Cornell IRB Policies & Procedures Effective January 21, 2019 Table of Contents 1. Introduction ................................................................................................................................................ 1 2. Key Provisions of the New Common Rule ................................................................................................. 2 3. Detailed description of Changes Affecting Cornell Researchers .............................................................. 3 4. Procedures for Pre-existing Studies ........................................................................................................ 10 5. Definitions ................................................................................................................................................ 11 6. Selected References ................................................................................................................................. 11 7. Appendices……………………………………………………………………………………………………………………………………12 1. Introduction On January 19, 2017, the U.S. Department of Health and Human Services (“HHS”) issued final revisions to the Federal Policy for the Protection of Human Subjects, 45 CFR 46 (the “New Common Rule” or “New Rule”). These are the first significant changes to human subject regulations since 1991 (the “Old Rule”). While some revisions reduce burdens on researchers and institutions, others involve new requirements. Following a previous delay announced in January 2018, on June 18, 2018, HHS informed researchers of an additional delay in the general compliance date of the New Rule, until January 21, 20191 (the “Effective Date”). The Cornell IRB has chosen to take advantage of flexibility that HHS has granted, which allows institutions to implement three burden-reducing provisions of the New Common Rule early. Thus, some of the provisions of the New Common Rule went in effect at Cornell on July 19, 2018. This document describes key changes introduced by the New Common Rule and how they impact protocols that received IRB approval or exemption before the Effective Date (“Pre-existing Studies”), as well as new studies first approved or exempted after the Effective Date. All researchers should familiarize themselves with the text of the New Rule and this guidance document, as they design future studies and decipher how the new regulations affect their research2. 1 A new requirement to use a single IRB for certain multi-site studies takes effect on January 20, 2020. 2 While the Common Rule only applies to federally conducted or federally sponsored research, as an institution Cornell chooses to apply the regulations to all research conducted by its faculty, staff and students, regardless of funding status. 2. Key Provisions of the New Common Rule a) Changes to Exemption Categories & Review Procedures: More research projects will qualify for exemption under the New Rule, which adds to and modifies the existing categories, including: broadening previous exemption Category 2 to include use of identifiable, sensitive information if the IRB conducts a special “limited IRB review” and the study meets certain criteria; expanding Category 4 to allow for secondary use of data that is not “on the shelf” at the time of exemption; explicitly permitting exemption of “benign behavioral interventions” (such as playing an online game) and storage and secondary use of identifiable private information and identifiable biospecimens where “broad consent” was obtained. For more information, see Section 3(a), below. b) Elimination of Continuing Review (Renewal) Requirement for Most Studies: With few exceptions, the annual renewal requirement has been eliminated for expedited review studies and for full board research that has progressed to the point that it involves only data analysis or accessing follow-up clinical data as part of clinical care. Amendments will still need to be filed with the IRB before making changes to approved protocols. For more information, see Section 3(b), below. c) Changes to Informed Consent: Additional elements have been added to the basic requirements for informed consent, along with a general requirement to begin informed consent with a concise presentation of key information most likely to assist a prospective subject in understanding why they might or might not want to participate. In addition, for clinical trials that are federally-funded, there is a new requirement to post a copy of a consent document after the study is closed to recruitment but within 60 days of the end of data collection. For more information, see Sections 3(c) and (e), below. d) Clinical Trials: The New Rule expands the concept of “clinical trial”, defining it as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Researchers with federally-funded clinical trials are responsible for complying with additional requirements. For more information, see Sections 3(c) and 3(e), below. e) New Single IRB (“sIRB”) Requirement: An sIRB is the IRB of record, selected on a study-by- study basis, which provides the ethical review and related administrative coordination for all sites participating in a multi-site study. Beginning in 2020, the New Common Rule will require use of an sIRB when domestic institutions are engaged in cooperative research. For NIH- funded studies only, a version of the sIRB requirement already applies. For more information, see Section 3(f), below. f) Revised Definitions: The New Rule includes some new and revised definitions, including narrowing the definition of Human Subjects Research by specifying that certain activities are now no longer included, such as certain scholarly and journalistic activities (such as oral history), public health surveillance and criminal justice and intelligence activities. For more information, see Section 5, below. 2 3. Detailed description of Changes Affecting Cornell Researchers a. Changes to Exemption Categories and Review Procedures As before, under the New Rule some research activities will meet the definition of human participant research but will not require, as a regulatory matter, review and oversight by the Institutional Review Board. The Cornell IRB will still require PIs to submit such studies for an administrative review and formal determination of exemption before they commence research with human participants. Researchers may not self-determine that their work is exempt. The new, single application form available on the website should be used by researchers seeking exemption, or any other level of IRB review. Revised Exemption Categories The New Rule introduces major changes to the exemption categories, with all but one category being revised, new categories added, and two new processes introduced: Limited IRB Review and Broad Consent.3 The exemption categories, as they appear in the New Rule, are described below: Category 1: Research in Established or Commonly Accepted Educational Settings Restriction added This category has been amended to include a requirement that the research is not likely to have adverse impacts on either students learning required educational content, or assessment of educators who provide instruction. As before, it may only be used for studies on normal educational practices. Category 2: Educational Tests, Surveys, Interviews, Observations of Public Behavior Broadened The New Rule allows for exemption as long as one of three criteria is met: • Information obtained is not identifiable; or • Disclosure outside of the research would not put subjects at risk of harm; or • Information obtained can be identifiable and potentially put participants at risk, but the IRB has done a Limited IRB Review to ensure adequate provisions for privacy and confidentiality If none of these criteria is met, the research must be reviewed as an expedited protocol. This category has been revised to include visual or auditory recording as research methods. As under the Old Rule, surveys or other permitted research methods cannot be combined or paired with non-exempt methods such as collection of biospecimens, as those additional activities would disqualify the research from this category. When research includes children, Category 2 still cannot be used as the basis of exemption, if the research involves surveys, interviews, or the investigator participating in the activities being observed (observation of public behavior without intervention is permitted). 3 In addition to new exemption categories and changes to existing categories, the New Rule allows all exemption categories to be used for research with prisoners, provided that the research involves a broader subject population and only incidentally includes prisoners (i.e., the research is not seeking to examine prisoners as a subpopulation). 3 Category 3: Benign Behavioral Interventions with Adult Subjects New Category This is a new category4 for benign behavioral research with adults, which must be “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.” An example provided is having subjects solve puzzles under various noise conditions. Exemption is permitted if: the data are recorded in such a way that the identity