Resources
Glossary
A
Agreement
SMART IRB Reliance Agreement.
Assurance
An assurance of compliance with the Federal Policy that is maintained with a federal department or agency.
C
Ceded Review
The transfer of authority to, and reliance on, a Reviewing IRB for IRB review and oversight of Research.
Confidential Information
Any non-public, confidential and/or proprietary information, including but not limited to the scientific content of Research proposals and information provided by the Overall PI, Site Investigator(s), or other Personnel not generally known or available to the public. Information is not Confidential Information hereunder if such information (a) is or becomes known to the receiving party independently of disclosure by the disclosing party, directly or indirectly from a source other than one having an obligation of confidentiality to the disclosing party; (b) becomes publicly known or otherwise ceases to be confidential, except through a breach of this Agreement by the receiving party; or (c) is independently developed by or on behalf of the receiving party. For clarity, as used in this Agreement, the term Confidential Information has no relation to the classification level of information/documents within a federal department or agency.
Covered Activity/Covered Activities
Ceded Review of Research and Exemption Determinations, individually or collectively.
CTSA
The Clinical and Translational Science Award (CTSA) program creates a definable academic home for the discipline of clinical and translational science at institutions across the country. The CTSA program is funded by the National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health (NIH).
D
Data Use Agreement
A written agreement meeting the requirements of 45 CFR 164.514(e)(4), pursuant to which a HIPAA Covered Entity may use or disclose a Limited Data Set for research purposes.
DHHS
U.S. Department of Health and Human Services.
E
Effective Date of a Joinder Agreement
The date on which the Participating Institution’s Institutional Official/Signatory executes the Joinder Agreement.
Effective Date of the Agreement
With respect to any Participating Institution, the Effective Date of its Joinder Agreement.
Effective Date of the Indemnification Addendum
With respect to any Indemnification Participating Institution, the date on which the Indemnification Participating Institution’s Institutional Official/Signatory executes the Indemnification Addendum Joinder Agreement.
Exemption Determination
A determination by a Reviewing IRB or Reviewing IRB Institution whether Research is exempt from some or all of the requirements of the Federal Policy.
F
FDA
U.S. Food and Drug Administration.
FDA Clinical Investigation Regulations
21 CFR Parts 50, 56, 312, and 812.
Federal Institution
An Institution/Participating Institution that is a department or agency of federal government.
Federal Policy
The Federal Policy for the Protection of Human Subjects set forth in the DHHS regulations at 45 CFR Part 46, Subpart A and in corresponding regulations of other federal departments and agencies adopting such policy.
Force Majeure Event
An unforeseeable natural, political, or similar event beyond the control of a Participating Institution, including, without limitation, fire, flood, pandemics, epidemics, riots, war, acts of terrorism, or governmental actions or decrees in response to same, except as provided in Section 8.13 hereof.
FWA
The OHRP-approved Federalwide Assurance in which an Institution commits to DHHS that it will comply with the Federal Policy.
H
HIPAA
Collectively, the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act of 2009, and their implementing privacy and security regulations, including but not limited to the implementing privacy regulations at 45 CFR Part 160 and 45 CFR Part 164, Subparts A and E.
HIPAA Covered Entity
A health care provider, health plan, or health care clearinghouse subject to HIPAA as further defined and provided in 45 CFR 160.103.
HIPAA Privacy Rule
The implementing regulations of HIPAA that address the privacy and rights of individuals with respect to PHI, found at 45 CFR Part 160 and Subparts A and E of Part 164.
Human Research Protection Program or HRPP
An Institution’s policies, procedures, and oversight mechanisms for addressing human research protections.
Human Subject (as Defined by DHHS)
A living individual about whom an investigator (professional or student) conducting research obtains (1) data through Intervention or Interaction with the individual, or (2) information that is both private information and identifiable information.
Human Subject (as defined by FDA)
An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may either be a healthy individual or patient.
I
Indemnification Addendum
The SMART IRB Indemnification Addendum attached to the Agreement at Exhibit C.
Indemnification Addendum Joinder Agreement
The SMART IRB Indemnification Addendum Joinder Agreement available at www.smartirb.org, which will be in substantially the same form as in Exhibit C.
Indemnification Participating Institution
A Participating Institution that joins the Indemnification Addendum.
Indemnification Terminating Institution
An Indemnification Participating Institution that terminates its participation in the Indemnification Addendum or whose participation in the Indemnification Addendum is terminated pursuant to Sections 7.2.2.2 or 7.2.2.3 hereof, respectively, or whose participation in the Indemnification Addendum ends as a result of the termination of the Indemnification Addendum in its entirety pursuant to Section 7.2.2.1.
Indemnified Party(ies)
An Indemnification Participating Institution and its trustees, directors, officers, Personnel, and IRB members eligible to be held harmless, indemnified, and defended by an Indemnifying Party under the Indemnification Addendum.
Indemnifying Party
An Indemnification Participating Institution that is a Private Institution and is agreeing in the Indemnification Addendum to hold harmless, indemnify, and defend the Indemnified Parties.
Independent IRB Organization
An independent IRB organization that provides IRB review services.
Institution
Any legal entity, private or public, including any institution or other research organization or site, and any department, agency, or instrumentality of federal, state, local, or other government.
Institutional Official/Signatory
The person who has the authority on behalf of an Institution to bind such Institution to the terms and conditions of the Agreement and, if applicable, the Indemnification Addendum.
IRB
Institutional Review Board.
J
Joinder Agreement
The SMART IRB Joinder Agreement available at www.smartirb.org, which will be in substantially the same form as attached to the Agreement at Exhibit B.
L
Lead PI
See Overall PI.
Lead Study Team
Generally, the Lead Study Team is the study team at the Reviewing IRB’s institution. The Lead Study Team is designated by the Overall PI (see below) and, working in collaboration with the Reviewing IRB, ensures coordination of communication to and from all Relying Site Study Teams (see below), routing all IRB submissions to the Reviewing IRB and communicating IRB determinations to Site Investigators.
Limited Data Set (LDS)
As defined in 45 CFR 164.514(e)(2), Protected Health Information that excludes the following direct identifiers of the individual or of relatives, employers, or household members of the individual: name; postal address information, other than town or city, state, and zip code; telephone numbers; fax numbers; electronic mail addresses; social security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate/license numbers; vehicle identifiers and serial numbers; device identifiers and serial numbers; web Universal Resource Locators (URLs); internet Protocol (IP) address numbers; biometric identifiers, including finger and voice prints; and full face photographic images and any comparable images. An LDS may contain, for example: dates of birth dates of death; dates of service; town or city; state; or zip code or a combination of only those elements.
Limited IRB Review
The IRB review required pursuant to 45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), or (d)(8) or the corresponding provisions in the regulations of any federal department or agency adopting the Federal Policy in order for Research to be considered exempt under one of those provisions.
Local Considerations
Requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews.
Losses
Any and all damages, judgments, liabilities, costs, expenses (including, without limitation, reasonable attorney’s fees and expenses of litigation), or other losses incurred by or imposed upon any Indemnified Party(ies) or Other Party(ies) as a result of third-party claims, suits, demands, actions, or causes of action.
M
Mandated Policy/Policies
Federal department- or agency-mandated policies and procedures governing the conduct of a reliance relationship once it is established.
Mandated Processes
Federal department or agency processes for initiating reliance and for determination of the Reviewing IRB/Reviewing IRB Institution
N
NCATS
National Center for Advancing Translational Sciences at NIH.
NIH
National Institutes of Health.
O
OHRP
The Office for Human Research Protections of DHHS.
Other Considerations
The requirements of any applicable federal laws or regulations or of relevant federal departments or agencies that are not readily apparent from the IRB submission for the Research or that are specific to the Relying Institution. For purposes of this Agreement, HIPAA and its requirements are not considered Other Considerations.
Other Party(ies)
An Indemnification Participating Institution and its trustees, directors, officers, Personnel, and IRB members to whom a Responsible Party is responsible and who are eligible to be reimbursed by a Responsible Party Under the Indemnification Addendum.
Other Policies
Policies and procedures for the conduct of a reliance relationship that are not Mandated Policies but that Participating Institutions agree among themselves to apply to a reliance relationship under the Agreement.
Overall PI
The lead multi-site principal investigator with ultimate responsibility for the conduct and integrity of an instance of Research (generally, the initiating principal investigator or funding principal investigator, as applicable).
P
Participating Institution
An institution (including an IRB organization) that meets the eligibility requirements set forth in the Agreement and agrees to accept the terms and conditions of the Agreement through the execution of a Joinder Agreement, thereby becoming a signatory party to this Agreement.
Party/Parties
A Participating Institution or, collectively, the Participating Institutions.
Personnel
Members of a Participating Institution’s team (including the Overall PI (if any) and Site Investigator(s)) involved in conducting an instance of Research. These individuals may include, as applicable, physicians, nurses, coordinators, data managers, lab technicians, postdoctoral fellows, students, volunteers and/or other personnel.
POC
Contact person or point of contact responsible for communicating on behalf of the Institution/Participating Institution with respect to matters concerning the initial and ongoing implementation of the Agreement.
Principal Investigators
Together, the Overall PI and Site PI(s).
Private Institution
An Institution/Participating Institution that is not a department, agency or instrumentality of federal, state, local, or other government.
Protected Health Information or PHI
Protected Health Information as defined in 45 CFR 160.103.
Public Institution
An Institution/Participating Institution that is a department, agency, or instrumentality of U.S. federal, state, local, or other domestic government.
Q
QI/QA
Quality improvement/quality assurance.
R
Reliance POC
The Reliance POC is a registered user of the SMART IRB Online Reliance system, who will be assigned to review and document determinations related to reliance requests involving that individual’s designated institution(s). Most often, we expect a Participating Institution’s designated POC or Alternate POC will also serve as the Reliance POC; however, some institutions may instead choose to designate another staff member to serve in this capacity.
Reliance Request
A request for Ceded Review or for an Exemption Determination, as applicable, with respect to an instance or multiple instances of Research.
Relying Institution
A Participating Institution that will obtain IRB review from a Reviewing IRB and/or determinations of exemption from IRB review from a Reviewing IRB or Reviewing IRB Institution under the Agreement.
Relying Site Study Team
Relying Site investigators, including any local site personnel designated by the site investigator to carry out the applicable communication, coordination, and administrative procedures described within the Agreement and SOPs.
Report
A report required under applicable federal human subjects protection regulations or under the terms of a Relying Institution’s Assurance to a federal human subjects research regulatory agency (e.g., OHRP, FDA) regarding any unanticipated problems involving risks to human subjects or others; serious and/or continuing noncompliance with the Federal Policy, other applicable federal human subjects protection regulations or policies, or the FDA Clinical Investigation Regulations, as applicable, or with the requirements or determinations of the Reviewing IRB; and/or any suspensions or terminations of IRB approval.
Reportable Event
Any potential unanticipated problems, noncompliance, or other information that must be reported to the Reviewing IRB in accordance with the Reviewing IRB’s policies and procedures.
Research
Any human subjects research within the meaning of the Federal Policy or within the
meaning of any other federal human subjects protection regulations or policies; any investigation/clinical investigation within the meaning of the FDA Clinical Investigation Regulations; and any other research for which any Participating Institution seeks or is required to rely on a Reviewing IRB. Research may reference a specific study or protocol (an instance of Research) or collectively any or all of the studies or protocols eligible under the Agreement.Research Personnel
Members of the research team (including Overall PI and Site Investigator(s)) engaged or involved in an instance of Research. These individuals may include, as applicable, physicians, research nurses, coordinators, data managers, lab technicians, postdoctoral fellows, students, volunteers and/or other personnel.
Responsible Party
An Indemnification Participating Institution that is a Public Institution and is agreeing in the Indemnification Addendum to be responsible to and to reimburse the Other Parties.
Reviewing IRB
The IRB of a Participating Institution that will provide IRB review and/or determinations of exemption from IRB review for a Relying Institution under the Agreement.
Reviewing IRB Institution
The Participating Institution whose IRB will become the Reviewing IRB for a Relying Institution under the Agreement and/or that will provide determinations of exemption from IRB review for a Relying Institution under this Agreement.
S
Site Investigator(s)
The investigator(s) responsible for the conduct of an instance of Research at their Participating Institution.
SMART IRB SOPs
The SMART IRB Standard Operating Procedures developed in support of the Agreement.
T
Terminating Institution
A Participating Institution that terminates its participation in the Agreement or whose participation in the Agreement is terminated pursuant to Sections 7.2.1.2 or 7.2.1.3 hereof, respectively, or whose participation in the Agreement ends as a result of the termination of the Agreement in its entirety pursuant to Section 7.2.1
