – a little stricter • Exempt 2 – broader • Exempt 3 – New Category! • Exempt 4 – broader • Exempt 5 and 6 – no changes

9. Exempt 1 – Education Research Research, conducted in established or commonly accepted educational settings • NEW RESTRICTION: Not likely to adversely impact students’ opportunity to learn or assessment of educators • Note: Some research under this category may require the submission of consent documents and scripts. • Exempt consent template language is available in the iRIS help menu.

10. Exempt 2 – Educational Tests, Surveys, Interviews, Public Observation • Restrictions: • Data collection only; • May include visual or auditory recording; • May NOT include intervention • Note: Einstein requires submission of consent documents and scripts for this category. • May include short oral scripts, cover letters, introductory paragraphs on surveys/research instruments and e-mails introducing potential research subjects to the study. • Signed documentation of consent not required (but may be required under HIPAA). • Exempt consent template language is available in the iRIS help menu.

11. Exempt 2 – Educational Tests, Surveys, Interviews, Public Observation Three types: • Recorded information cannot readily identify the subject (directly or indirectly/linked) OR • Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation) OR • NEW: Information is recorded with identifiers • Must state how you protect the privacy of subjects and to maintain the confidentiality of data and this is subject to “Limited IRB Review”

12. Exempt 3 – Benign Behavioral Research • We will do this one last….

13. Exempt 4 – Secondary Research Uses Secondary research uses of identifiable private information or identifiable biospecimens that have been or will be collected for some other ‘primary’ or ‘initial’ activity • NEW: Allows both retrospective and prospective secondary use

14. Exempt 4 – Secondary Research Uses Three types: • Publicly available OR • Information recorded so subject cannot readily be identified (directly or indirectly/linked); Investigator does not contact subjects and will not re-identify the subjects

15. Exempt 4 – Secondary Research Uses Three types: • Information or specimens whose use is regulated by HIPAA. • Einstein is NOT regulated by HIPAA. Research information freely flows between MMC/Jacobi/Burke and Einstein. • All applications in this category are automatically routed in iRIS to Expedited IRB review with: • A waiver of informed consent (no consent document!) • Receive one year approval – but have a very abbreviated progress report (no subject counts!) • IRB review process is very fast

16. Exempt 3 – Benign Behavioral Interventions NEW CATEGORY: Research involving benign behavioral interventions with adult subjects if the subjects prospectively agrees to the intervention and information collection • Restrictions: • NO Children; • May not include medical interventions; • Data may only be collected through verbal or written responses (including data entry) or audiovisual recording • Prospective consent required; • No deception unless participant prospectively agrees

17. Exempt 3 – Benign Behavioral Interventions • Note: Einstein IRB requires submission of consent documents and scripts for this category. • May include short oral scripts, cover letters, introductory paragraphs on surveys/research instruments and e-mails introducing potential research subjects to the study. • Signed documentation of consent not required (but may be required under HIPAA). • Exempt consent template language is available in the iRIS help menu.

18. Exempt 3 – Benign Behavioral Interventions What is a “benign behavioral intervention”? • Brief in duration • Painless/harmless • Not physically invasive • Not likely to have a significant adverse lasting impact on subjects • Unlikely that subjects will find interventions offensive or embarrassing

19. Exempt 3 – Benign Behavioral Interventions Three types: • Recorded information cannot readily identify the subject (directly or indirectly/linked) OR • Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation) OR • Information is recorded with identifiers • Must state how you protect the privacy of subjects and to maintain the confidentiality of data and this is subject to “Limited IRB Review”

20. Exempt 3 – Example 1: Research on self-control Graduate business students are asked to participate in research examining the influence of surfing a social media site on measures of self-control. Students were randomly assigned to browse a popular social networking site or a popular news site and then, as a measure of self-control and persistence, were timed in their efforts to solve a complex word puzzle (for which there was no solution). No identifiable information is recorded.

21. Exempt 3 – Example 1 Analysis • Behavioral intervention (the random assignment to browse the web site) followed by the collection of data on persistence on a complex task (by direct data entry). • The intervention is benign, in that it involves no appreciable risk of harm or pain or emotional distress for the subjects. • Assumption: Consent was obtained for participation • Question: Must the data be collected anonymously to be exempt? • Would disclosure of research results outside the research context place students at risk? Maybe. • If yes, are there appropriate confidentiality measures?

22. Exempt 3 – Example 2: Research on gratuities To study the influence of restaurant gratuity policies on overall satisfaction, customers calling for reservations are asked to take part in a research study involving the completion of an anonymous survey following their meal. Those who agree are randomly assigned to either a suggested service charge group or a group where there are no suggested gratuity amounts identified. Individuals are informed about a survey but not about the subject of the survey or assignment to one of these groups. All are told that certain aspects of the research will only be revealed to them at the conclusion of their involvement.

23. Exempt 3 – Example 2 Analysis • The intervention is benign • Since knowledge of the study purpose may influence customer responses to the anonymous survey, the research employs deception. • Subjects are informed of the research, of the fact that the research includes deception, and they prospectively agree to take part. • The random assignment to one of two commonly employed policies on gratuities is brief, harmless, painless, not likely to have a significant adverse impact on the subject, and not likely to cause offense or embarrassment. • Question: Must the data be collected anonymously to be exempt? • No. Disclosure of research results outside the research context are unlikely to place participants at risk.

24. Exempt 3 – Example 3: Research on reading comprehension Adult students agree to be videotaped while reading a passage from a standard text while alone in a quiet room. Ratings of vocal inflection and tone are assessed as predictors of comprehension and compared with the results of a written test of the subject’s ability to understand the same reading material. The procedures take 90-120 minutes.

25. Exempt 3 – Example 3 Analysis • Is this a benign behavioral intervention? • Brief in duration. • Is it benign? The intervention requires the subject to read a passage. While public reading or the performance of math problems in front of an audience of strangers may be used to provoke a stress response in some research, the subject in this example is alone in a quiet room and reading from a standard text. • Must the data be collected anonymously to be exempt? • No. If characteristics of the population suggest that an unintended disclosure of the subject’s responses would be damaging to employability or reputation or be significantly embarrassing, the PI must ensure that there are protections in place to address the possibility of unintended disclosure.

26. Exempt 3 – Example 4: Research on music in nursing homes Nursing home staff interview patients to complete a brief self-report scale measuring mood and anxiety at baseline and two weeks after music is played nightly in patient rooms on half of the wards. All subjects are informed that a study of the effect of music is planned, and music is played only the rooms of those patients who agree to the intervention and ratings.

27. Exempt 3 – Example 4 Analysis • The intervention is benign and the methods of collecting data are consistent with the exemption criteria. • Duration is not brief – two weeks • Considering the nature of the study (the playing of background music), the duration of exposure does not alter the fundamentally benign nature of the intervention. • Nonetheless, it would not be considered brief. • The study would NOT meet the requirements for exemption.

28. Exempt 3 – Example 5: Assessments of memory, attention and information processing speed Healthy adult subjects are asked to take part in two 2 hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software. The procedures are conducted during a single visit, and subjects are encouraged to take breaks when desired.

29. Exempt 3 – Example 5 Analysis • The intervention is benign • Requires healthy adult subjects to take part in a five-hour research study in which the benign behavioral intervention lasts one hour and the data collection lasts four hours. This would then meet the definition of brief in duration, • The research itself is not likely to be offensive or harmful. • Assumption: subjects are prospectively consented to participate. • Must the data be collected anonymously to be exempt? • No. Disclosure of research results outside the research context are unlikely to place participants at risk.

30. Exempt 3 – Example 6: Physiological arousal and cognitive performance Recordings of blood pressure and pulse are obtained along with the collection of a saliva specimen for the measure of cortisol level from adult subjects in a study linking physiological arousal to cognitive performance on a standard series of computer games. The procedures last 75 minutes.

31. Exempt 3 – Example 6 Analysis • The intervention is benign and brief. • The collection of blood pressure, pulse, and serum cortisol data would be considered medical interventions and so not consistent with the exemption. • Data collection (blood pressure, saliva analysis) is not consistent with the requirement that data collection be by oral or written responses only. • The study would NOT meet the requirements for exemption.

32. Exempt 3 – Example 7: Study on rejection College students take part in a study involving computer simulation of an online dating app in which each student is ultimately rejected by a prospective date who in fact is a member of the study team. The students are asked to agree to the research and are told that aspects of the research goals and methods are being withheld from them until after their participation.

33. Exempt 3 – Example 7 Analysis • Students do prospectively agree to the deception. • Is this benign? The aim of the intervention is to simulate rejection and elicit emotional responses. While some students may assume that their experience of rejection was an experimental manipulation, many will likely react to the intervention (and to the post-study debrief) with shame, embarrassment, and humiliation. • The study would NOT meet the requirements for exemption.

34. Exempt 3 – Example 8: Eye tracking experiment A study seeks to measure how individuals attend to visual stimuli with different emotional meaning. Each subject places his head on a chin rest in front of a computer monitor while being shown a matrix of 6 magazine photos of people with mildly sad, happy, surprised, frightened, and worried expressions. Subject eye movements/fixation are recorded by a digital camera. No identifying data is recorded.

35. Exempt 3 – Example 8 Analysis • The intervention is brief • Data collection involves only visual recording. • The intervention is benign. Given the description of the photos, the intervention is not likely to be harmful, frightening, likely to have a significant adverse lasting impact, or be considered offensive. • Assumption: subjects are prospectively consented to participate. • Must the data be collected anonymously to be exempt? • No. Disclosure of research results outside the research context are unlikely to place participants at risk.

36. Exempt 3 – Example 9: Educational session and exercise Clients at a health club are asked to participate in a study looking at the impact of a two hour educational session on the benefits of exercise. Clients are provided with a free Fitbit and then asked to come to the club every other day to have a reading taken of their daily steps as recorded on the Fitbit.

37. Exempt 3 – Example 9 Analysis • The intervention is benign. • This would NOT meet the exemption because the data recording by the Fitbit is not consistent with the requirement that data may only be collected using verbal or written responses or audiovisual recording.

38. Questions? • Guidance on the new categories available here: https://www.einstein.yu.edu/docs/administration/institutional-review-board/policies/exemption-categories-revised-common-rule.pdf • Exempt Determination Decision Chart: https://www.einstein.yu.edu/uploadedFiles/administration/IRB/Exempt%20Determination%20Decision%20Charts.docx • Exempt 3 Detailed Guidance: https://www.einstein.yu.edu/uploadedFiles/administration/IRB/Exempt%20Category%203.docx • Set up a consult from the IRB Office web page! https://www.einstein.yu.edu/administration/institutional-review-board/ Link on the right