Collaborative Research & Off-Site Research
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Collaborative Research & Off-Site Research
Tulane University (“TU”) Human Research Protection Program (“HRPP”)
Presented By: Brian J. Weimer,Tulane University Research Compliance Officer
Date: March 10, 2011Slides Prepared by: Wade Wootan
Learning ObjectivesTo better understand:
When does TU’s IRB have jurisdiction over collaborative research?
What are oversight requirements for off-site research?
What are responsibilities of deferring & reviewing IRBs?
HandoutsIRB Authorization Agreement (template)Individual Investigator Authorization Agreement
(template)Table on Coordination of IRB Research Review
Refer also to section 17 of TU’s HRPP standard operating policies (found at http://tulane.edu/asvpr/irb/upload/Tulane-HRPP-01-20-2010-30-12.pdf)
Potential Scope of Human Subjects Research
Spectrum of Research Performance Sites
TU performance siteTU 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 siteNon-TU performance
site (cooperative research with offsite facility engaged in research)
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 research
Tulane’s IRB may oversee research for another entity where:
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 IRBConduct initial & continuing
reviewsReview amendments to
approved protocolReview unanticipated
problemsSuspend or terminate research
for non-complianceNotify 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 IRBWill rely on IRB
review of deferring IRB
Not re-review studyComply with &
implement findings of reviewing IRB
Reviewing Institution Requirements Terminology (if TU is the
IRB responsible for research oversight)
TU IRB = Reviewing institution
Off-site entity = Deferring institution
Applicability: Only used for research
that is not greater than minimal risk
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 FWA/IRB)
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 determinations
Institutional Considerations
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
Factors for Institution to consider as to whether reviewing institution should serve
as IRB-of-record for another institution
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 locations
Example: If Tulane’s IRB is the reviewing institution, what is geographically remote?Northern Louisiana?West Virginia?Rwanda?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 RequirementsKnowledge of Local Research Context (cont.)
Anticipated scope of off-site facility’s research activities
Type of subject populations likely to be involved
Size & complexity of institution
Institutional commitments & requirements
Applicable lawsStandards of professional
conduct & practice
Method for equitable selection of subjects
Method for protection of subject privacy
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
Understanding the local research context by obtaining information on:
Reviewing Institution RequirementsAdditional 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) Infrastructure Justify use of recommended subject population
Reviewing Institution RequirementsKnowledge 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 RequirementsAn 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)
TerminologyTU IRB = Deferring institutionOff-site entity = Reviewing institution
When might Tulane consider deferring to another IRB?
Required by sponsorTU 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 institution
Appropriate expertise of other institution’s IRB, as compared to TU’s IRB
Research is not greater than minimal risk
Deferring Institution RequirementsRemember: the deferring institution continues to
retain ultimate responsibility for:Safeguarding rights & welfare of human subjects
involved in off-site researchIts employees Safeguarding rights/welfare of human subjects involved
in the researchEducating 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 RequirementsFor 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
onerous?Documentation of deferred responsibility
Written agreement (i.e., MOU, IRB Authorization Agreement, or Individual Investigator Agreement)
Tulane amending its FWA to reflect deferred responsibilityNote: When deferring, Tulane requires its PI acknowledges in
writing to comply with reviewing institution’s IRB requirements
Tulane PI ResponsibilitiesSubmit 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-of-record
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 Officer504.988.1147bweimer1@tulane.eduRoom 2425 of Tidewater Bldg.http//tulane.edu/asvpr/research-
compliance.cfm
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