What is (and isn’t) human subjects research What is (and isn’t) human subjects research? When do we need to cede review? New Single IRB policy; ESTR Tips & Tricks Alyssa Speier, MS, CIP Associate Director Regulatory Affairs & Research Compliance Email: aspeier@hsph.harvard.edu Tel. 617-432-2140

Agenda Who we are Human Subjects Research NIH sIRB Policy OHRA reliance/ceding practices Resources ESTR (Kim Serpico)

Who we are

Harvard University Faculty of Medicine Institutional Official Pam Caudill, Chief of Research and Administrative Operations Harvard T.H. Chan School of Public Health Institutional Official Delia Wolf, Associate Dean for Regulatory Affairs & Research Compliance Office of Human Research Administration Managing Director Leslie Howes IRB Operations Assistant Director Kim Serpico Quality Improvement Program Associate Director, ORARC Alyssa Speier Sr. IRB Review Specialist Keren-Nicole Insalaco IRB Review Specialists Jada Dixon Alma Castro Grace Bullock Sr. QA/QI Specialist Lisa Gabel QA/QI Specialist Scott Meyers Version Date 9-26-2016

Human Subjects Research

Why Care? HHS Policy for Protection of Human Research Subjects (45 CFR 46) “…applies to all research involving human subjects…”

Research “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…”

Human Subjects Research (HSR) Research with “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information” Intervention Physical procedures or manipulations of the subject/subject's environment Interaction Communication or interpersonal contact Private Info Information in which one can assume no observation or recording is taking place; information which has been provided for specific purposes and which will not be made public

Common Examples Human Subjects Research Not Human Subjects Research Clinical trial designed to evaluate the safety/efficacy of an investigational product (IND/IDE study) Interviewing community members to evaluate the reception of a new bicycle pathway in the community Medical record/chart review Animal research Literature search Exercises solely to fulfill course requirements or to train students Program evaluation Analyses of anonymized or de-identified data (i.e., data set obtained includes no identifiers)

Determining HSR Investigators may determine whether activities constitute human subjects research Harvard LMA IRB is available to make formal determinations (submission required) Recommended when activities are federally funded, publication anticipated, and/or activities proposed by student-investigators

NIH single IRB Policy

NIH single IRB Policy 6/21/2016 – NIH issued its Final Policy on the Use of a Single IRB for Multi-Site Research: “…establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single IRB to conduct ethical review required by the DHHS regulations…” Why? Streamline IRB review process; remove redundancies; allow research to proceed efficiently; reduce unnecessary admin. burden

Applicability NIH funded (e.g., grant, cooperative agt., contract, or NIH intramural Research Program) Excludes: career development, research training or fellowship awards Involves multiple sites (“participating sites”) Domestic Implementing “same” protocol Exclusions b/c these focus on providing training/career development opportunities Applies to sites regardless of whether they are subawards/primary awardee or separate awards made to sites multisite = 2 or more sites domestic sites Same research protocol = address same research question, involve the same methodologies, evaluate the same outcomes. Additionally, sites that are accruing research participants for studies that are identical except for variations due to local research context would be considered to be conducting the “same research protocol.”

Exceptions to Policy Review prohibited by a federal, tribal, or state law, regulation, or policy Requires compelling justification NIH expected to outline process for requests Policy does not prohibit participating sites from duplicating review (NIH funds may not cover related costs) Exceptions automatic for (1) research involving Tribal Nation, but should be noted in grant application/proposal/contract; (2) foreign sites.

Effective Date Competing grant applications (new, renewal, revision, or resubmission) with receipt dates of 9/25/2017 * or later; Ongoing, non-competing awards not expected to comply until grantee submits a competing renewal application *Updated in the Federal Register on 12/16/2016

Recent Update – 12/16/2016 Extended effective date Guidance from NIH now available: http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review

Reliance/Ceding Practices at OHRA/Harvard LMA IRB

Reliance Agreements Process whereby one institution relies on another for IRB review/continuing oversight Common nomenclature ceding, cedes, reliance, IRB Authorization Agreements (IAAs), sIRB, central IRB, etc. OHRA regularly pursues reliance agreements for multi-site non-exempt human research Regardless of funding

Serving as Reviewing IRB Aka Institituion/IRB of Record, sIRB, etc. No specific criteria, but appropriate when HMS/HSDM/HSPH engaged in non-exempt human research E.g., HMS/HSDM/HSPH in direct receipt of HHS funding; Harvard LMA School agents involved in interventions/interactions with participants, obtain informed consent, and/or access identifiable data

Serving as Relying IRB Aka Relying Institution/IRB, participating site, etc. Specific criteria outlined in our HRPP Plan (available at https://www.hsph.harvard.edu/ohra/hrpp-plan/) Designated IRB must hold a valid FWA AND one of the following: The IRB has been designated as the single IRB (“sIRB”) as per the NIH Policy. Institution is Harvard Catalyst affiliate/joinder of Harvard Catalyst reliance agreement Institution is AAHRPP accredited The Harvard Investigator(s) is a collaborator and human research primarily conducted at another organization (Harvard investigators are not interacting/intervening with participants) Harvard LMA School engaged solely because it’s receiving federal funds

To Request Reliance Contact OHRA to determine appropriateness Submit to the IRB “Create New Study” in ESTR (https://irb.harvard.edu) General guidance: http://estrsupport.fss.harvard.edu/creating-new-study When Harvard Catalyst affiliate/joinder involved, also submit a “cede request” through their system (http://catalyst.harvard.edu/services/irbcede/)

OHRA Resources Reliance/Cede-related questions: Scott Meyers (scmeyers@hsph.harvard.edu) Department-assigned IRB Review Specialist (https://www.hsph.harvard.edu/ohra/department-assignments/) Quality Improvement Program Service Request (https://harvard.az1.qualtrics.com/jfe/form/SV_9Hx4AQ5p974GvMF)