Investigator Manual

Table of Contents

  • The Institutional Review Board (IRB) for Kennesaw State University is organized and operates in compliance with the U.S. Department of Health & Human Services (DHHS) and Food & Drug Administration regulations for the protection of human subjects, State of Georgia law, and the Kennesaw State University policies for the conduct of human subject research. The institution holds a Federalwide Assurance (FWA) from the Office of Human Research Protection (OHRP), under DHHS, and are registered as follows:

    FWA00004584

    IORG0001072

    IRB00001469

    The KSU IRB provides oversight for research conducted under its assurance. Projects that require review by the IRB are defined in IRB Policy: Determination of Engagement in Human Subjects Research. No human subjects research may be initiated by KSU faculty, staff, students, or any other individuals acting as agents of KSU, prior to approval or determination of exemption by the IRB. 

  • he IRB has the authority and responsibility to approve, require modifications in, or disapprove all non-exempt human subject research, before it is initiated, to comply with ethical principles, federal, state, local laws, and university requirements. This includes exempt research activities for which limited IRB review is a condition of exemption.

    The IRB has the authority to suspend or terminate IRB approval of research that is not being conducted in accordance with their requirements, or that has been associated with unexpected serious harm to subjects.

    The IRB is responsible for prompt reporting to appropriate officials and entities (university, federal or state agencies, regulatory bodies, Office for Human Research Protections, U.S. Food and Drug Administration, sponsor agency, reliant IRB, etc.) of any unanticipated problems involving risks to subjects or others, of any serious or continuing noncompliance with federal regulations or IRB requirements, and of any suspension or termination of IRB approval.

    Research that has been approved by the IRB may be subject to further review and approval or disapproval by officials of the institution based on institutional policies. However, institutional officials may not approve the research if it has not been approved by an IRB.

    More information can be found in IRB Policy: Responsibilities of the IRB

  • Exempt Review

    DHHS regulations in 45 CFR 46.104 (Common Rule) identify several different categories of minimal risk research as being exempt from federal regulations for the protection of human subjects. This does not mean that submission to the IRB is not required. Exempt determinations must be made by qualified IRB staff or an IRB member; researchers cannot make this determination based on their own evaluation. Therefore, all human research projects must be submitted for review. 

    To be exempt, the research must be no greater than minimal risk and all of its activities must fall into one or more of the categories defined in the regulations. For additional information on Exempt research, including a list of the Exempt Categories, see IRB Policy: Exempt Review.

    Expedited Review

    Minimal risk research that does not meet criteria for exemption may qualify for expedited review. Research must be minimal risk and its activities fall within one or more of the expedited review categories provided by the Office for Human Research Protections (OHRP). Please see HRP Expedited Review Categories for more information.

    The expedited review procedure cannot be used in any of the following circumstances:

    1. The research involves minimal risk but does not appear in the categories of research eligible for expedited review;
    2. Identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal;
    3. The research randomizes subjects to a treatment group;
    4. The research is classified;
    5. Initial review of research involving individuals with diminished capacity and use of a legally authorized representative to obtain consent; and
    6. The reviewer determines that the study involves more than minimal risk, even when some or all of the research appears on the expedited review category list, or the IRB determines that full board review is required even if the study is eligible for expedited review (e.g., determined to be minimal risk and some or all of the research appears on the expedited review category list).

    Full Committee Review

    Committee review by the convened Institutional Review Board (IRB) is required for:

    1. All more than minimal risk research;
    2. Initial study submissions that are not eligible for exempt or expedited review procedures;
    3. Initial study submissions that are eligible for exempt or expedited review procedures, but the IRB otherwise determined convened review is required;
    4. Modifications that are non-minor changes to approved research that initially required committee review;
    5. Continuing review for renewed approval of research that initially required committee review. Exceptions to this requirement are listed below.
      1. Expedited review procedures may be used for continuing review of research previously approved by the convened IRB as follows:
        1. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
        2. where no subjects have been enrolled and no additional risks have been identified; or
        3. where the remaining research activities are limited to data analysis.
      2. Expedited review procedures may also be used for continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
    6. Disapproval of a research study, regardless of review level;
    7. Issues in which resolution cannot be made between the IRB reviewer and the investigator.
       
  • The Collaborative Institutional Training Initiative (CITI) online training program is the official certification program for KSU-affiliated personnel per our Federal-wide Assurance  of Compliance. Go to www.citiprogram.org to either register a profile or log in to the CITI training program website. Please contact irb@kennesaw.edu with any questions you may have. 

    citi registration how-to guide citi instructions on course selection
  • Login to Cayuse

    KSU IRB uses an online system for the submission and review of human research studies. Cayuse Research Suite is our portal for IRB submissions. Cayuse allows for the submission and review of new studies, modifications, continuing review including renewed approval and closure, and reports of new information. You will receive decision information and feedback emails from the IRB office via this system. 

    Access to Cayuse

    All faculty have existing access to Cayuse.  Staff and students who require access to Cayuse must submit an account request form. These requests are processed weekly.  

    How to Use Cayuse

    UITS has provided a walkthrough of initial proposal submission found  here.

    Cayuse also provides tutorials and help desk support at http://support.cayuse.com/.

    Cayuse Tutorials

    Researcher Dashboard Overview Video

    Creating a New Study

    Creating an Initial Submission

    Completing a Submission

    Searching for Studies and Submissions

    Viewing and Downloading Letters

    Addressing Comments

    Viewing Submission Details and History

    Linking a Study to Sponsored Projects

    Understanding Submission Types

    Creating a Modification Submission

    Creating a Renewal Submission

    Working with Legacy Submissions

    Closing a Study

    Deleting a Study or Submission

    What happens after I have complete my submission form?

    When a submission has been completed and submitted, the PI, and Co-PI (if applicable), will receive an email notification letting them know they need to log in and certify the submission in Cayuse. Once certified, the submission will be routed to the IRB Office and the PI, Co-PI (if applicable), and Primary Contact will receive an acknowledgment email. 

    Once a submission has been reviewed, the PI, Co-PI (if applicable), and Primary Contact will receive email notification to communicate the decision of the IRB. Emails with decision “Return to PI” communicate review comments and requests for additional information or changes needed before approval can be granted. Investigators should respond to review comments and requests for additional information or changes in a timely manner and must not begin research activities until receipt of email with decision “Approved”, determination “Exempt”, or decision “Not Human Subjects Research”.

    How long will it take to review a submission?

    The time it takes to receive feedback on the submission depends on the completeness of the submission, the complexity of the study, and the volume of studies already under review at the time the submission is received. Submissions are reviewed according to type and date received. Plan for review times to take 2-4 weeks.  Research that requires full committee review may take up to 8 weeks.  Research requiring full committee review should be submitted 30 days prior to the anticipated meeting date. 

  • Any individual who is engaged in human subjects research that is under the jurisdiction of the KSU is responsible for carrying out sound ethical research consistent with research plans either approved by the IRB or determined exempt. All faculty, staff, students, or other agents of KSU who are engaged in human subjects research are required to comply with all IRB determinations, appropriate KSU policies and procedures, and all applicable laws and regulations.

    All KSU researchers are responsible for the following:

    • Completing required training on human subject research prior to commencing any research activities that involve interaction or intervention with human subjects or their identifiable private information or identifiable biospecimens.
    • Disclosing financial conflicts of interest.
    • Obtaining IRB approval or an exempt determination before involving human subjects in research. This is generally a responsibility of the Principal Investigator (PI).
    • Using subject selection and recruitment processes that are fair and equitable.
      1. See Guidance: Subject Selection
      2. See Guidance: Recruitment
    • Obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research unless these requirements have been waived by the IRB.
      1. See IRB Policy: Informed Consent
    • Monitoring research subjects for potential harm and taking steps to minimize or mitigate those harms when possible.
    • Promptly reporting any activities or circumstances that affect the rights and/or welfare of research subjects, including subject complaints or questions, directly to the IRB or to the PI.
    • Promptly reporting suspected or confirmed non-compliance to the IRB. Reportable Information Reports are submitted via Cayuse.  Reports can also be directed to the IRB Office by phone or email Attn: IRB Chair.  
    • Maintaining, managing, and retaining research data and records relating to the research as required by applicable policies and regulations.
      1. See overview of KSU data security
      2. See KSU data storage matrix
    • Contacting the IRB if there are any questions about whether an activity involves human subject research.
      1. See IRB Policy: Determination of Engagement in Human Subject Research
  • PIs have additional responsibilities for the oversight and conduct of human subject research studies, including hiring qualified staff, ensuring that the staff have current training on ethical human subject research and applicable rules, following the IRB-approved research study, promptly reporting any potential non-compliance or unanticipated problems, maintaining IRB approval throughout the duration of the research, and maintaining oversight over the recruitment, consent, and research procedures. 

    Specific responsibilities of PIs include, but are not limited to:

    • Obtaining IRB approval or an exempt determination before involving human subjects in research.
    • Ensuring that individuals conducting human subject research (e.g., research staff) receive appropriate training prior to contact with research subjects or their identifiable private information.
    • Maintaining adequate and appropriate oversight over the conduct of the research study. Co-investigators and other members of the research team must adhere to appropriate policies and ethical standards related to the protection of human subjects. The PI is held responsible for the conduct of the research personnel (e.g., co-investigator, investigators, and research staff).
    • Using sound scientific study design in the research protocol and obtaining peer review of the research study as appropriate (e.g., thesis committee review, sponsor peer review, academic unit review).
    • Using research designs that appropriately protect human subjects’ privacy and confidentiality of their information.
    • Ensuring adequate resources are available to protect human subjects during the proposed research.
    • Ensuring informed consent is sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, 45 CFR 46.116 and/or 21 CFR 50 Subpart B.
    • Keeping a log documenting oral consent process if applicable.
    • Obtaining appropriate permissions at non-KSU recruitment and/or research sites.
    • Reporting any of the following to the KSU IRB:
      1. Adverse events or unanticipated problems involving risks to subjects or others.
      2. Subject complaints.
      3. Potential or confirmed non-compliance with the regulations or the requirements of the IRB.
      4. Emergency use of investigational drugs or devices.
      5. Any other circumstance that affects the rights and/or welfare of research subjects.
    • Obtaining approval from the IRB prior to making any modifications to the previously approved non-exempt research, except those necessary to eliminate apparent immediate hazards to subjects.
    • When continuing review is required, submitting a Renewal Request form for renewed approval to the IRB in sufficient time to allow for IRB review prior to the expiration date of current approval.
    • Keeping records relating to the research as required by applicable regulations after completion of the research study for a minimum of three years, or longer depending on the funding agency and type of record. This requirement also applies to research records for student research conducted under the supervision of the PI.
    • Posting clinical trial consent forms, when required.
    • Submitting a study closure when the research is complete.
  • Kennesaw State University researchers often engage in collaborative research with individuals and organizations external to KSU. In many circumstances, agreements between collaborators are necessary and must be in place before research with human subjects may begin. When planning collaborative research, investigators are encouraged to contact the IRB Office for consultation on securing appropriate IRB approval. 

    As of January 20, 2020, the 2018 Common Rule requires most federally supported, non-exempt, human subjects research involving more than one institution to comply with the requirement for a sIRB to review the research.

    NIH Single IRB Policy

    Smart IRB

    Extending an FWA to Cover Collaborating Investigators

  • Human research conducted outside of the United States must conform to the same ethical standards, university policies, and regulatory standards to which research conducted within the United States is held, as appropriate. International research must be conducted in accordance with applicable Kennesaw State University (KSU) policies for the conduct and review of human research, regardless of the location of the research. 

    Investigators are responsible for complying with laws or requirements relevant to their human research activities. Visit the Office for Human Research Protection (OHRP) website for compiled information on international requirements. Investigators should be aware that research determined exempt from the U.S. regulations by the KSU IRB may still be subject to requirements in the foreign country. 

    In addition to obtaining KSU IRB approval, if there is a local ethics board (e.g., local IRB, Independent Ethics Committee, or equivalent) in the country or at the international institution where the research will be conducted, review of the human research protocol by the local ethics board may be required by the country or international institution.

    The IRB may also require that the investigator and/or research staff demonstrate their knowledge of cultural norms and local laws relevant to their research or identify and consult with a local expert or community leader that can identify local cultural norms and laws prior to IRB review of the application. The local expert or community leader may be asked to provide information on the cultural experience of the locale where there is no equivalent ethics board or group, as appropriate. This local expert should be a native of the locale or have lived in the foreign country. The local expert should help the investigator design the research so that it is sensitive to the cultural norms of that locale and that it meets local requirements. The investigator would be responsible for identifying and recruiting such an individual. For research reviewed at the expedited or full board review level, the IRB may require, when appropriate, documentation of such review by the local ethics board, or description of how local approval or support of the research will be obtained. 

    In international research the consent process may present additional challenges. Consideration must be given to the consent process, including considering the literacy level of the subjects and the cultural norms. Consent must be obtained in a language that is comprehensible to the subjects. The consent form or verbal consent script and instruments provided to the IRB must include the English translation and should also include the native language versions when practicable. If research will be conducted in a country where there may be several different languages and cultures, the researcher should consider how to address this in advance and obtain consent documentation in all the languages that might be encountered when appropriate. 

    Additional expertise may be obtained as part of any of the IRB review processes (e.g., initial, continuing, modifications) when needed. 

  • Types of Informed Consent
    A researcher may not involve a human subject in research that is covered by the federal guidelines unless the legally effective informed consent of the subject or the subject's legally authorized representative (LAR) has been obtained. Consent documents must contain sufficient information, written in language easily understood by the intended audience, that provides an opportunity for the subject or LAR to consider whether to take part in a research study and that minimizes possible coercion or undue influence. One or more of the following types of consent documents should be used in research studies that include human subjects.

    To ensure that all mandatory elements of informed consent are addressed, researchers are encouraged to review the Consent Checklist.

    • Signed consent of all participants is required unless a waiver of signed consent is granted by the IRB. The researcher must provide the participant with two copies of the consent document to be signed. One signed copy is kept by the participant and the other copy by the investigator.

      Download Template - Exempt Consent

      Download Template - Non-Exempt Consent

    • Cover letters are used when a signed consent form is either not needed or would, by its use, compromise the anonymity of participants. The IRB may grant a waiver of signed consent when it is determined that a cover letter is acceptable.

      Download Template - Consent No Signature

      Download Sample - Consent No Signature

    • Participants under the age of 18 are unable to provide informed consent to participate in research.  Assent is a form of consent that is to be used in such cases when research involves participants under the age of 18. “Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.  This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. Researchers should consider age appropriateness of the language and terminology used and create assent forms accordingly. 

      Download Template - Minor Assent - Ages 7-10

      Download Template - Minor Assent - Ages 11-14

      Download Template - Minor Assent - Ages 15-17

    • For participants under the age of 18, adequate provisions should be made for soliciting the permission of the paren​t(s) or legal guardian(s). The regulations define “permission” as the “agreement of parent(s) or guardian to the participation of their child or ward in research.”

      The term “parent” means a “child's biological or adoptive parent.” The term “guardian” means “an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.” Parental permission should be documented in a manner similar to that used to document informed consent.  

      Download Template - Parental Permission

    Confidential vs. Anonymous 
    Confidential and anonymous are often used interchangeably while having very different definitions. Understanding the difference between these two terms  is important when considering research involving human subjects. 

    When data are anonymous, it is impossible to know whether or not an individual participated. When anonymous, there is no way to determine the connection between research subject and the data associated with them.  If a research subject is told that they will remain anonymous, they cannot be asked for any personal information that could be used to link the data to them. IP addresses are considered to be identifiers which makes it impossible to have anonymous data collection when conducting research online such as surveys. 

    When there is a connection between the research subject and the data they provide to researchers (name, email address, phone number, etc) that data is considered to be “identifiable.”(IP addresses are considered to be identifiers and, unless researchers can ensure that they will not be collected, research involving data collection via internet cannot be considered to be anonymous.) Methods employed to limit who will have access to this connection help keep it “confidential.”  The extent of the confidentiality measures is directly related to the level of risk associated with the data collection.  

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