Summary of Changes to Human Subjects Regulations: Effective January 21, 2019

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1 Summary of Changes to Human Subjects Regulations: Effective January 21, 2019 The New Human Subjects Regulations - What does it all mean? This guide serves to assist Clemson University researchers to understand the new human subjects regulations (new rule) and how it will be implemented at Clemson. This is not a comprehensive list of the changes in the new rule, but highlights the most important areas for researchers. Implementation Date Implementation Date All new IRB applications approved after January 21, 2019 will be approved under the new rule. IRB forms will be updated to comply with the new rule and will be available for download after January 11, The new forms will be required for all submissions received in the IRB office after January 11, Projects approved before January 21, 2019 All projects approved before the implementation date remain under the old rule. These projects will retain their existing level of review and all other IRB requirements, including continuing review requirements for Expedited and Full Board protocols. Definitions Definition of Human Subject Definition of Research The new rule expanded the definition of human subject to include a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. The new rule explicitly removes four categories of activities from the rule jurisdiction: Scholarly or journalistic activities, including oral history, journalism, biography, literary criticism, legal research, and historical scholarship; National security missions; Public health surveillance; Criminal justice activities. The Oral History Association (OHA) defines oral history as a field of study and a method of gathering, preserving and interpreting the voices and memories of

2 people, communities, and participants in past events. Projects using oral history methods but do not meet OHA s definition will require IRB review. Definition of a Clinical Trial The old rule provided no definition of a clinical trial. The new rule defines a clinical trial 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 the interventions on biomedical or behavioral health-related outcomes. The Office of Research Compliance (ORC) will provide guidance, at a future date, on the interpretation of this definition. Exempt Review Exempt project determination Exempt categories There is no change to exempt determination process. The exemption must be made by the ORC or a designated member of the IRB. The exempt categories have been revised as noted below. REVISED Exempt category 1 research conducted in educational settings Added that the research would not adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. REVISED Exempt category 2 research involving educational tests, survey procedures, interview procedures, or observations of public behavior Allows educational tests or observations of children under paragraphs 2(i) and (ii) only; Excludes interventions. NEW Exempt category 3 research involving benign interventions Participants have to prospectively agree to intervention; Research involving deception, participants have to be informed that study involves deception; Adult participants only. REVISED Exempt category 4 secondary research for which consent is not required of identifiable private information or identifiable biospecimens Removed the word existing ; Secondary data/specimens may be retrospective and prospective; HIPAA regulations apply for protected health information (PHI);

3 REVISED Exempt category 5 research and demonstration projects conducted or supported by a Federal department or agency Revised to clarify the scope of the exemption and allow for easier applicability; Research or project must be published on a public list; May involve children. UNCHANGED Exempt category 6 taste and food evaluations and consumer acceptance studies Criteria for exemption unchanged but new rule allows for taste and food studies with children. NEW Exempt category 7 storage and maintenance of identifiable private information or identifiable biospecimens for potential secondary research for which broad consent is required Allows for storage or maintenance of identifiable data/specimens; Valid consent required prior to data/specimens collection; HIPAA and other requirements may apply [e.g., Institutional Biosafety Committee (IBC), Clinical Laboratory Improvement Amendments (CLIA)]; NEW Exempt category 8 secondary research involving the use of identifiable private information or identifiable biospecimens for which broad consent was obtained Involves existing data/biospecimens; Secondary research is within the scope for which valid consent was obtained; Study plan does not include returning individual research results to participants; HIPAA and other requirements may apply [e.g., Institutional Biosafety Committee (IBC), Clinical Laboratory Improvement Amendments (CLIA)]; Exempt research and vulnerable populations Pregnant Women All exemptions may apply if the conditions of the exemption are met. Prisoners The exemptions do not apply, except for research aimed at involving a broader subject population that only incidentally includes prisoners. Children Exempt categories 1, 2(i) and (ii), and 4-8 may involve children. Exempt category 2(i) and (ii) only apply to educational tests or observation of public behavior when the investigator(s) do not participate in the activities being observed.

4 Exempt category 2(iii) is not applicable to research with children; 2(iii) involves collection and storage of identifiable data. Benign behavioral intervention New Exempt category (3) 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. Examples include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. Expedited Review Expedited review categories Continuing review requirement for Expedited protocols There is no change to the Expedited categories under the new rule. The Federal Government will assess the categories every four years. The rule clarifies that projects involving only activities on the list of expedited categories should be treated under expedited review unless the IRB determines and documents that the study involves more than minimal risk. Expedited review protocols approved after January 21, 2019 will no longer require annual review, unless the IRB finds and documents the need to require a continuing review to enhance the protections of research subjects. Existing protocols will be assessed at the next annual review period to determine if they should transition to the new rule. Moving a protocol to the new rule means the entire new rule applies. This may require revisions to the informed consent, reconsent of subjects, and increased data security and privacy standards for these existing studies. The new rule will allow the IRB office flexibility when issuing approval dates. A progress report will be required at the end of each approval period for Expedited protocols approved after January 21, Informed Consent Informed consent requirements The informed consent requirements have been modified. A brief explanation of the changes noted below: Significant changes to the content, organization, and presentation of information and process to facilitate a subject s decision about whether to participate; Changes to the basic and additional elements of consent; Creation of the concept of broad consent;

5 Changes in the criteria for the waiver or alteration of consent (only applies to Expedited and Full Board reviews); New provisions that allow IRBs to approve research for which investigators obtain information or biospecimens without consent for the purposes of screening, recruiting, or determining the eligibility of prospective subjects, provided certain conditions are met; Requirement to post to a federal website a copy of the IRB approved version of the consent form. Only one posting is required per multi-site study, which can be done by the sponsor. This only applies to clinical trials that are conducted or supported by a Federal department or agency. Website not developed yet. The IRB office will create new informed consent templates that meet the expectations of simplicity, clarity, and comprehension. The new templates will be available after January 11, Other Items of Interest Screening, recruiting, The new rule allows the IRB to approve access to identifiable information or or determining identifiable specimens without the prospective participant s informed consent eligibility of prospective for purposes of screening, recruiting, or determining eligibility if: subjects The investigator obtains information through oral or written communication with the prospective subject; OR The investigator obtains identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens. A waiver of informed consent will no longer be required to access identifiable information for determining eligibility. However, HIPAA does not allow disclosure of PHI without a signed Privacy Rule Authorization or a waiver or an alteration of Authorization. FDA The Food and Drug Administration (FDA) is an U.S. Department of Health & Human Services (HHS) agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA does not currently follow the new rule.