03-10-11 RCR Presentation on Collaborative

Tulane University (“TU”) Human Research Protection Program
Presented By: Brian J. Weimer,
Tulane University Research Compliance Officer
Date: March 10, 2011
Slides Prepared by: Wade Wootan
Learning Objectives
 To better understand:
 When does TU’s IRB have
jurisdiction over collaborative
 What are oversight requirements
for off-site research?
 What are responsibilities of
deferring & reviewing IRBs?
 IRB Authorization Agreement (template)
 Individual Investigator Authorization Agreement
 Table on Coordination of IRB Research Review
 Refer also to section 17 of TU’s HRPP standard operating
policies (found at
Potential Scope of
Human Subjects Research
Spectrum of Research
Performance Sites
 TU performance site
 TU performance site
(single site study only)
 TU performance site (as
part of multi-site study
where TU is not lead
site/lead investigator)
 TU performance site (as
part of multi-site study
where TU is lead
site/lead investigator)
 Non-TU performance
 Non-TU performance
site (cooperative
research with offsite
facility engaged in
 Non-TU performance
site (with no
cooperating institution,
facility or organization)
Range of Options for Collaborative
& Off-Site Research for Tulane
 Tulane’s IRB must assure
appropriate oversight of
research where:
 University is “engaged” in
human subjects research
On Tulane University
(“TU”)/Tulane University
Hospital & Clinic
(“TUHC”) premises
Involvement of Tulane
faculty/staff or students
Use of TU property/funds
TU administering of 3rd
party funds
 For other engaged entities
associated with TU
 Tulane’s IRB may oversee
research for another entity
 TU has agreed in writing
with another institution
(e.g., MOU with another
institution, IRB
authorization agreement or
individual authorization
agreement) & other
institution amends its FWA
 Tulane’s IRB may defer
oversight of research to
another entity where:
 TU has agreed in writing
with another institution
(e.g., MOU with another
institution, IRB
authorization agreement
or individual
authorization agreement)
& TU amends its FWA
Responsibilities of
Reviewing & Deferring IRBs
 Reviewing IRB
 Conduct initial & continuing
 Review amendments to
approved protocol
 Review unanticipated
 Suspend or terminate
research for non-compliance
 Notify deferring IRB of any
unanticipated problem,
suspension or termination of
research (as well as
Federal/funding agencies &
sponsors as appropriate)
 Consider conflict of interest
 Deferring IRB
 Will rely on IRB review of
deferring IRB
 Not re-review study
 Comply with & implement
findings of reviewing IRB
Reviewing Institution
 Terminology (if TU is the IRB
responsible for research
 TU IRB = Reviewing
 Off-site entity = Deferring
 Applicability:
 Only used for research that
is not greater than minimal
 At a reviewing institution
performance site; or
 Faculty/staff of Reviewing
institution conduct research
off-site of reviewing
institution(especially where
off-site location has no
 Remember: the deferring institution always
remains responsible for oversight of:
 Its employees
 Safeguarding rights/welfare of human subjects
involved in research at institution
 Educating members of its research community
 Implementing appropriate mechanisms to
ensure compliance with reviewing IRB
Institutional Considerations
Factors for Institution to consider as to whether
reviewing institution should serve as IRB-of-record
for another institution
 Time & resources required to conduct review
 Expertise required for initial & continuing review
 Ability to comply with local knowledge at the outside
entity & off-site location
 Resources, ability & willingness of outside
organization, the PI & off-site location to handle
complaints, review unanticipated problems, etc.
 Off-site ability to comply with additional requirements
imposed by reviewing institution’s IRB
Reviewing Institution Requirements
Knowledge of Local Research Context
 As the IRB for a deferring institution, TU’s IRB must ensure
that it possesses/obtains sufficient knowledge of the local
research context for geographically remote off-site research
 Example: If Tulane’s IRB is the reviewing institution, what
is geographically remote?
Northern Louisiana?
West Virginia?
Note: When Tulane’s IRB conducts non-local review, IRB
members must have sufficient knowledge of community
from which subjects are drawn to ensure protection of
subjects’ rights & appropriateness of consent process
See TU SOPs, sections 17.12 & 17.5.8
Reviewing Institution Requirements
Knowledge of Local Research Context (cont.)
Understanding the local research context by obtaining
information on:
 Anticipated scope of off-site
 Method for equitable selection
facility’s research activities
Type of subject populations
likely to be involved
Size & complexity of institution
Institutional commitments &
Applicable laws
Standards of professional
conduct & practice
of subjects
Method for protection of subject
Method for maintenance of
confidentiality of data
Languages understood by
prospective subjects
Method for minimizing
possibility of coercion or undue
influence in seeking consent
Safeguards to protect the rights
& welfare of vulnerable subjects
Reviewing Institution Requirements
Additional Considerations for International Research
 Review by reviewing IRB of research involving
human subjects in other countries also must
include appropriate expertise regarding:
 Consent & recruitment documents in
language readable & understandable by
subjects (or approved translation)
Cultural-sensitivity to local area
Benefits to subjects
Community leaders
Potential coercion
“Helicopter” research (e.g., data/sample
collection & leaving site with no follow-up)
Justify use of recommended subject
Reviewing Institution Requirements
Knowledge of Local Research Context (cont.)
 The IRB may ensure necessary expertise & knowledge
of local research context through one/more of
following (as appropriate to risk level):
 Local Approval by either local ethics committee or
local IRB
 Personal Knowledge by one/more IRB members of
local research context (through extended direct
experience with off-site location, its subject
population, or surrounding community)
 Consultants with knowledge of local research context,
communicated either in writing before IRB meeting
(so reviewers & IRB can review) or orally at IRB
meeting (personally or otherwise)
 Site Visit to research site by IRB members, HRPO staff
or University representatives to either
obtain/maintain knowledge of local research context
or interact with off-site institution liaisons
 Expand IRB Membership to include person from
community in question
Deferring Institution Requirements
 An institution may agree to defer responsibility for IRB
review to another institution’s IRB. This is the
exception, not the rule!
 Mere avoidance of duplication of effort is not enough
justification for an institution to defer to another entity
(and vice versa)
 Terminology
 TU IRB = Deferring institution
 Off-site entity = Reviewing institution
When might Tulane consider
deferring to another IRB?
 Required by sponsor
 TU employee’s role is limited (e.g., data
analysis only)
 Research began at another institution
before TU’s employment of individual +
remains active only at other institution +
funding remains under control of other
 Appropriate expertise of other institution’s
IRB, as compared to TU’s IRB
 Research is not greater than minimal
Deferring Institution Requirements
 Remember: the deferring institution continues to retain
ultimate responsibility for:
 Safeguarding rights & welfare of human subjects involved in
off-site research
Its employees
Safeguarding rights/welfare of human subjects involved in
the research
Educating members of its research community to establish &
maintain culture of compliance with applicable laws &
regulations & with its SOPs and its HRPP
Implementing appropriate mechanisms to ensure compliance
with reviewing institution IRB determinations
Deferring Institution Requirements
 For an institution to defer responsibility, the reviewing institution must
have an IRB & an approved assurance mechanism (e.g., FWA)
 Other considerations:
 Is reviewing institution AAHRPP accredited?
 Is reviewing institution willing to contract with deferring institution to
assure it complies with human subjects requirements?
 Are the requirements mandated by reviewing institution’s IRB overly
 Documentation of deferred responsibility
 Written agreement (i.e., MOU, IRB Authorization Agreement, or
Individual Investigator Agreement)
 Tulane amending its FWA to reflect deferred responsibility
 Note: When deferring, Tulane requires its PI acknowledges in writing
to comply with reviewing institution’s IRB requirements
Tulane PI Responsibilities
 Submit written request to HRPO to defer oversight to TU’s IRB.
 Include copies of prior submissions to relying IRB, protocol &
attachments, notification letters, unanticipated problem reports, etc.
 IRB authorization agreement signed by TU’s IO
 Individual investigator agreement signed by PI of deferring institution
 If TU IRB approves protocol, submit to relying IRB copies of
 Approval letter,
 Approved forms &
 Contact info for TU’s IRB staff
 Ensure that research does not begin prior to review & approval by IRB-
 Notify reviewing IRB of local personnel changes, local advertisements,
etc that require IRB approval
 Notify TU IRB promptly of unanticipated problems, protocol
deviations, protocol violations and protocol exceptions
The End
 Questions?
 Brian Weimer:
 Research Compliance Officer
 504.988.1147
 [email protected]
 Room 2425 of Tidewater Bldg.
 http//tulane.edu/asvpr/research-compliance.cfm

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