Common Rule Changes: Regulations for Protection of Human Subjects 45 CFR 46

1. Office of Research Integrity and Protections (ORIP)http://research integrity.syr.edu/ Key Changes to the Common Rule- Regulations for the Protection of Human Subjects 45 CFR 46

2. The final revisions to the Common Rule became effective on January 21, 2019. The changes are intended to reduce burden, delay and ambiguity for investigators.

3. Protocols approved by the IRB prior to January 21, 2019, will follow the previous regulations. Only studies approved after January 21, will follow the revisions to the Common Rule

4. Key Changes • Elimination of continuing review-for most minimal risk research • Expansion of exemption categories • Reframing of informed consent information including the additional required elements • Requirement of single IRB review for research conducted at more than one site on the same protocol (multi-site study).

5. Changes Related to Continuing Review Continuing review/renewal is no longer required for Expedited research approved after 1/21/19. • However, the IRB can require continuing review if there is cause. • Researchers will be asked to complete an Annual Expedited Research Status Report. • Continuing review/renewal is no longer required for Full Board research once all interaction with participants is complete.

6. What has NOT changed • Amendments for any changes to the protocol and/or supporting documentation are still required. • Reports of unanticipated problems/events are still required. • Continuing review/renewal of full board studies that remain active is still required.

7. What has NOT changed? Consent is required for all human subject participants 18 years of age or older. Assent is required for allhuman subject participants who are minors (17 years of age or younger) or those considered impaired in their decision making ability. Although you may request a waiver of the documentation of written consent/assent, i.e. electronic or oral consent/assent, you must obtain consent/assent from all participants who will engage in your study.

8. Exemption Changes • Categories for exemption have changed. • Two new categories were added.

9. Exempt-Category 1 Exempt Category 1 research activities include most research on regular and special educational strategies, and research on the effectiveness of, or the comparison among instructional techniques, curricula, or classroom management methods. Not allowable: Randomization to unproven teaching/educational techniques or research involving employment decisions.

10. Exempt-Category 1 The category has been amended to include the following conditions: • The research activities cannot take time or attention away from normal instruction that might negatively impact student achievement. • The research activities cannot have a negative impact on the employment/evaluation of the instructors. The research may include pregnant women, children and prisoners if the research is aimed at a broader population and only incidentally includes prisoners.

11. Exempt-Category 2 Exempt Category 2 research activities may involve one or more of the following: • Educational tests (cognitive, diagnostic, aptitude, achievement). Only applies to minors/children if the research activities are exclusively limited to educational tests. • Survey, interview procedures, or focus groups that do not include research activities with minors/children. • Observation of public behavior (including visual or auditory recording) of adults. This includes observation of public behavior that occurs in a public place where there is no expectation of privacy and where no special permission is required to observe others, such as public locale, street, park, etc.

12. Exempt-Category 2 Pre-changes allowed for exemption of surveys interviews, focus groups, unless: • The information obtained is recorded in such a manner that participants can be identified, directly or through identifiers. AND • Any disclosure of the participant’s responses outside of the research could reasonably place them at risk of civil/criminal liability, be damaging to their financial standing, employability, or reputation.

13. Exempt-Category 2 The new changes have broadened the definitions and eliminated the “and” and replaced it with an “or” under the following conditions: • The information is recorded in a manner that individuals cannot be identified (either directly or through identifiers linked to the individual). OR • Any disclosure of the participant’s responses outside of the research would not reasonably place them at risk of civil/criminal liability, be damaging to their financial standing, employability, educational advancement, or reputation. OR • If the information is recorded in a manner that individuals can be identified (either directly or through identifiers linked to the individual) and the IRB determines there are adequate provisions in place to protect both the privacy of the participant and the confidentiality of the data obtained.

14. Exempt-Category 2 Exempt Category 2: • May include pregnant women and prisoners if the research is aimed at a broader population and only incidentally includes prisoners. • May include minors/children ONLY if the researcher does not participate in or manipulate the activities being observed. All activities must be strictly limited to observation.

15. Exempt-Category 3 Exempt Category 3 is a completely new category. It is research involving benign behavioral interventions. Benign behavioral interventions are defined as: • Brief in duration • Harmless • Painless • Not physically invasive • Not likely to have a significant, lasting, adverse impact on the participant • Not embarrassing or offensive Examples of such benign behavioral interventions might include playing an on-line game, solving puzzles under various conditions, being exposed to stimuli such as color, light, sound, performing cognitive tasks, etc.

16. Exempt-Category 3 Methods of data collection of adult participants is limited to: • Verbal or written responses (surveys/interviews) • Data entry • Observation (including audiovisual recording) Data cannot be collected via physical procedures such as blood pressure monitoring, EEG, activity trackers (e.g.-FitBit), eye tracking, blood draws, etc. Behavioral interventions of adult participants may involve the performance of a cognitive, intellectual, educational or behavioral task; or the manipulation of the physical, sensory, social or emotional environment of the participant.

17. Exempt-Category 3 Deception regarding the nature or purpose for the research was not previously allowed for exempt research. Deception in Exempt Category 3 is ONLY applicable if the participant is made aware and agrees to the deception prior to engagement in the research. The participant must be told that they will be misled about the nature or purpose of the research PRIOR to engagement. Debriefing is not required, but is encouraged.

18. Exempt-Category 3 Exempt Category 3 research may include pregnant women and prisoners if the research is aimed at a broader population and only incidentally includes prisoners. Category 3 research is limited to ADULT participants. Minors/children and decisionally-impaired individuals are NOT eligible for this exemption.

19. Exempt-Category 4 Exempt Category 4 research may involves the use of identifiable private information or identifiable biospecimens for which consent is not required as long as certain criteria are met. Research activities involve data analysis only. Data do not need to be “existing” at the time of the research study, as was previously required. The data can be collected prospectively and still used for exempt secondary research under Category 4. Data/specimens would be allowed from pregnant women, children, decisionally-impaired individuals, and prisoners if the research is aimed at a broader population and only incidentally includes prisoners.

20. Exempt-Category 5 Exempt Category 5 remains basically the same, but has been revised to allow research supported by a federal agency (not just conducted). The types of public benefit and service programs covered must be provided. The federal components for which the exempt research is subject to authorization must be clearly stated (e.g.-delegated subordinate agencies).

21. Exempt-Categories 6, 7, and 8 Exempt Category 6 is the only category that remains unchanged. This category involves studies that involve taste/food quality evaluation and consumer acceptance. Categories 7 and 8 are new categories. These categories involve the use of Broad Consent. Because we will not use Broad Consent at Syracuse University. These categories do not apply.

22. Informed Consent Changes The goal of the informed consent process is to provide sufficient information so that a reasonable person can make an informed decision about whether to enroll in a study and/or to continue participation. Because of this, the consent form must be organized in such a manner that all key information is provided “up front” in a concise and focused manner.

23. Informed Consent Changes General requirements for Written, Oral and/or Electronic Consent: • Must begin with a concise and focused description of the purpose for the research (using language at a reading/comprehension level of the targeted population. • Information regarding the procedures. • Descriptions of all research activities, including their purpose and duration. • Descriptions of the types of measures you will use, including an explanation as to who will administer them. • A description of any possible risks and/or discomforts associated with participation and how the risks will be mitigated. • A description of any possible benefits associated with participation. • A description of how the privacy interests of the participant will be protected • A description of how the confidentiality of the data will be maintained. • A description of participant rights including a statement that participation is voluntary. • An explanation of who to contact for answers to pertinent questions.

24. Informed Consent New Required element: • Any research activities that involve the collection of identifiable private information or identifiable biospecimens must include one of the following: • A statement that identifiers might be removed from the identifiable private information /biospecimens and after such removal, the information/biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or • A statement that the subject's information/biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

25. Informed Consent Additional Requirements for Written, Oral and/or Electronic Consent when applicable: • A description of any alternatives to participation. • A description of any medium of recording (photographs, audio, video, film) which includes the purpose for the recording, how they will be used, who will have access to them, and the disposition of them when the study is complete. • A description of whether compensation will be offered which includes the method of compensation, how it will be awarded, and how it will be pro-rated if a participant withdraws prior to completion. • Information regarding situations of abuse, abuse or harm and a description of if/when mandated reporting is indicated. • Information regarding legal subpoena. • Information regarding Certificates of Confidentiality. • Information about whether relevant research results will be returned to the participants. • Information about possible commercial profit. • Information about whether research activities will include whole genome sequencing.

26. Applicationsand Consent Templates Due to changing regulations, IRB applications and consent form templates will be updated on a continual basis. It is best practice to download a new application from our website for each new submission. We cannot guarantee acceptance of outdated forms and/or consent form formats.

27. Where do I go for help? The Office of Research Integrity and Protections 214 Lyman Hall Phone Number: 315-443-3013 Email: orip@syr.edu Web: http://researchintegrity.syr.edu