Human Research Protection Program

There are several state changes during the review of a submission. New projects start as Drafts. When a new human research project is submitted to the UGA IRB, the record status changes from Draft to Pre-Review.

When the Pre-Review is complete, the status changes to Review.

When the Review is complete, the status changes to Post-Review.

When the review documentation is complete and any required quality assurance checks have been completed, the status changes to Approved.

During any of the review phases, the HSO staff or IRB reviewers may ask questions, request additional information, or recommend edits. When the study staff need to respond to the HSO/IRB, the state changes to Clarifications Requested.

Pre-review is the phase in the review process performed by HSO/HRPP professional staff to determine that a submission in the IRB portal is complete, includes all required responses and materials, and that the institutional requirements, such as completion of human subjects protection training, principal investigator (PI) eligibility, and conflict of interest disclosure, have been met. The staff also determine what regulations, laws, and policies need to be applied to the proposed activities. During this phase, the submission may be returned for additional information or changes to materials and application responses (e.g., Clarifications Requested) to ensure that  regulatory, legal, and policy requirements can be efficiently and effectively evaluated.

During this phase, the professional staff (all HSO/HRPP staff are also IRB members) analyze the submission and document that all applicable regulatory, legal, and policy requirements have been met. For non-exempt review levels, subject matter experts will also review the research design to confirm that the research has scientific or scholarly validity and that appropriate measures are in place to adequately protect participants. The state of the submission may be Subject Matter Review (IRB Member review) or Committee Review (if the project is being reviewed at a meeting.) During this phase, the submission may be returned for additional information or changes to materials and application responses (e.g., Clarifications Requested).

During this phase staff perform a final check to determine that all required review documentation is in the record and that all required determinations, waivers, and regulatory citations have been made and that the approval correspondence includes this information. Also any future submission deadlines are checked (e.g., expiration of approval or Progress Report due date). Once the quality assurance is complete, the review is submitted and the approval correspondence is attached to the portal record.

Only UGA faculty can be listed as Principal Investigators on human research submissions. Graduate students must identify a faculty PI and list themselves as contacts for correspondence on the first page of a submission as well as co-investigators on the Study Team Member page. More information about eligibility to be a PI can be found in our policy. If someone is listed as PI who is not eligible per the policy, the submission will be returned without further review until an eligible PI has been identified.

Often one or more members of a research team have not completed the correct training course, have not refreshed (renewed) their training, or have training that will expire soon. During pre-review, the PI will be notified through a portal comment that study team training requirements are not met. The submission may be returned for the training requirements to be satisfied before the review can proceed. If the project involves children or other vulnerable populations, use of the Internet to access or interact with participants, international sites, or the access or use of protected health information, additional courses may be required. Review the Required Training tab on our website for more information.

For non-exempt research, recruitment methods and materials are required:

• To recruit is to invite someone to participate. It is the first contact with a potential participant. Recruitment is also the beginning of the consent process.
• Be sure materials for each described method are attached to the submission: email, script, flyer, newspaper or radio ads, social media posts.

For all research, the following should be considered (even for Exempt research where recruitment is proposed):

• Only members of study team should conduct recruitment. If the recruitment plan involves people who are not UGA study team members, or external organizations, document the plan, and the non-UGA person/organization’s agreement to the plan, in the submission.
• Avoid trying to ‘sell’ the project, emphasizing monetary compensation, or describing incentives before the purpose of the project or the activities involved.
• Whenever possible, list eligibility criteria so that potential participants can self-select.
• If you need to collect data in order to screen for eligibility, consider using the eligibility screening consent script template.
• Refer to the Worksheet: Advertisements in the IRB Portal Library. This covers special considerations when targeting student research pools or crowd-sourcing groups like Amazon’s Mechanical Turk.
• The Georgia CTSA has a Recruitment Center that is available to give guidance and connect you with resources that may be useful for recruitment of research participants. The recruitment center team is a multi-institution collaboration, offering assistance to researchers at all GaCTSA member institutions. They also partner with research groups to evaluate the success of recruitment methods and evaluate reasons why potential participants do or do not choose to enroll in studies.
• Click here to join the GaCTSA Slack community where you can post your questions about recruitment or any useful resources you have found for finding research participants:https://join.slack.com/t/georgiactsa/shared_invite/enQtNzEyNTcyNzY3NjIwLWVkNmU4NWE1YmRmMTYyZDIyMTVkZmQyMGNiNDAzNzAxYTU2ZjMzZjBiZDAyMGRhMTk4YWM0NGFjODc1MTNlNjk

Working with external partners to conduct research includes: using another organization’s resources, staff, or facilities, seeking to enroll participants because they are at or are affiliated with another organization, obtaining collaborative funding, including people affiliated with another organization as part of your research team. The IRB can only grant final approval when all engaged parties have finalized review arrangements or when at least one site where the research will happen and/or participants will be enrolled has provided documentation of site authorization. Review the Plan & Collaborate tab for more information.

• Having anonymous participants and anonymous data requires specific design choices. Avoid using the word ‘anonymous’ unless:
  • You are not using the internet at all
  • You will have absolutely no contact with participants
  • You have taken steps to prevent unintentional tracking (envelopes with no return address)
  • Your sample size is large enough that demographic information could not be used to identify someone

• Sharing of information by participants in focus groups cannot be controlled; be sure to tell participants about this
• Research data are vulnerable to subpoena by courts so guarantees that identifiable information will not be shared by the research team should be qualified as follows: “unless required by law.”
• Review Georgia or local law and UGA policies pertaining to mandatory reporting
• Confidentiality should not be used as a reassurance or a guarantee of privacy (see the difference between privacy and confidentiality below)
• Data sharing and future use of research data must be planned and clearly documented in the consent process and materials as well as institutional agreements, when applicable. Review the guidance for receiving or transferring restricted data website for more information. The IRB can approve when the plan is provided and before the agreement is executed.

• The process is the most important part. Avoid simply stating that consent will be obtained. Explain where it happens, how much time is given for people to consider volunteering, how comprehension of the information is ensured, and who handles questions.
• Adults give consent for themselves
• Legally-authorized representatives give consent on behalf of someone who is not capable of consenting
• Children give assent for themselves
• Parents/Legal Guardians give permission for their children
• The process should include:
  • Time to decide
  • A chance to ask questions
  • Descriptions that facilitate comprehension
  • A way for the researcher to check understanding
• Consent Document templates and samples are available in the portal and on our website
  • Must be consistent with the information in the submission
  • Must be consistent throughout the document itself, especially consistent verb tense and pronoun use
  • Must avoid technical jargon and academic terms – Use plain language!
  • The most common inconsistency that we see: If risks and discomforts are identified in the submission, do not write “There are no risks or discomforts associated with this research” in the consent document.

When a submission is in a state that allows editing by the study team (e.g., any state that includes “Clarification Requested”), the study team can choose to temporarily withdraw the submission from further review. Executing the activity puts the submission back in Draft state and does not remove study team access to make edits. When ready, the PI can submit the project to begin the review process again.

If a submission is in a clarification requested state for 90 days or more without any communication from the study team, HSO staff will withdraw the submission from review. As stated above, the study team can still make edits and submit the project to begin the review process again.