Human Research Protection Program

UGA Sponsored Projects Administration is responsible for externally funded research, instruction, cooperative extension and public service. Anything internally funded does not go through SPA.

As part of the review process, the IRB must consider the funding source in order to determine the appropriate regulatory framework for the research. Projects that are or may be funded by a federal agency must comply with the Common Rule (45 CFR 46), including requirements for single IRB review of cooperative 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.

What the regulations and federal policies 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.

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. Review responsibilities under the NIH sIRB policy can be assigned to independent IRBs (e.g., WCG IRB 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.

NIH Single IRB Policy for Multi-site 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/

 

 What does this mean to me? 

The regulatory requirement 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
• If you believe the sIRB mandate applies to your research or that reliance would be beneficial, submit the Reliance Intake Form to the Reliance and Cooperative Research Coordinator at IRB@uga.edu to begin the discussion with the IRB

What information is the IRB going to request?

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

View our webinar for additional information regarding collaborations.

Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.

Per DoDI 3216.02, the DoD institution may rely on a non-DoD institution’s IRB if: the reviewing institution has an FWA, a registered IRB, the DoD and collaborating institution enter into an agreement specifying that the non-DoD will apply the aforementioned DoD requirements, and the DoD institution also reviews the protocol to ensure all applicable requirements are addressed.

The UGA PI retains important responsibilities to report study changes and reviewing IRB actions to the UGA IRB.  The UGA HRPP has the responsibility to ensure research conducted by agents of UGA receives appropriate IRB review and approval, even when another IRB is the IRB of record.  Accordingly, UGA PIs have an ongoing responsibility to ensure the information in the UGA IRB Portal is correct and current.

Step #1 – Create a submission to request reliance – an External IRB submission – in the UGA IRB Portal.

• Create Submission
• Answer “Yes” to the last question on the Project Basics page “Will an external IRB act as the IRB of record for this study?”
• Attach all materials submitted, or to be submitted, to the external IRB, including: the protocol, site specific consent documents, recruitment materials, and data collection materials
• A detailed scope of work for UGA.
• A list of all UGA study team members.
• Select the external IRB – *if not in the list, be sure to provide the organization official name in the contact information field
• Provide contact information for the External IRB office
• Approval correspondence is also required when it becomes available

Reliance Agreements
Based on the external organization IRB information provided in the portal submission, UGA HRPP will execute a reliance agreement for the project.

For federally-supported research, this agreement must be signed by the VP for Research.  For non-federally supported research, this agreement will be signed by the Human Subjects Office Director.

The UGA PI can only begin human research activities after the UGA HRPP has executed the agreement and provided a reliance letter in the UGA IRB portal.

Principal Investigator Responsibilities
When the UGA IRB relies on the review of another IRB, the PI is responsible for:

• Ensuring appropriate education and training of UGA study staff.
• Obtaining all local institutional reviews and ensuring research complies with all local compliance requirements, including conflict of interest review and the Policy for Programs and Activities Serving Minors.
• Communicating institutional requirements to the reviewing IRB.
• Engaging with the reviewing IRB for the initial and all future submissions, including modifications and progress reports or continuing reviews.

The UGA PI is also responsible for maintaining an up to date UGA IRB portal record of determinations, site-specific materials, study team members, and approvals with the UGA IRB via the IRB Portal (Use the “Update External IRB Information” link.)

• It is better to include too many communications rather than too few.
• It is not sufficient to add UGA HSO staff as contacts in the reviewing IRB’s electronic system.

Plan early (during funding proposal is recommended) and communicate with the Human Subjects Office to ensure that requirements are met.

Note: 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.

UGA Principal Investigator Responsibilities

Have a conversation with all collaborators to notify them that they must communicate with their IRB offices and know the process to request reliance on UGA IRB.

Identify all Non-UGA collaborating PIs (Study Team page) and their organizations (External Sites page) in the portal submission. Information about the external organization’s IRB office will be requested.

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

• 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. UGA will charge the small business for the IRB review. 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.

Independent IRBs are also known as “commercial” or “for-profit” IRBs. Sometimes federally-mandated cooperative review arrangements are handled by independent IRBs.

From time to time, institutions may use independent IRBs for other reasons: staffing issues, specific expertise needs, or when meetings of the institution’s IRB cannot be held due to emergency or disaster.

Submissions to the independent IRB must be authorized by HRPP staff. Determination that a project can be submitted to an independent IRB is made on a case-by-case basis and must be accompanied by a submission in the UGA IRB portal.

The applications that independent IRBs like WCG and Sterling have include sections regarding sponsorship and billing.

• The UGA HSO office must agree to the use of an external IRB before you submit to that IRB. You must create a submission in the UGA IRB Portal first to get the protocol ID (Project ID) to add to the external IRB’s application. Answer “yes” to the last question on the Project Basics page of a new study submission form (Will an external IRB act as the IRB of record for this study?)
• Billing – In the application, indicate that the invoice should be sent via email to Kim Fowler, kfowler@uga.edu
• Sponsor – This refers to the organization with responsibility for the research (not the funding organization). UGA is the sponsor for the research except for the rare cases where you are conducting industry sponsored research (e.g., drug or device research funded by the manufacturer.)
• The project PI is the Sponsor contact.
• UGA IRB has primary oversight responsibility for all research conducted by UGA. We are ceding the IRB review portion of that responsibility to the commercial IRB via a Master Services Agreement with WCG or Sterling.
• Generally speaking, the following types of studies may be authorized for review by an independent IRB:

  • Clinical investigations, funded or not
  • Research subject to sIRB rquirements

To start the submission process, visit the Sterling online portal to login or register: https://sterlingirb.my.irbmanager.com/. You will need to complete the New Study Submission Application Form. To navigate to this Form, you will simply click “Start Form” from your homepage in SilverLink and choose the appropriate form. Other documents that you may attach to the Form are:

• Study Protocol
• Proposed Consent Document(s) (Word format preferred – Please use the UGA templates in the Portal Library on under Forms and Policies on the right side of this webpage)
• Copy of Proposed study-wide Recruitment Materials and Study-Related/Retention Materials (instructions, diaries, etc.)
• Product Information / Package Insert/ Investigator’s Brochure

Once the New Study Submission is received, Sterling will follow up with any questions within 1 business day or sooner. If there are no questions, you will be informed that it is complete.

Now that the New Study Submission has been received, access to the PI application will become available. If you identified the PI and site contacts on the New Study Submission, Sterling will send out a “Welcome Email” to those contacts. This email will include instructions on completing the PI application. Additional items will be requested within the PI application including:

• CV for the Principal Investigator; signed, dated and current within two years.
• DEA Registration if the study involves controlled substances.
• Supplemental Site Form if the PI will conduct research at more than one location.
• Site-Specific consent if the site will make changes; other than the PI name and site information.
• Financial Disclosure Form; if applicable
• IRB Jurisdiction Form indicating that the “site” is under the jurisdiction of UGA IRB and that the institution (UGA) maintains a Master Service Agreement with Sterling IRB.

The study application and the PI application will be reviewed separately; study activities may not commence until the PI has been approved by the IRB, even if the study has already received approval.

Timelines: Sterling IRB meets five days a week, Monday, Wednesday, Thursday, Friday at noon ET, and Tuesday at 5pm ET. The Board requests five business days to review a new study after the administrative staff ensures initial submission is complete, for example, if you submitted a complete study on a Thursday, it would be reviewed at the meeting the following Thursday.

In general, most principal investigator applications may be reviewed by the expedited review procedure.

It typically takes 1 business day to review the application and 2 business days to prepare the approval documentation and site-specific consent forms.

Your Account Manager will send you a written summary of the Board’s questions and a proposed final draft of the consent form following meeting adjournment.  Once the study is approved, you will have approval documents within 2 business days or sooner.

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/

Connect with experts in your field through Georgia CTSA Match.

ResearchMatch

 

 

 

About ResearchMatch  

ResearchMatch.org is a national online participant recruitment tool for health-related human research, funded by the National Institutes of Health and maintained at Vanderbilt University.  Researchers and potential study volunteers across the country are matched through its secure online matching tool. UGA is part of the ResearchMatch Network.  UGA researchers conducting clinical, biomedical, translational, and socio-behavioral research studies with health-related outcomes or focus are eligible to use ResearchMatch at no cost.

To Access ResearchMatch

The first step to using ResearchMatch is to register as a researcher.  Visit ResearchMatch.org and click the ”RESEARCHERS” tab on the top bar.  Select the “University of Georgia” as your institution and complete the contact and registration information.  You do not need IRB approval to register.

Once registered, there are two levels of access available: feasibility access and recruitment access.  Feasibility access gives you the ability to assess the availability of volunteers that match your study’s eligibility criteria without an IRB-approved protocol.  Using this level of access, you can see if ResearchMatch has a population that would be useful for your study.  Recruitment access allows researchers with IRB-approved protocols to search and contact study volunteers.  The researcher uses the study criteria along with geographic, demographic, health condition and medication filters on ResearchMatch to generate a de-identified group of volunteers who “match” the study criteria.

ResearchMatch Training

Training resources can be found within the researcher dashboard.  Please attend one of the monthly Researcher trainings that is offered (via Zoom) every second Thursday, at 3 pm ET.  Register at https://zoom.us/meeting/register/tJAodOGprjorGdGeprUYUWehYHJFcoTD0ATe.

IRB Approval for Recruitment

To use ResearchMatch as a recruitment method for a new or previously approved IRB study, a researcher must complete and submit the ResearchMatch Researcher Request Form for review and approval by the IRB.  The Researcher Request Form, as well as the accompanying ResearchMatch Researcher Guide, may also be accessed from the IRB Portal Library, under the “General” tab.

Contact
Kimberly Schmitz
schmitzk@uga.edu

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.

See our Guidance and check out these additional resources:

View our Spring 2021 Webinar series “Community-based Participatory Research” for more information and tips from the experts.

Hear from Cooperative Extension about collaborating on community based research “Turning Research into Impact: How UGA Cooperative Extension Works with Georgia Communities”

If you are designing a research project to be conducted in Georgia communities, reach out to Laura Perry Johnson, Associate Dean for Extension, for guidance on recruitment, local issues, and how your research can be translated/applied within the community (lpj4h@uga.edu). It’s never too early in the planning stage to connect and hear directly from the community where you’ll be working!

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.

Effective 1/25/2023, research supported by NIH falls under the Data Management and Sharing Policy (DMS). The IRB is expected to review and approve the DMS plan. Under the DMS policy, NIH expects that investigators and institutions:

• Plan and budget for the managing and sharing of data
• Submit a DMS plan for review when applying for funding
• Comply with the approved DMS plan

The IRB does not require the DMS to be submitted for review/approval. The plan for managing and sharing should be described in the online submission and reflected in the consent materials. This includes plans to submit data (whether de-identified or controlled access) to a repository. The PI is responsible for providing an initial assessment of the probability of risk of re-identification (low, moderate, high). Moderate to high risk includes data that include sensitive information such as traits or behaviors that could cause group harm or discrimination, stigmatization, or that are unique attributes that may facilitate re-identification of individuals.

Learn more at Data Management & Sharing Policy Overview

Research and Computational Data Management (RCDM) offers resources and support for faculty and student research.

For tips on writing a Data Management Plan visit UGA Libraries

Tool for building a Data Management Plan (use UGA SSO) DMPTool

For information on ORCID visit UGA Libraries

Visit Transferring or Receiving Data for more information.

The Principal Investigator is responsible for obtaining current information related to any Conflict of Interest (COI) for all study team members and disclosing the COI in the IRB Portal submission and the Grants Portal. Documentation of COI review and the associated management plan, if applicable, must be provided to the IRB during the review process. Approval can only be granted after the IRB has  accepted the management plan.

Significant Financial Interest (SFI) means the following:

• Compensation or consulting fees exceeding $5,000;
• Ownership or equity interests in a publicly traded entity exceeding $5,000;
• Any ownership or equity interests in a non-publicly traded entity, even if worth $0 or the value is unknown (e.g., a start-up or spin-off company);
• Intellectual property rights and interests (e.g., copyrights, patents, royalties from rights) exceeding $5,000;
• Sponsored or reimbursed travel from an entity exceeding $5,000.

The UGA HRPP/IRB only has oversight responsibility for research conducted by UGA agents (e.g., staff, faculty, students) and does not provide letters of support or authorization when UGA is not engaged in collaborative research. Non-UGA researchers who want to recruit UGA staff, faculty, or students and who seek to utilize UGA resources (e.g., listservs, Directory information as defined in FERPA, student organizations, instructor communications) to extend recruitment invitations or disseminate research-related information should contact the individual, office or unit with direct authority over over the platforms or data. For example, the Office of the Registrar or Office for Institutional Research might consider providing Directory information (e.g., student emails). College Dean offices or individual Department Chairs/Heads might consider forwarding emails to their faculty. Finally, the Office of Student Affairs may also consult with external researchers interested in recruiting UGA students: https://studentaffairs.uga.edu/data/assessment-and-research-consulting/.

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 Role	What type of research is covered?	Link to Policies and Procedures (if available)
Augusta University	Reviewing or Relying (two way agreement) Reviewing IRB is Privacy Board	UGA reviews... *Research at UGA or Athens community sites AU reviews... *Research at AU or Augusta community sites	Augusta University
Children's Healthcare of Atlanta	Reviewing or Relying (two way agreement) 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 University	Reviewing or Relying (two way agreement) Emory IRB is Privacy Board	UGA reviews... *Emory student to join UGA PI's project *Majority of research activities are at UGA site Emory reviews... *UGA student to join Emory PI's project *Majority of research activities are at Emory site	Emory University
Georgia Institution of Technology	Reviewing or Relying (two way agreement) Reviewing IRB is Privacy Board	UGA reviews... *GA Tech student to join UGA PI's project *Majority of research activities are at UGA site GA Tech reviews... *UGA student to join GA Tech PI's project *Majority of research activities are at GA Tech	Georgia Institution of Technology
Phoebe Putney Memorial Hospital	Reviewing IRB for Research in Which Phoebe Putney AND UGA are Engaged (one way agreement) Phoebe Putney 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 Hospital	Relying IRB	Research involving Piedmont records, patients, or employees
St. Joseph's/Candler Health System	Reviewing or Relying (two way agreement) 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