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Points to Consider: Delegating Review of a Protocol

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Points to Consider When Delegating Review of a Protocol (General)

Protocol-specific factors

  • Phase
  • Interventional/non-interventional
  • Behavioral/biomedical
  • Risk assessment
  • Pediatric or adult
  • Demographics of target populations across the sites—homogenous/very heterogeneous
  • Special or vulnerable populations
  • Number of research participants
  • Number of sites
  • Type of sites
  • Estimated duration of the protocol
  • Primary funder/sponsor of the research
  • Whether the level of involvement of your institution’s employees meets the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) definition of “engaged in research”

Experience/expertise

Does your institution’s Institutional Review Board (IRB) have the expertise to review the protocol, e.g., novel therapies, rare diseases?

If not, would your institution’s leadership prefer outside expertise to supplement the board instead of delegating review to another IRB?

SOPs/policies

What are your institution’s policies/standard operating procedures (SOPs)/requirements (e.g., human research protection program, administrative, financial) for ceding IRB review to another institution?

Does your institution have procedures in place to ensure compliance with an outside IRB’s determinations?

Does your institution have mechanisms in place to ensure additional local approvals are obtained prior to initiating research?

Financial

If delegating review involves costs, how will these be covered?

Timing

For protocols in which initiation is time-sensitive (e.g., seasonal diseases, emerging infectious diseases), does your IRB have the capacity to review in a time frame required by the sponsor? Consider your IRB’s meeting frequency, workload, etc.

Points to Consider When Delegating Review to an IRB of Another Institution

Background

Is the IRB registered with OHRP?

Does the reviewing institution have a Federalwide Assurance?

Is the reviewing institution’s human research protections program (HRPP) accredited by the Association for the Accreditation of HRPPs (AAHRPP)?

Note: This is not required by law but may be required by some institutions’ policies; AAHRPP requires its accredited organizations using external IRBs to ensure that those external IRB operations meet the AAHRPP standards.

Is your institution affiliated with the reviewing institution?

Is your institution engaged in collaborative research with the reviewing institution?

Are there current or past IRB reliance (authorization) agreements with the reviewing institution?

For electronic submissions, are there information technology (IT) compatibility issues that need to be addressed in advance?

SOPs/policies

Will the reviewing institution agree to make available IRB SOPs, IRB roster, HRPP policies and procedures, training records, conflict of interest policies, etc., upon request?

Does the reviewing IRB have policies/procedures in place to address local context when reviewing off-site research?

Are the above SOPs, policies, etc., considered acceptable by your institutional officials/legal counsel?

Expertise

Does the reviewing IRB have the required expertise to review the research, e.g., novel therapies, rare diseases?

Financial

Are there costs involved in delegating review to this institution? If so, are they reasonable, and are there available funds to cover these costs?

Timing

For protocols in which initiation is time-sensitive (e.g., seasonal diseases, emerging infectious diseases), does the reviewing IRB have the capacity to review in a timeframe required by the sponsor and/or your institution? Consider meeting frequency, workload, etc.

If delegating review in a time-sensitive scenario, can the administrative process between institutions be completed within a timeframe that would not delay protocol initiation?

Points to Consider When Accepting Responsibility to Review Protocol for Another Institution

Background

Does the relying institution have a Federalwide Assurance?

Does the relying institution conducting the research have an accredited HRPP?

Note: This is not required by law but may be required by some institutions’ policies.

Is your institution affiliated with the other institution?

Is your institution engaged in collaborative research with the other institution?

Are there current or past IRB reliance (authorization) agreements with the other institution?

For electronic submissions, are there IT compatibility issues that need to be addressed in advance?

Does the proposed research create potential conflict of interest issues for your institution or current members of the IRB?

SOPs/policies

What are your institution’s policies/SOPs/requirements (e.g., HRPP, administrative, financial) for conducting review on behalf of another institution?

Does your institution’s IRB have policies/procedures in place to address local context when reviewing off-site research?

Will the relying institution agree to make available HRPP policies and procedures, training records, conflict of interest policies, etc., upon request?

Will the review of research conducted at another institution affect your institution’s insurance policy coverage?

Expertise/capacity

Does your institution’s IRB have the expertise to review the protocol, e.g., novel therapies, rare diseases?

Does your institution’s IRB have the capacity to take on additional workload over the projected time span of the protocol(s)?

Financial

If your institution will be charging for IRB services, what type of financial arrangements/contracts need to be initiated?

Points to Consider When Selecting an Independent (Commercial) IRB

Background

Is the commercial IRB registered with OHRP?

Is the IRB accredited by the AAHRPP?

Note: This is not required by law but may be required by some institutions’ policies.

Does the commercial IRB have the overall experience and capacity to review your research (e.g., years in business, numbers of reviews annually, numbers of separate boards)?

Note: These are factors to consider but not necessarily reliable quality indicators.

SOPs/policies

Has the commercial IRB provided you with SOPs, HRPP policies and procedures, training records, conflict of interest policies, quality assurance/quality improvement procedures, etc., upon request?

Have these documents been reviewed by institutional leadership (Federalwide Assurance signatory, legal counsel, etc.) and considered acceptable?

Expertise/experience

Does the commercial IRB have the expertise/experience to review your study with respect to the following factors?

  • Indication (e.g., therapeutic areas, novel therapies, rare diseases)
  • Type of study (e.g., Phase I–IV, behavioral, observational, natural history)

Does the commercial IRB have experience with reviewing government-sponsored research? National Institutes of Health (NIH)-sponsored research?

If your study is conducted through an NIH-sponsored research network, does the commercial IRB have experience reviewing NIH network studies? Other networks?

Financial

Do you have resources available for covering the cost for all aspects of commercial IRB review—for initial reviews, continuing reviews, and additional cost for interim services (e.g., adverse events/unanticipated problems review, supplemental information review, amendments, additional sites) as applicable?

International research (local context knowledge)

If your study will be conducted outside the United States, how does the commercial IRB obtain knowledge of local context of the study locations?

International research (local review experience)

If your study will be conducted outside the United States, does the commercial IRB have experience reviewing studies implemented in your targeted study locations?

Timing

If the turnaround time for IRB review is critical for study implementation (e.g., seasonal, emerging infectious diseases), does the IRB have the capacity to meet your institution’s (sponsor’s) requirement?

Last Updated April 25, 2013

Last Reviewed July 31, 2014