Agreement
SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.
Ceded Review
An instance of IRB review in which one or more Participating Institutions invoke this Agreement to transfer IRB review and oversight authority for an instance of Research and rely on another Participating Institution’s IRB that accepts responsibility for IRB review and oversight of such 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 or Site Investigator(s) or other research personnel not generally known or available to the public. Information will not be deemed confidential information hereunder if such information: (a) is known to the receiving party prior to receipt from the disclosing party directly or indirectly from a source other than one having an obligation of confidentiality to the disclosing party; (b) becomes known (independently of disclosure by the disclosing party) to the receiving party directly or indirectly from a source other than one having an obligation of confidentiality to the disclosing party; (c) becomes publicly known or otherwise ceases to be secret or confidential, except through a breach of this Agreement by the receiving party; or (d) is independently developed by the receiving party.
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).
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.
Effective Date
With respect to any Participating Institution, the effective date of its Joinder Agreement, as identified in the Joinder Agreement.
Exemption Determinations
Determinations that Research is exempt from IRB review pursuant to the federal policy.
FDA
The United States Food and Drug Administration.
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 corresponding regulations of other federal departments and agencies adopting such Policy.
FWA
The Federalwide Assurance in which a research institution commits to DHHS that it will comply with the federal policy.
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 regulations.
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.
HRPP
Human Research Protection Program.
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.
Institutional Official or Signatory
The person who has the authority on behalf of an institution to bind such institution to the terms and conditions of this Agreement.
IRB
Institutional Review Board.
IRB Organization
An independent IRB organization that provides IRB review services and has agreed to become the Reviewing IRB for another Participating Institution for an instance of research under this Agreement.
Joinder Agreement
Such agreement is substantially the same form set forth at Exhibit B of the Agreement by which an institution represents and warrants that it meets all eligibility requirements for participation in the Agreement and agrees to be bound by the terms and conditions of this Agreement.
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.
Lead PI
See Overall PI.
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.
Local Considerations
Requirements of any applicable state or local laws, regulations, institutional policies, standards or other local factors, including local ancillary reviews, relevant to an instance of research.
NCATS
National Center for Advancing Translational Sciences at the National Institutes of Health (NIH), one of 27 Institutes and Centers at the (NIH).
OHRP
The Office for Human Research Protections of DHHS.
Overall PI
The lead multisite principal investigator with ultimate responsibility for the conduct and integrity of research (generally, the initiating principal investigator or funding principal investigator, as applicable).
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.
Principal Investigators
Together, the Overall PI and Site PI(s).
PHI
Protected Health Information as defined in 45 CFR 160.103.
POC
Points of Contact. At least one individual who will serve as the contact person responsible for communicating on behalf of the institution with respect to matters concerning the initial and ongoing implementation of this Agreement. For example, the POC would be the person designated at each Participating Institution to make determinations regarding requests for his/her site to serve as the Reviewing IRB for Research or cede IRB review and are likely to be individuals within an IRB office or other component of the human research protection program.
QI/QA
Quality improvement/quality assurance.
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.
Relying Institution
A Participating Institution that cedes IRB review to a Reviewing IRB for an instance of Research 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.
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
Human subject research within the meaning of the Federal Policy or within the meaning of any other federal human subjects research regulations or policies; clinical investigations within the meaning of the FDA IRB regulations; and any other research, for which any Participating Institution(s) seek or are required to rely on a Reviewing IRB. As used in the Agreement, Research may reference a specific study or protocol in which there will be a reviewing and relying party operating pursuant to the terms of the Agreement, or collectively the studies subject to Ceded Review 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.
Reviewing IRB
The “IRB of record” (including an IRB Organization) to which authority for IRB review and oversight has been ceded by another Participating Institution for an instance of Research under the Agreement.
Reviewing IRB Institution
The Participating Institution whose IRB has become the Reviewing IRB for another Participating Institution for an instance of Research under this Agreement.
Site Investigator(s)
An investigator(s) responsible for the conduct of the Research at his/her Participating Institution.
SMART IRB Standard Operating Procedures (SOPs)
Standard Operating Procedures developed in support of the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.
Terminating Institution
A Participating Institution whose participation in this Agreement is terminating.