Overview of Changes to the Common Rule Baruch Human Research Protections Program Office

Welcome to our video which will summarize most of the changes being made to the Common Rule. This video will not cover most of the common rule changes in depth. These changes will be addressed in the videos specified in this presentation. The Baruch HRPP website and resources will be updated to be in compliance with revised common rules.

What is the Common Rule? The Common Rule are federal regulations that govern human subjects research. Currently, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have adopted the revisions to the Common Rule. These changes will go into effect on January 19, 2018. Summarize your research in three to five points.

When is CUNY HRPP or IRB Review Required (45 CFR 46.102) Definition of Research now defines what is not research (45 CFR 46.102 (d)). Human Subjects definition now includes “information or biospecimens” obtained from through intervention and interaction or “identifiable private information or biospecimens” (45 CFR 46.102 (e)) Clinical trials are now specifically defined. Definition of Identifiable or biospecimens/identifiable private information will be re-examined within one year and every four years after. For in depth descriptions of Research and Human Subjects Definitions please view our video “Does My Project Require HRPP or IRB Review?” Summarize your research in three to five points.

Continuing Review of Research (Exempt/Expedited Research) Continuing Review of Research will no longer be required for most expedited research. CUNY will also be eliminating continuing review for projects requiring exempt determinations. Continuing Review will still be required for projects requiring Convened/Full Board Review. For research approved prior to January 19, 2018 projects will be re-evaluated/and assessed during the continuing review process. Determinations will be made as to whether or not project will require continuing/annual review. Final Reports will still be required. Amendments will still be required for any changes made to research studies prior to implementation. Summarize your research in three to five points.

Changes to Exempt Categories (45 CFR 46.104(d)) Exempt Categories have been increased from 6 to 8 categories Exemption Categories 1, 2, 4, and 5 have been revised. Exemption Categories 3, 7, and 8 have been added. Exemption Category 3 is a new category that involves benign behavioral interventions involving adults. Exempt Determinations are solely made by the HRPP Office not the researchers themselves. For in depth information please view our “What Level of Review Does My Project Require?” video. Summarize your research in three to five points.

What is Limited IRB Review? (45 CFR 46.104(d)) Under the new revised Common rule, exempt categories 2, 3, 7 & 8 now include a provision for Limited IRB Review. Limited IRB Review must be performed by the IRB using expedited review procedures. Limited IRB is limited in scope and the review criteria differs based on the specific exemption category. Limited IRB Review is required for projects involving the collection of identifiable and sensitive data. See Exemption Categories 2 & 3. For these types of research limited IRB Review will consist of reviewing the data storage/maintenance, privacy and confidentiality procedures of the proposed research. Limited IRB Review is always required for Exemption Categories 7 & 8. The Limited IRB Review procedure for these categories are more extensive than Categories 2 & 3 and include (1)Broad consent for storage/maintenance and secondary research use of identifiable private information or identifiable biospecimens is obtained are in accordance with 45 CF 46.116, (2) Broad Consent is appropriately documented or waiver of documentation is appropriate, (3) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Summarize your research in three to five points.

Changes to Informed Consent (45 CFR 46.116) Allows waiver of informed consent for subject recruitment or screening under certain conditions. New Requirements for Key Information and Organization of Consent Document. Defines and References Requirements for New Broad Consent procedures. Specifically allows for Electronic signatures for consent documentation and specifies that a written copy must be given to the person signing the form. New basic element on collection of identifiable private information or identifiable biospecimens; three new additional elements on commercial profit, return of clinically relevant research results, and whole genome sequencing. CUNY Consent Templates (informed consent/broad consent templates) will be updated to include new consent requirements/elements. Summarize your research in three to five points.

Why are these changes important? These changes add more flexibility into the regulations. More research will now be determined to be exempt as additional exemption categories were added/revised to include research involving identifiable/sensitive data and benign behavioral interventions. Certain types of activities have been defined as not research. Scholarly and journalistic activities such as oral history, journalism, biography, literary criticism, legal research, and historical scholarship are activities that are now defined as not meeting the definition of research. IRB processes such as continuing reviews have been eliminated for most studies which should reduce administrative burdens of researchers and the HRPP/IRB. If you have any questions regarding the revised Common Rule please contact the HRPP Coordinator.

Revised Common Rule Resources http://www2.cuny.edu/research/research-compliance/human-research- protection-program-hrpp/ http://www.baruch.cuny.edu/hrpp/ https://about.citiprogram.org/en/final-rule-resources/ https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp- recommendations/index.html