SOP H102: IRB Review & Approval

In order to approve research, the IRB must determine that all of the following requirements are satisfied:

• Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk;
• Whenever appropriate, risks to subjects are minimized by using procedures already being performed on the subjects for educational, diagnostic or treatment (etc.) purposes.
• Assuring risks to subjects are reasonable in relation to the anticipated benefits, if any, to subjects and to the importance of the knowledge that may reasonably be expected to result.
• The IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies, activities or procedures subjects would receive or participate in even if not participating in the research).
• The IRB should not consider possible long-range effects of applying knowledge gained from the research (for example, the possible effects of the research in public policy or social development) as among those research risks that fall within the purview of its responsibility.
• While it is not the responsibility of the IRB to evaluate the scientific, social, or political worthiness of any research project, issues of project design are appropriate for IRB review as the risk to participants increases.
  • Design of the research becomes a determining factor for project approval when the design either directly or indirectly places the participant at undue risk.
  • The IRB will consider the level of risk involved when the design of the research is not expected to yield meaningful results.  
  • If the protocol introduces an element of risk that is not outweighed by the direct benefit to participants, the IRB may consider design when arriving at its decision to approve, request modification or reject the project.
• Guiding principles:
  • Respect for Persons is observed to allow participants autonomy of decision.  Extra care must be provided for individuals who have reduced capacity to make decisions.
  • Beneficence is observed to assure there is an appropriate balance between research participation risk and benefit.
    • Risk will exist in all research participation.  Greater risk studies will require a greater benefit to the participant or society for approval.
    • Risk to participants should be reduced as much as possible while still allowing for acquisition of the necessary data to answer the research question.
    • Confidentiality and privacy should be maintained to the greatest extent possible within the bounds of the study needs.  Adequate information to allow an informed choice about participation must be provided to participates.
  • Justice is observed to assure fair distribution of risk and benefit among potential or possible subject pools.
    • Recruitment must be fair and transparent
    • Recruitment should include as broad a segment of the population as possible to provide equal access to research outcomes. (e.g., pregnant women or children should not be excluded based upon their population where the study outcome benefit is important to their health and welfare.)
    • The subject pool chosen for each study should be based upon the purpose of the study – not convenience.
    • It is recognized that some studies may be conducted for the primary purpose of educating future researchers in research techniques and practice.

•  The following descriptions provide additional information about some possible kinds of risks that may occur in research studies:
  • Physical Harm: Pain, injury or impairment.  
    • For example, if you ask your participant to exert themselves beyond their resting state and/or there is a possibility for injury as the result of participating in the study, this risk should be described in the consent form and information should be provided as to what care the participant has access to should they become injured. For some studies it may be necessary to exclude participants whose health conditions increase the likelihood of injury.
  • Psychological Harm: Stress, worry (warranted or unwarranted), feeling upset or depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence or peace of mind.
    • An example of psychological harm would be stress or feelings of guilt or embarrassment from thinking or talking about one’s own behavior or attitudes on sensitive topics such as drug use, sexual orientation, selfishness, or violence. These feelings may be aroused from being interviewed or from filling out a questionnaire.
    • Another kind of risk would be invasion of privacy, for example, from covert observation (even in a public place) of behavior that participants would likely consider private.
    • Still another risk of psychological harm occurs when there is inadequate protection for the confidentiality of data that has been given voluntarily (e.g., by retaining audiotapes or videotapes longer than is necessary to analyze the relevant information).
  • Social and Economic Harm: Reputation, belonging, standing in the community
    • For example, if you are studying HIV patients and a participant has not disclosed their HIV status to the community, it is important that you keep that individual’s participation confidential and private, even to the level that your meeting together is done privately. In your protocol it is important that you demonstrate sensitivity to the social needs of your participants and that you describe how you will act with discretion to preserve the privacy and confidentiality of your participants.
  • Economic Harm: Costs associated with participation, effect of participation on employment or employ-ability
    • Researchers should consider any costs participants would have to bear in order to participate in the study such as travel, child care, food, etc.
    • Participants should be made aware of the amount of time it will take to participate in a study, particularly if it is time that they would spend away from their employment.
    • Participation in a drug use study may affect participants ability to obtain employment or insurance if confidential information is breached.
  • Legal Harm: Illegal behaviors, slander
    • Researchers cannot protect their participants confidences in a court of law.  Where information is collected that could be subpoenaed in the USA, a Certificate of Confidentiality should be sought through the NIH.
    • There may be certain circumstances in which you are obligated to breach confidentiality and report illegal behaviors and activities.  If a participant describes an immediate threat to hurt another individual, you may be legally or ethically required to report this information.  If you learn of child abuse, you may be legally or morally obligated to report it.
  • Inadequate Protection for the Confidentiality of Research Data:
    • Where identifiers of individual participants are not required by the design of the research study, none should be recorded.
    • If identifiers are recorded, they should be separated, if possible, from the data; stored securely, with linkage restored only when necessary to conduct the research; and destroyed when they are no longer needed.
    • More elaborate procedures may be needed in some studies, either to give participants the confidence they need to answer questions truthfully (e.g., promising to submit course grades before analyzing data from one’s own students) or to enable the researcher to offer honest assurances of confidentiality.
    • Even when participants are otherwise anonymous, there may be a danger of deducing the identity of individual participants by combining specific pieces of information collected during the research about the participants. Additional precautions may be needed to deal with these circumstances.
      

• Full Board Review
• Medical Board Review
• Expedited Review Review
• Exempt Review Review
• International Research
• Continuing Review
• Non-Human Subjects Research

Any application may be escalated to a higher level of review by the reviewing member.

• Applications must be submitted to the Office of Research Integrity IRB Office.
  • Preferred submission method: Single pdf file emailed to irb@georgiasouthern.edu
  • Alternate Submission Method: Via mail to the Georgia Southern University Office of Research Integrity, PO Box 8005, Statesboro, GA 30460.
  • Applications can be found on the Office of Research Integrity forms page at the Current Guidance and Access to Forms page.
• The application must be signed by the investigator and the researchers supervisor
  • If the investigator is a student, the students must sign the cover page, and the protocol must be reviewed and signed by the faculty adviser to provide evidence of the faculty adviser’s approval for the research.
  • Faculty investigators must obtain their department chairs signature to provide evidence of review of scientific merit within the discipline.
• All new protocol submissions must include the most current version of the IRB application as posted on the Office of Research Integrity forms page at https://research.georgiasouthern.edu/researchintegrity/institutional-review-board-forms/.
• All personnel involved in the research who will have access to the subjects or subject data (Principal Investigator, Co-Investigator, Faculty Adviser, and data collectors/analyzers), including exempt review projects, must complete the applicable CITI training and provide the certificate of completion with the IRB application.  Training is valid for three years from the date of completion. Visit the ORI training page for further information.  research.georgiasouthern.edu/researchintegrity/training/
• All applications must include applicable supporting materials:
  • a copy of the appropriate consent documents for research participants.  Please see the informed consent procedures for more information on content.
  • Any written instruments and/or questions to be used.
  • Any recruitment materials (flyers, emails, social media posts, oral recruiting script, etc.)
  • Letter(s) of cooperation

Review category is determined by administrative review upon application submission.  The assigned reviewer(s) may at their desegregation move any protocol to a higher level of review.

Individual reviewers may approve, request clarification or modification to protect subjects, or send a protocol to the fullboard for review.  Individual members may make suggestions for the improvement of the research. Items in the suggestion category are not required to be addressed by the applicant prior to approval.

Applicants must respond to all reviewer comments.  Responses may correct, clarify or justify research methods.

• Full Board Review  –  Review by a quorum of qualified IRB members in a called and minuted meeting.
• Medical Board Review – Review by a quorum of qualified IRB members in a called and minuted meeting.  Expedited review may be used through this board.
• Expedited Review Review – Review by 2 IRB members.
• Exempt Review Review –  Review by 1 IRB member or IRB administrator based upon current regulatory standards and definitions.  Researchers are reminded that the IRB must grant exemption status, the researcher may not make that determination.
• International Research –  Review by a quorum of qualified IRB members in a called and minuted meeting.
• Continuing Review – Review by 1 IRB member or IRB administrator.
• Non-Human Subjects Research –  Review by 1 IRB member or IRB administrator

Quorum consists of 50% plus 1 of the voting membership of the board.  A quorum is required for a protocol disposition vote to occur.  Where quorum can not be achieved, the protocol may be remanded to another board or held over for the next meeting.

• Approval – When an acceptable risk/benefit ratio exists and the criteria required for approval are deemed acceptable, protocol is approved as submitted or corrected.
• Conditional/Withheld Approval (Pending Changes) – The IRB determines that the protocol will meet the regulatory criteria for approval provided the investigator agrees to make specific changes to the IRB application including the informed consent document. Only when the convened IRB stipulates specific revisions requiring simple concurrence by the investigator may the IRB Executive Chair, Chair or another designated IRB member subsequently approve the revised research protocol on behalf of the IRB under an expedited review procedure.  Research may not be initiated until a letter of IRB approval is received and other applicable committee reviews are satisfied.
• Tabled/Re-submission – The IRB requires substantive changes that are directly relevant to the determinations required by the IRB under federal regulations at §_.111, the IRB will table the approval of the protocol or remand the protocol for re-submission pending subsequent review by the convened IRB of the responsive material.
• Disapproved – The IRB determines that the research does not meet the regulatory criteria for approval and cannot provide modifications that may allow the protocol to be approved.

IRB review appeals process

Reserved

Reserved

Reserved

Reserved