1. 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
Tel

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

3. Who we are

4. 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

5. Human Subjects Research

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

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

8. 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

9. 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)

10. 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

11. NIH single IRB Policy

12. 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

13. 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.”

14. 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.

15. 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

16. Recent Update – 12/16/2016 Extended effective date
Guidance from NIH now available:

17. Reliance/Ceding Practices at OHRA/Harvard LMA IRB

18. 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

19. 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

20. Serving as Relying IRB
Aka Relying Institution/IRB, participating site, etc.
Specific criteria outlined in our HRPP Plan (available at
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

21. To Request Reliance Contact OHRA to determine appropriateness
Submit to the IRB
“Create New Study” in ESTR (
General guidance:
When Harvard Catalyst affiliate/joinder involved, also submit a “cede request” through their system (

22. OHRA Resources Reliance/Cede-related questions:
Scott Meyers
Department-assigned IRB Review Specialist (
Quality Improvement Program
Service Request (