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, 2011 Slides Prepared by: Wade Wootan

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Page 1: Collaborative Research & Off-Site Research

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

Page 2: Collaborative Research & Off-Site Research

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?

Page 3: Collaborative Research & Off-Site Research

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)

Page 4: Collaborative Research & Off-Site Research

Potential Scope of Human Subjects Research

Page 5: Collaborative Research & Off-Site 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)

Page 6: Collaborative Research & Off-Site Research

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

Page 7: Collaborative Research & Off-Site Research

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

Page 8: Collaborative Research & Off-Site Research

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

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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

Page 10: Collaborative Research & Off-Site Research

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

Page 11: Collaborative Research & Off-Site Research

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:

Page 12: Collaborative Research & Off-Site Research

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

Page 13: Collaborative Research & Off-Site Research

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

Page 14: Collaborative Research & Off-Site Research

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

Page 15: Collaborative Research & Off-Site Research

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

Page 16: Collaborative Research & Off-Site Research

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

Page 17: Collaborative Research & Off-Site Research

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

Page 18: Collaborative Research & Off-Site Research

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

Page 19: Collaborative Research & Off-Site Research

The End

Questions?Brian Weimer:

Research Compliance [email protected] 2425 of Tidewater Bldg.http//tulane.edu/asvpr/research-

compliance.cfm