Transcript Office of Research Retreat October 24, 2000

Determining the Appropriate IRB
Application for Your Research
June 7, 2011
Federal Definitions
 Human Subject – a living individual about whom an investigator
(whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual or
(2) identifiable private information.
 Research – a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge.
 Minimal Risk - the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological
examinations or tests.
Local Definitions
 Vanderbilt HRPP – a human research protection program
(HRPP) designed to ensure the protection of humans
participating in research studies.
 IRB Committee – a committee of scientists and nonscientists charged with reviewing the risk/benefit ratio of
proposed research.
 Analyst – a person who works on one of four teams that
support the IRB Committees by conducting pre-reviews of
research studies and making sure everything is in order for a
study before it is reviewed.
Applications Available
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Non-Human/Non-Research Determination Request
Umbrella Request
Exemption Request
Specimen/Data Repository Application
Coordinating Center Application
Biomedical/Health Sciences Applications
Behavioral/Social Sciences Applications
HSRC and/or RDRC Applications
Supplemental Forms
Additional Submission Forms
Non-Human/Non-Research
Determination Request
 When & Why
 Your project meets the non-human and/or the nonresearch definition shown on the Federal Definitions page
and you need documentation from the IRB to give to your
sponsor, funder, or granting agency. Note: This form may not be
appropriate if the proposal is funded by a Federal grant that involves
human subjects for which you are the PI or the direct recipient of the
grant. Consider using the Application for Coordinating Center Activities
(Form #1125).
 What
 Completed Form #1122
 Submitted through the DISCOVR-E portal
 Reviewed by Analyst
Umbrella Request
When & Why
 Your project needs IRB acknowledgement of the
intent of research for funding purposes; however, the
individual study or studies have not yet been fully
developed. Note: An umbrella approval does not grant
approval for research on human participants; it is simply an
acknowledgement of the intent of the grant application, but does
not constitute an approval of the grant.
What
 Completed Form #1106
 Submitted through the DISCOVR-E portal
 Reviewed by Committee Chair or a designee
Exemption Request
 Must meet definition of minimal risk shown previously on the
Federal Definitions slide.
 Falls into one or more of the 6 exemption categories.
 At Vanderbilt, exempt status can only be determined by the
IRB.
 Exemption from Subpart A of the Federal Regulations does
not mean a study is exempt from human subjects protections
or Vanderbilt HRPP policies and procedures.
Exemption Request
 Overview of 6 Exempt Categories
 Research conducted in established or commonly accepted educational
settings, involving normal educational practices
 Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or
observation of public behavior (exceptions)
 Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior with elected officials or federal statutes
requiring confidentiality
 Research involving the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens, if publicly available
or recorded with no links
 Research and demonstration projects, which are conducted by or subject to
the approval of Federal Department or Agency heads, and which are designed
to study, evaluate, or otherwise examine public service agencies
 Taste and food quality evaluation and consumer acceptance studies
Exemption Request
When & Why
 Your research meets at least one of the six
categories shown on the preceding slide.
 An exempt determination must be made by someone
other than PI. Vanderbilt has designated the IRB as
the party responsible for making exempt
determinations
What
 Completed Form #1102
 Submitted through the DISCOVR-E portal
 Reviewed by Analyst II or higher
Specimen/Data Repository
Application
Specimens/data to be collected prospectively
or retrospectively (previously stored), for
undefined future research purposes that will be
shared, used again, or stored for research
purposes should be banked in a “research
repository.”
Specimen/Data Repository
Application
 When & Why
 Repositories may be proposed, built, and maintained by
individuals (e.g., Investigators), groups, programs, departments,
or institutes. A single Investigator or a group of Investigators may
wish to pool research specimens/data from multiple research
studies into a single specimen bank or database that could be
accessed by the group and others for further use.
 When data contained in a database will be accessed for multiple
projects or by multiple Investigators, a repository should be
established.
 What
 Completed Form #1103
 Submitted through the DISCOVR-E portal
 Reviewed Full Committee or Expedited, whichever is most
applicable based on the study
Coordinating Center Application
A Coordinating Center (CC) may consist of a
group of individual researchers or a single
Investigator responsible for oversight of more
than one performance site engaged in
research. Additionally, a CC maintains
sufficient mechanisms for the protection of
research participants with regard to its
activities and responsibilities.
Coordinating Center Application
 When & Why
 When the Investigator’s responsibility in the research is
strictly limited to the Coordinating Center function (not
enrolling at Vanderbilt).
 OHRP Guidance indicates that an IRB should assure
human subject protections are in place when the institution
operates a coordinating center.
 What
 Completed Form #1125
 Submitted through the DISCOVR-E portal
 Reviewed Full Committee or Expedited, whichever is most
applicable based on the study
Biomedical/Health Sciences and
Behavioral/Social Sciences
 Biomedical/Health Sciences – Studies designed
primarily to increase the scientific base of information
about normal or abnormal physiology and
development, and studies primarily intended to
evaluate the safety, efficacy, and usefulness of drugs,
biologics, devices, medical products, procedures or
interventions.
 Behavioral/Social Sciences – Studies designed to
contribute to behavioral, educational, and social
science research. Includes quantitative and qualitative
investigations of individual and group characteristics.
Biomedical/Health Sciences and
Behavioral/Social Sciences
 Most frequently used applications. Both Standard and
Expedited applications available.
 Type of research will determine the level of review required.
Standard - full committee (10 person panel); or Expedited sub-committee (1 designated committee member).
 Keep in mind “Expedited” review indicates a sub-committee
review not necessarily a faster review or less comprehensive
review (criteria for approval found in 45 CFR§46.111 must
still be met) and must be minimal risk to qualify.
 Expedited applications incorporate the review categories.
Biomedical/Health Sciences
 When & Why
 Use when research involves human subjects in a research
project involving greater than minimal risk (e.g., new drug
or indication, a device that has not been cleared, etc.) or
minimal risk research that fits in one of the expedited
review categories identified in Form #1133.
 What
 Completed Form #1100 or #1133
 Submitted through the DISCOVR-E portal
 Reviewed by Full Committee or Expedited review,
whichever is applicable to the study submitted
Behavioral/Social Sciences
 When & Why
 Use when research involves human subjects in a research
project that involves greater than minimal risk, a complex
intervention that includes a vulnerable population, or
minimal risk research that fits in one of the expedited
review categories identified in Form #1119.
 What
 Completed Form #1124 or #1119
 Submitted through the DISCOVR-E portal
 Reviewed by Full Committee or Expedited review,
whichever is applicable to the study submitted
Human Subject Radiation Committee
(HSRC) and/or Radioactive Drug
Research Committee (RDRC)
 HSRC – For review and approval of research studies
involving human participants and radiation exposure for
research purposes only
 RDRC – For review of the use of any substance defined as
a drug under the Federal Food, Drug and Cosmetic Act that
exhibits spontaneous disintegration of unstable nuclei with
the emission of nuclear particles or photons. Included are
any non-radioactive reagent kit or nuclide generator that is
intended to be used in the preparation of a radioactive drug
and "radioactive biological products."
HSRC and/or RDRC Applications
 When & Why
 Your project includes radiation ionizing procedures for research
purposes submit a HSRC application concurrently with the IRB
application
 Your project includes the administration of a radioactive drug as
described in the previous slide submit a RDRC application
concurrently with the IRB application
 What
 Completed Form #1107 or #1108 and Form #1100
 Submitted through the DISCOVR-E portal
 Reviewed by Full Committee for the study and Full Committee or
Expedited review for HSRC/RDRC
Supplemental Forms
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Coded Data Agreement (Form #1142)
Coordinating Center Supplemental Form (Form #1132)
Specimen/Data Repository Supplemental Form (Form #1136)
Data Use Agreement (Form #1109)
Complaint Report (Form #1114)
Waiver of Consent and/or Authorization to Access PHI (Form #1112)
Vulnerable Population Forms
 Children (#1117), Prisoners (#1115), Pregnant Women (#1116), and Cognitively Impaired
(#1118)
Conflict of Interest Opinion Request (Form #1120)
Investigator Held IND Supplemental Form (Form #1135)
Supplemental Form for Devices (Form #1134)
Specimen/Data Repository Supplemental Form (Form #1136)
Phase I and Phase I/II Supplemental Form (Form #1143)
Research Procedure Supplemental Form (Form #1140)
Supplemental Forms
 When & Why
 Supplemental forms, as well as any additional study
documents, are to be completed and submitted in
conjunction with the corresponding IRB application.
Based on answers to questions within the IRB
applications, the Investigator will be guided to which
supplemental forms are required with the submission.
 What
 Supplemental forms related to the study are to be
downloaded, completed, and submitted electronically
through the DISCOVR-E portal.
Other Types of Submissions
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Continuing Review
Umbrella Continuing Review
Adverse Event Report
Amendment Request
Administrative Amendment Request
Non-compliance with the Protocol
 The title of form represents the type of submission it should be
used for; however, if additional guidance is needed after
reviewing the specific form and/or accompanying instructions,
please contact a protocol analyst for further assistance.
Resources Available
 VHRPP Staff - Protocol Analysts
 Use for specific IRB questions related to a specific ongoing project or a
proposed new project.
 Process Improvement Team - PIT crew
 Use for education and assistance on topics related specifically to IRB
related policies/procedures, as well as compliance and documentation
issues.
 Other Resources
 Use for issues related to a specific component of the research that falls
within the purview of an established department, such as:
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Office of Grants & Contracts Management
Clinical Trials Billing Compliance within the Department of Finance
Tech Transfer
Medical Center Conflicts of Interest Committee
Contact Information
 IRB Front Office – 322-2918
 http://www.mc.vanderbilt.edu/irb/
 http://irbtipoftheweek.wordpress.com/