Human Research Protection Program

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As part of the review process, the HRPP must consider the funding source in order to determine the appropriate regulatory framework for the research. UGA does not apply the federal regulations to projects that do not have federal support. Instead these projects are reviewed within the UGA HRPP policy framework. IRB submission and Grant congruence review is no longer required by federal regulation; it is the responsibility of the PI to ensure that the research plan submitted to the IRB is congruent with the terms of the external funding. If research that is already approved receives new funding, the PI must submit a modification to notify the IRB of the new funding. The PI must also carefully review the approved research to determine if it matches what was proposed in the new funding. It may be necessary to modify the research description, consent materials, and other documents to reflect what has been funded. In some cases, it may be necessary to start a new submission instead. Please contact the Human Subjects Office (IRB@uga.edu) if you have questions.

An External Site is a site or location, not owned by or under the direct authority of UGA, where the investigator would not normally have privileges to conduct human research activities.
The difference between an External Site and an External Collaborating Site
The UGA IRB considers an External Site to be a site that is not engaged in research. An External Site that is engaged is considered to be an External Collaborating Site.
Submission requirements
In order to ensure that the appropriate procedures are followed, the IRB Portal collects information on “External Sites.” This submission page should be completed for every project that involves recruitment and/or data collection at a school or business (including non-governmental organizations and not-for-profit agencies).
External sites may need to provide a letter of authorization to the reviewing IRB. See the UGA IRB policy on External Sites in research on the Policy and Procedures web-page.
The IRB may require a letter of authorization prior to conducting review but most often will require written authorization before approval is granted so start working with research sites early in project development. See School Site Authorization Template or External Site Authorization Template.

It is common in collaborative and multi-site projects for one site to take the lead. Often this is the primary awardee site. The lead site IRB may provide oversight for all sites but IRB oversight might also be provided by one of the collaborating sites or an independent IRB. The decision about which IRB will provide oversight should be made during the design of the study in consultation with the UGA Human Subjects Office and the collaborating site IRB/s. In some circumstances, it is recommended that this consultation takes place prior to submission of a grant proposal.
The difference between an External Site and an External Collaborating Site
The UGA IRB considers an External Site to be a site that is not engaged in research. An External Collaborating Site is an institution, organization, or school that is not affiliated with UGA and is engaged in research according to federal guidance. For non-exempt research, the engaged sites’ IRBs will enter into a reliance arrangement so that only one IRB reviews while the other sites rely on that IRB.
Reviewing versus Relying
When a project involving multiple sites is proposed and one IRB is chosen to review for all of the sites, this IRB is called the “Reviewing IRB.” The other collaborating sites’ IRBs are called the “Relying IRBs.”
Submission requirements
If both sites agree to the reliance arrangement, in order to ensure that the appropriate procedures are followed, the IRB Portal collects information on “External Sites.” When UGA IRB has been selected as the reviewing IRB, this submission page should be completed. There are additional principal investigator responsibilities for this type of review arrangement. Review the information for UGA as Reviewing IRB for Collaborative Research.
Smart IRB
UGA has joined a national platform to facilitate single IRB review. This platform helps lead principal investigators to communicate with collaborating with IRBs and helps IRBs communicate with each other. If you are part of a multi-site trial, check with your collaborating institutions to see if they use Smart IRB and, if they do, if their IRB requires submission via that platform. More about Smart IRB: https://smartirb.org/

The NIH Policy, effective January 25, 2018

  • Applies to: NIH-funded domestic studies in which the research sites are all using the same protocol. These will typically be clinical trials but can include observational studies.
  • Exceptions: VA sites; international sites; site involving tribal nations; Exempt research.

All competing NIH grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018, must include a plan describing the use of an sIRB for the study.
Associated Cost
The NIH sIRB policy anticipates that sIRBs will charge fees. Those fees will be the responsibility of the lead site.
UGA IRB Review
Review responsibilities under the NIH sIRB policy can be assigned to independent IRBs (e.g., WIRB, Quorum, or Sterling), a collaborating institution’s IRB, or UGA. The arrangements must be discussed with the UGA Human Subjects Office before they are submitted to the sponsoring agency as part of the proposal.

Single IRB Policy for Multi-site Research

What the regulations say:

45 CFR 46.114 (b) (1)   Cooperative research.

Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.

 What does this mean to me? 

The mandate applies only to federally-funded* human subjects research collaborations between multiple engaged institutions. It does not apply to EXEMPT research. Additional information pertaining to sIRB exceptions is provided by the Office for Human Research Protections.

*Federally-funded means the external support comes to UGA from a federal department or agency, or UGA receives a sub-award from an institution that received external support from a federal department or agency.

  • Consult the Human Subjects Office as early as possible to determine what review method will be most appropriate. If your project falls under any of the federally-defined exempt categories, then the sIRB mandate does not apply, and each institution will need to review.  A majority of the research reviewed by the IRB at UGA is exempt.
  • For each site, it is important to determine engagement.   See guidance on engagement at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html

What information is the IRB going to request when I call?

  1. Funding flow – is UGA the primary awardee or a sub-awardee?
  2. Scope of work/ engagement level for each collaborating site – a description of the research activities to be conducted at each site
  3. Preference of all other IRBs involved for either relying or serving as the sIRB

The Common Rule regulation, effective January 19, 2020

  • Applies to: Federally funded cooperative research – that is, studies that involve more than one institution.
  • Exceptions: VA sites; international sites; site involving tribal nations.

+UGA as Reviewing IRB for collaborative research
UGA IRB can provide review for many collaborations. Plan early (during funding proposal is recommended) and communicate with the Human Subjects Office to ensure that requirements are met.
Multi-site clinical trials—
If the project is NIH-supported, meets the definition of a clinical trial, and there are multiple sites, the project falls under the sIRB mandate. Review additional information about the sIRB Mandate. Work with the Human Subjects Office to select an appropriate IRB to review. See information about UGA as Relying IRB for collaborative research.
If the multi-site trial is not NIH-supported but falls under FDA regulations, work with the sponsor and the Human Subjects Office to select an independent IRB (e.g., WIRB, Quorum, Sterling) or the UGA IRB may review and may charge a fee (contact the Human Subjects Office for the current Fee Schedule).
Other collaborations—UGA IRB review
When a project involves more than one engaged site but each site has a different scope of work or when the project does not fall under one of the federal mandates for single IRB review, the project may still be designed to use one IRB only.  Consult with the Human Subjects Office to determine if UGA IRB can provide the review services for the other sites and, if we can, consult with the other site’s IRB to determine their interest in relying on the UGA IRB.
UGA Principal Investigator Responsibilities
The UGA Principal Investigator has ultimate responsibility for the following actions and activities at the University of Georgia and all participating external sites:

  1. the conduct of the study.
  2. the ethical performance of the project
  3. the protection of the rights and welfare of human participants
  4. strict adherence to the study protocol and any stipulations imposed by the University of Georgia Institutional Review Board

The UGA Principal Investigator must have a management and communication plan in place between all of the participating external sites to ensure that the lead investigator is always aware of information that may be relevant to the protection of research participants, such as:

  • Unanticipated problems involving risks to participants or others
  • Interim results
  • Protocol modifications and amendments

The UGA Principal Investigator must also ensure each site is adequately equipped to handle safety concerns.  See the PI Checklist below for additional information.
PI Checklist

UGA IRB can rely on the IRBs of other institutions to avoid duplicate review efforts.
Exempt Research
If a human research project meets criteria for exemption, no reliance arrangement is required.  Submit the project for UGA IRB determination.
Federally supported research vs. non-federally supported research
For federally-supported research, the UGA IRB must enter into a reliance agreement with the reviewing IRB and this agreement must be signed by the VP for Research.  For non-federally supported research, the UGA IRB must enter into a reliance agreement with the reviewing IRB and this agreement will be signed by the Human Subjects Office Director.
MOUs (Memoranda of Understanding)
UGA has several broad review agreements with other institutions. If you are working with Emory University, Children’s Hospital of Atlanta, Augusta University, Georgia Institute of Technology, St. Joseph Candler Hospital, Phoebe-Putney Hospital, or Piedmont Athens Regional Hospital, it is likely that a reliance agreement for your specific project is unnecessary.
Independent IRB Contracts
UGA has a review-contract with Western Institutional Review Board (WIRB), an independent IRB located in Olympia, Washington. We can negotiate limited contracts/agreements with other independent IRBs as needed.
Submission Requirements
A submission in the IRB portal is required to initiate reliance on an External IRB. All materials submitted to the external IRB, including the protocol, consent documents, recruitment materials, and data collection materials should be made available to the UGA IRB. Approval letters and contact information for the External IRB are also required.
Principal Investigator Responsibilities
When the UGA IRB relies on the review of another IRB, the PI is responsible both for engaging with the reviewing IRB for submissions and reviews and for maintaining an up to date record of determinations, requirements, and approvals with the UGA IRB.

Please see the table of our current umbrella agreements/MOUs.  We will update this table as new agreements are finalized. Note: Privacy Board responsibilities apply to studies that involve access to and use of Protected Health Information (HIPAA covered activities.)

Research Partner (Collaborating Institution)UGA IRB's RoleWhat type of research is covered?Link to Policies and Procedures (if available)
Augusta UniversityBoth Reviewing and Relying Under Different Circumstances for Research in Which Augusta University AND UGA are Engaged

Reviewing IRB is Privacy Board
UGA reviews...
*Research conducted by AU Faculty or dual-appointment PI conducted in collaboration with UGA Faculty or students at UGA or Athens community sites
*Research conducted by UGA PI in collaboration with AU/Dual Appointed PI or AU students conducted at both UGA and AU sites or at non-affiliated sites

AU reviews...
*Research conducted by UGA Faculty or dual-appointment PI conducted in collaboration with AU Faculty or students at AU or Augusta community sites
*Research conducted by AU PI in collaboration with UGA/Dual Appointed PI or UGA students conducted at both UGA and AU sites or at non-affiliated sites
Augusta University
Children's Healthcare of AtlantaBoth Reviewing and Relying Under Different Circumstances for Research in Which CHOA AND UGA are Engaged

CHOA will be Privacy Board
UGA reviews...
*Majority of research activities are at UGA site

CHOA reviews...
*Majority of research activities are at CHOA
Emory UniversityBoth Reviewing and Relying Under Different Circumstances for Research in Which Emory AND UGA are Engaged

Emory IRB is Privacy Board
UGA reviews...
*Student research initiated by Emory student with UGA PI
*Emory student to join UGA PI's project
*Majority of research activities are at UGA site

Emory reviews...
*Student research initiated by UGA student with Emory PI
*UGA student to join Emory PI's project
*Majority of research activities are at Emory site
Emory University
Georgia Institution of TechnologyBoth Reviewing and Relying Under Different Circumstances for Research in Which GA Tech AND UGA are Engaged

Reviewing IRB is Privacy Board
UGA reviews...
*Student research initiated by GA Tech student with UGA PI
*GA Tech student to join UGA PI's project
*Majority of research activities are at UGA site

GA Tech reviews...
*Student research initiated by UGA student with GA Tech PI
*UGA student to join GA Tech PI's project
*Majority of research activities are at GA Tech
Georgia Institution of Technology
Phoebe Putney Memorial HospitalReviewing IRB for Research in Which Phoebe Putney AND UGA are Engaged

UGA IRB is Privacy Board
Minimal Risk Research conducted by UGA Faculty/students involving activities such as Medical Chart Review and patient surveys

Piedmont Athens Regional HospitalRelying IRB Research involving Piedmont records, patients, or employees
St. Joseph's/Candler Health SystemBoth Reviewing and Relying Under Different Circumstances for Research in Which St. Joseph's/Candler AND UGA are Engaged

Reviewing IRB is Privacy Board
UGA reviews...
Minimal Risk Research conducted by UGA Faculty/students involving activities such as Medical Chart Review and patient surveys

St. Joseph's/Candler reviews...
Clinical interventions or trials
Western Institutional Review Board (WIRB)UGA Relying on WIRB

WIRB is Privacy Board
All industry-sponsored or industry initiated protocols when UGA is lead site and any other protocols at IRB discretionUpon request

Georgia CTSA (Georgia Clinical & Translational Science Alliance) is funded through the National Center for Advancing Translational Sciences, part of the National Institutes of Health’s Clinical and Translational Science Awards (CTSA).  For more information, please refer to the Quick Links Tip Sheet or the website at https://georgiactsa.org/

Data that will be shared with others requires additional oversight to uphold the privacy of the research participant and the confidentiality of their data. Researchers must obtain consent from participants to share data from the study with others outside the research team even if the data are de-identified. Data sharing is often a requirement by the sponsor so this must be reflected in the consent document and, most importantly, in the consent process (discussion).  The consent process should includes the acknowledgement of the data sharing practices and the possible risk of re-identification when applicable. Researchers should not guarantee that de-identified data cannot be relinked and the participant’s identity disclosed.  As technology evolves, so does the potential risk of re-identification.

The IRB does not need signed copies of contracts/Material Transfer Agreements (MTAs)/Data Use Agreements (DUAs) to be provided in the submission.  Rather, the description of research design and confidentiality/privacy concerns in the submission should include the expected transfer, what data/specimens will be transferred, and entities/persons involved in the transfer.  For example: “The study team at UGA will transfer de-identified data to the University of Iowa for external analysis once appropriate agreements between the institutions have been fully executed.”

Note the following exception:  the IRB may request a copy of the draft agreement as part of the review process.

Visit Transferring or Receiving Data for more information.

  • The prime awardee of the SBIR or STTR funding is a small business. As the recipient of the funds supporting human research activities, even when all activities involving human subjects are carried out by another institution, the small business must apply for and be granted a Federalwide Assurance AND obtain IRB approval for their role as the prime awardee of the grant. The University of Georgia’s Federal Wide Assurance and IRB approval of the research conducted by their faculty, staff and students DO NOT extend to the small business.
  • The small business will need to apply for and obtain their own Federal Wide Assurance naming an IRB other than the UGA IRB.
  • The University of Georgia IRB may be able to act as the single IRB for Phase I but may not for future phases where the small business has increased levels of engagement. Costs associated with IRB review should be considered during the grant submission phase.
  • Written legal agreements are needed for UGA to act as the IRB for the small business and for UGA to rely on another IRB.

Additional information can be found in the Guidance under Policies and Procedures. *Special thanks to Washington University in St. Louis for allowing us to use their guidance as a reference.

The University of Georgia’s Human Research Protection Program (HRPP) is committed to supporting the active engagement of communities in UGA research. The promotion of diversity, inclusion, and equity is critical to protecting participants and elevating the integrity of research and its value to society.