Transcript Coordinating Center Application - Vanderbilt University Medical

How to Determine the Appropriate
IRB Application for Your Research
Denise Roe, MSM, CCRP, CIP, RAC
Dena Johnson, BS, CCRP, CIP
March 14, 2008
Learning Objectives
 Identify the applications available
•
•
•
Why
When
How
 Identify the resources available
•
•
•
•
IRB
PIT Crew
Research Support Services
Other Resources
Applications Available
Non-Human/Non-Research Determination Request
Umbrella Request
Exemption Request
Specimen/Data Repository Application
Coordinating Center Application
Health Sciences and Behavioral Social Sciences
Applications
 HSRC and/or RDRC Applications
 Supplemental Forms
 Other Types of Submission Forms






Non-Human/Non-Research
Determination Request
Do I Really Need IRB
Approval?
Human Subject – A living individual about
whom an Investigator (whether professional
or student) conducting research obtains
either data (of any kind) through
intervention or interaction with the
individual or identifiable private information
(of any kind) even in the absence of
intervention or interaction or an individual
who is or becomes a participant in research,
either as a recipient of the test article or as
a control.
Research – Any systematic investigation
(including research development, testing
and evaluation) designed to develop or
contribute to generalizable knowledge.
Non-Human/Non-Research
Determination Request
 When & Why
•
If your project meets the non-human and/or the
non-research definition and you need
documentation from the IRB for your sponsor that
this is the case
 What
•
•
•
Submit through DISCOVR-E or paper IRB form
#1122
Reviewed by Protocol Analyst
Approximately 7 business days
Umbrella Request
Umbrella Review: The review of a grant where
the research study or studies are not yet fully
developed.
Umbrella Request
 When & Why
•
Need IRB acknowledgement of a grant 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
•
•
•
Submit through the DISCOVR-E portal or paper
IRB Form #1106
Reviewed by Chair or designee
Approximately 7 to 10 business days
Exemption Request
 Must meet definition of
minimal risk
 Fall into one or more of
the 6 exemption
categories
 At VU Exempt status can
only be determined by
the IRB
 Exemption from Subpart
A does not mean exempt
from human subjects
protections.
Exemption Request


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.
6 Categories Overview
•
•
•
•
•
•
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
•
•
If research meets at least one of six categories
Does not require full committee review, but
determination must be made by someone other
than PI. VU has designated the IRB as the party
responsible for making exempt determinations
 What
•
•
•
Submit through the DISCOVR-E portal or paper
IRB Form #1102
Reviewed by PA level II or higher
Approximately 7 to 10 business days
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 the data contained in a database will be accessed for multiple
projects or by multiple Investigators, a repository should be
established.
What
•
•
•
Submit through the DISCOVR-E portal or paper IRB Form #1103
Reviewed by Full Committee or Expedited review, whichever is
applicable
Approximately 10 – 12 business days for first Committee Action
Letter
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 an
enrolling site)
OHRP Guidance indicates that an IRB should assure human
subject protections are in place when the institution operates
a coordinating center
 What
•
•
•
Submit through the DISCOVR-E portal or paper IRB Form
#1125
Reviewed by Full Committee or Expedited review, whichever
is applicable
Approximately 10 – 12 business days for first Committee
Action Letter
Health Sciences or Behavioral
Social Science Main Application

Health Science – Studies designated 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 Science – Studies designed to contribute to behavioral,
educational, and social science research. Both quantitative and qualitative
evaluations address issues of confidentiality, coercion, distress, and effects on
social status.
Health Sciences or Behavioral
Social Science Main Application
 Most frequently used application
 Type of research will determine level of review
required (Standard = full committee or
Expedited = sub-committee)
 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 still must
be met)
Health Sciences or Behavioral
Social Science Main Application
Expedited Review Category Comments
 Established Federal Review Categories
 Must be Minimal Risk to qualify
 Behavioral Social Science Application
incorporates expedited review categories
 Health Science paper application does allow
the Investigator to choose an expedited
category; however, electronic submission
through DISCOVR-E will guide the Investigator
through a much shortened expedited
application. Best advice is use DISCOVR-E
Health Sciences or Behavioral
Social Science Main Application
 When & Why
•
Use when research involves human subjects in a research
project that involves greater than minimal risk or minimal
risk research that fits in one of the expedited review
categories and the proposed research does not fit into one
of the aforementioned applications
 What
•
•
•
Submit through the DISCOVR-E portal or paper IRB Form
#1100 (health science) or #1124 (behavioral social science)
Reviewed by Full Committee or Expedited review, whichever
is applicable
Approximately 10 – 14 business days for first Committee
Action Letter
Human Subject Radiation
Committee (HSRC) and/or
Radioactive Drug Research
Committee (RDRC) Applications


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
•
•
•

If the project includes radiation ionizing procedures for research
purposes submit a HSRC application concurrently with the IRB
application
If the project includes the administration of a radioactive drug as
described in the previous slide submit a RDRC application
concurrently with the IRB application
Of note: the most typical IRB Application used in conjunction with
an HSRC or RDRC application is the “main” application.
What
•
•
•
Submit through the DISCOVR-E portal or paper IRB Form #1107
(HSRC) or #1108 (RDRC)
Reviewed by Full Committee or Expedited review, whichever is
applicable
Approximately 10 – 14 business days for first Committee Action
Letter if expedited and 15 – 20 business days if full committee as
both of these committees only meet once a month
Supplemental Forms




CRC Supplemental Form
Coordinating Center Supplemental Form
Specimen/Data Repository Supplemental Form
HIPPA Compliance Forms
•
Data Use Agreement, if applicable
 Waiver of Consent Authorization Form
 Vulnerable Population Forms
 Conflict of Interest Forms
Supplemental Forms
 When & Why
•
Supplemental forms are to be completed and
submitted in conjunction with the IRB application.
Typically the IRB Application selected will guide the
preparer on which supplemental forms are
required.
 What
•
Specific supplemental forms are downloaded,
completed, and submitted in whichever format the
Investigator has chosen either electronically
through DISCOVR-E or paper submission via IRB
main office.
Other Types of Submission
Forms






Continuing Review
Umbrella Continuing Review
Adverse Event Report
Amendment Request
Administrative Amendment Request
Protocol Deviation Report
Other Types of Submission
Forms
 In general title of form is self-explanatory
 If further guidance needed review
specific form and/or instructions for
applicability
 Contact a Protocol Analyst for further
guidance
Resources Available

IRB Protocol Analyst Staff
•

IRB Performance Improvement Team (PIT crew)
•


Excellent resource for specific IRB questions related either to a specific
ongoing project or a proposed new project
Excellent resource for additional education/assistance on topics related
specifically to IRB related issues/processes
Research Support Services
•
Excellent resource for broader issues related to the conduct of research
•
Excellent resource for issues related to a specific component of the research
that falls within the purview of an established department, such as:
Other Resources
•
 Office of Grants & Contracts Management
 Clinical Trials Billing Compliance within the Department of Finance
 Tech Transfer
Other leaders of successful research programs within Vanderbilt
IRB HOME PAGE
Contact Information
 IRB Front Office – 322-2918
 http://www.mc.vanderbilt.edu/irb/