Human Research Protection Program

Review & Respond

Required
Training

Plan &
Collaborate

Develop &
Submit

Review &
Respond

Post Approval
& Reporting

  • Exempt: Certain categories of Human Research may be exempt from regulations but require determination that the project meets the exemption criteria. It is the responsibility of the IRB or Human Subjects Office Staff, not the investigator, to determine whether Human Research is exempt from IRB review.
  • Review Using the Expedited Procedure: Certain categories of non-exempt Human Research may qualify for review using the expedited procedure. These studies are reviewed by a designated IRB reviewer(s) and not by a convened IRB.
  • Review by the Full Committee (Convened IRB): Non-Exempt Human Research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB.
  • 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.
  • Attach the materials to the submission: email, script, flyer, newspaper or radio ads, social media posts.
  • Only members of study team should conduct recruitment.
  • 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
  • Incentives and monetary compensation should not be described as research benefits.
  • Incentives are for participation and should not be paid contingent upon completion of all project activities so pro-rate the incentive based on individual activities completed or duration of participation.
  • The UGA Business Office or an individual college, sponsor, or department may require tracking of payments, so please check with the people who will be processing the payments and describe the process in your submission.
  • Georgia law requires a license or an open invitation for raffles/drawings. If conducting outside of GA, check local laws.
  • 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
  • Consent is a process, not just a document, so describe the process
  • 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
    • Must be consistent with the information in the submission
    • Must be consistent throughout the document itself, especially consistent verb tense and pronoun use
    • 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.
  • Subject privacy – is related to setting; it relates to control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
  • Confidentiality – is related to information/data; it pertains to the steps taken to protect an individual’s personal information (limited access; masking with a code; password-protection) including the assurances made to a subject in the consent form that his/her information will not be divulged to unauthorized personnel without their permission.
  • 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) statue pertaining to mandatory reporting
  • Confidentiality should not be used as a reassurance or a guarantee of privacy
  • The common phrase of ‘anonymous source’ used in journalism is confusing – ‘Anonymous Tip’ vs. ‘Confidential Informant’
  • These are considered direct identifiers, so you need to be very clear about
    • How long you will keep them
    • How you will keep them secure
    • How you will use them

If the project involves access and use of Protected Health Information (PHI), see additional FAQs.